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[ "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] " ]

[ "200" ]

[ "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place. ", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. ", "Patients may decline offered treatments (e.g., OT) and may also decline risk mitigation strategies (e.g., UDT, pill counts) that are recommended in the course of clinical care. However, providers should discuss this decision with the patient, including the likelihood that their decision may result in the risks of LOT outweighing its potential benefits. This would require a consideration of patient’s safety, and a clinical decision may be made not to initiate OT or to discontinue ongoing OT through tapering (see Recommendation 14 and Recommendation 17). ", "Similar to other risk factors, continuing OT beyond 90 days’ duration should be weighed heavily in the risk benefit calculus for LOT. Continuing OT for longer than 90 days is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks. That must be determined through individual clinical assessment. ", "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. ", "Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15). " ]

[ "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose." ]

[ "201" ]

[ "With the passage of the Patient Protection and Affordable Care Act (PPACA) in March 2010, the Interagency Pain Research Coordinating Committee was created to coordinate pain research efforts throughout federal government agencies. The Committee was tasked with summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations. The Committee published the National Pain Strategy in March 2016 in response to the call from the National Academy of Medicine to increase awareness of pain as a significant public health issue in the U.S. The strategy made recommendations in a number of areas including prevention and care, professional education and training, and population research. The plan is aimed at decreasing the prevalence of all types of pain (acute and chronic) in the U.S., as well as the disability and morbidity associated with pain.", "Other initiatives are aimed at improving the safe use of opioids, including the OSI Toolkit and the patient guide “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain”. The OSI Toolkit was developed to provide clinicians with materials to inform clinical decision-making regarding opioid therapy and safe opioid prescribing. The toolkit materials can be found at the following link: https://www.va.gov/PAINMANAGEMENT/Opioid_Safety_Initiative_Toolkit.asp. “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain” is aimed at providing information to patients as well as their providers regarding the safe use of opioids. More information can be found at the following link: http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf. To further promote safety and patient centered care, the VHA issued a policy in 2014 requiring standardized education and signature informed consent for all patients receiving LOT for non-cancer pain. ", "Chronic pain is a national public health problem as outlined in the 2011 study by the National Academy of Medicine (previously the Institute of Medicine [IOM]). At least 100 million Americans suffer from some form of chronic pain. Until recently, the treatment of chronic pain with opioids was increasing at an alarming rate. The increase in prescriptions of these medications has been accompanied by an epidemic of opioid-related adverse events.", "In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting body of research expanding detailing the lack of benefit and severe harms of LOT.", "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. ", "This OT CPG is in line with the efforts described above to improve our understanding and treatment of pain, as well as to mitigate the inappropriate prescribing and ill effects of opioids. It is intended for VA and DoD healthcare practitioners including physicians, nurse practitioners, physician assistants, physical and occupational therapists, psychologists, social workers, nurses, clinical pharmacists, chaplains, addiction counselors, and others involved in the care of Service Members and their beneficiaries, retirees and their beneficiaries, or Veterans on or being considered for LOT. In conjunction with other efforts already under way, this CPG is aimed at improving safe and appropriate prescribing and use of opioids to treat chronic pain. ", "Given the recognized risks of opioid therapy, an optimal approach to care should include a robust, signature informed consent process that is patient-centered and provides patients with information about known benefits and harms of OT and treatment alternatives. In 2014, VA established a requirement for signature informed consent, consistent with VA policy for other treatments or procedures with a significant risk of complications or morbidity. See Appendix A, Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain (found at http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf), and 38 C.F.R. §17.32 (2012). ", "The increasing use of opioids, as well as the accompanying rise in morbidity and mortality associated with opioid use, has garnered increasing attention from federal and local officials as well as other policy makers. This public health issue, which has been labeled an epidemic, became a focus of the President’s National Drug Control Strategy in 2010 and has since remained a focus. Two main goals introduced in the 2010 strategy included curtailing illicit drug consumption in America and improving the health and safety of the American people by reducing the consequences of drug abuse. The 2015 strategy, and an accompanying presidential memorandum on preventing prescription drug abuse and heroin use, released in October 2015, encouraged the improvement of health and safety using evidence-based methods by calling for change in a number of key areas including preventing drug use in communities, seeking early intervention opportunities, and integrating SUD treatment and supporting recovery.", "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. " ]

[ "Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid." ]

[ "202" ]

[ "Chronic pain is a national public health problem as outlined in the 2011 study by the National Academy of Medicine (previously the Institute of Medicine [IOM]). At least 100 million Americans suffer from some form of chronic pain. Until recently, the treatment of chronic pain with opioids was increasing at an alarming rate. The increase in prescriptions of these medications has been accompanied by an epidemic of opioid-related adverse events.", "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "The increase in opioid prescribing is matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance use disorders (SUD) treatment admissions from 1999 to 2008. In 2009, drug overdose became the leading cause of injury-related death in the U.S., surpassing deaths from traffic accidents. In 2014, 1.9 million Americans were affected by an OUD related to non-medical use of prescription pain relievers, and in the same year, 18,893 individuals died as a result of a prescription drug overdose. There has been a four-fold increase in the absolute number of deaths associated with use of opioids since 2000, and a 14% increase between 2013 and 2014 alone. In a survey of patients prescribed opioids for chronic non-cancer pain (CNCP) and their family members, 34% of patients reported that they thought they were “addicted” or “dependent” on opioid pain medication, 34% said that they used the medication for “fun” or to “get high,” while 22% used the medication to relieve day-to-day stress.", "The U.S. is in the midst of a cultural transformation in the way pain is viewed and treated. The biomedical model of pain care, in which the pain experience is reduced to a pain generator and pain treatment is aimed at fixing or numbing pain with medications, interventions, or surgery, dominated the 1990s and the first decade of the 2000s. As the cost, potential harm, and limited effectiveness of the approach in the biomedical model of pain care to chronic pain was becoming apparent, the National Academy of Medicine issued a call for the transformation of pain care to a biopsychosocial, multimodal, interdisciplinary model.", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Chronic pain is defined as pain lasting three months or more. It is often associated with changes in the central nervous system (CNS) known as central sensitization. Whereas acute and subacute pain are thought to involve primarily nociceptive processing areas in the CNS, chronic pain is thought to be associated with alterations in brain centers involved with emotions, reward, and executive function as well as central sensitization of nociceptive pathways across several CNS areas.", "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. ", "Individuals with conditions that result in or co-occur with chronic pain may have different needs or respond to treatment differently than individuals with chronic pain alone. Many different physical and psychological conditions have a pain component that can be difficult to distinguish from the underlying mechanism of illness. Furthermore, the treatment of co-occurring pain and other conditions may vary or require special considerations during their management. Readers are encouraged to consult other VA/DoD CPGs for further information (see VA/DoD Clinical Practice Guidelines website: www.healthquality.va.gov). ", "There has been limited research on the effectiveness of LOT for non-end-of-life pain. At the same time, there is mounting evidence of the ill effects of LOT, including increased mortality, OUD, overdose, sexual dysfunction, fractures, myocardial infarction, constipation, and sleep-disordered breathing. Despite increasing awareness of the known harms of opioids, 259 million opioid prescriptions were still written in 2012." ]

[ "True allergy to opioid agents: Morphine causes a release of histamine that frequently results in itching, but this does not constitute an allergic reaction. True allergy to opioid agents (e.g., anaphylaxis) is not common, but does occur. Generally, allergy to one opioid does not mean the patient is allergic to other opioids; many times, rotating to a different opioid may be effective. When an opioid allergy is present and OT is being considered, consultation with an allergist may be helpful." ]

[ "203" ]

[ "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate. ", "Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation.", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. ", "The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime.", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "In addition to non-pharmacological therapies (e.g., exercise, CBT), appropriate mechanism and condition specific non-opioid pharmacologic agents should be tried and optimized before consideration of opioid medications (e.g., gabapentin in neuropathic pain states).[83] Potential contraindications and long-term risks of use should be considered for non-opioid pharmacologic agents as well, as these also can carry risk of harm, depending on the specific patient and chosen medication. ", "VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns.", "Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids: Serious harm may occur should patients be prescribed additional (or different) opioids if prior administration of opioids led to serious adverse effects or was not tolerated. It is also inadvisable to prescribe opioids to patients who already have had an adequate opioid trial (of sufficient dose and duration to determine whether or not it will optimize benefit) without a positive response. ", "We recommend interdisciplinary care that addresses pain, substance use disorders, and/or mental health problems for patients presenting with high risk and/or aberrant behavior. We recommend offering medication assisted treatment for opioid use disorder to patients with chronic pain and opioid use disorder. Note: See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders.", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] " ]

[ "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. " ]

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[ "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] " ]

[ "With the passage of the Patient Protection and Affordable Care Act (PPACA) in March 2010, the Interagency Pain Research Coordinating Committee was created to coordinate pain research efforts throughout federal government agencies. The Committee was tasked with summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations. The Committee published the National Pain Strategy in March 2016 in response to the call from the National Academy of Medicine to increase awareness of pain as a significant public health issue in the U.S. The strategy made recommendations in a number of areas including prevention and care, professional education and training, and population research. The plan is aimed at decreasing the prevalence of all types of pain (acute and chronic) in the U.S., as well as the disability and morbidity associated with pain." ]

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[ "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "Chronic pain is a national public health problem as outlined in the 2011 study by the National Academy of Medicine (previously the Institute of Medicine [IOM]). At least 100 million Americans suffer from some form of chronic pain. Until recently, the treatment of chronic pain with opioids was increasing at an alarming rate. The increase in prescriptions of these medications has been accompanied by an epidemic of opioid-related adverse events.", "The U.S. is in the midst of a cultural transformation in the way pain is viewed and treated. The biomedical model of pain care, in which the pain experience is reduced to a pain generator and pain treatment is aimed at fixing or numbing pain with medications, interventions, or surgery, dominated the 1990s and the first decade of the 2000s. As the cost, potential harm, and limited effectiveness of the approach in the biomedical model of pain care to chronic pain was becoming apparent, the National Academy of Medicine issued a call for the transformation of pain care to a biopsychosocial, multimodal, interdisciplinary model.", "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. ", "A paradigm shift in the use of OT for chronic non-terminal pain has paralleled this transformation in pain care. Prior to the 1980s, OT was rarely used outside of severe acute injury or post-surgical pain, primarily due to concern for tolerance, physical dependence, and addiction. As the hospice and palliative care movement began defining end-of-life care in the U.S. during the 1980s and emphasizing the importance of pain relief, OT increasingly became a mainstay for cancer and end-of-life pain. Efforts to destigmatize the use of prescription opioids for chronic non-terminal pain encompassed primary care providers and the public. The efforts led to an unprecedented increase in opioid prescribing for chronic non-terminal pain. Chronic pain management became synonymous with LOT in the 1990s and the first decade of the 2000s with significant numbers of patients in pain clinics receiving LOT. Despite the absence of long-term safety or efficacy data, OT for chronic non-terminal pain became a mainstay of therapy. However, as observational and epidemiologic data of harm from LOT accumulated, a much more cautious approach to OT for chronic non-terminal pain has emerged in the decade of the 2010s.", "The increasing use of opioids, as well as the accompanying rise in morbidity and mortality associated with opioid use, has garnered increasing attention from federal and local officials as well as other policy makers. This public health issue, which has been labeled an epidemic, became a focus of the President’s National Drug Control Strategy in 2010 and has since remained a focus. Two main goals introduced in the 2010 strategy included curtailing illicit drug consumption in America and improving the health and safety of the American people by reducing the consequences of drug abuse. The 2015 strategy, and an accompanying presidential memorandum on preventing prescription drug abuse and heroin use, released in October 2015, encouraged the improvement of health and safety using evidence-based methods by calling for change in a number of key areas including preventing drug use in communities, seeking early intervention opportunities, and integrating SUD treatment and supporting recovery.", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "Psychological therapies (e.g., cognitive behavioral interventions such as Cognitive Behavioral Therapy [CBT], biofeedback) have been found to be effective for pain reduction in multiple pain conditions.[80-82] Exercise treatments, including yoga, also have evidence of benefit for reducing pain intensity and disability when compared to usual care in the treatment of chronic pain conditions.[83-85] Exercise and psychological therapies may each exert their influence through multiple mechanisms including but not limited to the reduction in fear-avoidance, reduction in catastrophizing, and/or enhancing mood.[80] Similarly, multidisciplinary biopsychosocial rehabilitation (described as a combination of a physical intervention such as graded exercise and a psychological, social, or occupational intervention) has been shown to be more effective than usual care in improving pain and disability.[81] These interventions are safe and have not been shown to increase morbidity or mortality. In light of the low harms associated with exercise and psychological therapies when compared with LOT these treatments are preferred over LOT, and should be offered to all patients with chronic pain including those currently receiving LOT. There is insufficient evidence to recommend psychological over physical therapies or vice versa; the choice of which to try first should be individualized based on patient assessment and a shared decision making process (see Patient Focus Group Methods and Findings).[80] ", "Chronic pain is defined as pain lasting three months or more. It is often associated with changes in the central nervous system (CNS) known as central sensitization. Whereas acute and subacute pain are thought to involve primarily nociceptive processing areas in the CNS, chronic pain is thought to be associated with alterations in brain centers involved with emotions, reward, and executive function as well as central sensitization of nociceptive pathways across several CNS areas.", "Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid." ]

[ "Take Back Programs: Returning unused opioid medications has been explored as a strategy to reduce the amount of opioids in the community, as it has been estimated that 70% of opioid prescriptions are left unused.[115] Accordingly, the National Drug Control Strategy advocates take back programs as an effective tool.[24] For example, in a 2013 medication take back event in a Michigan community, 3,633 containers containing 345 different prescription medications were collected in four hours. The top five most common medications collected were pain relievers.[116] System-wide efficacy of a nationwide program is unknown.[117] " ]

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[ "Community-based Needle Exchange Programs or Syringe Service Programs: Nearly 80% of new users of injectable opioids had previously used prescription oral opioid pain medication.[118,119] Illicit use of injectable opioids is accompanied by an increased rate of human immunodeficiency virus (HIV) and hepatitis infection. Community-based needle exchange programs have been shown to be an effective risk mitigation strategy for reducing high-risk behaviors (e.g., sharing needles) and infectious disease transmission among injection drug users.[120] For those patients who develop OUD and progress to intravenous drug use, the first recommendation should be for medication assisted treatment (MAT) for OUD (see Recommendation 17). For patients who decline MAT for OUD, clinicians should consider educating the patient regarding sterile injection techniques and community based needle exchange programs, if programs are available. The 2015 outbreak of HIV/hepatitis in rural Indiana and subsequent successful implementation of a needle exchange program is an example of the threat to rural communities from non-prescription opioid use and the potential benefits of needle exchange programs for use as a risk mitigation strategy.[121,122] ", "The increasing use of opioids, as well as the accompanying rise in morbidity and mortality associated with opioid use, has garnered increasing attention from federal and local officials as well as other policy makers. This public health issue, which has been labeled an epidemic, became a focus of the President’s National Drug Control Strategy in 2010 and has since remained a focus. Two main goals introduced in the 2010 strategy included curtailing illicit drug consumption in America and improving the health and safety of the American people by reducing the consequences of drug abuse. The 2015 strategy, and an accompanying presidential memorandum on preventing prescription drug abuse and heroin use, released in October 2015, encouraged the improvement of health and safety using evidence-based methods by calling for change in a number of key areas including preventing drug use in communities, seeking early intervention opportunities, and integrating SUD treatment and supporting recovery.", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "There is moderate quality evidence that intensification of monitoring helps mitigate the risk of suicide among patients on LOT. Im et al. (2015) found moderate quality evidence that, at the facility level, patients on LOT within facilities ordering more drug screens than the comparison group were associated with decreased risk of suicide attempt (chronic short-acting opioid group: OR: 0.2, 95% CI: 0.1-0.3; chronic long acting opioid group: OR: 0.3, 95% CI: 0.2-0.6). In addition, patients on long-acting opioids within the facilities providing more follow-up after new prescriptions were associated with decreased risk of suicide attempt (OR: 0.2, 95% CI: 0.0-0.7).[61] ", "For those at higher risk of adverse events related to opioid therapy, the following strategies may help to decrease opioid-related overdose events and unintended long-term use: checking the PDMP, performing a UDT, placement in an inpatient setting or monitored environment, and/or providing OEND. ", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "Naloxone administration has been identified as a life saving measure following opioid overdose. A systematic review of 22 observational studies provided moderate quality evidence that take home naloxone programs are effective in improving overdose survival and decreasing mortality, with a low rate of adverse events.[108] One meta-analysis of nine studies determined that take home naloxone kits were used approximately nine times within the first three months of follow-up for every 100 individuals trained.[109] Further, studies have shown that naloxone administration has been efficacious whether given by medical personnel or lay people, with more than 26,000 reversals documented by the CDC from 1996-2014.[110,111] In addition, prescription of naloxone rescue and accompanying education has also been found to reduce opioid-related emergency department visits.[112] Distribution of naloxone for reversal is supported by SAMHSA, the American Medical Association (AMA), and other medical societies, and is facilitated through the VA via Pharmacy Benefits Management. Clinical efficacy has been established for its use on short-acting opioids, but not for its use on long-acting opioids such as methadone or exceptionally potent opioids.[108] ", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. " ]

[ "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. " ]

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[ "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place. ", "For those at higher risk of adverse events related to opioid therapy, the following strategies may help to decrease opioid-related overdose events and unintended long-term use: checking the PDMP, performing a UDT, placement in an inpatient setting or monitored environment, and/or providing OEND. ", "Implementing more extensive risk mitigation strategies entails an investment of resources. Primary care providers may require more time with patients to allow for shared decision making and treatment planning. More frequent follow-up of patients on LOT can affect access to care for all empaneled patients. VHA providers must also follow VHA policy regarding education and signature informed consent when providing LOT for patients with non-cancer pain.[101] ", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate. ", "As part of the patient-centered care approach, clinicians should review the patient’s history including previous treatment approaches, their results, and any other outcomes with the patient. They should ask the patient about his or her willingness to accept a referral to an addiction or other behavioral health specialist when appropriate. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care. The below approach may be used in setting SMART (Specific, Measurable, Action Oriented, Realistic, Timed) goals for the patient (Table 1).", "Educate the Veteran by using Bio-Psycho-Social Model e.g., PHI’s “Whole Health” approach. Offer Veterans pain education groups [especially Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for Pain, if available]. Clinicians should offer physical therapy and Complementary and Integrative Health (CIH) interventions such as acupuncture, meditation, yoga. Clinicians should offer slow tapering of opioids to reduce opioid risks while not “cutting off” the Veteran. Clinicians should offer non-opioid pain medications when appropriate. Clinicians should commit to working with the Veteran on other options for improved function and some decrease in pain." ]

[ "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics." ]

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[ "Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT. Further research is needed to identify strategies for safely managing patients at elevated risk of suicide who demand opioid medications or become further destabilized during tapering. ", "The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime.", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns.", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. ", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors." ]

[ "A paradigm shift in the use of OT for chronic non-terminal pain has paralleled this transformation in pain care. Prior to the 1980s, OT was rarely used outside of severe acute injury or post-surgical pain, primarily due to concern for tolerance, physical dependence, and addiction. As the hospice and palliative care movement began defining end-of-life care in the U.S. during the 1980s and emphasizing the importance of pain relief, OT increasingly became a mainstay for cancer and end-of-life pain. Efforts to destigmatize the use of prescription opioids for chronic non-terminal pain encompassed primary care providers and the public. The efforts led to an unprecedented increase in opioid prescribing for chronic non-terminal pain. Chronic pain management became synonymous with LOT in the 1990s and the first decade of the 2000s with significant numbers of patients in pain clinics receiving LOT. Despite the absence of long-term safety or efficacy data, OT for chronic non-terminal pain became a mainstay of therapy. However, as observational and epidemiologic data of harm from LOT accumulated, a much more cautious approach to OT for chronic non-terminal pain has emerged in the decade of the 2010s." ]

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[ "There is a paradigm shift occurring in approaches to ensuring and documenting patient and provider understanding and expectations regarding the risks and benefits of LOT. The 2010 OT CPG reflected prior practice of using opioid treatment (or pain care) agreements. OTAs have been described as coercive rather than therapeutic, lack respect for individual autonomy, can be a barrier to pain care, and may be harmful to the patient-provider relationship.[102-105] ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting body of research expanding detailing the lack of benefit and severe harms of LOT.", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "Monitoring standards with administration of OT for acute pain vary depending on a number of factors including the setting, specifics of the painful insult, patient medical factors, and selected medication potency/dose/route of administration/adjunct selection. ", "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. " ]

[ "We recommend against the concurrent use of benzodiazepines and opioids. Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate. We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits." ]

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[ "a) We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. (Strong against) b) For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, New-replaced) ", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. (Strong for| Reviewed, New-replaced) Note: Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits. For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies (see Recommendations 7-9), assessment for opioid use disorder, and consideration for tapering when risks exceed benefits (see Recommendation 14). (Strong for| Reviewed, New-replaced) ", "For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies, assessment for opioid use disorder, and consideration for tapering when risks exceed benefits. We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering.", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "Some may interpret the recommendation to limit opioid use by age as arbitrary and potentially discriminatory when taken out of context; however, there is good neurophysiologic rationale explaining the relationship between age and OUD and overdose. Studies in other areas (e.g., use of different substances) indicate that developing brains (age <30 years) are at increased risk of abnormalities and addiction when exposed to substance use early in life.[95-98] ", "We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. (Strong against) For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, Amended) ", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. " ]

[ "Headache not responsive to other pain treatment modalities: LOT is an ineffective treatment modality for patients with migraine headaches (with or without aura), tension-type headaches, occipital neuralgia, or myofascial pain and may result in worsening of the underlying headache condition through factors such as central sensitization and withdrawal. " ]

[ "211" ]

[ "The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime.", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.8", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.9", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.10", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.", "We strongly recommend against initiation of long-term opioid therapy for chronic pain. We recommend alternatives to opioid therapy such as self-management strategies and other non-pharmacological treatments. When pharmacologic therapies are used, we recommend non-opioids over opioids. If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. Note: Consideration of opioid therapy beyond 90 days requires reevaluation and discussion with patient of risks and benefits.", "There was insufficient evidence to recommend for or against any specific opioid or opioid formulation, specifically the following: Short-acting versus long-acting opioids (for LOT for chronic pain), Route of administration/delivery among alternatives such as transdermal, buccal, sublingual, or pumps, Abuse deterrent formulations of opioids compared to non-abuse deterrent formulations, Tramadol and other dual-mechanism opioids. Buprenorphine for pain (compared to other opioids), Methadone (with QT monitoring). ", "The accumulation of evidence of harms and the absence of evidence of long-term benefits has warranted a newly cautious approach to LOT that prioritizes safety. This approach coupled with the evidence of both the safety and efficacy for non-pharmacologic and non-opioid pharmacologic pain therapies has led to the current transformation in the way in which pain is viewed and treated. The biopsychosocial model of pain recognizes pain as a complex multidimensional experience that requires multimodal and integrated care approaches. Within this context, non-pharmacologic treatments and non-opioid medications are the preferred treatments for chronic non-terminal pain. OT has a limited role, primarily in the treatment of severe acute pain, post-operative pain, and end-of-life pain. ", "Route of Administration/Delivery: The systematic evidence review for this CPG did not find any studies that compared alternative delivery systems (e.g., fentanyl transdermal, fentanyl buccal) to other delivery systems (e.g., oral, intravenous) (information on transdermal and sublingual buprenorphine is included in the following section on Buprenorphine for Pain). The concomitant use of oral and transdermal opioids or oral and intrathecal pumps should be approached with extreme caution and warrants specialty consultation. Discussions of intrathecal pumps are beyond the scope of this guideline. ", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily." ]

[ "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily." ]

[ "212" ]

[ "The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime.", "We recommend alternatives to opioids for mild-to-moderate acute pain. We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.", "We recommend alternatives to opioids for mild-to-moderate acute pain. (Strong for). We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. (Weak for). If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. (Strong for). Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.", "There was insufficient evidence to recommend for or against any specific opioid or opioid formulation, specifically the following: Short-acting versus long-acting opioids (for LOT for chronic pain), Route of administration/delivery among alternatives such as transdermal, buccal, sublingual, or pumps, Abuse deterrent formulations of opioids compared to non-abuse deterrent formulations, Tramadol and other dual-mechanism opioids. Buprenorphine for pain (compared to other opioids), Methadone (with QT monitoring). ", "Synthetic opioids such as fentanyl analogs, potent opioid receptor agonists, are responsible for a recent rise in death rates. Fentanyl analogs that may be used to create counterfeit opioid analgesic pills can cause a toxidrome characterized by significant CNS and profound respiratory depression requiring multiple naloxone doses for reversal.[113] ", "Use a shared decision-making approach to discuss options for OUD treatment. Medication-Assisted Therapy (MAT) is the first-line treatment for OUD. The preferred OUD treatment is Opioid Agonist Therapy (OAT). Opioid agonist treatment involves taking opioid agonist medications such as buprenorphine/naloxone (Suboxone) or methadone. Methadone must be provided through a federally regulated opioid treatment program for OUD therapy. The alternative OUD treatment is extended-release (ER) injectable naltrexone (Vivitrol). MAT can be provided in a variety of treatment settings including residential SUD treatment, intensive outpatient SUD treatment, regular SUD specialty care clinic, primary care or general mental health clinic, or federally regulated opioid treatment program. Moral injury is an act of transgression that leads to serious inner conflict typically brought on by betrayal, disproportionate violence, incidents involving civilians, within-rank violence. For moral injury, treatment via psychologists or chaplains is available. Central sensitization (e .g., fibromyalgia, chronic headaches, and likely many other types of complex chronic pain). Some examples of medical complications are lung disease, hepatic disease, renal disease, or fall risk. Sleep apnea is a sleep disorder.", "Acute psychiatric instability or intermediate to high acute suicide risk: Intermediate to high acute suicide risk, severe depression, unstable bipolar disorder, or unstable psychotic disorder precludes the safe use of self-administered LOT.[60] Im et al. (2015) (n=487,462) found that a diagnosis of a mood disorder was significantly associated with suicide attempts for the chronic use of short-acting and long-acting opioids compared with no diagnosis of a mood disorder.[61] In a study of patients on opioids, Campbell et al. (2015) reported that those with bipolar disorder had 2.9 times the odds of suicidal ideation within the past 12 months as well as 3.2 times the odds of a lifetime suicide attempt compared to those with no bipolar disorder.[62] See Recommendation 8 and the VA/DoD Suicide CPG2 for more information on suicidality. See the VA/DoD Clinical Practice Guideline for Management of Bipolar Disorder in Adults (VA/DoD BD CPG) for more information on bipolar disorder.3 Merrill and colleagues found that high dose chronic opioid therapy for pain was associated with depressed mood.[63] Treatment for chronic pain with movement, exercise, and cognitive-behavioral therapy for pain may have benefits in treating depression, PTSD, and in reducing suicide risk.[64] ", "There is a large variation in patient preference regarding the concurrent use of benzodiazepines and LOT. This is especially true for patients who are already accustomed to receiving both medications (see Patient Focus Group Methods and Findings). Concurrent benzodiazepine and LOT use is a serious risk factor for unintentional overdose death and should be weighed heavily in the risk-benefit evaluation for tapering versus continuing one or both agents. Once initiated, benzodiazepines can be challenging to discontinue due to symptoms related to benzodiazepine dependence, exacerbations of PTSD, and/or anxiety.[91] Moreover, abrupt discontinuation of benzodiazepines should be avoided, as it can lead to serious adverse effects including seizures and death. Tapering benzodiazepines should be performed with caution and within a team environment when possible (see Recommendation 26 in the VA/DoD SUD CPG).7 Due to the difficulty of tapering or discontinuing benzodiazepines, particular caution should be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain. The VA/DoD PTSD CPG recommends against benzodiazepines for the prevention of PTSD and cautions against their use in treatment of PTSD. Benzodiazepines to treat acute anxiety symptoms after trauma are associated with a higher incidence of PTSD symptoms. For treatment of PTSD, there is evidence of lack of efficacy from small clinical trials and evidence of harm from observational studies of benzodiazepines for PTSD. Although anxiety may initially improve with benzodiazepines, the improvement is short-lived and may result in tolerance to increasing doses and eventual failure of the treatment. Even gradual benzodiazepine taper may result in exacerbation of severe PTSD symptoms. Concomitant use of benzodiazepines is considered a contraindication to initiation of OT. ", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "In addition to non-pharmacological therapies (e.g., exercise, CBT), appropriate mechanism and condition specific non-opioid pharmacologic agents should be tried and optimized before consideration of opioid medications (e.g., gabapentin in neuropathic pain states).[83] Potential contraindications and long-term risks of use should be considered for non-opioid pharmacologic agents as well, as these also can carry risk of harm, depending on the specific patient and chosen medication. " ]

[ "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level." ]

[ "213" ]

[ "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. ", "The VA/DoD OT CPG was developed with a specific patient population in mind—Service Members, Veterans, and their families—that has unique characteristics and needs related to the military culture and communities to which they return. Throughout the VA/DoD OT CPG, attention is paid to the characteristics and needs of these patients, particularly regarding specific risk factors such as risk for suicide, SUD, and other medical and mental health co-occurring conditions that may complicate the management of pain for these patients. Further, these recommendations were made keeping in mind the implications they would have within the VA/DoD healthcare settings, particularly regarding considerations such as resource use, accessibility, and equity related to each recommendation and the urgent need for rigorous attention to the balance of risks and benefits for patients within the VA/DoD specifically. ", "This OT CPG is designed to assist healthcare providers in managing or co-managing patients on or being considered for LOT. Specifically, this CPG is intended for adults, including Veterans as well as deployed and non-deployed Active Duty Service Members, their beneficiaries, and retirees and their beneficiaries, with chronic pain who are receiving care from the VA or DoD healthcare delivery systems. This CPG is not intended for and does not provide recommendations for the management of pain with LOT in children or adolescents, in patients with acute pain, or in patients receiving end-of-life care. As is so for any pharmacotherapy, any decision about prescribing opioids, or alternative medications for pain, for pregnant women should be made with due caution and cognizance of applicable U.S. Food and Drug Administration (FDA) labeling. Any patient in the VA or DoD healthcare system should be offered access to the interventions that are recommended in this guideline after taking into consideration the patient’s specific circumstances. ", "The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG. ", "Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15). ", "The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “…Health Executive Council on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration and Military Health System,” by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations. This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with chronic pain who are on or being considered for long-term opioid therapy (LOT). ", "Educate the Veteran by using Bio-Psycho-Social Model e.g., PHI’s “Whole Health” approach. Offer Veterans pain education groups [especially Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for Pain, if available]. Clinicians should offer physical therapy and Complementary and Integrative Health (CIH) interventions such as acupuncture, meditation, yoga. Clinicians should offer slow tapering of opioids to reduce opioid risks while not “cutting off” the Veteran. Clinicians should offer non-opioid pain medications when appropriate. Clinicians should commit to working with the Veteran on other options for improved function and some decrease in pain.", "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses." ]

[ "The components of biopsychosocial assessment are pain assessment, patient functional goals, impact of pain on family, work, life, review of previous diagnostic studies, additional consultations and referrals, coexisting illness and treatments and effect on pain, significant psychological, social, or behavioral factors that may affect treatment, family history of chronic pain, collateral of family involvement, patient beliefs/knowledge of the cause of their pain and their treatment preferences along with the perceived efficacy of various treatment options. For patients already on OT, include assessment of psychological factors related to continuing vs. tapering OT. The psychological factors are beliefs, expectations, fears. Pain assessment includes history, physical exam, comorbidities, previous treatment and medications, duration of symptoms, onset and triggers. Examples of absolute contraindications to initiating opioid therapy for chronic pain are true life-threatening allergy to opioids, active SUD, elevated suicide risk, concomitant use of benzodiazepines. LOT refers to long-term opioid therapy; OT refers to opioid therapy; PDMP refers to Prescription Drug Monitoring Program; SUD refers to substance use disorder; UDT refers to urine drug test; VA/DoD Suicide CPG refers to VA/DoD Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide." ]

[ "214" ]

[ "Opioids carry a significant risk for OUD, overdose, and death, especially among patients with untreated SUD. The recommendation against LOT for patients with SUD is supported by five large studies (four retrospective case cohort studies and one case cohort study).[59,61,66,86,87] Individually, these studies are of moderate strength; however, the combined weight of their results is strongly supportive of this recommendation. Clinicians should note that this recommendation does not refer to patients whose sole SUD relates to tobacco misuse. ", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.8", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.9", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.10", "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Given the increasing use of cannabis among patients with chronic pain and the lack of RCTs comparing outcomes of prescribing LOT versus other therapies for patients with and without cannabis use and cannabis use disorder, future research is needed to optimize care for these patients. Research is also needed to determine which subpopulations of patients with active SUD are at greatest risk of OUD, overdose, and death. Finally, further research is needed on the efficacy of alternative treatments for pain and ways to mitigate risks of opioid-related adverse events in patients with SUD and pain. " ]

[ "While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place. " ]

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[ "Opioids are not first-line or routine therapy for chronic pain. Establish treatment goals before starting opioid therapy and a plan if therapy is discontinued. Only continue opioid if there is clinically meaningful improvement in pain and function. Discuss risks, benefits and responsibilities for managing therapy before starting and during treatment.", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "Use immediate-release (IR) opioids when starting therapy. Prescribe the lowest effective dose. When using opioids for acute pain, provide no more than needed for the condition. Follow up and review benefits and risks before starting and during therapy. If benefits do not outweigh harms, consider tapering opioids to lower doses or taper and discontinue.", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. ", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.", "For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies, assessment for opioid use disorder, and consideration for tapering when risks exceed benefits. We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering." ]

[ "This guideline is not intended as a standard of care and should not be used as such. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advances and patterns evolve. Today there is variation among state regulations, and this guideline does not cover the variety of ever-changing state regulations that may be pertinent. The ultimate judgement regarding a particular clinical procedure or treatment course must be made by the individual clinician, in light of the patient’s clinical presentation, patient preferences, and the available diagnostic and treatment options. As noted previously, the guideline can assist care providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, in the care for an individual patient." ]

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[ " This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation.", "As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient. ", "The shared decision making process for chronic pain treatment planning is based on the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider (Figure 1). The patient-centered assessment incorporates a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations. Next, the clinician performs a biopsychosocial assessment and determines clinically appropriate therapeutic options in which benefits are likely to outweigh risks. The process culminates in a shared decision making process to develop a patient-centered treatment plan by the patient selecting from the clinically appropriate treatment options generated in the first two steps. ", "Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation.", "As part of the patient-centered care approach, clinicians should review the patient’s history including previous treatment approaches, their results, and any other outcomes with the patient. They should ask the patient about his or her willingness to accept a referral to an addiction or other behavioral health specialist when appropriate. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care. The below approach may be used in setting SMART (Specific, Measurable, Action Oriented, Realistic, Timed) goals for the patient (Table 1).", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. ", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate. ", "The system-wide goal of this guideline is to improve the patient’s health and well-being by providing evidence-based guidance to providers who are taking care of patients on or being considered for LOT. The expected outcome of successful implementation of this guideline is to assess the patient’s condition, provide education, and determine the best treatment methods in collaboration with the patient and a multidisciplinary care team, optimize the patient’s health outcomes and function and improve quality of life, minimize preventable complications and morbidity, emphasize the use of patient-centered care.", "The framework for recommendations in this CPG considered factors beyond the strength of the evidence, including balancing desired outcomes with potential harms of treatment, equity of resource availability, the potential for variation in patient values and preferences, and other considerations (see Methods for more information). Applicability of the evidence to VA/DoD populations was also taken into consideration. A structured algorithm (see Algorithm) accompanies the guideline to provide an overview of the recommendations in the context of the flow of patient care and clinician decision making and to assist with training providers. The algorithm may be used to help facilitate translation of guideline recommendations into effective practice. ", "This CPG follows an algorithm that is designed to facilitate understanding of the clinical pathway and decision making process used in management of LOT. The use of the algorithm format as a way to represent patient management was chosen based on the understanding that such a format may promote more efficient diagnostic and therapeutic decision making and has the potential to change patterns of resource use. Although the Work Group recognizes that not all clinical practices are linear, the simplified linear approach depicted through the algorithm and its format allows the provider to assess the critical information needed at the major decision points in the clinical process. It includes an ordered sequence of steps of care, recommended observations and examinations, decisions to be considered, actions to be taken." ]

[ "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors." ]

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[ "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Patients may decline offered treatments (e.g., OT) and may also decline risk mitigation strategies (e.g., UDT, pill counts) that are recommended in the course of clinical care. However, providers should discuss this decision with the patient, including the likelihood that their decision may result in the risks of LOT outweighing its potential benefits. This would require a consideration of patient’s safety, and a clinical decision may be made not to initiate OT or to discontinue ongoing OT through tapering (see Recommendation 14 and Recommendation 17). ", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] ", "Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered. ", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "As this guideline is related to LOT, the use of opioids for acute pain is not reviewed in detail. However, because acute OT can be a gateway to LOT, it is part of this CPG. A review of the literature indicates that LOT can result from acute opioid use initially intended for short-term therapy. Further, there is a risk of opioid-related overdose even during acute OT. While it is understood that acute OT for severe pain due to injuries or surgery is the most effective option for many patients, the risks associated with acute therapy must be addressed when opioids are prescribed or considered. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). " ]

[ "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. " ]

[ "218" ]

[ "Opioids are not first-line or routine therapy for chronic pain. Establish treatment goals before starting opioid therapy and a plan if therapy is discontinued. Only continue opioid if there is clinically meaningful improvement in pain and function. Discuss risks, benefits and responsibilities for managing therapy before starting and during treatment.", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "Use immediate-release (IR) opioids when starting therapy. Prescribe the lowest effective dose. When using opioids for acute pain, provide no more than needed for the condition. Follow up and review benefits and risks before starting and during therapy. If benefits do not outweigh harms, consider tapering opioids to lower doses or taper and discontinue.", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).", "We recommend assessing suicide risk and intervening when necessary when considering initiating or continuing long-term opioid therapy. We recommend evaluating benefits of continued opioid therapy and risk for opioid-related adverse events at least every three months. If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. Note: There is no absolutely safe dose of opioids. ", "There are situations in which opioids may be necessary therapy for acute pain, even when substantial risk factors exist. It is important to incorporate opioid risk mitigation strategies into opioid prescribing for acute pain. These strategies should include patient education, use of non-opioid adjunctive therapy, and structured reassessment of opioid risks and benefits for all on acute OT. Also, consider checking the PDMP and performing a UDT. ", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Given the recognized risks of opioid therapy, an optimal approach to care should include a robust, signature informed consent process that is patient-centered and provides patients with information about known benefits and harms of OT and treatment alternatives. In 2014, VA established a requirement for signature informed consent, consistent with VA policy for other treatments or procedures with a significant risk of complications or morbidity. See Appendix A, Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain (found at http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf), and 38 C.F.R. §17.32 (2012). ", "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. " ]

[ "Younger patients are also at a higher risk of opioid misuse (as suggested by a UDT indicating high-risk medication-related behavior). Turner et al. (2014) showed that patients in the 45-64 year age group were significantly less likely to have an aberrant UDT (detection of a non-prescribed opioid, non-prescribed benzodiazepine, illicit drug, or tetrahydrocannabinol [THC]) in comparison to patients in the 20-44 age group.[94] Patients in the 45-64 and ≥65 age groups were significantly less likely than 20-44 year olds to have non-detection of a prescribed opioid as well (indicating possible diversion).[94] " ]

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[ "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "Evidence for or history of diversion of controlled substances: The clinician should communicate to patients that drug diversion is a crime and constitutes an absolute contraindication to prescribing additional medications. Because suspicion is subjective and may be based on impression, bias, or prejudice, it is important that providers who suspect diversion base treatment plans on objective evidence. Suspicions may be confirmed by a negative mass spectrometry/liquid chromatography UDT for the substance being prescribed in the absence of withdrawal symptoms in someone who is receiving opioids. A negative UDT for the prescribed opioid could also by itself be a sign of diversion. Signs of diversion may also include frequent requests for early refills or atypically large quantities required to control pain. Routine UDT, however, may not reliably detect synthetic opioids (e.g., methadone, fentanyl, tramadol) or semi-synthetic opioids (e.g., oxycodone, hydrocodone, hydromorphone). When there is evidence that the patient is diverting opioids, discontinue opioids according to Recommendations 14 and 15 and assess for underlying OUD and/or psychiatric comorbidities. Consultation with a pain specialist, psychiatrist, or SUD specialist may be warranted. Also consider consultation with local risk management and/or counsel. For patients with OUD, keep in mind that sudden discontinuation of opioids due to suspected diversion may place them at high risk for illicit opioid use and resulting opioid overdose (see Recommendation 17).", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. ", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "Moderate quality evidence demonstrates that the prevalence of OUD in patients with CNCP is related to duration of opioid use as well as dose (see Recommendations 7-9).[86-88] There are two studies of patients with CNCP which support the current recommendations. Edlund et al. (2014) conducted a large retrospective cohort study where they examined claims data from a health insurance database between 2000 and 2005 to examine factors predictive of developing OUD.[86] Days’ supply of opioids was categorized as none, acute duration (1-90 days), or chronic duration (91+ days). Average daily dose was defined as none, low (1-36 mg MEDD), medium (36-120 mg MEDD), or high (>120 mg MEDD). The OR of developing OUD ranged based on dose and duration (OR: 3.03, 95% CI: 2.32-3.95 for low dose, acute opioid prescription; OR: 14.92, 95% CI: 10.38-21.46 for low dose, chronic opioids prescriptions; OR: 3.10, 95% CI: 1.67-5.77 for high dose, acute opioid prescriptions; OR: 122.45, 95% CI: 72.79-205.99 for high dose, chronic opioid prescriptions). They found that even greater than opioid dose, duration of OT was the strongest predictor of developing OUD. Additionally, a study by Boscarino et al. (2011) examined medical records from a large healthcare system.[89] Through interviews with a random sample of patients on LOT, they examined factors associated with and the prevalence of OUD (using DSM IV and 5 criteria). These results showed that the prevalence of lifetime OUD for patients on LOT was 34.9% (based on DSM-5 criteria) and 35.5% (based on DSM-IV criteria). " ]

[ "The components of biopsychosocial assessment are pain assessment, patient functional goals, impact of pain on family, work, life, review of previous diagnostic studies, additional consultations and referrals, coexisting illness and treatments and effect on pain, significant psychological, social, or behavioral factors that may affect treatment, family history of chronic pain, collateral of family involvement, patient beliefs/knowledge of the cause of their pain and their treatment preferences along with the perceived efficacy of various treatment options. For patients already on OT, include assessment of psychological factors related to continuing vs. tapering OT. The psychological factors are beliefs, expectations, fears. Pain assessment includes history, physical exam, comorbidities, previous treatment and medications, duration of symptoms, onset and triggers. Examples of absolute contraindications to initiating opioid therapy for chronic pain are true life-threatening allergy to opioids, active SUD, elevated suicide risk, concomitant use of benzodiazepines. LOT refers to long-term opioid therapy; OT refers to opioid therapy; PDMP refers to Prescription Drug Monitoring Program; SUD refers to substance use disorder; UDT refers to urine drug test; VA/DoD Suicide CPG refers to VA/DoD Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide." ]

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[ "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "There has been limited research on the effectiveness of LOT for non-end-of-life pain. At the same time, there is mounting evidence of the ill effects of LOT, including increased mortality, OUD, overdose, sexual dysfunction, fractures, myocardial infarction, constipation, and sleep-disordered breathing. Despite increasing awareness of the known harms of opioids, 259 million opioid prescriptions were still written in 2012.", "A paradigm shift in the use of OT for chronic non-terminal pain has paralleled this transformation in pain care. Prior to the 1980s, OT was rarely used outside of severe acute injury or post-surgical pain, primarily due to concern for tolerance, physical dependence, and addiction. As the hospice and palliative care movement began defining end-of-life care in the U.S. during the 1980s and emphasizing the importance of pain relief, OT increasingly became a mainstay for cancer and end-of-life pain. Efforts to destigmatize the use of prescription opioids for chronic non-terminal pain encompassed primary care providers and the public. The efforts led to an unprecedented increase in opioid prescribing for chronic non-terminal pain. Chronic pain management became synonymous with LOT in the 1990s and the first decade of the 2000s with significant numbers of patients in pain clinics receiving LOT. Despite the absence of long-term safety or efficacy data, OT for chronic non-terminal pain became a mainstay of therapy. However, as observational and epidemiologic data of harm from LOT accumulated, a much more cautious approach to OT for chronic non-terminal pain has emerged in the decade of the 2010s.", "As outlined in this CPG, there is a rapidly growing understanding of the significant harms of LOT even at doses lower than 50 mg oral morphine equivalent daily dose [MEDD], including but not limited to overdose and OUD. At the same time there is a lack of high quality evidence that LOT improves pain, function, and/or quality of life. The literature review conducted for this CPG identified no studies evaluating the effectiveness of LOT for outcomes lasting longer than 16 weeks. Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, non-opioid treatments are preferred for chronic pain. Patient values, goals, concerns, and preferences must be factored into clinical decision making on a case-by-case basis. When considering the initiation or continuation of LOT, it is important to consider whether LOT will result in clinically meaningful improvements in function such as readiness to return to work/duty and/or measurable improvement in other areas of function, such that the benefits outweigh the potential harms. ", "While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place. ", "Similar to other risk factors, continuing OT beyond 90 days’ duration should be weighed heavily in the risk benefit calculus for LOT. Continuing OT for longer than 90 days is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks. That must be determined through individual clinical assessment. ", "Headache not responsive to other pain treatment modalities: LOT is an ineffective treatment modality for patients with migraine headaches (with or without aura), tension-type headaches, occipital neuralgia, or myofascial pain and may result in worsening of the underlying headache condition through factors such as central sensitization and withdrawal. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "There is a paradigm shift occurring in approaches to ensuring and documenting patient and provider understanding and expectations regarding the risks and benefits of LOT. The 2010 OT CPG reflected prior practice of using opioid treatment (or pain care) agreements. OTAs have been described as coercive rather than therapeutic, lack respect for individual autonomy, can be a barrier to pain care, and may be harmful to the patient-provider relationship.[102-105] ", "The system-wide goal of this guideline is to improve the patient’s health and well-being by providing evidence-based guidance to providers who are taking care of patients on or being considered for LOT. The expected outcome of successful implementation of this guideline is to assess the patient’s condition, provide education, and determine the best treatment methods in collaboration with the patient and a multidisciplinary care team, optimize the patient’s health outcomes and function and improve quality of life, minimize preventable complications and morbidity, emphasize the use of patient-centered care." ]

[ "From 2000 through 2010, the proportion of pain visits during which opioid and non-opioid pharmacologic therapies were prescribed increased from 11.3% to 19.6% and from 26% to 29%, respectively. In 2012, for every 100 persons in the United States (U.S.), 82.5 opioid prescriptions and 37.6 benzodiazepine prescriptions were written by healthcare providers. In the emergency department, at least 17% of discharges included prescriptions for opioids." ]

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[ "Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid.", "The increase in opioid prescribing is matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance use disorders (SUD) treatment admissions from 1999 to 2008. In 2009, drug overdose became the leading cause of injury-related death in the U.S., surpassing deaths from traffic accidents. In 2014, 1.9 million Americans were affected by an OUD related to non-medical use of prescription pain relievers, and in the same year, 18,893 individuals died as a result of a prescription drug overdose. There has been a four-fold increase in the absolute number of deaths associated with use of opioids since 2000, and a 14% increase between 2013 and 2014 alone. In a survey of patients prescribed opioids for chronic non-cancer pain (CNCP) and their family members, 34% of patients reported that they thought they were “addicted” or “dependent” on opioid pain medication, 34% said that they used the medication for “fun” or to “get high,” while 22% used the medication to relieve day-to-day stress.", "The accumulation of evidence of harms and the absence of evidence of long-term benefits has warranted a newly cautious approach to LOT that prioritizes safety. This approach coupled with the evidence of both the safety and efficacy for non-pharmacologic and non-opioid pharmacologic pain therapies has led to the current transformation in the way in which pain is viewed and treated. The biopsychosocial model of pain recognizes pain as a complex multidimensional experience that requires multimodal and integrated care approaches. Within this context, non-pharmacologic treatments and non-opioid medications are the preferred treatments for chronic non-terminal pain. OT has a limited role, primarily in the treatment of severe acute pain, post-operative pain, and end-of-life pain. ", "A paradigm shift in the use of OT for chronic non-terminal pain has paralleled this transformation in pain care. Prior to the 1980s, OT was rarely used outside of severe acute injury or post-surgical pain, primarily due to concern for tolerance, physical dependence, and addiction. As the hospice and palliative care movement began defining end-of-life care in the U.S. during the 1980s and emphasizing the importance of pain relief, OT increasingly became a mainstay for cancer and end-of-life pain. Efforts to destigmatize the use of prescription opioids for chronic non-terminal pain encompassed primary care providers and the public. The efforts led to an unprecedented increase in opioid prescribing for chronic non-terminal pain. Chronic pain management became synonymous with LOT in the 1990s and the first decade of the 2000s with significant numbers of patients in pain clinics receiving LOT. Despite the absence of long-term safety or efficacy data, OT for chronic non-terminal pain became a mainstay of therapy. However, as observational and epidemiologic data of harm from LOT accumulated, a much more cautious approach to OT for chronic non-terminal pain has emerged in the decade of the 2010s.", "Concurrent with the increase in prescription opioid use, the rate of heroin overdose deaths increased nearly four-fold between 2000 and 2013. According to a survey of patients entering SUD treatment for heroin use, the prescription opioid epidemic has resulted in a marked shift in how and which opioids are abused. In the 1960s, 80% of people entering treatment for heroin use started using heroin as their first opioid, while in the 2000s, 75% of people entering treatment for heroin use started using prescription opioids as their first opioid. This increase in the use of opioids, as well as associated morbidity, mortality, and other adverse outcomes, has called attention to the need for a paradigm shift in pain and in the way it is treated. Consult the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders (VA/DoD SUD CPG) for further information. ", "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.", "There is a paradigm shift occurring in approaches to ensuring and documenting patient and provider understanding and expectations regarding the risks and benefits of LOT. The 2010 OT CPG reflected prior practice of using opioid treatment (or pain care) agreements. OTAs have been described as coercive rather than therapeutic, lack respect for individual autonomy, can be a barrier to pain care, and may be harmful to the patient-provider relationship.[102-105] ", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting body of research expanding detailing the lack of benefit and severe harms of LOT.", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. " ]

[ "We recommend against the concurrent use of benzodiazepines and opioids. Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate. We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits." ]

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[ "We recommend against the concurrent use of benzodiazepines and opioids. (Strong against | Reviewed, New-added) Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate (see Recommendation 14 and the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders). ", "We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. (Strong against) For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, Amended) ", "For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies, assessment for opioid use disorder, and consideration for tapering when risks exceed benefits. We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering.", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. (Strong for| Reviewed, New-replaced) Note: Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits. For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies (see Recommendations 7-9), assessment for opioid use disorder, and consideration for tapering when risks exceed benefits (see Recommendation 14). (Strong for| Reviewed, New-replaced) ", "There is a large variation in patient preference regarding the concurrent use of benzodiazepines and LOT. This is especially true for patients who are already accustomed to receiving both medications (see Patient Focus Group Methods and Findings). Concurrent benzodiazepine and LOT use is a serious risk factor for unintentional overdose death and should be weighed heavily in the risk-benefit evaluation for tapering versus continuing one or both agents. Once initiated, benzodiazepines can be challenging to discontinue due to symptoms related to benzodiazepine dependence, exacerbations of PTSD, and/or anxiety.[91] Moreover, abrupt discontinuation of benzodiazepines should be avoided, as it can lead to serious adverse effects including seizures and death. Tapering benzodiazepines should be performed with caution and within a team environment when possible (see Recommendation 26 in the VA/DoD SUD CPG).7 Due to the difficulty of tapering or discontinuing benzodiazepines, particular caution should be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain. The VA/DoD PTSD CPG recommends against benzodiazepines for the prevention of PTSD and cautions against their use in treatment of PTSD. Benzodiazepines to treat acute anxiety symptoms after trauma are associated with a higher incidence of PTSD symptoms. For treatment of PTSD, there is evidence of lack of efficacy from small clinical trials and evidence of harm from observational studies of benzodiazepines for PTSD. Although anxiety may initially improve with benzodiazepines, the improvement is short-lived and may result in tolerance to increasing doses and eventual failure of the treatment. Even gradual benzodiazepine taper may result in exacerbation of severe PTSD symptoms. Concomitant use of benzodiazepines is considered a contraindication to initiation of OT. ", "a) We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. (Strong against) b) For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, New-replaced) ", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "We strongly recommend against initiation of long-term opioid therapy for chronic pain. We recommend alternatives to opioid therapy such as self-management strategies and other non-pharmacological treatments. When pharmacologic therapies are used, we recommend non-opioids over opioids. If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. Note: Consideration of opioid therapy beyond 90 days requires reevaluation and discussion with patient of risks and benefits." ]

[ "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. " ]

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[ "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "Other initiatives are aimed at improving the safe use of opioids, including the OSI Toolkit and the patient guide “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain”. The OSI Toolkit was developed to provide clinicians with materials to inform clinical decision-making regarding opioid therapy and safe opioid prescribing. The toolkit materials can be found at the following link: https://www.va.gov/PAINMANAGEMENT/Opioid_Safety_Initiative_Toolkit.asp. “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain” is aimed at providing information to patients as well as their providers regarding the safe use of opioids. More information can be found at the following link: http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf. To further promote safety and patient centered care, the VHA issued a policy in 2014 requiring standardized education and signature informed consent for all patients receiving LOT for non-cancer pain. ", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "The components of biopsychosocial assessment are pain assessment, patient functional goals, impact of pain on family, work, life, review of previous diagnostic studies, additional consultations and referrals, coexisting illness and treatments and effect on pain, significant psychological, social, or behavioral factors that may affect treatment, family history of chronic pain, collateral of family involvement, patient beliefs/knowledge of the cause of their pain and their treatment preferences along with the perceived efficacy of various treatment options. For patients already on OT, include assessment of psychological factors related to continuing vs. tapering OT. The psychological factors are beliefs, expectations, fears. Pain assessment includes history, physical exam, comorbidities, previous treatment and medications, duration of symptoms, onset and triggers. Examples of absolute contraindications to initiating opioid therapy for chronic pain are true life-threatening allergy to opioids, active SUD, elevated suicide risk, concomitant use of benzodiazepines. LOT refers to long-term opioid therapy; OT refers to opioid therapy; PDMP refers to Prescription Drug Monitoring Program; SUD refers to substance use disorder; UDT refers to urine drug test; VA/DoD Suicide CPG refers to VA/DoD Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide.", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82] ", "The presidential memorandum of October 2015 mandated that executive departments and agencies shall, to the extent permitted by law, provide training on the appropriate and effective prescribing of opioid medications to all employees who are health care professionals and who prescribe controlled substances as part of their federal responsibilities and duties. The DoD Opioid Prescriber Safety Training Program, launched accordingly, includes modules on pain management and opioid prescribing safety, the recent Centers for Disease Control and Prevention (CDC) guideline, and the identification of substance misuse and referral to specialized services. Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury is sponsoring the training and related management support. Training is available online at http://opstp.cds.pesgce.com/hub.php. ", "In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting body of research expanding detailing the lack of benefit and severe harms of LOT.", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "Consequently, a recommendation to update the 2010 OT CPG was initiated in 2015. The updated CPG, titled Clinical Practice Guideline for Opioid Therapy for Chronic Pain (OT CPG), includes objective, evidence-based information on the management of chronic pain. It is intended to assist healthcare providers in all aspects of patient care, including, but not limited to, diagnosis, treatment, and follow-up." ]

[ "We recommend against the concurrent use of benzodiazepines and opioids. (Strong against | Reviewed, New-added) Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate (see Recommendation 14 and the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders). " ]

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[ "We recommend against the concurrent use of benzodiazepines and opioids. Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate. We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits.", "We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules.", "There is a large variation in patient preference regarding the concurrent use of benzodiazepines and LOT. This is especially true for patients who are already accustomed to receiving both medications (see Patient Focus Group Methods and Findings). Concurrent benzodiazepine and LOT use is a serious risk factor for unintentional overdose death and should be weighed heavily in the risk-benefit evaluation for tapering versus continuing one or both agents. Once initiated, benzodiazepines can be challenging to discontinue due to symptoms related to benzodiazepine dependence, exacerbations of PTSD, and/or anxiety.[91] Moreover, abrupt discontinuation of benzodiazepines should be avoided, as it can lead to serious adverse effects including seizures and death. Tapering benzodiazepines should be performed with caution and within a team environment when possible (see Recommendation 26 in the VA/DoD SUD CPG).7 Due to the difficulty of tapering or discontinuing benzodiazepines, particular caution should be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain. The VA/DoD PTSD CPG recommends against benzodiazepines for the prevention of PTSD and cautions against their use in treatment of PTSD. Benzodiazepines to treat acute anxiety symptoms after trauma are associated with a higher incidence of PTSD symptoms. For treatment of PTSD, there is evidence of lack of efficacy from small clinical trials and evidence of harm from observational studies of benzodiazepines for PTSD. Although anxiety may initially improve with benzodiazepines, the improvement is short-lived and may result in tolerance to increasing doses and eventual failure of the treatment. Even gradual benzodiazepine taper may result in exacerbation of severe PTSD symptoms. Concomitant use of benzodiazepines is considered a contraindication to initiation of OT. ", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "a) We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. (Strong against) b) For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, New-replaced) ", "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances", "For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies, assessment for opioid use disorder, and consideration for tapering when risks exceed benefits. We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "In addition to benzodiazepines, the addition of other psychoactive medications to LOT must be made with caution. While the evidence for harm associated with the combination of opioids and Z-drugs (e.g., zolpidem, eszopiclone) is not as strong as the evidence for harm associated with the combination of opioids and benzodiazepines, we suggest not prescribing Z-drugs to patients who are on LOT, as moderate quality evidence demonstrates that the combination of zolpidem and opioids increases the AOR of overdose.[66] The evidence reviewed also identifies potential adverse outcomes (e.g., risk of overdose) with the combined use of antidepressants and opioids in patients who do not have depression.[66] This particular study did not differentiate between classes of antidepressants, limiting the ability of the Work Group to recommend for or against prescribing opioids and a specific class of antidepressants. As such, there is no recommendation in this guideline with respect to using specific classes of antidepressants and LOT. " ]

[ "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics." ]

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[ "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Opioids are not first-line or routine therapy for chronic pain. Establish treatment goals before starting opioid therapy and a plan if therapy is discontinued. Only continue opioid if there is clinically meaningful improvement in pain and function. Discuss risks, benefits and responsibilities for managing therapy before starting and during treatment.", "We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules.", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder)." ]

[ "Community-based Needle Exchange Programs or Syringe Service Programs: Nearly 80% of new users of injectable opioids had previously used prescription oral opioid pain medication.[118,119] Illicit use of injectable opioids is accompanied by an increased rate of human immunodeficiency virus (HIV) and hepatitis infection. Community-based needle exchange programs have been shown to be an effective risk mitigation strategy for reducing high-risk behaviors (e.g., sharing needles) and infectious disease transmission among injection drug users.[120] For those patients who develop OUD and progress to intravenous drug use, the first recommendation should be for medication assisted treatment (MAT) for OUD (see Recommendation 17). For patients who decline MAT for OUD, clinicians should consider educating the patient regarding sterile injection techniques and community based needle exchange programs, if programs are available. The 2015 outbreak of HIV/hepatitis in rural Indiana and subsequent successful implementation of a needle exchange program is an example of the threat to rural communities from non-prescription opioid use and the potential benefits of needle exchange programs for use as a risk mitigation strategy.[121,122] " ]

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[ "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "Acute psychiatric instability or intermediate to high acute suicide risk: Intermediate to high acute suicide risk, severe depression, unstable bipolar disorder, or unstable psychotic disorder precludes the safe use of self-administered LOT.[60] Im et al. (2015) (n=487,462) found that a diagnosis of a mood disorder was significantly associated with suicide attempts for the chronic use of short-acting and long-acting opioids compared with no diagnosis of a mood disorder.[61] In a study of patients on opioids, Campbell et al. (2015) reported that those with bipolar disorder had 2.9 times the odds of suicidal ideation within the past 12 months as well as 3.2 times the odds of a lifetime suicide attempt compared to those with no bipolar disorder.[62] See Recommendation 8 and the VA/DoD Suicide CPG2 for more information on suicidality. See the VA/DoD Clinical Practice Guideline for Management of Bipolar Disorder in Adults (VA/DoD BD CPG) for more information on bipolar disorder.3 Merrill and colleagues found that high dose chronic opioid therapy for pain was associated with depressed mood.[63] Treatment for chronic pain with movement, exercise, and cognitive-behavioral therapy for pain may have benefits in treating depression, PTSD, and in reducing suicide risk.[64] ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] ", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] ", "In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188] ", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "Co-administration of a drug capable of inducing fatal drug-drug interactions: Providers should carefully rule out and avoid potential drug interactions prior to initiating LOT. For example, the following combinations are dangerous:[66] i)Opioids with benzodiazepines (compared to patients with no prescription, the odds ratio [OR] and 95% confidence interval [CI] for drug-related death was OR: 14.92, 95% CI: 7.00- 31.77 for patients who filled a prescription for opioids and benzodiazepines; OR: 3.40, 95% CI: 1.60-7.21 for patients who filled only an opioid prescription, and 7.21, 95% CI: 3.33-15.60 for patients who filled only a benzodiazepine prescription) (see Recommendation 5) [66,67], ii)Fentanyl with CYP3A4 inhibitors, iii) Methadone with drugs that can prolong the QT interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) (e.g., CYP450 2B6 inhibitors) ", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. " ]

[ "Opioids are not first-line or routine therapy for chronic pain. Establish treatment goals before starting opioid therapy and a plan if therapy is discontinued. Only continue opioid if there is clinically meaningful improvement in pain and function. Discuss risks, benefits and responsibilities for managing therapy before starting and during treatment." ]

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[ "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. ", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. (Strong for| Reviewed, New-replaced) Note: Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits. For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies (see Recommendations 7-9), assessment for opioid use disorder, and consideration for tapering when risks exceed benefits (see Recommendation 14). (Strong for| Reviewed, New-replaced) ", "The shared decision making process for chronic pain treatment planning is based on the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider (Figure 1). The patient-centered assessment incorporates a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations. Next, the clinician performs a biopsychosocial assessment and determines clinically appropriate therapeutic options in which benefits are likely to outweigh risks. The process culminates in a shared decision making process to develop a patient-centered treatment plan by the patient selecting from the clinically appropriate treatment options generated in the first two steps. ", "Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82] ", "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. " ]

[ "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached." ]

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[ "Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Short-term oral medications can be utilized to assist with managing the withdrawal symptoms, especially when prescribing fast tapers. Do not treat withdrawal symptoms with an opioid or benzodiazepine. Withdrawal symptoms are not life-threatening and may not be seen with a gradual taper. Early symptoms take hours to days to appear. Early symptoms include anxiety/restlessness, rapid short respirations, runny nose, tearing eyes, sweating, insomnia, and dilated reactive pupils. Late symptoms take days to weeks to appear. Late symptoms include runny nose, tearing eyes, rapid breathing, yawning, tremor, diffuse muscle spasms/aches, piloerection, nausea, vomiting, and diarrhea, abdominal pain, fever, chills, increased white blood cells if sudden withdrawal. Prolonged symptoms take weeks to months to appear. Prolonged symptoms include irritability, fatigue, bradycardia, decreased body temperature, craving, insomnia. Early symptoms generally resolve 5 to 10 days following opioid dose reduction/cessation but may take longer depending on the half-life of the opioid (e.g., methadone). Some symptoms of withdrawal such as dysphoria, insomnia and prolonged craving may take longer. Patients with chronic pain may find that symptoms, such as fatigue, mental functioning, pain, and well-being, improve over time.", "Here is an example of an opioid taper plan for a Veteran. Veteran is currently taking morphine SR 60 mg, 1 tablet every 8 hours. Goal is to reduce the dose of morphine to SR 30 mg every 8 hours using a slow taper. Dose will be reduced by 15 mg every 10 days. Using morphine SR 15 mg tablets, follow the schedule below. From days 1 to 10, take 4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 11 to 20, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 21 to 30, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 3 tablets = 45 mg in the evening.", "Use immediate-release (IR) opioids when starting therapy. Prescribe the lowest effective dose. When using opioids for acute pain, provide no more than needed for the condition. Follow up and review benefits and risks before starting and during therapy. If benefits do not outweigh harms, consider tapering opioids to lower doses or taper and discontinue." ]

[ "A number of studies suggest certain chronic pain conditions represent an independent risk factor for suicide.[123-130] A recent large retrospective cohort study also suggests an association with prescribed opioid dose and suicide risk among Veterans receiving OT for CNCP.[131] Suicide risk is not static, and many factors influence an individual’s risk of suicide at any given point in time, as noted in the VA/DoD Suicide CPG. Thus, ongoing assessment of suicide risk is important whether one is initiating, maintaining, or terminating LOT. " ]

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[ "Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT. Further research is needed to identify strategies for safely managing patients at elevated risk of suicide who demand opioid medications or become further destabilized during tapering. ", "Similar to other risk factors, continuing OT beyond 90 days’ duration should be weighed heavily in the risk benefit calculus for LOT. Continuing OT for longer than 90 days is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks. That must be determined through individual clinical assessment. ", "While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place. ", "Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15). ", "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "There is moderate quality evidence that intensification of monitoring helps mitigate the risk of suicide among patients on LOT. Im et al. (2015) found moderate quality evidence that, at the facility level, patients on LOT within facilities ordering more drug screens than the comparison group were associated with decreased risk of suicide attempt (chronic short-acting opioid group: OR: 0.2, 95% CI: 0.1-0.3; chronic long acting opioid group: OR: 0.3, 95% CI: 0.2-0.6). In addition, patients on long-acting opioids within the facilities providing more follow-up after new prescriptions were associated with decreased risk of suicide attempt (OR: 0.2, 95% CI: 0.0-0.7).[61] ", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. ", "We recommend assessing suicide risk when considering initiating or continuing long-term opioid therapy and intervening when necessary. (Strong for | Reviewed, Amended) ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. " ]

[ "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level." ]

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[ "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. ", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Here is an example of an opioid taper plan for a Veteran. Veteran is currently taking morphine SR 60 mg, 1 tablet every 8 hours. Goal is to reduce the dose of morphine to SR 30 mg every 8 hours using a slow taper. Dose will be reduced by 15 mg every 10 days. Using morphine SR 15 mg tablets, follow the schedule below. From days 1 to 10, take 4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 11 to 20, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 21 to 30, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 3 tablets = 45 mg in the evening.", "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics." ]

[ "Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid." ]

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[ "From 2000 through 2010, the proportion of pain visits during which opioid and non-opioid pharmacologic therapies were prescribed increased from 11.3% to 19.6% and from 26% to 29%, respectively. In 2012, for every 100 persons in the United States (U.S.), 82.5 opioid prescriptions and 37.6 benzodiazepine prescriptions were written by healthcare providers. In the emergency department, at least 17% of discharges included prescriptions for opioids.", "The increase in opioid prescribing is matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance use disorders (SUD) treatment admissions from 1999 to 2008. In 2009, drug overdose became the leading cause of injury-related death in the U.S., surpassing deaths from traffic accidents. In 2014, 1.9 million Americans were affected by an OUD related to non-medical use of prescription pain relievers, and in the same year, 18,893 individuals died as a result of a prescription drug overdose. There has been a four-fold increase in the absolute number of deaths associated with use of opioids since 2000, and a 14% increase between 2013 and 2014 alone. In a survey of patients prescribed opioids for chronic non-cancer pain (CNCP) and their family members, 34% of patients reported that they thought they were “addicted” or “dependent” on opioid pain medication, 34% said that they used the medication for “fun” or to “get high,” while 22% used the medication to relieve day-to-day stress.", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "A paradigm shift in the use of OT for chronic non-terminal pain has paralleled this transformation in pain care. Prior to the 1980s, OT was rarely used outside of severe acute injury or post-surgical pain, primarily due to concern for tolerance, physical dependence, and addiction. As the hospice and palliative care movement began defining end-of-life care in the U.S. during the 1980s and emphasizing the importance of pain relief, OT increasingly became a mainstay for cancer and end-of-life pain. Efforts to destigmatize the use of prescription opioids for chronic non-terminal pain encompassed primary care providers and the public. The efforts led to an unprecedented increase in opioid prescribing for chronic non-terminal pain. Chronic pain management became synonymous with LOT in the 1990s and the first decade of the 2000s with significant numbers of patients in pain clinics receiving LOT. Despite the absence of long-term safety or efficacy data, OT for chronic non-terminal pain became a mainstay of therapy. However, as observational and epidemiologic data of harm from LOT accumulated, a much more cautious approach to OT for chronic non-terminal pain has emerged in the decade of the 2010s.", "In a prospective cohort study (not included in the evidence review as it did not include information on acute versus chronic pain in the patient population), Dasgupta et al. (2015) compared residents of North Carolina who had received an opioid prescription in the last year to residents who had not. The study examined the outcome of population-based rates of opioid overdose mortality by opioid dose, without use of a presupposed threshold (Table 3).[135] There was no safe dose of opioid. Among the over nine million individuals followed for one year, 629 died from opioid overdose. Of these 629 individuals, 151 had no record of having been dispensed an opioid. It is possible these opioids were obtained through illicit channels or social sharing/diversion. Of the 478 patients who died from an opioid overdose who were prescribed opioids, 235 (49%) had been prescribed <80 mg MEDD. Overdose incidence rate ratios (IRRs) doubled each time the MEDD ranges increase from 60.0-79.9 mg to 80.0-99.9 mg (IRR 2.9 to 6.2), then to 120-139.9 mg (IRR 14.1), 160-179.9 mg (IRR 29.5), and 350-399.9 mg (IRR 63.2). ", "The Edlund et al. (2014) study of 568,640 commercial health plan patients (see Recommendation 2 and 3) found that those diagnosed with CNCP and an alcohol use or non-opioid drug use disorder had higher rates of OUD (OR: 3.22, 95% CI: 1.79-5.80 for patients with pre-index alcohol use disorder compared to no alcohol use disorder; OR: 8.26, 95% CI: 4.74-14.39 for patients with pre-index non-opioid drug use disorders compared to no non-opioid drug use disorders).[86] Moreover, Huffman et al. (2015) found that the presence of a lifetime history of SUD for patients with CNCP was associated with 28 times increased odds of therapeutic opioid addiction compared to patients with CNCP without a lifetime history of SUD (OR: 28.58, 95% CI: 10.86-75.27).[87] ", "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.", "Chronic pain is a national public health problem as outlined in the 2011 study by the National Academy of Medicine (previously the Institute of Medicine [IOM]). At least 100 million Americans suffer from some form of chronic pain. Until recently, the treatment of chronic pain with opioids was increasing at an alarming rate. The increase in prescriptions of these medications has been accompanied by an epidemic of opioid-related adverse events.", "The accumulation of evidence of harms and the absence of evidence of long-term benefits has warranted a newly cautious approach to LOT that prioritizes safety. This approach coupled with the evidence of both the safety and efficacy for non-pharmacologic and non-opioid pharmacologic pain therapies has led to the current transformation in the way in which pain is viewed and treated. The biopsychosocial model of pain recognizes pain as a complex multidimensional experience that requires multimodal and integrated care approaches. Within this context, non-pharmacologic treatments and non-opioid medications are the preferred treatments for chronic non-terminal pain. OT has a limited role, primarily in the treatment of severe acute pain, post-operative pain, and end-of-life pain. ", "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. " ]

[ "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]" ]

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[ "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] ", "As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Note: Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20- 50 mg morphine equivalent daily dose.", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] ", "In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188] ", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "The increase in opioid prescribing is matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance use disorders (SUD) treatment admissions from 1999 to 2008. In 2009, drug overdose became the leading cause of injury-related death in the U.S., surpassing deaths from traffic accidents. In 2014, 1.9 million Americans were affected by an OUD related to non-medical use of prescription pain relievers, and in the same year, 18,893 individuals died as a result of a prescription drug overdose. There has been a four-fold increase in the absolute number of deaths associated with use of opioids since 2000, and a 14% increase between 2013 and 2014 alone. In a survey of patients prescribed opioids for chronic non-cancer pain (CNCP) and their family members, 34% of patients reported that they thought they were “addicted” or “dependent” on opioid pain medication, 34% said that they used the medication for “fun” or to “get high,” while 22% used the medication to relieve day-to-day stress.", "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] ", "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. ", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "In a prospective cohort study (not included in the evidence review as it did not include information on acute versus chronic pain in the patient population), Dasgupta et al. (2015) compared residents of North Carolina who had received an opioid prescription in the last year to residents who had not. The study examined the outcome of population-based rates of opioid overdose mortality by opioid dose, without use of a presupposed threshold (Table 3).[135] There was no safe dose of opioid. Among the over nine million individuals followed for one year, 629 died from opioid overdose. Of these 629 individuals, 151 had no record of having been dispensed an opioid. It is possible these opioids were obtained through illicit channels or social sharing/diversion. Of the 478 patients who died from an opioid overdose who were prescribed opioids, 235 (49%) had been prescribed <80 mg MEDD. Overdose incidence rate ratios (IRRs) doubled each time the MEDD ranges increase from 60.0-79.9 mg to 80.0-99.9 mg (IRR 2.9 to 6.2), then to 120-139.9 mg (IRR 14.1), 160-179.9 mg (IRR 29.5), and 350-399.9 mg (IRR 63.2). " ]

[ "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. " ]

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[ "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Future research is needed to ascertain whether abuse deterrent formulations actually reduce OUD when used for chronic pain, and whether said formulations differ across clinical outcomes such as pain, function, and adverse events. ", "Moderate quality evidence demonstrates that the prevalence of OUD in patients with CNCP is related to duration of opioid use as well as dose (see Recommendations 7-9).[86-88] There are two studies of patients with CNCP which support the current recommendations. Edlund et al. (2014) conducted a large retrospective cohort study where they examined claims data from a health insurance database between 2000 and 2005 to examine factors predictive of developing OUD.[86] Days’ supply of opioids was categorized as none, acute duration (1-90 days), or chronic duration (91+ days). Average daily dose was defined as none, low (1-36 mg MEDD), medium (36-120 mg MEDD), or high (>120 mg MEDD). The OR of developing OUD ranged based on dose and duration (OR: 3.03, 95% CI: 2.32-3.95 for low dose, acute opioid prescription; OR: 14.92, 95% CI: 10.38-21.46 for low dose, chronic opioids prescriptions; OR: 3.10, 95% CI: 1.67-5.77 for high dose, acute opioid prescriptions; OR: 122.45, 95% CI: 72.79-205.99 for high dose, chronic opioid prescriptions). They found that even greater than opioid dose, duration of OT was the strongest predictor of developing OUD. Additionally, a study by Boscarino et al. (2011) examined medical records from a large healthcare system.[89] Through interviews with a random sample of patients on LOT, they examined factors associated with and the prevalence of OUD (using DSM IV and 5 criteria). These results showed that the prevalence of lifetime OUD for patients on LOT was 34.9% (based on DSM-5 criteria) and 35.5% (based on DSM-IV criteria). ", "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "Monitoring standards with administration of OT for acute pain vary depending on a number of factors including the setting, specifics of the painful insult, patient medical factors, and selected medication potency/dose/route of administration/adjunct selection. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Future Research: Future research is needed to better determine the impact of systematic reductions in MEDD in terms of pain relief, specific pain and medical conditions, overdose morbidity and mortality as well as potential adverse outcomes (e.g., the incidence of associated OUD, infectious diseases related to intravenous drug use disorder, and drug-related crime and diversion) and to determine whether/which conditions may be appropriately treated with LOT. Research is also needed to determine how frequency of monitoring should be impacted by dose.", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "As outlined in this CPG, there is a rapidly growing understanding of the significant harms of LOT even at doses lower than 50 mg oral morphine equivalent daily dose [MEDD], including but not limited to overdose and OUD. At the same time there is a lack of high quality evidence that LOT improves pain, function, and/or quality of life. The literature review conducted for this CPG identified no studies evaluating the effectiveness of LOT for outcomes lasting longer than 16 weeks. Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, non-opioid treatments are preferred for chronic pain. Patient values, goals, concerns, and preferences must be factored into clinical decision making on a case-by-case basis. When considering the initiation or continuation of LOT, it is important to consider whether LOT will result in clinically meaningful improvements in function such as readiness to return to work/duty and/or measurable improvement in other areas of function, such that the benefits outweigh the potential harms. " ]

[ "There is a large variation in patient preference regarding the concurrent use of benzodiazepines and LOT. This is especially true for patients who are already accustomed to receiving both medications (see Patient Focus Group Methods and Findings). Concurrent benzodiazepine and LOT use is a serious risk factor for unintentional overdose death and should be weighed heavily in the risk-benefit evaluation for tapering versus continuing one or both agents. Once initiated, benzodiazepines can be challenging to discontinue due to symptoms related to benzodiazepine dependence, exacerbations of PTSD, and/or anxiety.[91] Moreover, abrupt discontinuation of benzodiazepines should be avoided, as it can lead to serious adverse effects including seizures and death. Tapering benzodiazepines should be performed with caution and within a team environment when possible (see Recommendation 26 in the VA/DoD SUD CPG).7 Due to the difficulty of tapering or discontinuing benzodiazepines, particular caution should be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain. The VA/DoD PTSD CPG recommends against benzodiazepines for the prevention of PTSD and cautions against their use in treatment of PTSD. Benzodiazepines to treat acute anxiety symptoms after trauma are associated with a higher incidence of PTSD symptoms. For treatment of PTSD, there is evidence of lack of efficacy from small clinical trials and evidence of harm from observational studies of benzodiazepines for PTSD. Although anxiety may initially improve with benzodiazepines, the improvement is short-lived and may result in tolerance to increasing doses and eventual failure of the treatment. Even gradual benzodiazepine taper may result in exacerbation of severe PTSD symptoms. Concomitant use of benzodiazepines is considered a contraindication to initiation of OT. " ]

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[ "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "We recommend against the concurrent use of benzodiazepines and opioids. (Strong against | Reviewed, New-added) Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate (see Recommendation 14 and the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders). ", "In addition to benzodiazepines, the addition of other psychoactive medications to LOT must be made with caution. While the evidence for harm associated with the combination of opioids and Z-drugs (e.g., zolpidem, eszopiclone) is not as strong as the evidence for harm associated with the combination of opioids and benzodiazepines, we suggest not prescribing Z-drugs to patients who are on LOT, as moderate quality evidence demonstrates that the combination of zolpidem and opioids increases the AOR of overdose.[66] The evidence reviewed also identifies potential adverse outcomes (e.g., risk of overdose) with the combined use of antidepressants and opioids in patients who do not have depression.[66] This particular study did not differentiate between classes of antidepressants, limiting the ability of the Work Group to recommend for or against prescribing opioids and a specific class of antidepressants. As such, there is no recommendation in this guideline with respect to using specific classes of antidepressants and LOT. ", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "Acute psychiatric instability or intermediate to high acute suicide risk: Intermediate to high acute suicide risk, severe depression, unstable bipolar disorder, or unstable psychotic disorder precludes the safe use of self-administered LOT.[60] Im et al. (2015) (n=487,462) found that a diagnosis of a mood disorder was significantly associated with suicide attempts for the chronic use of short-acting and long-acting opioids compared with no diagnosis of a mood disorder.[61] In a study of patients on opioids, Campbell et al. (2015) reported that those with bipolar disorder had 2.9 times the odds of suicidal ideation within the past 12 months as well as 3.2 times the odds of a lifetime suicide attempt compared to those with no bipolar disorder.[62] See Recommendation 8 and the VA/DoD Suicide CPG2 for more information on suicidality. See the VA/DoD Clinical Practice Guideline for Management of Bipolar Disorder in Adults (VA/DoD BD CPG) for more information on bipolar disorder.3 Merrill and colleagues found that high dose chronic opioid therapy for pain was associated with depressed mood.[63] Treatment for chronic pain with movement, exercise, and cognitive-behavioral therapy for pain may have benefits in treating depression, PTSD, and in reducing suicide risk.[64] ", "The components of biopsychosocial assessment are pain assessment, patient functional goals, impact of pain on family, work, life, review of previous diagnostic studies, additional consultations and referrals, coexisting illness and treatments and effect on pain, significant psychological, social, or behavioral factors that may affect treatment, family history of chronic pain, collateral of family involvement, patient beliefs/knowledge of the cause of their pain and their treatment preferences along with the perceived efficacy of various treatment options. For patients already on OT, include assessment of psychological factors related to continuing vs. tapering OT. The psychological factors are beliefs, expectations, fears. Pain assessment includes history, physical exam, comorbidities, previous treatment and medications, duration of symptoms, onset and triggers. Examples of absolute contraindications to initiating opioid therapy for chronic pain are true life-threatening allergy to opioids, active SUD, elevated suicide risk, concomitant use of benzodiazepines. LOT refers to long-term opioid therapy; OT refers to opioid therapy; PDMP refers to Prescription Drug Monitoring Program; SUD refers to substance use disorder; UDT refers to urine drug test; VA/DoD Suicide CPG refers to VA/DoD Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide.", "We recommend against the concurrent use of benzodiazepines and opioids. Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate. We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits.", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime.", "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. " ]

[ "Evidence for or history of diversion of controlled substances: The clinician should communicate to patients that drug diversion is a crime and constitutes an absolute contraindication to prescribing additional medications. Because suspicion is subjective and may be based on impression, bias, or prejudice, it is important that providers who suspect diversion base treatment plans on objective evidence. Suspicions may be confirmed by a negative mass spectrometry/liquid chromatography UDT for the substance being prescribed in the absence of withdrawal symptoms in someone who is receiving opioids. A negative UDT for the prescribed opioid could also by itself be a sign of diversion. Signs of diversion may also include frequent requests for early refills or atypically large quantities required to control pain. Routine UDT, however, may not reliably detect synthetic opioids (e.g., methadone, fentanyl, tramadol) or semi-synthetic opioids (e.g., oxycodone, hydrocodone, hydromorphone). When there is evidence that the patient is diverting opioids, discontinue opioids according to Recommendations 14 and 15 and assess for underlying OUD and/or psychiatric comorbidities. Consultation with a pain specialist, psychiatrist, or SUD specialist may be warranted. Also consider consultation with local risk management and/or counsel. For patients with OUD, keep in mind that sudden discontinuation of opioids due to suspected diversion may place them at high risk for illicit opioid use and resulting opioid overdose (see Recommendation 17)." ]

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[ "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.", "As part of the patient-centered care approach, clinicians should review the patient’s history including previous treatment approaches, their results, and any other outcomes with the patient. They should ask the patient about his or her willingness to accept a referral to an addiction or other behavioral health specialist when appropriate. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care. The below approach may be used in setting SMART (Specific, Measurable, Action Oriented, Realistic, Timed) goals for the patient (Table 1).", " This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation.", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient. ", "As substance misuse in patients on LOT is more than 30% in some series,[107] UDT and confirmatory testing is used as an additional method of examining for patient substance misuse and adherence to the prescribed regimen. UDTs, used in the appropriate way, help to address safety, fairness, and trust with OT. Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to the false positive and negative rates associated with UDTs.[53] Interpretation of a UDT and confirmatory results requires education and knowledge of the local procedures and clinical scenario. Local education and access to expert interpretation is necessary. UDT results are helpful and can help identify active SUD or possible diversion. Accordingly, clinicians should obtain UDT prior to initiating or continuing LOT and periodically thereafter. When a patient is referred for SUD treatment or is engaged in on-going treatment there should be close communication between the SUD and pain management providers. The ideal approach is an interdisciplinary format (see Recommendation 16). For more information, see Appendix B on UDT and confirmatory testing. ", "VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns.", "This guideline is not intended as a standard of care and should not be used as such. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advances and patterns evolve. Today there is variation among state regulations, and this guideline does not cover the variety of ever-changing state regulations that may be pertinent. The ultimate judgement regarding a particular clinical procedure or treatment course must be made by the individual clinician, in light of the patient’s clinical presentation, patient preferences, and the available diagnostic and treatment options. As noted previously, the guideline can assist care providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, in the care for an individual patient.", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution." ]

[ "Community-based Needle Exchange Programs or Syringe Service Programs: Nearly 80% of new users of injectable opioids had previously used prescription oral opioid pain medication.[118,119] Illicit use of injectable opioids is accompanied by an increased rate of human immunodeficiency virus (HIV) and hepatitis infection. Community-based needle exchange programs have been shown to be an effective risk mitigation strategy for reducing high-risk behaviors (e.g., sharing needles) and infectious disease transmission among injection drug users.[120] For those patients who develop OUD and progress to intravenous drug use, the first recommendation should be for medication assisted treatment (MAT) for OUD (see Recommendation 17). For patients who decline MAT for OUD, clinicians should consider educating the patient regarding sterile injection techniques and community based needle exchange programs, if programs are available. The 2015 outbreak of HIV/hepatitis in rural Indiana and subsequent successful implementation of a needle exchange program is an example of the threat to rural communities from non-prescription opioid use and the potential benefits of needle exchange programs for use as a risk mitigation strategy.[121,122] " ]

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[ "Concurrent with the increase in prescription opioid use, the rate of heroin overdose deaths increased nearly four-fold between 2000 and 2013. According to a survey of patients entering SUD treatment for heroin use, the prescription opioid epidemic has resulted in a marked shift in how and which opioids are abused. In the 1960s, 80% of people entering treatment for heroin use started using heroin as their first opioid, while in the 2000s, 75% of people entering treatment for heroin use started using prescription opioids as their first opioid. This increase in the use of opioids, as well as associated morbidity, mortality, and other adverse outcomes, has called attention to the need for a paradigm shift in pain and in the way it is treated. Consult the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders (VA/DoD SUD CPG) for further information. ", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] ", "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid.", "There is moderate quality evidence to support that opioids taken PRN (as needed) for chronic cancer pain versus regularly scheduled doses, or simultaneous PRN plus regularly scheduled, places patients at elevated risk for opioid overdose (HR: 2.75, 95% CI: 1.31-5.78 for as needed; HR: 1.00 for regularly scheduled; HR: 1.84, 95% CI: 0.83-4.05 for simultaneous PRN plus regularly scheduled).[59]", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] " ]

[ "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community." ]

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[ "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. ", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Short-term oral medications can be utilized to assist with managing the withdrawal symptoms, especially when prescribing fast tapers. Do not treat withdrawal symptoms with an opioid or benzodiazepine. Withdrawal symptoms are not life-threatening and may not be seen with a gradual taper. Early symptoms take hours to days to appear. Early symptoms include anxiety/restlessness, rapid short respirations, runny nose, tearing eyes, sweating, insomnia, and dilated reactive pupils. Late symptoms take days to weeks to appear. Late symptoms include runny nose, tearing eyes, rapid breathing, yawning, tremor, diffuse muscle spasms/aches, piloerection, nausea, vomiting, and diarrhea, abdominal pain, fever, chills, increased white blood cells if sudden withdrawal. Prolonged symptoms take weeks to months to appear. Prolonged symptoms include irritability, fatigue, bradycardia, decreased body temperature, craving, insomnia. Early symptoms generally resolve 5 to 10 days following opioid dose reduction/cessation but may take longer depending on the half-life of the opioid (e.g., methadone). Some symptoms of withdrawal such as dysphoria, insomnia and prolonged craving may take longer. Patients with chronic pain may find that symptoms, such as fatigue, mental functioning, pain, and well-being, improve over time." ]

[ "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community." ]

[ "238" ]

[ "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "Here is an example of an opioid taper plan for a Veteran. Veteran is currently taking morphine SR 60 mg, 1 tablet every 8 hours. Goal is to reduce the dose of morphine to SR 30 mg every 8 hours using a slow taper. Dose will be reduced by 15 mg every 10 days. Using morphine SR 15 mg tablets, follow the schedule below. From days 1 to 10, take 4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 11 to 20, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 21 to 30, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 3 tablets = 45 mg in the evening.", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics." ]

[ "The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “…Health Executive Council on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration and Military Health System,” by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations. This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with chronic pain who are on or being considered for long-term opioid therapy (LOT). " ]

[ "239" ]

[ "The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG. ", "In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting body of research expanding detailing the lack of benefit and severe harms of LOT.", "There were also some differences in the methodology used between the development of the VA/DoD OT CPG and the CDC guideline. Along with a clinical evidence review, during which the evidence was evaluated using GRADE, the CDC guideline developers also considered the findings of a contextual evidence review. Further, the CDC Core Expert Group, which consisted of subject matter experts, representatives of primary care professional societies and state agencies, and an expert in guideline methodology, reviewed recommendations drafted by the CDC and evaluated how the evidence was used in the development of the recommendations, rather than developing the recommendations themselves (as was the VA/DoD OT Work Group’s role in the development of the VA/DoD OT CPG). While experts provided feedback on the CDC recommendations and their development, the CDC determined the final recommendations. CDC also used a review process considering and incorporating feedback from federal partners (e.g., SAMHSA, VA, DoD), stakeholders (e.g., professional organizations, delivery systems, community organizations), and other constituents (e.g., clinicians, prospective patients). The CDC guideline development process included notice in the Federal Register for a public review and comment period as well as peer review. Thus, the recommendations made in the CDC guideline, although similar to those made in this CPG, were likely based on a slightly different evidence base and revised based on the feedback of individuals who were considering a larger group of potential patients relative to the VA/DoD. Thus, while the VA/DoD OT Work Group was aware of the release of the CDC guideline and considered potential implications, the CDC guideline did not form the basis of the deliberations on the strength or direction of these recommendations. The Work Group followed the VA/DoD Guideline for Guidelines, a document that details the process by which VA/DoD guidelines will be developed, including the use of the GRADE methodology. As required by Congress in CARA, the Work Group reviewed and considered the CDC guideline and its inclusion in the VA/DoD OT CPG.", "The VA/DoD OT CPG was developed with a specific patient population in mind—Service Members, Veterans, and their families—that has unique characteristics and needs related to the military culture and communities to which they return. Throughout the VA/DoD OT CPG, attention is paid to the characteristics and needs of these patients, particularly regarding specific risk factors such as risk for suicide, SUD, and other medical and mental health co-occurring conditions that may complicate the management of pain for these patients. Further, these recommendations were made keeping in mind the implications they would have within the VA/DoD healthcare settings, particularly regarding considerations such as resource use, accessibility, and equity related to each recommendation and the urgent need for rigorous attention to the balance of risks and benefits for patients within the VA/DoD specifically. ", "The presidential memorandum of October 2015 mandated that executive departments and agencies shall, to the extent permitted by law, provide training on the appropriate and effective prescribing of opioid medications to all employees who are health care professionals and who prescribe controlled substances as part of their federal responsibilities and duties. The DoD Opioid Prescriber Safety Training Program, launched accordingly, includes modules on pain management and opioid prescribing safety, the recent Centers for Disease Control and Prevention (CDC) guideline, and the identification of substance misuse and referral to specialized services. Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury is sponsoring the training and related management support. Training is available online at http://opstp.cds.pesgce.com/hub.php. ", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "The 2017 version of the VA/DoD OT CPG is the second update to the original CPG. It provides practice recommendations for the care of populations with chronic pain already on or being considered for LOT. Although there are many other approaches to the treatment of chronic pain, the scope of this CPG is to focus on the use of opioids for chronic pain rather than being comprehensive about all treatment options. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the treatment and management of patients with chronic pain on or being considered for LOT. ", "The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management.", "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.", "On July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) was enacted with the aim of addressing the epidemic of overdoses from prescription opioids and other prescription drugs and heroin. While this act was primarily focused on opioid abuse treatment and prevention, it also gave specific instruction to the VA in regard to broad aspects of OT including consideration of the CDC guideline in revising the prior VA/DoD OT CPG and adopting it for the VA. There are, however, some important distinctions between the CDC guideline and the VA/DoD OT CPG. " ]

[ "Although some patients may prefer either transdermal or buccal opioid delivery for opioids, there is significant potential for harm from OT with these delivery mechanisms, with no evidence of benefit over traditional opioid delivery systems in patients with chronic pain. Clinicians need to be especially aware of the risks associated with a fentanyl transdermal delivery system (or patch) (Appendix D) including its: Unique pharmacokinetic profile, Continuous delivery, even after the patch is removed due to depot effect, Increased rate of delivery, Unpredictable variation in rate of delivery - Due to alterations in temperature due to external heat, skin integrity, and amount of adipose tissue, Among patients with fever, skin damage, or cachexia." ]

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[ "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "As this guideline is related to LOT, the use of opioids for acute pain is not reviewed in detail. However, because acute OT can be a gateway to LOT, it is part of this CPG. A review of the literature indicates that LOT can result from acute opioid use initially intended for short-term therapy. Further, there is a risk of opioid-related overdose even during acute OT. While it is understood that acute OT for severe pain due to injuries or surgery is the most effective option for many patients, the risks associated with acute therapy must be addressed when opioids are prescribed or considered. ", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] ", "Co-administration of a drug capable of inducing fatal drug-drug interactions: Providers should carefully rule out and avoid potential drug interactions prior to initiating LOT. For example, the following combinations are dangerous:[66] i)Opioids with benzodiazepines (compared to patients with no prescription, the odds ratio [OR] and 95% confidence interval [CI] for drug-related death was OR: 14.92, 95% CI: 7.00- 31.77 for patients who filled a prescription for opioids and benzodiazepines; OR: 3.40, 95% CI: 1.60-7.21 for patients who filled only an opioid prescription, and 7.21, 95% CI: 3.33-15.60 for patients who filled only a benzodiazepine prescription) (see Recommendation 5) [66,67], ii)Fentanyl with CYP3A4 inhibitors, iii) Methadone with drugs that can prolong the QT interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) (e.g., CYP450 2B6 inhibitors) ", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "Opioids carry a significant risk for OUD, overdose, and death, especially among patients with untreated SUD. The recommendation against LOT for patients with SUD is supported by five large studies (four retrospective case cohort studies and one case cohort study).[59,61,66,86,87] Individually, these studies are of moderate strength; however, the combined weight of their results is strongly supportive of this recommendation. Clinicians should note that this recommendation does not refer to patients whose sole SUD relates to tobacco misuse. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). " ]

[ "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] " ]

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[ "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188] ", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] ", "As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Note: Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20- 50 mg morphine equivalent daily dose.", "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. ", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "QTc interval >450 ms for using methadone: Unlike most other commonly used opioids, methadone has unique pharmacodynamic properties that can prolong the QTc interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) and precipitate torsades de pointes, a dangerous or fatal cardiac arrhythmia. Patients who may be at risk include those with other risk factors for QTc prolongation, current or prior electrocardiograms (ECGs) with a prolonged QTc >450 ms, or a history of syncope. Therefore, ECGs before and after initiating methadone are highly advised (see Methadone Dosing Guidance). ", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] " ]

[ "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics." ]

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[ "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules.", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "Use immediate-release (IR) opioids when starting therapy. Prescribe the lowest effective dose. When using opioids for acute pain, provide no more than needed for the condition. Follow up and review benefits and risks before starting and during therapy. If benefits do not outweigh harms, consider tapering opioids to lower doses or taper and discontinue.", "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached." ]

[ "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] " ]

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[ "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "Younger patients are also at a higher risk of opioid misuse (as suggested by a UDT indicating high-risk medication-related behavior). Turner et al. (2014) showed that patients in the 45-64 year age group were significantly less likely to have an aberrant UDT (detection of a non-prescribed opioid, non-prescribed benzodiazepine, illicit drug, or tetrahydrocannabinol [THC]) in comparison to patients in the 20-44 age group.[94] Patients in the 45-64 and ≥65 age groups were significantly less likely than 20-44 year olds to have non-detection of a prescribed opioid as well (indicating possible diversion).[94] ", "The Edlund et al. (2014) study of 568,640 commercial health plan patients (see Recommendation 2 and 3) found that those diagnosed with CNCP and an alcohol use or non-opioid drug use disorder had higher rates of OUD (OR: 3.22, 95% CI: 1.79-5.80 for patients with pre-index alcohol use disorder compared to no alcohol use disorder; OR: 8.26, 95% CI: 4.74-14.39 for patients with pre-index non-opioid drug use disorders compared to no non-opioid drug use disorders).[86] Moreover, Huffman et al. (2015) found that the presence of a lifetime history of SUD for patients with CNCP was associated with 28 times increased odds of therapeutic opioid addiction compared to patients with CNCP without a lifetime history of SUD (OR: 28.58, 95% CI: 10.86-75.27).[87] ", "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] ", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Some may interpret the recommendation to limit opioid use by age as arbitrary and potentially discriminatory when taken out of context; however, there is good neurophysiologic rationale explaining the relationship between age and OUD and overdose. Studies in other areas (e.g., use of different substances) indicate that developing brains (age <30 years) are at increased risk of abnormalities and addiction when exposed to substance use early in life.[95-98] ", "Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15). " ]

[ "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. " ]

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[ "Moderate quality evidence demonstrates that the prevalence of OUD in patients with CNCP is related to duration of opioid use as well as dose (see Recommendations 7-9).[86-88] There are two studies of patients with CNCP which support the current recommendations. Edlund et al. (2014) conducted a large retrospective cohort study where they examined claims data from a health insurance database between 2000 and 2005 to examine factors predictive of developing OUD.[86] Days’ supply of opioids was categorized as none, acute duration (1-90 days), or chronic duration (91+ days). Average daily dose was defined as none, low (1-36 mg MEDD), medium (36-120 mg MEDD), or high (>120 mg MEDD). The OR of developing OUD ranged based on dose and duration (OR: 3.03, 95% CI: 2.32-3.95 for low dose, acute opioid prescription; OR: 14.92, 95% CI: 10.38-21.46 for low dose, chronic opioids prescriptions; OR: 3.10, 95% CI: 1.67-5.77 for high dose, acute opioid prescriptions; OR: 122.45, 95% CI: 72.79-205.99 for high dose, chronic opioid prescriptions). They found that even greater than opioid dose, duration of OT was the strongest predictor of developing OUD. Additionally, a study by Boscarino et al. (2011) examined medical records from a large healthcare system.[89] Through interviews with a random sample of patients on LOT, they examined factors associated with and the prevalence of OUD (using DSM IV and 5 criteria). These results showed that the prevalence of lifetime OUD for patients on LOT was 34.9% (based on DSM-5 criteria) and 35.5% (based on DSM-IV criteria). ", "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "As substance misuse in patients on LOT is more than 30% in some series,[107] UDT and confirmatory testing is used as an additional method of examining for patient substance misuse and adherence to the prescribed regimen. UDTs, used in the appropriate way, help to address safety, fairness, and trust with OT. Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to the false positive and negative rates associated with UDTs.[53] Interpretation of a UDT and confirmatory results requires education and knowledge of the local procedures and clinical scenario. Local education and access to expert interpretation is necessary. UDT results are helpful and can help identify active SUD or possible diversion. Accordingly, clinicians should obtain UDT prior to initiating or continuing LOT and periodically thereafter. When a patient is referred for SUD treatment or is engaged in on-going treatment there should be close communication between the SUD and pain management providers. The ideal approach is an interdisciplinary format (see Recommendation 16). For more information, see Appendix B on UDT and confirmatory testing. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "Future research is needed to ascertain whether abuse deterrent formulations actually reduce OUD when used for chronic pain, and whether said formulations differ across clinical outcomes such as pain, function, and adverse events. ", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping)." ]

[ "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. " ]

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[ "Opioids are not first-line or routine therapy for chronic pain. Establish treatment goals before starting opioid therapy and a plan if therapy is discontinued. Only continue opioid if there is clinically meaningful improvement in pain and function. Discuss risks, benefits and responsibilities for managing therapy before starting and during treatment.", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. ", "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Given the recognized risks of opioid therapy, an optimal approach to care should include a robust, signature informed consent process that is patient-centered and provides patients with information about known benefits and harms of OT and treatment alternatives. In 2014, VA established a requirement for signature informed consent, consistent with VA policy for other treatments or procedures with a significant risk of complications or morbidity. See Appendix A, Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain (found at http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf), and 38 C.F.R. §17.32 (2012). ", "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. ", "There is a paradigm shift occurring in approaches to ensuring and documenting patient and provider understanding and expectations regarding the risks and benefits of LOT. The 2010 OT CPG reflected prior practice of using opioid treatment (or pain care) agreements. OTAs have been described as coercive rather than therapeutic, lack respect for individual autonomy, can be a barrier to pain care, and may be harmful to the patient-provider relationship.[102-105] ", "The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG. " ]

[ "Use a shared decision-making approach to discuss options for OUD treatment. Medication-Assisted Therapy (MAT) is the first-line treatment for OUD. The preferred OUD treatment is Opioid Agonist Therapy (OAT). Opioid agonist treatment involves taking opioid agonist medications such as buprenorphine/naloxone (Suboxone) or methadone. Methadone must be provided through a federally regulated opioid treatment program for OUD therapy. The alternative OUD treatment is extended-release (ER) injectable naltrexone (Vivitrol). MAT can be provided in a variety of treatment settings including residential SUD treatment, intensive outpatient SUD treatment, regular SUD specialty care clinic, primary care or general mental health clinic, or federally regulated opioid treatment program. Moral injury is an act of transgression that leads to serious inner conflict typically brought on by betrayal, disproportionate violence, incidents involving civilians, within-rank violence. For moral injury, treatment via psychologists or chaplains is available. Central sensitization (e .g., fibromyalgia, chronic headaches, and likely many other types of complex chronic pain). Some examples of medical complications are lung disease, hepatic disease, renal disease, or fall risk. Sleep apnea is a sleep disorder." ]

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[ "There are situations in which opioids may be necessary therapy for acute pain, even when substantial risk factors exist. It is important to incorporate opioid risk mitigation strategies into opioid prescribing for acute pain. These strategies should include patient education, use of non-opioid adjunctive therapy, and structured reassessment of opioid risks and benefits for all on acute OT. Also, consider checking the PDMP and performing a UDT. ", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "Given the recognized risks of opioid therapy, an optimal approach to care should include a robust, signature informed consent process that is patient-centered and provides patients with information about known benefits and harms of OT and treatment alternatives. In 2014, VA established a requirement for signature informed consent, consistent with VA policy for other treatments or procedures with a significant risk of complications or morbidity. See Appendix A, Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain (found at http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf), and 38 C.F.R. §17.32 (2012). ", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "For those at higher risk of adverse events related to opioid therapy, the following strategies may help to decrease opioid-related overdose events and unintended long-term use: checking the PDMP, performing a UDT, placement in an inpatient setting or monitored environment, and/or providing OEND. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education." ]

[ "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily." ]

[ "247" ]

[ "Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.", "Here is an example of an opioid taper plan for a Veteran. Veteran is currently taking morphine SR 60 mg, 1 tablet every 8 hours. Goal is to reduce the dose of morphine to SR 30 mg every 8 hours using a slow taper. Dose will be reduced by 15 mg every 10 days. Using morphine SR 15 mg tablets, follow the schedule below. From days 1 to 10, take 4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 11 to 20, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 21 to 30, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 3 tablets = 45 mg in the evening.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation. We recommend against prescribing long-acting opioids for acute pain, as an as-needed medication, or on initiation of long-term opioid therapy. ", "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules." ]

[ "The components of biopsychosocial assessment are pain assessment, patient functional goals, impact of pain on family, work, life, review of previous diagnostic studies, additional consultations and referrals, coexisting illness and treatments and effect on pain, significant psychological, social, or behavioral factors that may affect treatment, family history of chronic pain, collateral of family involvement, patient beliefs/knowledge of the cause of their pain and their treatment preferences along with the perceived efficacy of various treatment options. For patients already on OT, include assessment of psychological factors related to continuing vs. tapering OT. The psychological factors are beliefs, expectations, fears. Pain assessment includes history, physical exam, comorbidities, previous treatment and medications, duration of symptoms, onset and triggers. Examples of absolute contraindications to initiating opioid therapy for chronic pain are true life-threatening allergy to opioids, active SUD, elevated suicide risk, concomitant use of benzodiazepines. LOT refers to long-term opioid therapy; OT refers to opioid therapy; PDMP refers to Prescription Drug Monitoring Program; SUD refers to substance use disorder; UDT refers to urine drug test; VA/DoD Suicide CPG refers to VA/DoD Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide." ]

[ "248" ]

[ "A comprehensive pain assessment includes a biopsychosocial interview and focused physical exam. Elements of the biopsychosocial pain interview include a pain-related history, assessment of pertinent medical and psychiatric comorbidities including personal and family history of SUD, functional status and functional goals, coping strategies, and a variety of psychosocial factors such as the patient’s beliefs and expectations about chronic pain and its treatment. Patients with chronic pain may also experience worsened quality of life, mental health, immune system function, physical function, sleep, employment status, and impaired personal relationships. Worsening of some of these factors (e.g., quality of life, change in employment status) seems to also be associated with pain severity and the presence of psychiatric comorbidities. Patients with chronic pain report psychological complaints (e.g., depression, anxiety, poor self-efficacy, poor general emotional functioning) more often than patients without chronic pain. Further, there can be social and psychological consequences such as decreased ability to successfully maintain relationship and career roles and increased depression, fear, and anxiety as a result of pain.", "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "The shared decision making process for chronic pain treatment planning is based on the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider (Figure 1). The patient-centered assessment incorporates a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations. Next, the clinician performs a biopsychosocial assessment and determines clinically appropriate therapeutic options in which benefits are likely to outweigh risks. The process culminates in a shared decision making process to develop a patient-centered treatment plan by the patient selecting from the clinically appropriate treatment options generated in the first two steps. ", "Pain is defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage…Pain is always subjective…It is unquestionably a sensation in a part or parts of the body, but it is also always unpleasant and therefore also an emotional experience.” All of these facets signify the complexity of pain as a condition by itself and how it relates to both the brain and the body. Pain as a symptom is multifaceted and is described and characterized by many factors such as its quality (e.g., sharp versus dull), intensity, timing, location, and whether it is associated with position or movement. ", "Chronic pain is defined as pain lasting three months or more. It is often associated with changes in the central nervous system (CNS) known as central sensitization. Whereas acute and subacute pain are thought to involve primarily nociceptive processing areas in the CNS, chronic pain is thought to be associated with alterations in brain centers involved with emotions, reward, and executive function as well as central sensitization of nociceptive pathways across several CNS areas.", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "Monitoring standards with administration of OT for acute pain vary depending on a number of factors including the setting, specifics of the painful insult, patient medical factors, and selected medication potency/dose/route of administration/adjunct selection. ", "With the passage of the Patient Protection and Affordable Care Act (PPACA) in March 2010, the Interagency Pain Research Coordinating Committee was created to coordinate pain research efforts throughout federal government agencies. The Committee was tasked with summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations. The Committee published the National Pain Strategy in March 2016 in response to the call from the National Academy of Medicine to increase awareness of pain as a significant public health issue in the U.S. The strategy made recommendations in a number of areas including prevention and care, professional education and training, and population research. The plan is aimed at decreasing the prevalence of all types of pain (acute and chronic) in the U.S., as well as the disability and morbidity associated with pain.", "Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82] ", "The accumulation of evidence of harms and the absence of evidence of long-term benefits has warranted a newly cautious approach to LOT that prioritizes safety. This approach coupled with the evidence of both the safety and efficacy for non-pharmacologic and non-opioid pharmacologic pain therapies has led to the current transformation in the way in which pain is viewed and treated. The biopsychosocial model of pain recognizes pain as a complex multidimensional experience that requires multimodal and integrated care approaches. Within this context, non-pharmacologic treatments and non-opioid medications are the preferred treatments for chronic non-terminal pain. OT has a limited role, primarily in the treatment of severe acute pain, post-operative pain, and end-of-life pain. " ]

[ "Future research is needed to ascertain whether abuse deterrent formulations actually reduce OUD when used for chronic pain, and whether said formulations differ across clinical outcomes such as pain, function, and adverse events. " ]

[ "249" ]

[ "There was insufficient evidence to recommend for or against any specific opioid or opioid formulation, specifically the following: Short-acting versus long-acting opioids (for LOT for chronic pain), Route of administration/delivery among alternatives such as transdermal, buccal, sublingual, or pumps, Abuse deterrent formulations of opioids compared to non-abuse deterrent formulations, Tramadol and other dual-mechanism opioids. Buprenorphine for pain (compared to other opioids), Methadone (with QT monitoring). ", "As outlined in this CPG, there is a rapidly growing understanding of the significant harms of LOT even at doses lower than 50 mg oral morphine equivalent daily dose [MEDD], including but not limited to overdose and OUD. At the same time there is a lack of high quality evidence that LOT improves pain, function, and/or quality of life. The literature review conducted for this CPG identified no studies evaluating the effectiveness of LOT for outcomes lasting longer than 16 weeks. Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, non-opioid treatments are preferred for chronic pain. Patient values, goals, concerns, and preferences must be factored into clinical decision making on a case-by-case basis. When considering the initiation or continuation of LOT, it is important to consider whether LOT will result in clinically meaningful improvements in function such as readiness to return to work/duty and/or measurable improvement in other areas of function, such that the benefits outweigh the potential harms. ", "Monitoring standards with administration of OT for acute pain vary depending on a number of factors including the setting, specifics of the painful insult, patient medical factors, and selected medication potency/dose/route of administration/adjunct selection. ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "Future Research: Future research is needed to better determine the impact of systematic reductions in MEDD in terms of pain relief, specific pain and medical conditions, overdose morbidity and mortality as well as potential adverse outcomes (e.g., the incidence of associated OUD, infectious diseases related to intravenous drug use disorder, and drug-related crime and diversion) and to determine whether/which conditions may be appropriately treated with LOT. Research is also needed to determine how frequency of monitoring should be impacted by dose.", "Individuals with conditions that result in or co-occur with chronic pain may have different needs or respond to treatment differently than individuals with chronic pain alone. Many different physical and psychological conditions have a pain component that can be difficult to distinguish from the underlying mechanism of illness. Furthermore, the treatment of co-occurring pain and other conditions may vary or require special considerations during their management. Readers are encouraged to consult other VA/DoD CPGs for further information (see VA/DoD Clinical Practice Guidelines website: www.healthquality.va.gov). ", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "We do not recommend for or against abuse deterrent formulations for LOT. Our searches identified two RCTs in which the benefits of co-prescribing of naloxone with opioids were examined.[143,144] However, both RCTs were rated as low to very low quality with short-term follow-up. One open-label RCT enrolling 453 patients with chronic low back pain considered the safety and tolerability of an abuse deterrent formulation of oxycodone/naloxone relative to oxycodone or morphine at 12-week follow-up.[143] Another RCT considered the safety and efficacy of oxycodone/naloxone prolonged-release relative to oxycodone prolonged-release in 184 patients with moderate-to-severe chronic cancer pain at four-week follow-up.[144] An observational study (not included in the evidence review) suggested that the Introductory information of abuse deterrent opioid formulations did not help reduce abuse of opioids as a class and that patients may switch from one opioid to another based on the availability or the lack of availability of abuse deterrent formulations.[145] ", "Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered. ", "Given the relevance of all four domains in grading recommendations, the Work Group encountered multiple instances in which confidence in the quality of the evidence was low or very low, while there was marked imbalance of benefits and harms, as well as certain other important considerations arising from the domains of values and preferences and/or other implications. In particular, the harms due to the potential for severe adverse events associated with opioids, particularly overdose and OUD, often far outweigh the potential benefits. As such, in accounting for all four domains, these factors contributed to strong recommendations in multiple instances." ]

[ "A number of studies suggest certain chronic pain conditions represent an independent risk factor for suicide.[123-130] A recent large retrospective cohort study also suggests an association with prescribed opioid dose and suicide risk among Veterans receiving OT for CNCP.[131] Suicide risk is not static, and many factors influence an individual’s risk of suicide at any given point in time, as noted in the VA/DoD Suicide CPG. Thus, ongoing assessment of suicide risk is important whether one is initiating, maintaining, or terminating LOT. " ]

[ "250" ]

[ "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "Moderate quality evidence demonstrates that the prevalence of OUD in patients with CNCP is related to duration of opioid use as well as dose (see Recommendations 7-9).[86-88] There are two studies of patients with CNCP which support the current recommendations. Edlund et al. (2014) conducted a large retrospective cohort study where they examined claims data from a health insurance database between 2000 and 2005 to examine factors predictive of developing OUD.[86] Days’ supply of opioids was categorized as none, acute duration (1-90 days), or chronic duration (91+ days). Average daily dose was defined as none, low (1-36 mg MEDD), medium (36-120 mg MEDD), or high (>120 mg MEDD). The OR of developing OUD ranged based on dose and duration (OR: 3.03, 95% CI: 2.32-3.95 for low dose, acute opioid prescription; OR: 14.92, 95% CI: 10.38-21.46 for low dose, chronic opioids prescriptions; OR: 3.10, 95% CI: 1.67-5.77 for high dose, acute opioid prescriptions; OR: 122.45, 95% CI: 72.79-205.99 for high dose, chronic opioid prescriptions). They found that even greater than opioid dose, duration of OT was the strongest predictor of developing OUD. Additionally, a study by Boscarino et al. (2011) examined medical records from a large healthcare system.[89] Through interviews with a random sample of patients on LOT, they examined factors associated with and the prevalence of OUD (using DSM IV and 5 criteria). These results showed that the prevalence of lifetime OUD for patients on LOT was 34.9% (based on DSM-5 criteria) and 35.5% (based on DSM-IV criteria). ", "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. ", "Opioid medications are potentially lethal and an assessment of current suicide risk should be made at every phase of treatment. The VA/DoD Suicide CPG recommends restricting the availability of lethal means for patients considered to be at intermediate or high acute risk of suicide (determined by presence and severity of suicidal ideation, level of intention to act, existence of risk factors, limited or absent protective factors, etc.). Accordingly, suicidality is considered to be an important risk factor for OT (see Risk Factors for Adverse Outcomes of Opioid Therapy). ", "This OT CPG is in line with the efforts described above to improve our understanding and treatment of pain, as well as to mitigate the inappropriate prescribing and ill effects of opioids. It is intended for VA and DoD healthcare practitioners including physicians, nurse practitioners, physician assistants, physical and occupational therapists, psychologists, social workers, nurses, clinical pharmacists, chaplains, addiction counselors, and others involved in the care of Service Members and their beneficiaries, retirees and their beneficiaries, or Veterans on or being considered for LOT. In conjunction with other efforts already under way, this CPG is aimed at improving safe and appropriate prescribing and use of opioids to treat chronic pain. ", "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.", "In a prospective cohort study (not included in the evidence review as it did not include information on acute versus chronic pain in the patient population), Dasgupta et al. (2015) compared residents of North Carolina who had received an opioid prescription in the last year to residents who had not. The study examined the outcome of population-based rates of opioid overdose mortality by opioid dose, without use of a presupposed threshold (Table 3).[135] There was no safe dose of opioid. Among the over nine million individuals followed for one year, 629 died from opioid overdose. Of these 629 individuals, 151 had no record of having been dispensed an opioid. It is possible these opioids were obtained through illicit channels or social sharing/diversion. Of the 478 patients who died from an opioid overdose who were prescribed opioids, 235 (49%) had been prescribed <80 mg MEDD. Overdose incidence rate ratios (IRRs) doubled each time the MEDD ranges increase from 60.0-79.9 mg to 80.0-99.9 mg (IRR 2.9 to 6.2), then to 120-139.9 mg (IRR 14.1), 160-179.9 mg (IRR 29.5), and 350-399.9 mg (IRR 63.2). ", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]" ]

[ "In addition to benzodiazepines, the addition of other psychoactive medications to LOT must be made with caution. While the evidence for harm associated with the combination of opioids and Z-drugs (e.g., zolpidem, eszopiclone) is not as strong as the evidence for harm associated with the combination of opioids and benzodiazepines, we suggest not prescribing Z-drugs to patients who are on LOT, as moderate quality evidence demonstrates that the combination of zolpidem and opioids increases the AOR of overdose.[66] The evidence reviewed also identifies potential adverse outcomes (e.g., risk of overdose) with the combined use of antidepressants and opioids in patients who do not have depression.[66] This particular study did not differentiate between classes of antidepressants, limiting the ability of the Work Group to recommend for or against prescribing opioids and a specific class of antidepressants. As such, there is no recommendation in this guideline with respect to using specific classes of antidepressants and LOT. " ]

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[ "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] " ]

[ "Use a shared decision-making approach to discuss options for OUD treatment. Medication-Assisted Therapy (MAT) is the first-line treatment for OUD. The preferred OUD treatment is Opioid Agonist Therapy (OAT). Opioid agonist treatment involves taking opioid agonist medications such as buprenorphine/naloxone (Suboxone) or methadone. Methadone must be provided through a federally regulated opioid treatment program for OUD therapy. The alternative OUD treatment is extended-release (ER) injectable naltrexone (Vivitrol). MAT can be provided in a variety of treatment settings including residential SUD treatment, intensive outpatient SUD treatment, regular SUD specialty care clinic, primary care or general mental health clinic, or federally regulated opioid treatment program. Moral injury is an act of transgression that leads to serious inner conflict typically brought on by betrayal, disproportionate violence, incidents involving civilians, within-rank violence. For moral injury, treatment via psychologists or chaplains is available. Central sensitization (e .g., fibromyalgia, chronic headaches, and likely many other types of complex chronic pain). Some examples of medical complications are lung disease, hepatic disease, renal disease, or fall risk. Sleep apnea is a sleep disorder." ]

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[ "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime.", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Chronic pain is defined as pain lasting three months or more. It is often associated with changes in the central nervous system (CNS) known as central sensitization. Whereas acute and subacute pain are thought to involve primarily nociceptive processing areas in the CNS, chronic pain is thought to be associated with alterations in brain centers involved with emotions, reward, and executive function as well as central sensitization of nociceptive pathways across several CNS areas.", "Synthetic opioids such as fentanyl analogs, potent opioid receptor agonists, are responsible for a recent rise in death rates. Fentanyl analogs that may be used to create counterfeit opioid analgesic pills can cause a toxidrome characterized by significant CNS and profound respiratory depression requiring multiple naloxone doses for reversal.[113] ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "Acute psychiatric instability or intermediate to high acute suicide risk: Intermediate to high acute suicide risk, severe depression, unstable bipolar disorder, or unstable psychotic disorder precludes the safe use of self-administered LOT.[60] Im et al. (2015) (n=487,462) found that a diagnosis of a mood disorder was significantly associated with suicide attempts for the chronic use of short-acting and long-acting opioids compared with no diagnosis of a mood disorder.[61] In a study of patients on opioids, Campbell et al. (2015) reported that those with bipolar disorder had 2.9 times the odds of suicidal ideation within the past 12 months as well as 3.2 times the odds of a lifetime suicide attempt compared to those with no bipolar disorder.[62] See Recommendation 8 and the VA/DoD Suicide CPG2 for more information on suicidality. See the VA/DoD Clinical Practice Guideline for Management of Bipolar Disorder in Adults (VA/DoD BD CPG) for more information on bipolar disorder.3 Merrill and colleagues found that high dose chronic opioid therapy for pain was associated with depressed mood.[63] Treatment for chronic pain with movement, exercise, and cognitive-behavioral therapy for pain may have benefits in treating depression, PTSD, and in reducing suicide risk.[64] ", "We recommend interdisciplinary care that addresses pain, substance use disorders, and/or mental health problems for patients presenting with high risk and/or aberrant behavior. We recommend offering medication assisted treatment for opioid use disorder to patients with chronic pain and opioid use disorder. Note: See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders.", "Headache not responsive to other pain treatment modalities: LOT is an ineffective treatment modality for patients with migraine headaches (with or without aura), tension-type headaches, occipital neuralgia, or myofascial pain and may result in worsening of the underlying headache condition through factors such as central sensitization and withdrawal. " ]

[ "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses." ]

[ "253" ]

[ "Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "The increase in opioid prescribing is matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance use disorders (SUD) treatment admissions from 1999 to 2008. In 2009, drug overdose became the leading cause of injury-related death in the U.S., surpassing deaths from traffic accidents. In 2014, 1.9 million Americans were affected by an OUD related to non-medical use of prescription pain relievers, and in the same year, 18,893 individuals died as a result of a prescription drug overdose. There has been a four-fold increase in the absolute number of deaths associated with use of opioids since 2000, and a 14% increase between 2013 and 2014 alone. In a survey of patients prescribed opioids for chronic non-cancer pain (CNCP) and their family members, 34% of patients reported that they thought they were “addicted” or “dependent” on opioid pain medication, 34% said that they used the medication for “fun” or to “get high,” while 22% used the medication to relieve day-to-day stress.", "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. (Strong for| Reviewed, New-replaced) Note: Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits. For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies (see Recommendations 7-9), assessment for opioid use disorder, and consideration for tapering when risks exceed benefits (see Recommendation 14). (Strong for| Reviewed, New-replaced) ", "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. ", "In a prospective cohort study (not included in the evidence review as it did not include information on acute versus chronic pain in the patient population), Dasgupta et al. (2015) compared residents of North Carolina who had received an opioid prescription in the last year to residents who had not. The study examined the outcome of population-based rates of opioid overdose mortality by opioid dose, without use of a presupposed threshold (Table 3).[135] There was no safe dose of opioid. Among the over nine million individuals followed for one year, 629 died from opioid overdose. Of these 629 individuals, 151 had no record of having been dispensed an opioid. It is possible these opioids were obtained through illicit channels or social sharing/diversion. Of the 478 patients who died from an opioid overdose who were prescribed opioids, 235 (49%) had been prescribed <80 mg MEDD. Overdose incidence rate ratios (IRRs) doubled each time the MEDD ranges increase from 60.0-79.9 mg to 80.0-99.9 mg (IRR 2.9 to 6.2), then to 120-139.9 mg (IRR 14.1), 160-179.9 mg (IRR 29.5), and 350-399.9 mg (IRR 63.2). ", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting body of research expanding detailing the lack of benefit and severe harms of LOT.", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "From 2000 through 2010, the proportion of pain visits during which opioid and non-opioid pharmacologic therapies were prescribed increased from 11.3% to 19.6% and from 26% to 29%, respectively. In 2012, for every 100 persons in the United States (U.S.), 82.5 opioid prescriptions and 37.6 benzodiazepine prescriptions were written by healthcare providers. In the emergency department, at least 17% of discharges included prescriptions for opioids." ]

[ "Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered. " ]

[ "254" ]

[ "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances", "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] ", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "Individuals with conditions that result in or co-occur with chronic pain may have different needs or respond to treatment differently than individuals with chronic pain alone. Many different physical and psychological conditions have a pain component that can be difficult to distinguish from the underlying mechanism of illness. Furthermore, the treatment of co-occurring pain and other conditions may vary or require special considerations during their management. Readers are encouraged to consult other VA/DoD CPGs for further information (see VA/DoD Clinical Practice Guidelines website: www.healthquality.va.gov). ", "Future Research: Future research is needed to better determine the impact of systematic reductions in MEDD in terms of pain relief, specific pain and medical conditions, overdose morbidity and mortality as well as potential adverse outcomes (e.g., the incidence of associated OUD, infectious diseases related to intravenous drug use disorder, and drug-related crime and diversion) and to determine whether/which conditions may be appropriately treated with LOT. Research is also needed to determine how frequency of monitoring should be impacted by dose.", "Co-administration of a drug capable of inducing fatal drug-drug interactions: Providers should carefully rule out and avoid potential drug interactions prior to initiating LOT. For example, the following combinations are dangerous:[66] i)Opioids with benzodiazepines (compared to patients with no prescription, the odds ratio [OR] and 95% confidence interval [CI] for drug-related death was OR: 14.92, 95% CI: 7.00- 31.77 for patients who filled a prescription for opioids and benzodiazepines; OR: 3.40, 95% CI: 1.60-7.21 for patients who filled only an opioid prescription, and 7.21, 95% CI: 3.33-15.60 for patients who filled only a benzodiazepine prescription) (see Recommendation 5) [66,67], ii)Fentanyl with CYP3A4 inhibitors, iii) Methadone with drugs that can prolong the QT interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) (e.g., CYP450 2B6 inhibitors) ", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. " ]

[ "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution." ]

[ "255" ]

[ "Future Research: Future research is needed to better determine the impact of systematic reductions in MEDD in terms of pain relief, specific pain and medical conditions, overdose morbidity and mortality as well as potential adverse outcomes (e.g., the incidence of associated OUD, infectious diseases related to intravenous drug use disorder, and drug-related crime and diversion) and to determine whether/which conditions may be appropriately treated with LOT. Research is also needed to determine how frequency of monitoring should be impacted by dose.", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. ", "Use a shared decision-making approach to discuss options for OUD treatment. Medication-Assisted Therapy (MAT) is the first-line treatment for OUD. The preferred OUD treatment is Opioid Agonist Therapy (OAT). Opioid agonist treatment involves taking opioid agonist medications such as buprenorphine/naloxone (Suboxone) or methadone. Methadone must be provided through a federally regulated opioid treatment program for OUD therapy. The alternative OUD treatment is extended-release (ER) injectable naltrexone (Vivitrol). MAT can be provided in a variety of treatment settings including residential SUD treatment, intensive outpatient SUD treatment, regular SUD specialty care clinic, primary care or general mental health clinic, or federally regulated opioid treatment program. Moral injury is an act of transgression that leads to serious inner conflict typically brought on by betrayal, disproportionate violence, incidents involving civilians, within-rank violence. For moral injury, treatment via psychologists or chaplains is available. Central sensitization (e .g., fibromyalgia, chronic headaches, and likely many other types of complex chronic pain). Some examples of medical complications are lung disease, hepatic disease, renal disease, or fall risk. Sleep apnea is a sleep disorder.", "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. ", "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] ", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "Community-based Needle Exchange Programs or Syringe Service Programs: Nearly 80% of new users of injectable opioids had previously used prescription oral opioid pain medication.[118,119] Illicit use of injectable opioids is accompanied by an increased rate of human immunodeficiency virus (HIV) and hepatitis infection. Community-based needle exchange programs have been shown to be an effective risk mitigation strategy for reducing high-risk behaviors (e.g., sharing needles) and infectious disease transmission among injection drug users.[120] For those patients who develop OUD and progress to intravenous drug use, the first recommendation should be for medication assisted treatment (MAT) for OUD (see Recommendation 17). For patients who decline MAT for OUD, clinicians should consider educating the patient regarding sterile injection techniques and community based needle exchange programs, if programs are available. The 2015 outbreak of HIV/hepatitis in rural Indiana and subsequent successful implementation of a needle exchange program is an example of the threat to rural communities from non-prescription opioid use and the potential benefits of needle exchange programs for use as a risk mitigation strategy.[121,122] ", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances" ]

[ "The treatment options for nausea are prochlorperazine 5 to 10 mg every 4 hours as needed, promethazine 25 mg orally or rectally every 6 hours as needed, ondansetron 4 mg every 6 hours as needed. The treatment option for abdominal cramping is dicyclomine 20 mg every 6 to 8 hours as needed. The treatment options for diarrhea are loperamide 4 mg orally initially, then 2 mg with each loose stool, not to exceed 16 mg daily; bismuth subsalicylate 524 mg every 0.5 to 1 hour orally, not to exceed 4192 mg/day." ]

[ "256" ]

[ "The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime.", "Use a shared decision-making approach to discuss options for OUD treatment. Medication-Assisted Therapy (MAT) is the first-line treatment for OUD. The preferred OUD treatment is Opioid Agonist Therapy (OAT). Opioid agonist treatment involves taking opioid agonist medications such as buprenorphine/naloxone (Suboxone) or methadone. Methadone must be provided through a federally regulated opioid treatment program for OUD therapy. The alternative OUD treatment is extended-release (ER) injectable naltrexone (Vivitrol). MAT can be provided in a variety of treatment settings including residential SUD treatment, intensive outpatient SUD treatment, regular SUD specialty care clinic, primary care or general mental health clinic, or federally regulated opioid treatment program. Moral injury is an act of transgression that leads to serious inner conflict typically brought on by betrayal, disproportionate violence, incidents involving civilians, within-rank violence. For moral injury, treatment via psychologists or chaplains is available. Central sensitization (e .g., fibromyalgia, chronic headaches, and likely many other types of complex chronic pain). Some examples of medical complications are lung disease, hepatic disease, renal disease, or fall risk. Sleep apnea is a sleep disorder.", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "We recommend alternatives to opioids for mild-to-moderate acute pain. We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "We recommend alternatives to opioids for mild-to-moderate acute pain. (Strong for). We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. (Weak for). If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. (Strong for). Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.", "Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82] ", "There was insufficient evidence to recommend for or against any specific opioid or opioid formulation, specifically the following: Short-acting versus long-acting opioids (for LOT for chronic pain), Route of administration/delivery among alternatives such as transdermal, buccal, sublingual, or pumps, Abuse deterrent formulations of opioids compared to non-abuse deterrent formulations, Tramadol and other dual-mechanism opioids. Buprenorphine for pain (compared to other opioids), Methadone (with QT monitoring). " ]

[ "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level." ]

[ "257" ]

[ "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.", "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. ", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.", "Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules." ]

[ "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community." ]

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[ "We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules.", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.", "a) We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. (Strong against) b) For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, New-replaced) " ]

[ "The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime." ]

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[ "Use a shared decision-making approach to discuss options for OUD treatment. Medication-Assisted Therapy (MAT) is the first-line treatment for OUD. The preferred OUD treatment is Opioid Agonist Therapy (OAT). Opioid agonist treatment involves taking opioid agonist medications such as buprenorphine/naloxone (Suboxone) or methadone. Methadone must be provided through a federally regulated opioid treatment program for OUD therapy. The alternative OUD treatment is extended-release (ER) injectable naltrexone (Vivitrol). MAT can be provided in a variety of treatment settings including residential SUD treatment, intensive outpatient SUD treatment, regular SUD specialty care clinic, primary care or general mental health clinic, or federally regulated opioid treatment program. Moral injury is an act of transgression that leads to serious inner conflict typically brought on by betrayal, disproportionate violence, incidents involving civilians, within-rank violence. For moral injury, treatment via psychologists or chaplains is available. Central sensitization (e .g., fibromyalgia, chronic headaches, and likely many other types of complex chronic pain). Some examples of medical complications are lung disease, hepatic disease, renal disease, or fall risk. Sleep apnea is a sleep disorder.", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "The treatment options for nausea are prochlorperazine 5 to 10 mg every 4 hours as needed, promethazine 25 mg orally or rectally every 6 hours as needed, ondansetron 4 mg every 6 hours as needed. The treatment option for abdominal cramping is dicyclomine 20 mg every 6 to 8 hours as needed. The treatment options for diarrhea are loperamide 4 mg orally initially, then 2 mg with each loose stool, not to exceed 16 mg daily; bismuth subsalicylate 524 mg every 0.5 to 1 hour orally, not to exceed 4192 mg/day.", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "We recommend interdisciplinary care that addresses pain, substance use disorders, and/or mental health problems for patients presenting with high risk and/or aberrant behavior. We recommend offering medication assisted treatment for opioid use disorder to patients with chronic pain and opioid use disorder. Note: See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders.", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).", "Headache not responsive to other pain treatment modalities: LOT is an ineffective treatment modality for patients with migraine headaches (with or without aura), tension-type headaches, occipital neuralgia, or myofascial pain and may result in worsening of the underlying headache condition through factors such as central sensitization and withdrawal. ", "There was insufficient evidence to recommend for or against any specific opioid or opioid formulation, specifically the following: Short-acting versus long-acting opioids (for LOT for chronic pain), Route of administration/delivery among alternatives such as transdermal, buccal, sublingual, or pumps, Abuse deterrent formulations of opioids compared to non-abuse deterrent formulations, Tramadol and other dual-mechanism opioids. Buprenorphine for pain (compared to other opioids), Methadone (with QT monitoring). ", "Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82] ", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities." ]

[ "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. " ]

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[ "Consequently, a recommendation to update the 2010 OT CPG was initiated in 2015. The updated CPG, titled Clinical Practice Guideline for Opioid Therapy for Chronic Pain (OT CPG), includes objective, evidence-based information on the management of chronic pain. It is intended to assist healthcare providers in all aspects of patient care, including, but not limited to, diagnosis, treatment, and follow-up.", "The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG. ", "This OT CPG is in line with the efforts described above to improve our understanding and treatment of pain, as well as to mitigate the inappropriate prescribing and ill effects of opioids. It is intended for VA and DoD healthcare practitioners including physicians, nurse practitioners, physician assistants, physical and occupational therapists, psychologists, social workers, nurses, clinical pharmacists, chaplains, addiction counselors, and others involved in the care of Service Members and their beneficiaries, retirees and their beneficiaries, or Veterans on or being considered for LOT. In conjunction with other efforts already under way, this CPG is aimed at improving safe and appropriate prescribing and use of opioids to treat chronic pain. ", "Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid.", "The 2017 version of the VA/DoD OT CPG is the second update to the original CPG. It provides practice recommendations for the care of populations with chronic pain already on or being considered for LOT. Although there are many other approaches to the treatment of chronic pain, the scope of this CPG is to focus on the use of opioids for chronic pain rather than being comprehensive about all treatment options. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the treatment and management of patients with chronic pain on or being considered for LOT. ", "Chronic pain is a national public health problem as outlined in the 2011 study by the National Academy of Medicine (previously the Institute of Medicine [IOM]). At least 100 million Americans suffer from some form of chronic pain. Until recently, the treatment of chronic pain with opioids was increasing at an alarming rate. The increase in prescriptions of these medications has been accompanied by an epidemic of opioid-related adverse events.", "This OT CPG is designed to assist healthcare providers in managing or co-managing patients on or being considered for LOT. Specifically, this CPG is intended for adults, including Veterans as well as deployed and non-deployed Active Duty Service Members, their beneficiaries, and retirees and their beneficiaries, with chronic pain who are receiving care from the VA or DoD healthcare delivery systems. This CPG is not intended for and does not provide recommendations for the management of pain with LOT in children or adolescents, in patients with acute pain, or in patients receiving end-of-life care. As is so for any pharmacotherapy, any decision about prescribing opioids, or alternative medications for pain, for pregnant women should be made with due caution and cognizance of applicable U.S. Food and Drug Administration (FDA) labeling. Any patient in the VA or DoD healthcare system should be offered access to the interventions that are recommended in this guideline after taking into consideration the patient’s specific circumstances. ", "In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting body of research expanding detailing the lack of benefit and severe harms of LOT.", "Given the recognized risks of opioid therapy, an optimal approach to care should include a robust, signature informed consent process that is patient-centered and provides patients with information about known benefits and harms of OT and treatment alternatives. In 2014, VA established a requirement for signature informed consent, consistent with VA policy for other treatments or procedures with a significant risk of complications or morbidity. See Appendix A, Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain (found at http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf), and 38 C.F.R. §17.32 (2012). ", "Opioids are not first-line or routine therapy for chronic pain. Establish treatment goals before starting opioid therapy and a plan if therapy is discontinued. Only continue opioid if there is clinically meaningful improvement in pain and function. Discuss risks, benefits and responsibilities for managing therapy before starting and during treatment." ]

[ "The Opioid Taper Decision Tool is designed to assist Primary Care providers in determining if an opioid taper is necessary for a specific patient, in performing the taper, and in providing follow-up and support during the taper." ]

[ "261" ]

[ "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. ", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Other initiatives are aimed at improving the safe use of opioids, including the OSI Toolkit and the patient guide “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain”. The OSI Toolkit was developed to provide clinicians with materials to inform clinical decision-making regarding opioid therapy and safe opioid prescribing. The toolkit materials can be found at the following link: https://www.va.gov/PAINMANAGEMENT/Opioid_Safety_Initiative_Toolkit.asp. “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain” is aimed at providing information to patients as well as their providers regarding the safe use of opioids. More information can be found at the following link: http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf. To further promote safety and patient centered care, the VHA issued a policy in 2014 requiring standardized education and signature informed consent for all patients receiving LOT for non-cancer pain. ", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors." ]

[ "VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns." ]

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[ "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate. ", "The system-wide goal of this guideline is to improve the patient’s health and well-being by providing evidence-based guidance to providers who are taking care of patients on or being considered for LOT. The expected outcome of successful implementation of this guideline is to assess the patient’s condition, provide education, and determine the best treatment methods in collaboration with the patient and a multidisciplinary care team, optimize the patient’s health outcomes and function and improve quality of life, minimize preventable complications and morbidity, emphasize the use of patient-centered care.", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. ", "Implementing more extensive risk mitigation strategies entails an investment of resources. Primary care providers may require more time with patients to allow for shared decision making and treatment planning. More frequent follow-up of patients on LOT can affect access to care for all empaneled patients. VHA providers must also follow VHA policy regarding education and signature informed consent when providing LOT for patients with non-cancer pain.[101] ", "Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82] ", "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "As part of the patient-centered care approach, clinicians should review the patient’s history including previous treatment approaches, their results, and any other outcomes with the patient. They should ask the patient about his or her willingness to accept a referral to an addiction or other behavioral health specialist when appropriate. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care. The below approach may be used in setting SMART (Specific, Measurable, Action Oriented, Realistic, Timed) goals for the patient (Table 1).", "The VA/DoD OT CPG was developed with a specific patient population in mind—Service Members, Veterans, and their families—that has unique characteristics and needs related to the military culture and communities to which they return. Throughout the VA/DoD OT CPG, attention is paid to the characteristics and needs of these patients, particularly regarding specific risk factors such as risk for suicide, SUD, and other medical and mental health co-occurring conditions that may complicate the management of pain for these patients. Further, these recommendations were made keeping in mind the implications they would have within the VA/DoD healthcare settings, particularly regarding considerations such as resource use, accessibility, and equity related to each recommendation and the urgent need for rigorous attention to the balance of risks and benefits for patients within the VA/DoD specifically. ", "Educate the Veteran by using Bio-Psycho-Social Model e.g., PHI’s “Whole Health” approach. Offer Veterans pain education groups [especially Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for Pain, if available]. Clinicians should offer physical therapy and Complementary and Integrative Health (CIH) interventions such as acupuncture, meditation, yoga. Clinicians should offer slow tapering of opioids to reduce opioid risks while not “cutting off” the Veteran. Clinicians should offer non-opioid pain medications when appropriate. Clinicians should commit to working with the Veteran on other options for improved function and some decrease in pain.", "This guideline is not intended as a standard of care and should not be used as such. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advances and patterns evolve. Today there is variation among state regulations, and this guideline does not cover the variety of ever-changing state regulations that may be pertinent. The ultimate judgement regarding a particular clinical procedure or treatment course must be made by the individual clinician, in light of the patient’s clinical presentation, patient preferences, and the available diagnostic and treatment options. As noted previously, the guideline can assist care providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, in the care for an individual patient." ]

[ "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached." ]

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[ "Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Here is an example of an opioid taper plan for a Veteran. Veteran is currently taking morphine SR 60 mg, 1 tablet every 8 hours. Goal is to reduce the dose of morphine to SR 30 mg every 8 hours using a slow taper. Dose will be reduced by 15 mg every 10 days. Using morphine SR 15 mg tablets, follow the schedule below. From days 1 to 10, take 4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 11 to 20, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 21 to 30, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 3 tablets = 45 mg in the evening.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation. We recommend against prescribing long-acting opioids for acute pain, as an as-needed medication, or on initiation of long-term opioid therapy. ", "If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15). " ]

[ "There are situations in which opioids may be necessary therapy for acute pain, even when substantial risk factors exist. It is important to incorporate opioid risk mitigation strategies into opioid prescribing for acute pain. These strategies should include patient education, use of non-opioid adjunctive therapy, and structured reassessment of opioid risks and benefits for all on acute OT. Also, consider checking the PDMP and performing a UDT. " ]

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[ "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. ", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "As this guideline is related to LOT, the use of opioids for acute pain is not reviewed in detail. However, because acute OT can be a gateway to LOT, it is part of this CPG. A review of the literature indicates that LOT can result from acute opioid use initially intended for short-term therapy. Further, there is a risk of opioid-related overdose even during acute OT. While it is understood that acute OT for severe pain due to injuries or surgery is the most effective option for many patients, the risks associated with acute therapy must be addressed when opioids are prescribed or considered. ", "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. ", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. (Strong for| Reviewed, New-replaced) Note: Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits. For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies (see Recommendations 7-9), assessment for opioid use disorder, and consideration for tapering when risks exceed benefits (see Recommendation 14). (Strong for| Reviewed, New-replaced) " ]

[ "Younger patients are also at a higher risk of opioid misuse (as suggested by a UDT indicating high-risk medication-related behavior). Turner et al. (2014) showed that patients in the 45-64 year age group were significantly less likely to have an aberrant UDT (detection of a non-prescribed opioid, non-prescribed benzodiazepine, illicit drug, or tetrahydrocannabinol [THC]) in comparison to patients in the 20-44 age group.[94] Patients in the 45-64 and ≥65 age groups were significantly less likely than 20-44 year olds to have non-detection of a prescribed opioid as well (indicating possible diversion).[94] " ]

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[ "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15). ", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "There is moderate quality evidence that intensification of monitoring helps mitigate the risk of suicide among patients on LOT. Im et al. (2015) found moderate quality evidence that, at the facility level, patients on LOT within facilities ordering more drug screens than the comparison group were associated with decreased risk of suicide attempt (chronic short-acting opioid group: OR: 0.2, 95% CI: 0.1-0.3; chronic long acting opioid group: OR: 0.3, 95% CI: 0.2-0.6). In addition, patients on long-acting opioids within the facilities providing more follow-up after new prescriptions were associated with decreased risk of suicide attempt (OR: 0.2, 95% CI: 0.0-0.7).[61] ", "The Edlund et al. (2014) study of 568,640 commercial health plan patients (see Recommendation 2 and 3) found that those diagnosed with CNCP and an alcohol use or non-opioid drug use disorder had higher rates of OUD (OR: 3.22, 95% CI: 1.79-5.80 for patients with pre-index alcohol use disorder compared to no alcohol use disorder; OR: 8.26, 95% CI: 4.74-14.39 for patients with pre-index non-opioid drug use disorders compared to no non-opioid drug use disorders).[86] Moreover, Huffman et al. (2015) found that the presence of a lifetime history of SUD for patients with CNCP was associated with 28 times increased odds of therapeutic opioid addiction compared to patients with CNCP without a lifetime history of SUD (OR: 28.58, 95% CI: 10.86-75.27).[87] " ]

[ "Implementing more extensive risk mitigation strategies entails an investment of resources. Primary care providers may require more time with patients to allow for shared decision making and treatment planning. More frequent follow-up of patients on LOT can affect access to care for all empaneled patients. VHA providers must also follow VHA policy regarding education and signature informed consent when providing LOT for patients with non-cancer pain.[101] " ]

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[ "This OT CPG is designed to assist healthcare providers in managing or co-managing patients on or being considered for LOT. Specifically, this CPG is intended for adults, including Veterans as well as deployed and non-deployed Active Duty Service Members, their beneficiaries, and retirees and their beneficiaries, with chronic pain who are receiving care from the VA or DoD healthcare delivery systems. This CPG is not intended for and does not provide recommendations for the management of pain with LOT in children or adolescents, in patients with acute pain, or in patients receiving end-of-life care. As is so for any pharmacotherapy, any decision about prescribing opioids, or alternative medications for pain, for pregnant women should be made with due caution and cognizance of applicable U.S. Food and Drug Administration (FDA) labeling. Any patient in the VA or DoD healthcare system should be offered access to the interventions that are recommended in this guideline after taking into consideration the patient’s specific circumstances. ", "Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82] ", "The accumulation of evidence of harms and the absence of evidence of long-term benefits has warranted a newly cautious approach to LOT that prioritizes safety. This approach coupled with the evidence of both the safety and efficacy for non-pharmacologic and non-opioid pharmacologic pain therapies has led to the current transformation in the way in which pain is viewed and treated. The biopsychosocial model of pain recognizes pain as a complex multidimensional experience that requires multimodal and integrated care approaches. Within this context, non-pharmacologic treatments and non-opioid medications are the preferred treatments for chronic non-terminal pain. OT has a limited role, primarily in the treatment of severe acute pain, post-operative pain, and end-of-life pain. ", "Other initiatives are aimed at improving the safe use of opioids, including the OSI Toolkit and the patient guide “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain”. The OSI Toolkit was developed to provide clinicians with materials to inform clinical decision-making regarding opioid therapy and safe opioid prescribing. The toolkit materials can be found at the following link: https://www.va.gov/PAINMANAGEMENT/Opioid_Safety_Initiative_Toolkit.asp. “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain” is aimed at providing information to patients as well as their providers regarding the safe use of opioids. More information can be found at the following link: http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf. To further promote safety and patient centered care, the VHA issued a policy in 2014 requiring standardized education and signature informed consent for all patients receiving LOT for non-cancer pain. ", "This OT CPG is in line with the efforts described above to improve our understanding and treatment of pain, as well as to mitigate the inappropriate prescribing and ill effects of opioids. It is intended for VA and DoD healthcare practitioners including physicians, nurse practitioners, physician assistants, physical and occupational therapists, psychologists, social workers, nurses, clinical pharmacists, chaplains, addiction counselors, and others involved in the care of Service Members and their beneficiaries, retirees and their beneficiaries, or Veterans on or being considered for LOT. In conjunction with other efforts already under way, this CPG is aimed at improving safe and appropriate prescribing and use of opioids to treat chronic pain. ", "A paradigm shift in the use of OT for chronic non-terminal pain has paralleled this transformation in pain care. Prior to the 1980s, OT was rarely used outside of severe acute injury or post-surgical pain, primarily due to concern for tolerance, physical dependence, and addiction. As the hospice and palliative care movement began defining end-of-life care in the U.S. during the 1980s and emphasizing the importance of pain relief, OT increasingly became a mainstay for cancer and end-of-life pain. Efforts to destigmatize the use of prescription opioids for chronic non-terminal pain encompassed primary care providers and the public. The efforts led to an unprecedented increase in opioid prescribing for chronic non-terminal pain. Chronic pain management became synonymous with LOT in the 1990s and the first decade of the 2000s with significant numbers of patients in pain clinics receiving LOT. Despite the absence of long-term safety or efficacy data, OT for chronic non-terminal pain became a mainstay of therapy. However, as observational and epidemiologic data of harm from LOT accumulated, a much more cautious approach to OT for chronic non-terminal pain has emerged in the decade of the 2010s.", "The 2017 version of the VA/DoD OT CPG is the second update to the original CPG. It provides practice recommendations for the care of populations with chronic pain already on or being considered for LOT. Although there are many other approaches to the treatment of chronic pain, the scope of this CPG is to focus on the use of opioids for chronic pain rather than being comprehensive about all treatment options. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the treatment and management of patients with chronic pain on or being considered for LOT. ", "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. ", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT. Further research is needed to identify strategies for safely managing patients at elevated risk of suicide who demand opioid medications or become further destabilized during tapering. " ]

[ "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. " ]

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[ "Educate the Veteran by using Bio-Psycho-Social Model e.g., PHI’s “Whole Health” approach. Offer Veterans pain education groups [especially Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for Pain, if available]. Clinicians should offer physical therapy and Complementary and Integrative Health (CIH) interventions such as acupuncture, meditation, yoga. Clinicians should offer slow tapering of opioids to reduce opioid risks while not “cutting off” the Veteran. Clinicians should offer non-opioid pain medications when appropriate. Clinicians should commit to working with the Veteran on other options for improved function and some decrease in pain.", "Other initiatives are aimed at improving the safe use of opioids, including the OSI Toolkit and the patient guide “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain”. The OSI Toolkit was developed to provide clinicians with materials to inform clinical decision-making regarding opioid therapy and safe opioid prescribing. The toolkit materials can be found at the following link: https://www.va.gov/PAINMANAGEMENT/Opioid_Safety_Initiative_Toolkit.asp. “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain” is aimed at providing information to patients as well as their providers regarding the safe use of opioids. More information can be found at the following link: http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf. To further promote safety and patient centered care, the VHA issued a policy in 2014 requiring standardized education and signature informed consent for all patients receiving LOT for non-cancer pain. ", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "A second non-inferiority RCT compared once-daily hydromorphone ER to twice-daily oxycodone controlled-release in patients with moderate-to-severe cancer pain. The primary efficacy endpoint was patient assessment of “Brief Pain Inventory (BPI) worst pain in the past 24 hr.” Results demonstrated similar improvements in BPI and that the once-daily hydromorphone formulation was non-inferior to the twice-daily oxycodone formulation. Treatment-emergent adverse events were comparable between the groups as well.[141] The efficacy of long-acting opioids used once-daily is non-inferior to twice-daily use. There was a lack of statistical analysis of the outcomes and a lack of statistical power in both studies, and a small sample size in one study. ", "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "There is moderate quality evidence to support that opioids taken PRN (as needed) for chronic cancer pain versus regularly scheduled doses, or simultaneous PRN plus regularly scheduled, places patients at elevated risk for opioid overdose (HR: 2.75, 95% CI: 1.31-5.78 for as needed; HR: 1.00 for regularly scheduled; HR: 1.84, 95% CI: 0.83-4.05 for simultaneous PRN plus regularly scheduled).[59]", "The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG. ", "Pain is defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage…Pain is always subjective…It is unquestionably a sensation in a part or parts of the body, but it is also always unpleasant and therefore also an emotional experience.” All of these facets signify the complexity of pain as a condition by itself and how it relates to both the brain and the body. Pain as a symptom is multifaceted and is described and characterized by many factors such as its quality (e.g., sharp versus dull), intensity, timing, location, and whether it is associated with position or movement. ", "With the passage of the Patient Protection and Affordable Care Act (PPACA) in March 2010, the Interagency Pain Research Coordinating Committee was created to coordinate pain research efforts throughout federal government agencies. The Committee was tasked with summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations. The Committee published the National Pain Strategy in March 2016 in response to the call from the National Academy of Medicine to increase awareness of pain as a significant public health issue in the U.S. The strategy made recommendations in a number of areas including prevention and care, professional education and training, and population research. The plan is aimed at decreasing the prevalence of all types of pain (acute and chronic) in the U.S., as well as the disability and morbidity associated with pain.", "Implementing more extensive risk mitigation strategies entails an investment of resources. Primary care providers may require more time with patients to allow for shared decision making and treatment planning. More frequent follow-up of patients on LOT can affect access to care for all empaneled patients. VHA providers must also follow VHA policy regarding education and signature informed consent when providing LOT for patients with non-cancer pain.[101] " ]

[ "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances" ]

[ "268" ]

[ "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188] ", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] ", "Co-administration of a drug capable of inducing fatal drug-drug interactions: Providers should carefully rule out and avoid potential drug interactions prior to initiating LOT. For example, the following combinations are dangerous:[66] i)Opioids with benzodiazepines (compared to patients with no prescription, the odds ratio [OR] and 95% confidence interval [CI] for drug-related death was OR: 14.92, 95% CI: 7.00- 31.77 for patients who filled a prescription for opioids and benzodiazepines; OR: 3.40, 95% CI: 1.60-7.21 for patients who filled only an opioid prescription, and 7.21, 95% CI: 3.33-15.60 for patients who filled only a benzodiazepine prescription) (see Recommendation 5) [66,67], ii)Fentanyl with CYP3A4 inhibitors, iii) Methadone with drugs that can prolong the QT interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) (e.g., CYP450 2B6 inhibitors) ", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. " ]

[ "There is moderate quality evidence to support that opioids taken PRN (as needed) for chronic cancer pain versus regularly scheduled doses, or simultaneous PRN plus regularly scheduled, places patients at elevated risk for opioid overdose (HR: 2.75, 95% CI: 1.31-5.78 for as needed; HR: 1.00 for regularly scheduled; HR: 1.84, 95% CI: 0.83-4.05 for simultaneous PRN plus regularly scheduled).[59]" ]

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[ "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188] ", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] ", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] ", "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] ", "Opioids carry a significant risk for OUD, overdose, and death, especially among patients with untreated SUD. The recommendation against LOT for patients with SUD is supported by five large studies (four retrospective case cohort studies and one case cohort study).[59,61,66,86,87] Individually, these studies are of moderate strength; however, the combined weight of their results is strongly supportive of this recommendation. Clinicians should note that this recommendation does not refer to patients whose sole SUD relates to tobacco misuse. " ]

[ "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. " ]

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[ "Educate the Veteran by using Bio-Psycho-Social Model e.g., PHI’s “Whole Health” approach. Offer Veterans pain education groups [especially Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for Pain, if available]. Clinicians should offer physical therapy and Complementary and Integrative Health (CIH) interventions such as acupuncture, meditation, yoga. Clinicians should offer slow tapering of opioids to reduce opioid risks while not “cutting off” the Veteran. Clinicians should offer non-opioid pain medications when appropriate. Clinicians should commit to working with the Veteran on other options for improved function and some decrease in pain.", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate. ", "As part of the patient-centered care approach, clinicians should review the patient’s history including previous treatment approaches, their results, and any other outcomes with the patient. They should ask the patient about his or her willingness to accept a referral to an addiction or other behavioral health specialist when appropriate. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care. The below approach may be used in setting SMART (Specific, Measurable, Action Oriented, Realistic, Timed) goals for the patient (Table 1).", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns." ]

[ "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events." ]

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[ "Moderate quality evidence demonstrates that the prevalence of OUD in patients with CNCP is related to duration of opioid use as well as dose (see Recommendations 7-9).[86-88] There are two studies of patients with CNCP which support the current recommendations. Edlund et al. (2014) conducted a large retrospective cohort study where they examined claims data from a health insurance database between 2000 and 2005 to examine factors predictive of developing OUD.[86] Days’ supply of opioids was categorized as none, acute duration (1-90 days), or chronic duration (91+ days). Average daily dose was defined as none, low (1-36 mg MEDD), medium (36-120 mg MEDD), or high (>120 mg MEDD). The OR of developing OUD ranged based on dose and duration (OR: 3.03, 95% CI: 2.32-3.95 for low dose, acute opioid prescription; OR: 14.92, 95% CI: 10.38-21.46 for low dose, chronic opioids prescriptions; OR: 3.10, 95% CI: 1.67-5.77 for high dose, acute opioid prescriptions; OR: 122.45, 95% CI: 72.79-205.99 for high dose, chronic opioid prescriptions). They found that even greater than opioid dose, duration of OT was the strongest predictor of developing OUD. Additionally, a study by Boscarino et al. (2011) examined medical records from a large healthcare system.[89] Through interviews with a random sample of patients on LOT, they examined factors associated with and the prevalence of OUD (using DSM IV and 5 criteria). These results showed that the prevalence of lifetime OUD for patients on LOT was 34.9% (based on DSM-5 criteria) and 35.5% (based on DSM-IV criteria). ", "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "The Edlund et al. (2014) study of 568,640 commercial health plan patients (see Recommendation 2 and 3) found that those diagnosed with CNCP and an alcohol use or non-opioid drug use disorder had higher rates of OUD (OR: 3.22, 95% CI: 1.79-5.80 for patients with pre-index alcohol use disorder compared to no alcohol use disorder; OR: 8.26, 95% CI: 4.74-14.39 for patients with pre-index non-opioid drug use disorders compared to no non-opioid drug use disorders).[86] Moreover, Huffman et al. (2015) found that the presence of a lifetime history of SUD for patients with CNCP was associated with 28 times increased odds of therapeutic opioid addiction compared to patients with CNCP without a lifetime history of SUD (OR: 28.58, 95% CI: 10.86-75.27).[87] ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "The increase in opioid prescribing is matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance use disorders (SUD) treatment admissions from 1999 to 2008. In 2009, drug overdose became the leading cause of injury-related death in the U.S., surpassing deaths from traffic accidents. In 2014, 1.9 million Americans were affected by an OUD related to non-medical use of prescription pain relievers, and in the same year, 18,893 individuals died as a result of a prescription drug overdose. There has been a four-fold increase in the absolute number of deaths associated with use of opioids since 2000, and a 14% increase between 2013 and 2014 alone. In a survey of patients prescribed opioids for chronic non-cancer pain (CNCP) and their family members, 34% of patients reported that they thought they were “addicted” or “dependent” on opioid pain medication, 34% said that they used the medication for “fun” or to “get high,” while 22% used the medication to relieve day-to-day stress.", "Opioids carry a significant risk for OUD, overdose, and death, especially among patients with untreated SUD. The recommendation against LOT for patients with SUD is supported by five large studies (four retrospective case cohort studies and one case cohort study).[59,61,66,86,87] Individually, these studies are of moderate strength; however, the combined weight of their results is strongly supportive of this recommendation. Clinicians should note that this recommendation does not refer to patients whose sole SUD relates to tobacco misuse. ", "Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid.", "There has been limited research on the effectiveness of LOT for non-end-of-life pain. At the same time, there is mounting evidence of the ill effects of LOT, including increased mortality, OUD, overdose, sexual dysfunction, fractures, myocardial infarction, constipation, and sleep-disordered breathing. Despite increasing awareness of the known harms of opioids, 259 million opioid prescriptions were still written in 2012." ]

[ "Short-term oral medications can be utilized to assist with managing the withdrawal symptoms, especially when prescribing fast tapers. Do not treat withdrawal symptoms with an opioid or benzodiazepine. Withdrawal symptoms are not life-threatening and may not be seen with a gradual taper. Early symptoms take hours to days to appear. Early symptoms include anxiety/restlessness, rapid short respirations, runny nose, tearing eyes, sweating, insomnia, and dilated reactive pupils. Late symptoms take days to weeks to appear. Late symptoms include runny nose, tearing eyes, rapid breathing, yawning, tremor, diffuse muscle spasms/aches, piloerection, nausea, vomiting, and diarrhea, abdominal pain, fever, chills, increased white blood cells if sudden withdrawal. Prolonged symptoms take weeks to months to appear. Prolonged symptoms include irritability, fatigue, bradycardia, decreased body temperature, craving, insomnia. Early symptoms generally resolve 5 to 10 days following opioid dose reduction/cessation but may take longer depending on the half-life of the opioid (e.g., methadone). Some symptoms of withdrawal such as dysphoria, insomnia and prolonged craving may take longer. Patients with chronic pain may find that symptoms, such as fatigue, mental functioning, pain, and well-being, improve over time." ]

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[ "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. ", "Chronic pain is defined as pain lasting three months or more. It is often associated with changes in the central nervous system (CNS) known as central sensitization. Whereas acute and subacute pain are thought to involve primarily nociceptive processing areas in the CNS, chronic pain is thought to be associated with alterations in brain centers involved with emotions, reward, and executive function as well as central sensitization of nociceptive pathways across several CNS areas.", "A comprehensive pain assessment includes a biopsychosocial interview and focused physical exam. Elements of the biopsychosocial pain interview include a pain-related history, assessment of pertinent medical and psychiatric comorbidities including personal and family history of SUD, functional status and functional goals, coping strategies, and a variety of psychosocial factors such as the patient’s beliefs and expectations about chronic pain and its treatment. Patients with chronic pain may also experience worsened quality of life, mental health, immune system function, physical function, sleep, employment status, and impaired personal relationships. Worsening of some of these factors (e.g., quality of life, change in employment status) seems to also be associated with pain severity and the presence of psychiatric comorbidities. Patients with chronic pain report psychological complaints (e.g., depression, anxiety, poor self-efficacy, poor general emotional functioning) more often than patients without chronic pain. Further, there can be social and psychological consequences such as decreased ability to successfully maintain relationship and career roles and increased depression, fear, and anxiety as a result of pain.", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "As outlined in this CPG, there is a rapidly growing understanding of the significant harms of LOT even at doses lower than 50 mg oral morphine equivalent daily dose [MEDD], including but not limited to overdose and OUD. At the same time there is a lack of high quality evidence that LOT improves pain, function, and/or quality of life. The literature review conducted for this CPG identified no studies evaluating the effectiveness of LOT for outcomes lasting longer than 16 weeks. Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, non-opioid treatments are preferred for chronic pain. Patient values, goals, concerns, and preferences must be factored into clinical decision making on a case-by-case basis. When considering the initiation or continuation of LOT, it is important to consider whether LOT will result in clinically meaningful improvements in function such as readiness to return to work/duty and/or measurable improvement in other areas of function, such that the benefits outweigh the potential harms. ", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "There has been limited research on the effectiveness of LOT for non-end-of-life pain. At the same time, there is mounting evidence of the ill effects of LOT, including increased mortality, OUD, overdose, sexual dysfunction, fractures, myocardial infarction, constipation, and sleep-disordered breathing. Despite increasing awareness of the known harms of opioids, 259 million opioid prescriptions were still written in 2012.", "Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events." ]

[ "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping)." ]

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[ "We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules.", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. ", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "a) We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. (Strong against) b) For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, New-replaced) ", "For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies, assessment for opioid use disorder, and consideration for tapering when risks exceed benefits. We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering.", "Patients may decline offered treatments (e.g., OT) and may also decline risk mitigation strategies (e.g., UDT, pill counts) that are recommended in the course of clinical care. However, providers should discuss this decision with the patient, including the likelihood that their decision may result in the risks of LOT outweighing its potential benefits. This would require a consideration of patient’s safety, and a clinical decision may be made not to initiate OT or to discontinue ongoing OT through tapering (see Recommendation 14 and Recommendation 17). ", "There is a large variation in patient preference regarding the concurrent use of benzodiazepines and LOT. This is especially true for patients who are already accustomed to receiving both medications (see Patient Focus Group Methods and Findings). Concurrent benzodiazepine and LOT use is a serious risk factor for unintentional overdose death and should be weighed heavily in the risk-benefit evaluation for tapering versus continuing one or both agents. Once initiated, benzodiazepines can be challenging to discontinue due to symptoms related to benzodiazepine dependence, exacerbations of PTSD, and/or anxiety.[91] Moreover, abrupt discontinuation of benzodiazepines should be avoided, as it can lead to serious adverse effects including seizures and death. Tapering benzodiazepines should be performed with caution and within a team environment when possible (see Recommendation 26 in the VA/DoD SUD CPG).7 Due to the difficulty of tapering or discontinuing benzodiazepines, particular caution should be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain. The VA/DoD PTSD CPG recommends against benzodiazepines for the prevention of PTSD and cautions against their use in treatment of PTSD. Benzodiazepines to treat acute anxiety symptoms after trauma are associated with a higher incidence of PTSD symptoms. For treatment of PTSD, there is evidence of lack of efficacy from small clinical trials and evidence of harm from observational studies of benzodiazepines for PTSD. Although anxiety may initially improve with benzodiazepines, the improvement is short-lived and may result in tolerance to increasing doses and eventual failure of the treatment. Even gradual benzodiazepine taper may result in exacerbation of severe PTSD symptoms. Concomitant use of benzodiazepines is considered a contraindication to initiation of OT. ", "Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT. Further research is needed to identify strategies for safely managing patients at elevated risk of suicide who demand opioid medications or become further destabilized during tapering. ", "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community." ]

[ "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached." ]

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[ "Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Here is an example of an opioid taper plan for a Veteran. Veteran is currently taking morphine SR 60 mg, 1 tablet every 8 hours. Goal is to reduce the dose of morphine to SR 30 mg every 8 hours using a slow taper. Dose will be reduced by 15 mg every 10 days. Using morphine SR 15 mg tablets, follow the schedule below. From days 1 to 10, take 4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 11 to 20, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 21 to 30, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 3 tablets = 45 mg in the evening.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation. We recommend against prescribing long-acting opioids for acute pain, as an as-needed medication, or on initiation of long-term opioid therapy. ", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "Use immediate-release (IR) opioids when starting therapy. Prescribe the lowest effective dose. When using opioids for acute pain, provide no more than needed for the condition. Follow up and review benefits and risks before starting and during therapy. If benefits do not outweigh harms, consider tapering opioids to lower doses or taper and discontinue." ]

[ "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. " ]

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[ "The following recommendations were made using a systematic approach considering four domains as per the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. These domains include: confidence in the quality of the evidence, balance of desirable and undesirable outcomes (i.e., benefits and harms), patient or provider values and preferences, and other implications, as appropriate (e.g., resource use, equity, acceptability).", "There were also some differences in the methodology used between the development of the VA/DoD OT CPG and the CDC guideline. Along with a clinical evidence review, during which the evidence was evaluated using GRADE, the CDC guideline developers also considered the findings of a contextual evidence review. Further, the CDC Core Expert Group, which consisted of subject matter experts, representatives of primary care professional societies and state agencies, and an expert in guideline methodology, reviewed recommendations drafted by the CDC and evaluated how the evidence was used in the development of the recommendations, rather than developing the recommendations themselves (as was the VA/DoD OT Work Group’s role in the development of the VA/DoD OT CPG). While experts provided feedback on the CDC recommendations and their development, the CDC determined the final recommendations. CDC also used a review process considering and incorporating feedback from federal partners (e.g., SAMHSA, VA, DoD), stakeholders (e.g., professional organizations, delivery systems, community organizations), and other constituents (e.g., clinicians, prospective patients). The CDC guideline development process included notice in the Federal Register for a public review and comment period as well as peer review. Thus, the recommendations made in the CDC guideline, although similar to those made in this CPG, were likely based on a slightly different evidence base and revised based on the feedback of individuals who were considering a larger group of potential patients relative to the VA/DoD. Thus, while the VA/DoD OT Work Group was aware of the release of the CDC guideline and considered potential implications, the CDC guideline did not form the basis of the deliberations on the strength or direction of these recommendations. The Work Group followed the VA/DoD Guideline for Guidelines, a document that details the process by which VA/DoD guidelines will be developed, including the use of the GRADE methodology. As required by Congress in CARA, the Work Group reviewed and considered the CDC guideline and its inclusion in the VA/DoD OT CPG.", "The systematic review conducted for the update of this CPG encompassed interventional studies (primarily randomized controlled trials [RCTs]) published between March 2009 and December 2016 and targeted nine key questions (KQs) focusing on the means by which the delivery of healthcare could be optimized for patients on or being considered for LOT. Because a comprehensive review of the evidence related to LOT was not feasible, the nine selected KQs were prioritized from many possible KQs. Therefore, many of the 2010 OT CPG recommendations were considered for inclusion in the updated version of the guideline without an updated review of the evidence. The section on Recommendations delineates whether or not the current CPG recommendations were based on an updated evidence review. Appendix H delineates whether the 2010 OT CPG recommendations were considered for inclusion in the update based on an updated evidence review or based on the evidence included in the 2010 OT CPG. The section on Recommendation Categorization further describes the methodology used for the categorization. ", "As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient. ", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "Given the relevance of all four domains in grading recommendations, the Work Group encountered multiple instances in which confidence in the quality of the evidence was low or very low, while there was marked imbalance of benefits and harms, as well as certain other important considerations arising from the domains of values and preferences and/or other implications. In particular, the harms due to the potential for severe adverse events associated with opioids, particularly overdose and OUD, often far outweigh the potential benefits. As such, in accounting for all four domains, these factors contributed to strong recommendations in multiple instances.", "The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG. ", "The components of biopsychosocial assessment are pain assessment, patient functional goals, impact of pain on family, work, life, review of previous diagnostic studies, additional consultations and referrals, coexisting illness and treatments and effect on pain, significant psychological, social, or behavioral factors that may affect treatment, family history of chronic pain, collateral of family involvement, patient beliefs/knowledge of the cause of their pain and their treatment preferences along with the perceived efficacy of various treatment options. For patients already on OT, include assessment of psychological factors related to continuing vs. tapering OT. The psychological factors are beliefs, expectations, fears. Pain assessment includes history, physical exam, comorbidities, previous treatment and medications, duration of symptoms, onset and triggers. Examples of absolute contraindications to initiating opioid therapy for chronic pain are true life-threatening allergy to opioids, active SUD, elevated suicide risk, concomitant use of benzodiazepines. LOT refers to long-term opioid therapy; OT refers to opioid therapy; PDMP refers to Prescription Drug Monitoring Program; SUD refers to substance use disorder; UDT refers to urine drug test; VA/DoD Suicide CPG refers to VA/DoD Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide.", "This guideline can be used in a variety of ways. This guideline can be used by general clinicians or specialists to study and consider the latest information on opioid therapy (OT) and how and whether to incorporate that information or recommendations into their practice. It can be used to provide specific information to guide a patient encounter, such as looking up the dosing of a medication used less frequently or the meaning of the urine drug testing (UDT) result. The section on tapering and its accompanying appendix can be used to assist in the development of a framework for guiding an individualized, informed discussion when tapering is being considered. Patients can examine the guideline to educate themselves and better understand their care. A health care system can use the CPG to assure that its clinicians and patients have the resources available to compassionately, effectively, and safely evaluate and deliver LOT in a timely, culturally sensitive manner. The guideline can also be used to suggest specific education for identified gaps. " ]

[ "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. " ]

[ "276" ]

[ "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "In addition to non-pharmacological therapies (e.g., exercise, CBT), appropriate mechanism and condition specific non-opioid pharmacologic agents should be tried and optimized before consideration of opioid medications (e.g., gabapentin in neuropathic pain states).[83] Potential contraindications and long-term risks of use should be considered for non-opioid pharmacologic agents as well, as these also can carry risk of harm, depending on the specific patient and chosen medication. ", "Further studies may help determine earlier in the course of treatment which patients are most likely to benefit from a specific non-pharmacologic therapy (physical, psychological, and pain rehabilitation) or non opioid pharmacologic therapies alone or as part of a multimodal approach. ", "We recommend alternatives to opioids for mild-to-moderate acute pain. We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "There are situations in which opioids may be necessary therapy for acute pain, even when substantial risk factors exist. It is important to incorporate opioid risk mitigation strategies into opioid prescribing for acute pain. These strategies should include patient education, use of non-opioid adjunctive therapy, and structured reassessment of opioid risks and benefits for all on acute OT. Also, consider checking the PDMP and performing a UDT. ", "We recommend alternatives to opioids for mild-to-moderate acute pain. (Strong for). We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. (Weak for). If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. (Strong for). Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities." ]

[ "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. (Strong for| Reviewed, New-replaced) Note: Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits. For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies (see Recommendations 7-9), assessment for opioid use disorder, and consideration for tapering when risks exceed benefits (see Recommendation 14). (Strong for| Reviewed, New-replaced) " ]

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[ "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Patients may decline offered treatments (e.g., OT) and may also decline risk mitigation strategies (e.g., UDT, pill counts) that are recommended in the course of clinical care. However, providers should discuss this decision with the patient, including the likelihood that their decision may result in the risks of LOT outweighing its potential benefits. This would require a consideration of patient’s safety, and a clinical decision may be made not to initiate OT or to discontinue ongoing OT through tapering (see Recommendation 14 and Recommendation 17). ", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "There may be some variation in patient values and preferences. Certain patients may appreciate the use of risk mitigation strategies and others may not. Participants in the patient focus group expressed an understanding of why various risk mitigation strategies were used (see Patient Focus Group Methods and Findings). ", "We recommend evaluating benefits of continued opioid therapy and risk for opioid-related adverse events at least every three months. (Strong for | Reviewed, New-replaced) ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education." ]

[ "Short-term oral medications can be utilized to assist with managing the withdrawal symptoms, especially when prescribing fast tapers. Do not treat withdrawal symptoms with an opioid or benzodiazepine. Withdrawal symptoms are not life-threatening and may not be seen with a gradual taper. Early symptoms take hours to days to appear. Early symptoms include anxiety/restlessness, rapid short respirations, runny nose, tearing eyes, sweating, insomnia, and dilated reactive pupils. Late symptoms take days to weeks to appear. Late symptoms include runny nose, tearing eyes, rapid breathing, yawning, tremor, diffuse muscle spasms/aches, piloerection, nausea, vomiting, and diarrhea, abdominal pain, fever, chills, increased white blood cells if sudden withdrawal. Prolonged symptoms take weeks to months to appear. Prolonged symptoms include irritability, fatigue, bradycardia, decreased body temperature, craving, insomnia. Early symptoms generally resolve 5 to 10 days following opioid dose reduction/cessation but may take longer depending on the half-life of the opioid (e.g., methadone). Some symptoms of withdrawal such as dysphoria, insomnia and prolonged craving may take longer. Patients with chronic pain may find that symptoms, such as fatigue, mental functioning, pain, and well-being, improve over time." ]

[ "278" ]

[ "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Evidence for or history of diversion of controlled substances: The clinician should communicate to patients that drug diversion is a crime and constitutes an absolute contraindication to prescribing additional medications. Because suspicion is subjective and may be based on impression, bias, or prejudice, it is important that providers who suspect diversion base treatment plans on objective evidence. Suspicions may be confirmed by a negative mass spectrometry/liquid chromatography UDT for the substance being prescribed in the absence of withdrawal symptoms in someone who is receiving opioids. A negative UDT for the prescribed opioid could also by itself be a sign of diversion. Signs of diversion may also include frequent requests for early refills or atypically large quantities required to control pain. Routine UDT, however, may not reliably detect synthetic opioids (e.g., methadone, fentanyl, tramadol) or semi-synthetic opioids (e.g., oxycodone, hydrocodone, hydromorphone). When there is evidence that the patient is diverting opioids, discontinue opioids according to Recommendations 14 and 15 and assess for underlying OUD and/or psychiatric comorbidities. Consultation with a pain specialist, psychiatrist, or SUD specialist may be warranted. Also consider consultation with local risk management and/or counsel. For patients with OUD, keep in mind that sudden discontinuation of opioids due to suspected diversion may place them at high risk for illicit opioid use and resulting opioid overdose (see Recommendation 17)." ]

[ "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community." ]

[ "279" ]

[ "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.", "Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Here is an example of an opioid taper plan for a Veteran. Veteran is currently taking morphine SR 60 mg, 1 tablet every 8 hours. Goal is to reduce the dose of morphine to SR 30 mg every 8 hours using a slow taper. Dose will be reduced by 15 mg every 10 days. Using morphine SR 15 mg tablets, follow the schedule below. From days 1 to 10, take 4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 11 to 20, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 21 to 30, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 3 tablets = 45 mg in the evening.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Short-term oral medications can be utilized to assist with managing the withdrawal symptoms, especially when prescribing fast tapers. Do not treat withdrawal symptoms with an opioid or benzodiazepine. Withdrawal symptoms are not life-threatening and may not be seen with a gradual taper. Early symptoms take hours to days to appear. Early symptoms include anxiety/restlessness, rapid short respirations, runny nose, tearing eyes, sweating, insomnia, and dilated reactive pupils. Late symptoms take days to weeks to appear. Late symptoms include runny nose, tearing eyes, rapid breathing, yawning, tremor, diffuse muscle spasms/aches, piloerection, nausea, vomiting, and diarrhea, abdominal pain, fever, chills, increased white blood cells if sudden withdrawal. Prolonged symptoms take weeks to months to appear. Prolonged symptoms include irritability, fatigue, bradycardia, decreased body temperature, craving, insomnia. Early symptoms generally resolve 5 to 10 days following opioid dose reduction/cessation but may take longer depending on the half-life of the opioid (e.g., methadone). Some symptoms of withdrawal such as dysphoria, insomnia and prolonged craving may take longer. Patients with chronic pain may find that symptoms, such as fatigue, mental functioning, pain, and well-being, improve over time.", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily." ]

[ "On July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) was enacted with the aim of addressing the epidemic of overdoses from prescription opioids and other prescription drugs and heroin. While this act was primarily focused on opioid abuse treatment and prevention, it also gave specific instruction to the VA in regard to broad aspects of OT including consideration of the CDC guideline in revising the prior VA/DoD OT CPG and adopting it for the VA. There are, however, some important distinctions between the CDC guideline and the VA/DoD OT CPG. " ]

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[ "With the passage of the Patient Protection and Affordable Care Act (PPACA) in March 2010, the Interagency Pain Research Coordinating Committee was created to coordinate pain research efforts throughout federal government agencies. The Committee was tasked with summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations. The Committee published the National Pain Strategy in March 2016 in response to the call from the National Academy of Medicine to increase awareness of pain as a significant public health issue in the U.S. The strategy made recommendations in a number of areas including prevention and care, professional education and training, and population research. The plan is aimed at decreasing the prevalence of all types of pain (acute and chronic) in the U.S., as well as the disability and morbidity associated with pain.", "These guidelines are not intended to represent TRICARE policy. Further, inclusion of recommendations for specific testing and/or therapeutic interventions within these guidelines does not guarantee coverage of civilian sector care. Additional information on current TRICARE benefits may be found at www.tricare.mil or by contacting your regional TRICARE Managed Care Support Contractor. ", "The system-wide goal of this guideline is to improve the patient’s health and well-being by providing evidence-based guidance to providers who are taking care of patients on or being considered for LOT. The expected outcome of successful implementation of this guideline is to assess the patient’s condition, provide education, and determine the best treatment methods in collaboration with the patient and a multidisciplinary care team, optimize the patient’s health outcomes and function and improve quality of life, minimize preventable complications and morbidity, emphasize the use of patient-centered care.", "There were also some differences in the methodology used between the development of the VA/DoD OT CPG and the CDC guideline. Along with a clinical evidence review, during which the evidence was evaluated using GRADE, the CDC guideline developers also considered the findings of a contextual evidence review. Further, the CDC Core Expert Group, which consisted of subject matter experts, representatives of primary care professional societies and state agencies, and an expert in guideline methodology, reviewed recommendations drafted by the CDC and evaluated how the evidence was used in the development of the recommendations, rather than developing the recommendations themselves (as was the VA/DoD OT Work Group’s role in the development of the VA/DoD OT CPG). While experts provided feedback on the CDC recommendations and their development, the CDC determined the final recommendations. CDC also used a review process considering and incorporating feedback from federal partners (e.g., SAMHSA, VA, DoD), stakeholders (e.g., professional organizations, delivery systems, community organizations), and other constituents (e.g., clinicians, prospective patients). The CDC guideline development process included notice in the Federal Register for a public review and comment period as well as peer review. Thus, the recommendations made in the CDC guideline, although similar to those made in this CPG, were likely based on a slightly different evidence base and revised based on the feedback of individuals who were considering a larger group of potential patients relative to the VA/DoD. Thus, while the VA/DoD OT Work Group was aware of the release of the CDC guideline and considered potential implications, the CDC guideline did not form the basis of the deliberations on the strength or direction of these recommendations. The Work Group followed the VA/DoD Guideline for Guidelines, a document that details the process by which VA/DoD guidelines will be developed, including the use of the GRADE methodology. As required by Congress in CARA, the Work Group reviewed and considered the CDC guideline and its inclusion in the VA/DoD OT CPG.", "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. ", "As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient. ", "There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.", "As part of the patient-centered care approach, clinicians should review the patient’s history including previous treatment approaches, their results, and any other outcomes with the patient. They should ask the patient about his or her willingness to accept a referral to an addiction or other behavioral health specialist when appropriate. Lastly, they should involve the patient in prioritizing problems to be addressed and in setting specific goals regardless of the selected setting or level of care. The below approach may be used in setting SMART (Specific, Measurable, Action Oriented, Realistic, Timed) goals for the patient (Table 1).", "The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management.", "This guideline is not intended as a standard of care and should not be used as such. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advances and patterns evolve. Today there is variation among state regulations, and this guideline does not cover the variety of ever-changing state regulations that may be pertinent. The ultimate judgement regarding a particular clinical procedure or treatment course must be made by the individual clinician, in light of the patient’s clinical presentation, patient preferences, and the available diagnostic and treatment options. As noted previously, the guideline can assist care providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, in the care for an individual patient." ]

[ "State database queries for detection of multi-sourcing of controlled substances are used throughout the country. Data comparing states with an implemented state database program to states without one showed 1.55 fewer deaths per 100,000 people.[106] The CDC currently recommends at least quarterly checks of the state database system.[33] " ]

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[ "As substance misuse in patients on LOT is more than 30% in some series,[107] UDT and confirmatory testing is used as an additional method of examining for patient substance misuse and adherence to the prescribed regimen. UDTs, used in the appropriate way, help to address safety, fairness, and trust with OT. Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to the false positive and negative rates associated with UDTs.[53] Interpretation of a UDT and confirmatory results requires education and knowledge of the local procedures and clinical scenario. Local education and access to expert interpretation is necessary. UDT results are helpful and can help identify active SUD or possible diversion. Accordingly, clinicians should obtain UDT prior to initiating or continuing LOT and periodically thereafter. When a patient is referred for SUD treatment or is engaged in on-going treatment there should be close communication between the SUD and pain management providers. The ideal approach is an interdisciplinary format (see Recommendation 16). For more information, see Appendix B on UDT and confirmatory testing. ", "Take Back Programs: Returning unused opioid medications has been explored as a strategy to reduce the amount of opioids in the community, as it has been estimated that 70% of opioid prescriptions are left unused.[115] Accordingly, the National Drug Control Strategy advocates take back programs as an effective tool.[24] For example, in a 2013 medication take back event in a Michigan community, 3,633 containers containing 345 different prescription medications were collected in four hours. The top five most common medications collected were pain relievers.[116] System-wide efficacy of a nationwide program is unknown.[117] ", "The increasing use of opioids, as well as the accompanying rise in morbidity and mortality associated with opioid use, has garnered increasing attention from federal and local officials as well as other policy makers. This public health issue, which has been labeled an epidemic, became a focus of the President’s National Drug Control Strategy in 2010 and has since remained a focus. Two main goals introduced in the 2010 strategy included curtailing illicit drug consumption in America and improving the health and safety of the American people by reducing the consequences of drug abuse. The 2015 strategy, and an accompanying presidential memorandum on preventing prescription drug abuse and heroin use, released in October 2015, encouraged the improvement of health and safety using evidence-based methods by calling for change in a number of key areas including preventing drug use in communities, seeking early intervention opportunities, and integrating SUD treatment and supporting recovery.", "Naloxone administration has been identified as a life saving measure following opioid overdose. A systematic review of 22 observational studies provided moderate quality evidence that take home naloxone programs are effective in improving overdose survival and decreasing mortality, with a low rate of adverse events.[108] One meta-analysis of nine studies determined that take home naloxone kits were used approximately nine times within the first three months of follow-up for every 100 individuals trained.[109] Further, studies have shown that naloxone administration has been efficacious whether given by medical personnel or lay people, with more than 26,000 reversals documented by the CDC from 1996-2014.[110,111] In addition, prescription of naloxone rescue and accompanying education has also been found to reduce opioid-related emergency department visits.[112] Distribution of naloxone for reversal is supported by SAMHSA, the American Medical Association (AMA), and other medical societies, and is facilitated through the VA via Pharmacy Benefits Management. Clinical efficacy has been established for its use on short-acting opioids, but not for its use on long-acting opioids such as methadone or exceptionally potent opioids.[108] ", "There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.", "Evidence for or history of diversion of controlled substances: The clinician should communicate to patients that drug diversion is a crime and constitutes an absolute contraindication to prescribing additional medications. Because suspicion is subjective and may be based on impression, bias, or prejudice, it is important that providers who suspect diversion base treatment plans on objective evidence. Suspicions may be confirmed by a negative mass spectrometry/liquid chromatography UDT for the substance being prescribed in the absence of withdrawal symptoms in someone who is receiving opioids. A negative UDT for the prescribed opioid could also by itself be a sign of diversion. Signs of diversion may also include frequent requests for early refills or atypically large quantities required to control pain. Routine UDT, however, may not reliably detect synthetic opioids (e.g., methadone, fentanyl, tramadol) or semi-synthetic opioids (e.g., oxycodone, hydrocodone, hydromorphone). When there is evidence that the patient is diverting opioids, discontinue opioids according to Recommendations 14 and 15 and assess for underlying OUD and/or psychiatric comorbidities. Consultation with a pain specialist, psychiatrist, or SUD specialist may be warranted. Also consider consultation with local risk management and/or counsel. For patients with OUD, keep in mind that sudden discontinuation of opioids due to suspected diversion may place them at high risk for illicit opioid use and resulting opioid overdose (see Recommendation 17).", "Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.", "There is moderate quality evidence that intensification of monitoring helps mitigate the risk of suicide among patients on LOT. Im et al. (2015) found moderate quality evidence that, at the facility level, patients on LOT within facilities ordering more drug screens than the comparison group were associated with decreased risk of suicide attempt (chronic short-acting opioid group: OR: 0.2, 95% CI: 0.1-0.3; chronic long acting opioid group: OR: 0.3, 95% CI: 0.2-0.6). In addition, patients on long-acting opioids within the facilities providing more follow-up after new prescriptions were associated with decreased risk of suicide attempt (OR: 0.2, 95% CI: 0.0-0.7).[61] ", "On July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) was enacted with the aim of addressing the epidemic of overdoses from prescription opioids and other prescription drugs and heroin. While this act was primarily focused on opioid abuse treatment and prevention, it also gave specific instruction to the VA in regard to broad aspects of OT including consideration of the CDC guideline in revising the prior VA/DoD OT CPG and adopting it for the VA. There are, however, some important distinctions between the CDC guideline and the VA/DoD OT CPG. ", "This guideline can be used in a variety of ways. This guideline can be used by general clinicians or specialists to study and consider the latest information on opioid therapy (OT) and how and whether to incorporate that information or recommendations into their practice. It can be used to provide specific information to guide a patient encounter, such as looking up the dosing of a medication used less frequently or the meaning of the urine drug testing (UDT) result. The section on tapering and its accompanying appendix can be used to assist in the development of a framework for guiding an individualized, informed discussion when tapering is being considered. Patients can examine the guideline to educate themselves and better understand their care. A health care system can use the CPG to assure that its clinicians and patients have the resources available to compassionately, effectively, and safely evaluate and deliver LOT in a timely, culturally sensitive manner. The guideline can also be used to suggest specific education for identified gaps. " ]

[ "In addition to benzodiazepines, the addition of other psychoactive medications to LOT must be made with caution. While the evidence for harm associated with the combination of opioids and Z-drugs (e.g., zolpidem, eszopiclone) is not as strong as the evidence for harm associated with the combination of opioids and benzodiazepines, we suggest not prescribing Z-drugs to patients who are on LOT, as moderate quality evidence demonstrates that the combination of zolpidem and opioids increases the AOR of overdose.[66] The evidence reviewed also identifies potential adverse outcomes (e.g., risk of overdose) with the combined use of antidepressants and opioids in patients who do not have depression.[66] This particular study did not differentiate between classes of antidepressants, limiting the ability of the Work Group to recommend for or against prescribing opioids and a specific class of antidepressants. As such, there is no recommendation in this guideline with respect to using specific classes of antidepressants and LOT. " ]

[ "282" ]

[ "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188] ", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Note: Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20- 50 mg morphine equivalent daily dose.", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] ", "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] ", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] " ]

[ "As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Note: Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20- 50 mg morphine equivalent daily dose." ]

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[ "In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188] ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187] ", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] ", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.", "The Edlund et al. (2014) study of 568,640 commercial health plan patients (see Recommendation 2 and 3) found that those diagnosed with CNCP and an alcohol use or non-opioid drug use disorder had higher rates of OUD (OR: 3.22, 95% CI: 1.79-5.80 for patients with pre-index alcohol use disorder compared to no alcohol use disorder; OR: 8.26, 95% CI: 4.74-14.39 for patients with pre-index non-opioid drug use disorders compared to no non-opioid drug use disorders).[86] Moreover, Huffman et al. (2015) found that the presence of a lifetime history of SUD for patients with CNCP was associated with 28 times increased odds of therapeutic opioid addiction compared to patients with CNCP without a lifetime history of SUD (OR: 28.58, 95% CI: 10.86-75.27).[87] " ]

[ "With the passage of the Patient Protection and Affordable Care Act (PPACA) in March 2010, the Interagency Pain Research Coordinating Committee was created to coordinate pain research efforts throughout federal government agencies. The Committee was tasked with summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations. The Committee published the National Pain Strategy in March 2016 in response to the call from the National Academy of Medicine to increase awareness of pain as a significant public health issue in the U.S. The strategy made recommendations in a number of areas including prevention and care, professional education and training, and population research. The plan is aimed at decreasing the prevalence of all types of pain (acute and chronic) in the U.S., as well as the disability and morbidity associated with pain." ]

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[ "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "The shared decision making process for chronic pain treatment planning is based on the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider (Figure 1). The patient-centered assessment incorporates a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations. Next, the clinician performs a biopsychosocial assessment and determines clinically appropriate therapeutic options in which benefits are likely to outweigh risks. The process culminates in a shared decision making process to develop a patient-centered treatment plan by the patient selecting from the clinically appropriate treatment options generated in the first two steps. ", "The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development. ", "Chronic pain is a national public health problem as outlined in the 2011 study by the National Academy of Medicine (previously the Institute of Medicine [IOM]). At least 100 million Americans suffer from some form of chronic pain. Until recently, the treatment of chronic pain with opioids was increasing at an alarming rate. The increase in prescriptions of these medications has been accompanied by an epidemic of opioid-related adverse events.", "The U.S. is in the midst of a cultural transformation in the way pain is viewed and treated. The biomedical model of pain care, in which the pain experience is reduced to a pain generator and pain treatment is aimed at fixing or numbing pain with medications, interventions, or surgery, dominated the 1990s and the first decade of the 2000s. As the cost, potential harm, and limited effectiveness of the approach in the biomedical model of pain care to chronic pain was becoming apparent, the National Academy of Medicine issued a call for the transformation of pain care to a biopsychosocial, multimodal, interdisciplinary model.", "The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG. ", "A paradigm shift in the use of OT for chronic non-terminal pain has paralleled this transformation in pain care. Prior to the 1980s, OT was rarely used outside of severe acute injury or post-surgical pain, primarily due to concern for tolerance, physical dependence, and addiction. As the hospice and palliative care movement began defining end-of-life care in the U.S. during the 1980s and emphasizing the importance of pain relief, OT increasingly became a mainstay for cancer and end-of-life pain. Efforts to destigmatize the use of prescription opioids for chronic non-terminal pain encompassed primary care providers and the public. The efforts led to an unprecedented increase in opioid prescribing for chronic non-terminal pain. Chronic pain management became synonymous with LOT in the 1990s and the first decade of the 2000s with significant numbers of patients in pain clinics receiving LOT. Despite the absence of long-term safety or efficacy data, OT for chronic non-terminal pain became a mainstay of therapy. However, as observational and epidemiologic data of harm from LOT accumulated, a much more cautious approach to OT for chronic non-terminal pain has emerged in the decade of the 2010s.", "The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “…Health Executive Council on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration and Military Health System,” by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations. This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with chronic pain who are on or being considered for long-term opioid therapy (LOT). ", "The 2017 version of the VA/DoD OT CPG is the second update to the original CPG. It provides practice recommendations for the care of populations with chronic pain already on or being considered for LOT. Although there are many other approaches to the treatment of chronic pain, the scope of this CPG is to focus on the use of opioids for chronic pain rather than being comprehensive about all treatment options. A particular strength of this CPG is the multidisciplinary stakeholder involvement from its inception, ensuring representation from the broad spectrum of clinicians engaged in the treatment and management of patients with chronic pain on or being considered for LOT. ", "Consequently, a recommendation to update the 2010 OT CPG was initiated in 2015. The updated CPG, titled Clinical Practice Guideline for Opioid Therapy for Chronic Pain (OT CPG), includes objective, evidence-based information on the management of chronic pain. It is intended to assist healthcare providers in all aspects of patient care, including, but not limited to, diagnosis, treatment, and follow-up." ]

[ "There is moderate quality evidence that intensification of monitoring helps mitigate the risk of suicide among patients on LOT. Im et al. (2015) found moderate quality evidence that, at the facility level, patients on LOT within facilities ordering more drug screens than the comparison group were associated with decreased risk of suicide attempt (chronic short-acting opioid group: OR: 0.2, 95% CI: 0.1-0.3; chronic long acting opioid group: OR: 0.3, 95% CI: 0.2-0.6). In addition, patients on long-acting opioids within the facilities providing more follow-up after new prescriptions were associated with decreased risk of suicide attempt (OR: 0.2, 95% CI: 0.0-0.7).[61] " ]

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[ "Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT. Further research is needed to identify strategies for safely managing patients at elevated risk of suicide who demand opioid medications or become further destabilized during tapering. ", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. ", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "Acute psychiatric instability or intermediate to high acute suicide risk: Intermediate to high acute suicide risk, severe depression, unstable bipolar disorder, or unstable psychotic disorder precludes the safe use of self-administered LOT.[60] Im et al. (2015) (n=487,462) found that a diagnosis of a mood disorder was significantly associated with suicide attempts for the chronic use of short-acting and long-acting opioids compared with no diagnosis of a mood disorder.[61] In a study of patients on opioids, Campbell et al. (2015) reported that those with bipolar disorder had 2.9 times the odds of suicidal ideation within the past 12 months as well as 3.2 times the odds of a lifetime suicide attempt compared to those with no bipolar disorder.[62] See Recommendation 8 and the VA/DoD Suicide CPG2 for more information on suicidality. See the VA/DoD Clinical Practice Guideline for Management of Bipolar Disorder in Adults (VA/DoD BD CPG) for more information on bipolar disorder.3 Merrill and colleagues found that high dose chronic opioid therapy for pain was associated with depressed mood.[63] Treatment for chronic pain with movement, exercise, and cognitive-behavioral therapy for pain may have benefits in treating depression, PTSD, and in reducing suicide risk.[64] ", "Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15). ", "While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place. ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "A number of studies suggest certain chronic pain conditions represent an independent risk factor for suicide.[123-130] A recent large retrospective cohort study also suggests an association with prescribed opioid dose and suicide risk among Veterans receiving OT for CNCP.[131] Suicide risk is not static, and many factors influence an individual’s risk of suicide at any given point in time, as noted in the VA/DoD Suicide CPG. Thus, ongoing assessment of suicide risk is important whether one is initiating, maintaining, or terminating LOT. ", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.8", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD." ]

[ "Use a shared decision-making approach to discuss options for OUD treatment. Medication-Assisted Therapy (MAT) is the first-line treatment for OUD. The preferred OUD treatment is Opioid Agonist Therapy (OAT). Opioid agonist treatment involves taking opioid agonist medications such as buprenorphine/naloxone (Suboxone) or methadone. Methadone must be provided through a federally regulated opioid treatment program for OUD therapy. The alternative OUD treatment is extended-release (ER) injectable naltrexone (Vivitrol). MAT can be provided in a variety of treatment settings including residential SUD treatment, intensive outpatient SUD treatment, regular SUD specialty care clinic, primary care or general mental health clinic, or federally regulated opioid treatment program. Moral injury is an act of transgression that leads to serious inner conflict typically brought on by betrayal, disproportionate violence, incidents involving civilians, within-rank violence. For moral injury, treatment via psychologists or chaplains is available. Central sensitization (e .g., fibromyalgia, chronic headaches, and likely many other types of complex chronic pain). Some examples of medical complications are lung disease, hepatic disease, renal disease, or fall risk. Sleep apnea is a sleep disorder." ]

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[ "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).", "Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82] ", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. ", "As substance misuse in patients on LOT is more than 30% in some series,[107] UDT and confirmatory testing is used as an additional method of examining for patient substance misuse and adherence to the prescribed regimen. UDTs, used in the appropriate way, help to address safety, fairness, and trust with OT. Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to the false positive and negative rates associated with UDTs.[53] Interpretation of a UDT and confirmatory results requires education and knowledge of the local procedures and clinical scenario. Local education and access to expert interpretation is necessary. UDT results are helpful and can help identify active SUD or possible diversion. Accordingly, clinicians should obtain UDT prior to initiating or continuing LOT and periodically thereafter. When a patient is referred for SUD treatment or is engaged in on-going treatment there should be close communication between the SUD and pain management providers. The ideal approach is an interdisciplinary format (see Recommendation 16). For more information, see Appendix B on UDT and confirmatory testing. ", "Monitoring standards with administration of OT for acute pain vary depending on a number of factors including the setting, specifics of the painful insult, patient medical factors, and selected medication potency/dose/route of administration/adjunct selection. ", "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. ", "Community-based Needle Exchange Programs or Syringe Service Programs: Nearly 80% of new users of injectable opioids had previously used prescription oral opioid pain medication.[118,119] Illicit use of injectable opioids is accompanied by an increased rate of human immunodeficiency virus (HIV) and hepatitis infection. Community-based needle exchange programs have been shown to be an effective risk mitigation strategy for reducing high-risk behaviors (e.g., sharing needles) and infectious disease transmission among injection drug users.[120] For those patients who develop OUD and progress to intravenous drug use, the first recommendation should be for medication assisted treatment (MAT) for OUD (see Recommendation 17). For patients who decline MAT for OUD, clinicians should consider educating the patient regarding sterile injection techniques and community based needle exchange programs, if programs are available. The 2015 outbreak of HIV/hepatitis in rural Indiana and subsequent successful implementation of a needle exchange program is an example of the threat to rural communities from non-prescription opioid use and the potential benefits of needle exchange programs for use as a risk mitigation strategy.[121,122] ", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution." ]

[ "We recommend against the concurrent use of benzodiazepines and opioids. Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate. We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits." ]

[ "287" ]

[ "a) We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. (Strong against) b) For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, New-replaced) ", "If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. (Strong for| Reviewed, New-replaced) Note: Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits. For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies (see Recommendations 7-9), assessment for opioid use disorder, and consideration for tapering when risks exceed benefits (see Recommendation 14). (Strong for| Reviewed, New-replaced) ", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15). ", "We strongly recommend against initiation of long-term opioid therapy for chronic pain. We recommend alternatives to opioid therapy such as self-management strategies and other non-pharmacological treatments. When pharmacologic therapies are used, we recommend non-opioids over opioids. If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. Note: Consideration of opioid therapy beyond 90 days requires reevaluation and discussion with patient of risks and benefits.", "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] ", "We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. (Strong against) For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, Amended) ", "For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies, assessment for opioid use disorder, and consideration for tapering when risks exceed benefits. We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering.", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "We recommend assessing suicide risk and intervening when necessary when considering initiating or continuing long-term opioid therapy. We recommend evaluating benefits of continued opioid therapy and risk for opioid-related adverse events at least every three months. If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. Note: There is no absolutely safe dose of opioids. " ]

[ "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. " ]

[ "288" ]

[ "As outlined in this CPG, there is a rapidly growing understanding of the significant harms of LOT even at doses lower than 50 mg oral morphine equivalent daily dose [MEDD], including but not limited to overdose and OUD. At the same time there is a lack of high quality evidence that LOT improves pain, function, and/or quality of life. The literature review conducted for this CPG identified no studies evaluating the effectiveness of LOT for outcomes lasting longer than 16 weeks. Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, non-opioid treatments are preferred for chronic pain. Patient values, goals, concerns, and preferences must be factored into clinical decision making on a case-by-case basis. When considering the initiation or continuation of LOT, it is important to consider whether LOT will result in clinically meaningful improvements in function such as readiness to return to work/duty and/or measurable improvement in other areas of function, such that the benefits outweigh the potential harms. ", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.", "While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place. ", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient. ", "Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C. ", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily." ]

[ "VA/DoD CPGs encourage clinicians to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences. Regardless of setting, all patients in the healthcare system should be offered access to evidence-based interventions appropriate to that patient. When properly executed, patient-centered care may decrease patient anxiety, increase trust in clinicians,[77] and improve treatment adherence.[78] Improved patient-clinician communication through patient-centered care can be used to convey openness to discuss any future concerns." ]

[ "289" ]

[ "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. The information that patients are given about treatment and care should be culturally appropriate and also available to people with limited literacy skills. It should also be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family involvement should be considered if appropriate. ", "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. ", "While these guidelines are broadly recommended, their implementation is intended to be patient centered. Thus, treatment and care should take into account a patient’s needs and preferences. Good communication between healthcare professionals and the patient about the patient’s pain experience, treatment goals, and challenges is essential and should be guided by evidence-based information tailored to the patient’s needs. An empathetic and non-judgmental (versus a confrontational or adversarial) approach to communication with a patient is highly recommended in order to build trust and facilitate frank discussions relating to the social, economic, emotional, and cultural factors that influence patients’ perceptions, behaviors, and decision making. ", "This guideline can be used in a variety of ways. This guideline can be used by general clinicians or specialists to study and consider the latest information on opioid therapy (OT) and how and whether to incorporate that information or recommendations into their practice. It can be used to provide specific information to guide a patient encounter, such as looking up the dosing of a medication used less frequently or the meaning of the urine drug testing (UDT) result. The section on tapering and its accompanying appendix can be used to assist in the development of a framework for guiding an individualized, informed discussion when tapering is being considered. Patients can examine the guideline to educate themselves and better understand their care. A health care system can use the CPG to assure that its clinicians and patients have the resources available to compassionately, effectively, and safely evaluate and deliver LOT in a timely, culturally sensitive manner. The guideline can also be used to suggest specific education for identified gaps. ", "There is a paradigm shift occurring in approaches to ensuring and documenting patient and provider understanding and expectations regarding the risks and benefits of LOT. The 2010 OT CPG reflected prior practice of using opioid treatment (or pain care) agreements. OTAs have been described as coercive rather than therapeutic, lack respect for individual autonomy, can be a barrier to pain care, and may be harmful to the patient-provider relationship.[102-105] ", "Future Research: Future research is needed to better determine the impact of systematic reductions in MEDD in terms of pain relief, specific pain and medical conditions, overdose morbidity and mortality as well as potential adverse outcomes (e.g., the incidence of associated OUD, infectious diseases related to intravenous drug use disorder, and drug-related crime and diversion) and to determine whether/which conditions may be appropriately treated with LOT. Research is also needed to determine how frequency of monitoring should be impacted by dose.", "Other initiatives are aimed at improving the safe use of opioids, including the OSI Toolkit and the patient guide “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain”. The OSI Toolkit was developed to provide clinicians with materials to inform clinical decision-making regarding opioid therapy and safe opioid prescribing. The toolkit materials can be found at the following link: https://www.va.gov/PAINMANAGEMENT/Opioid_Safety_Initiative_Toolkit.asp. “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain” is aimed at providing information to patients as well as their providers regarding the safe use of opioids. More information can be found at the following link: http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf. To further promote safety and patient centered care, the VHA issued a policy in 2014 requiring standardized education and signature informed consent for all patients receiving LOT for non-cancer pain. ", "We do not recommend for or against abuse deterrent formulations for LOT. Our searches identified two RCTs in which the benefits of co-prescribing of naloxone with opioids were examined.[143,144] However, both RCTs were rated as low to very low quality with short-term follow-up. One open-label RCT enrolling 453 patients with chronic low back pain considered the safety and tolerability of an abuse deterrent formulation of oxycodone/naloxone relative to oxycodone or morphine at 12-week follow-up.[143] Another RCT considered the safety and efficacy of oxycodone/naloxone prolonged-release relative to oxycodone prolonged-release in 184 patients with moderate-to-severe chronic cancer pain at four-week follow-up.[144] An observational study (not included in the evidence review) suggested that the Introductory information of abuse deterrent opioid formulations did not help reduce abuse of opioids as a class and that patients may switch from one opioid to another based on the availability or the lack of availability of abuse deterrent formulations.[145] ", "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education." ]

[ "There is moderate quality evidence from retrospective cohort and retrospective case-control studies indicating that risk of prescription opioid overdose and overdose death exists even at low opioid dosage levels and increases with increasing doses. Significant risk (approximately 1.5 times) exists at a daily dosage range of 20 to <50 mg MEDD and further increases (approximately 2.6 times) at a range of 50 to <100 mg MEDD compared to risk at <20 mg MEDD. Risk continues to increase at higher dosage ranges (≥100 mg MEDD) (Table 2).[58,59,66,133] " ]

[ "290" ]

[ "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. ", "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] ", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Note: Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20- 50 mg morphine equivalent daily dose.", "In a prospective cohort study (not included in the evidence review as it did not include information on acute versus chronic pain in the patient population), Dasgupta et al. (2015) compared residents of North Carolina who had received an opioid prescription in the last year to residents who had not. The study examined the outcome of population-based rates of opioid overdose mortality by opioid dose, without use of a presupposed threshold (Table 3).[135] There was no safe dose of opioid. Among the over nine million individuals followed for one year, 629 died from opioid overdose. Of these 629 individuals, 151 had no record of having been dispensed an opioid. It is possible these opioids were obtained through illicit channels or social sharing/diversion. Of the 478 patients who died from an opioid overdose who were prescribed opioids, 235 (49%) had been prescribed <80 mg MEDD. Overdose incidence rate ratios (IRRs) doubled each time the MEDD ranges increase from 60.0-79.9 mg to 80.0-99.9 mg (IRR 2.9 to 6.2), then to 120-139.9 mg (IRR 14.1), 160-179.9 mg (IRR 29.5), and 350-399.9 mg (IRR 63.2). ", "In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188] ", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] ", "If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. (Strong for | Reviewed, New-replaced) Note: There is no absolutely safe dose of opioids. As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Risks for opioid use disorder start at any dose and increase in a dose-dependent manner. • Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose. (Strong for | Reviewed, New- replaced) We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. (Strong against | Reviewed, New-replaced) Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation (see Recommendations 14 and 15). " ]

[ "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community." ]

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[ "Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.", "Short-term oral medications can be utilized to assist with managing the withdrawal symptoms, especially when prescribing fast tapers. Do not treat withdrawal symptoms with an opioid or benzodiazepine. Withdrawal symptoms are not life-threatening and may not be seen with a gradual taper. Early symptoms take hours to days to appear. Early symptoms include anxiety/restlessness, rapid short respirations, runny nose, tearing eyes, sweating, insomnia, and dilated reactive pupils. Late symptoms take days to weeks to appear. Late symptoms include runny nose, tearing eyes, rapid breathing, yawning, tremor, diffuse muscle spasms/aches, piloerection, nausea, vomiting, and diarrhea, abdominal pain, fever, chills, increased white blood cells if sudden withdrawal. Prolonged symptoms take weeks to months to appear. Prolonged symptoms include irritability, fatigue, bradycardia, decreased body temperature, craving, insomnia. Early symptoms generally resolve 5 to 10 days following opioid dose reduction/cessation but may take longer depending on the half-life of the opioid (e.g., methadone). Some symptoms of withdrawal such as dysphoria, insomnia and prolonged craving may take longer. Patients with chronic pain may find that symptoms, such as fatigue, mental functioning, pain, and well-being, improve over time.", "Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.", "Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.", "Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.", "Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors." ]

[ "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. " ]

[ "292" ]

[ "Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15). ", "While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place. ", "Similar to other risk factors, continuing OT beyond 90 days’ duration should be weighed heavily in the risk benefit calculus for LOT. Continuing OT for longer than 90 days is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks. That must be determined through individual clinical assessment. ", "Conditions that significantly increase the risk of adverse outcomes from LOT are Duration and dose of OT, Severe respiratory instability or sleep disordered breathing, Acute psychiatric instability or intermediate to high acute suicide risk, Mental health disorders, History of drug overdose, Under 30 years of age, Co-administration of a drug capable of inducing fatal drug-drug interactions, QTc interval >450 ms for using methadone, Evidence for or history of diversion of controlled substances, Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids, Impaired bowel motility unresponsive to therapy, Headache not responsive to other pain treatment modalities, Traumatic brain injury (TBI), True allergy to opioid agents.", "Implementing more extensive risk mitigation strategies entails an investment of resources. Primary care providers may require more time with patients to allow for shared decision making and treatment planning. More frequent follow-up of patients on LOT can affect access to care for all empaneled patients. VHA providers must also follow VHA policy regarding education and signature informed consent when providing LOT for patients with non-cancer pain.[101] ", "Patients may decline offered treatments (e.g., OT) and may also decline risk mitigation strategies (e.g., UDT, pill counts) that are recommended in the course of clinical care. However, providers should discuss this decision with the patient, including the likelihood that their decision may result in the risks of LOT outweighing its potential benefits. This would require a consideration of patient’s safety, and a clinical decision may be made not to initiate OT or to discontinue ongoing OT through tapering (see Recommendation 14 and Recommendation 17). ", "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT. Further research is needed to identify strategies for safely managing patients at elevated risk of suicide who demand opioid medications or become further destabilized during tapering. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). " ]

[ "Psychological therapies (e.g., cognitive behavioral interventions such as Cognitive Behavioral Therapy [CBT], biofeedback) have been found to be effective for pain reduction in multiple pain conditions.[80-82] Exercise treatments, including yoga, also have evidence of benefit for reducing pain intensity and disability when compared to usual care in the treatment of chronic pain conditions.[83-85] Exercise and psychological therapies may each exert their influence through multiple mechanisms including but not limited to the reduction in fear-avoidance, reduction in catastrophizing, and/or enhancing mood.[80] Similarly, multidisciplinary biopsychosocial rehabilitation (described as a combination of a physical intervention such as graded exercise and a psychological, social, or occupational intervention) has been shown to be more effective than usual care in improving pain and disability.[81] These interventions are safe and have not been shown to increase morbidity or mortality. In light of the low harms associated with exercise and psychological therapies when compared with LOT these treatments are preferred over LOT, and should be offered to all patients with chronic pain including those currently receiving LOT. There is insufficient evidence to recommend psychological over physical therapies or vice versa; the choice of which to try first should be individualized based on patient assessment and a shared decision making process (see Patient Focus Group Methods and Findings).[80] " ]

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[ "Further studies may help determine earlier in the course of treatment which patients are most likely to benefit from a specific non-pharmacologic therapy (physical, psychological, and pain rehabilitation) or non opioid pharmacologic therapies alone or as part of a multimodal approach. ", "In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly. ", "a) We recommend against initiation of long-term opioid therapy for chronic pain. (Strong against) b) We recommend alternatives to opioid therapy such as self-management strategies and other non-pharmacological treatments. (Strong for) c) When pharmacologic therapies are used, we recommend non-opioids over opioids. (Strong for) (Reviewed, New-replaced)", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "The accumulation of evidence of harms and the absence of evidence of long-term benefits has warranted a newly cautious approach to LOT that prioritizes safety. This approach coupled with the evidence of both the safety and efficacy for non-pharmacologic and non-opioid pharmacologic pain therapies has led to the current transformation in the way in which pain is viewed and treated. The biopsychosocial model of pain recognizes pain as a complex multidimensional experience that requires multimodal and integrated care approaches. Within this context, non-pharmacologic treatments and non-opioid medications are the preferred treatments for chronic non-terminal pain. OT has a limited role, primarily in the treatment of severe acute pain, post-operative pain, and end-of-life pain. ", "Acute psychiatric instability or intermediate to high acute suicide risk: Intermediate to high acute suicide risk, severe depression, unstable bipolar disorder, or unstable psychotic disorder precludes the safe use of self-administered LOT.[60] Im et al. (2015) (n=487,462) found that a diagnosis of a mood disorder was significantly associated with suicide attempts for the chronic use of short-acting and long-acting opioids compared with no diagnosis of a mood disorder.[61] In a study of patients on opioids, Campbell et al. (2015) reported that those with bipolar disorder had 2.9 times the odds of suicidal ideation within the past 12 months as well as 3.2 times the odds of a lifetime suicide attempt compared to those with no bipolar disorder.[62] See Recommendation 8 and the VA/DoD Suicide CPG2 for more information on suicidality. See the VA/DoD Clinical Practice Guideline for Management of Bipolar Disorder in Adults (VA/DoD BD CPG) for more information on bipolar disorder.3 Merrill and colleagues found that high dose chronic opioid therapy for pain was associated with depressed mood.[63] Treatment for chronic pain with movement, exercise, and cognitive-behavioral therapy for pain may have benefits in treating depression, PTSD, and in reducing suicide risk.[64] ", "In addition to non-pharmacological therapies (e.g., exercise, CBT), appropriate mechanism and condition specific non-opioid pharmacologic agents should be tried and optimized before consideration of opioid medications (e.g., gabapentin in neuropathic pain states).[83] Potential contraindications and long-term risks of use should be considered for non-opioid pharmacologic agents as well, as these also can carry risk of harm, depending on the specific patient and chosen medication. ", "The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD). ", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Some patients with SUD may disagree with the recommendation to use non-opioid modalities in lieu of LOT to treat their pain. However, the lack of evidence of efficacy of LOT and considerable evidence of significant harms of overdose, death from overdose, and increased risk of suicide outweigh any potential modest benefit of prescribing LOT in this population. See Recommendation 7 for additional information regarding UDT and risk mitigation. See the VA/DoD SUD CPG for guidance on management of SUD.8" ]

[ "The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59] " ]

[ "294" ]

[ "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "Younger patients are also at a higher risk of opioid misuse (as suggested by a UDT indicating high-risk medication-related behavior). Turner et al. (2014) showed that patients in the 45-64 year age group were significantly less likely to have an aberrant UDT (detection of a non-prescribed opioid, non-prescribed benzodiazepine, illicit drug, or tetrahydrocannabinol [THC]) in comparison to patients in the 20-44 age group.[94] Patients in the 45-64 and ≥65 age groups were significantly less likely than 20-44 year olds to have non-detection of a prescribed opioid as well (indicating possible diversion).[94] ", "The relationship between OUD and duration of therapy is magnified when patients have a history of previous opioid or non-opioid SUD. A cross-sectional cohort study found that provision of LOT (four prescriptions within a 12 month period) to CNCP patients who had a history of severe OUD resulted in increased odds of developing OUD (OR: 56.36, 95% CI: 32.49-97.76).[88] ", "Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6. ", "Moderate quality evidence demonstrates that the prevalence of OUD in patients with CNCP is related to duration of opioid use as well as dose (see Recommendations 7-9).[86-88] There are two studies of patients with CNCP which support the current recommendations. Edlund et al. (2014) conducted a large retrospective cohort study where they examined claims data from a health insurance database between 2000 and 2005 to examine factors predictive of developing OUD.[86] Days’ supply of opioids was categorized as none, acute duration (1-90 days), or chronic duration (91+ days). Average daily dose was defined as none, low (1-36 mg MEDD), medium (36-120 mg MEDD), or high (>120 mg MEDD). The OR of developing OUD ranged based on dose and duration (OR: 3.03, 95% CI: 2.32-3.95 for low dose, acute opioid prescription; OR: 14.92, 95% CI: 10.38-21.46 for low dose, chronic opioids prescriptions; OR: 3.10, 95% CI: 1.67-5.77 for high dose, acute opioid prescriptions; OR: 122.45, 95% CI: 72.79-205.99 for high dose, chronic opioid prescriptions). They found that even greater than opioid dose, duration of OT was the strongest predictor of developing OUD. Additionally, a study by Boscarino et al. (2011) examined medical records from a large healthcare system.[89] Through interviews with a random sample of patients on LOT, they examined factors associated with and the prevalence of OUD (using DSM IV and 5 criteria). These results showed that the prevalence of lifetime OUD for patients on LOT was 34.9% (based on DSM-5 criteria) and 35.5% (based on DSM-IV criteria). ", "The Edlund et al. (2014) study of 568,640 commercial health plan patients (see Recommendation 2 and 3) found that those diagnosed with CNCP and an alcohol use or non-opioid drug use disorder had higher rates of OUD (OR: 3.22, 95% CI: 1.79-5.80 for patients with pre-index alcohol use disorder compared to no alcohol use disorder; OR: 8.26, 95% CI: 4.74-14.39 for patients with pre-index non-opioid drug use disorders compared to no non-opioid drug use disorders).[86] Moreover, Huffman et al. (2015) found that the presence of a lifetime history of SUD for patients with CNCP was associated with 28 times increased odds of therapeutic opioid addiction compared to patients with CNCP without a lifetime history of SUD (OR: 28.58, 95% CI: 10.86-75.27).[87] ", "Some may interpret the recommendation to limit opioid use by age as arbitrary and potentially discriminatory when taken out of context; however, there is good neurophysiologic rationale explaining the relationship between age and OUD and overdose. Studies in other areas (e.g., use of different substances) indicate that developing brains (age <30 years) are at increased risk of abnormalities and addiction when exposed to substance use early in life.[95-98] ", "In patients receiving LOT, moderate quality evidence indicated that men are 50% more likely (HR: 1.44, 95% CI: 1.21-1.70) to escalate to high-dose opioids (defined as >200 mg MEDD) and twice as likely to experience an opioid-related death (adjusted HR: 2.04, 95% CI: 1.18-3.53) compared to women.[136] Risk of opioid overdose morbidity or mortality is also increased in non-Hispanic white versus non-Hispanic black patients (moderate quality evidence).[59,136] " ]

[ "In addition to benzodiazepines, the addition of other psychoactive medications to LOT must be made with caution. While the evidence for harm associated with the combination of opioids and Z-drugs (e.g., zolpidem, eszopiclone) is not as strong as the evidence for harm associated with the combination of opioids and benzodiazepines, we suggest not prescribing Z-drugs to patients who are on LOT, as moderate quality evidence demonstrates that the combination of zolpidem and opioids increases the AOR of overdose.[66] The evidence reviewed also identifies potential adverse outcomes (e.g., risk of overdose) with the combined use of antidepressants and opioids in patients who do not have depression.[66] This particular study did not differentiate between classes of antidepressants, limiting the ability of the Work Group to recommend for or against prescribing opioids and a specific class of antidepressants. As such, there is no recommendation in this guideline with respect to using specific classes of antidepressants and LOT. " ]

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[ "Achieving an improved understanding of the factors contributing to prescription opioid-related overdose is an essential step toward addressing this epidemic problem. Although it is widely accepted that progressively higher doses of prescribed opioids result in correspondingly higher risks of opioid overdose, patients using any dose of opioids can still experience life-threatening respiratory or CNS depression, especially when opioid-naïve. This risk begins to increase with MEDD as low as 20-50 mg. Risk is further increased when certain concomitant demographic factors, co-occurring medical or psychiatric conditions, or interacting medications or substances exist. ", "Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]", "Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91] ", "Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT. ", "Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]", "Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances", "Acute psychiatric instability or intermediate to high acute suicide risk: Intermediate to high acute suicide risk, severe depression, unstable bipolar disorder, or unstable psychotic disorder precludes the safe use of self-administered LOT.[60] Im et al. (2015) (n=487,462) found that a diagnosis of a mood disorder was significantly associated with suicide attempts for the chronic use of short-acting and long-acting opioids compared with no diagnosis of a mood disorder.[61] In a study of patients on opioids, Campbell et al. (2015) reported that those with bipolar disorder had 2.9 times the odds of suicidal ideation within the past 12 months as well as 3.2 times the odds of a lifetime suicide attempt compared to those with no bipolar disorder.[62] See Recommendation 8 and the VA/DoD Suicide CPG2 for more information on suicidality. See the VA/DoD Clinical Practice Guideline for Management of Bipolar Disorder in Adults (VA/DoD BD CPG) for more information on bipolar disorder.3 Merrill and colleagues found that high dose chronic opioid therapy for pain was associated with depressed mood.[63] Treatment for chronic pain with movement, exercise, and cognitive-behavioral therapy for pain may have benefits in treating depression, PTSD, and in reducing suicide risk.[64] ", "There is concern for additional overdose risk associated with long-acting versus short-acting opioids. A study (not included in the evidence review due to its design) suggests increased risk for non-fatal overdose in VA patients with initiation of a long-acting opioid compared with immediate-release opioids.[137] Also, recent research demonstrates that patients with CNCP on long-acting OT have a significantly increased risk of all-cause mortality compared to patients with CNCP who are taking an analgesic anticonvulsants or a low-dose antidepressant.[10] ", "Further studies may help determine earlier in the course of treatment which patients are most likely to benefit from a specific non-pharmacologic therapy (physical, psychological, and pain rehabilitation) or non opioid pharmacologic therapies alone or as part of a multimodal approach. ", "Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups. " ]

[ "Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena. " ]

[ "296" ]

[ "Future Research: Future research is needed to better determine the impact of systematic reductions in MEDD in terms of pain relief, specific pain and medical conditions, overdose morbidity and mortality as well as potential adverse outcomes (e.g., the incidence of associated OUD, infectious diseases related to intravenous drug use disorder, and drug-related crime and diversion) and to determine whether/which conditions may be appropriately treated with LOT. Research is also needed to determine how frequency of monitoring should be impacted by dose.", "As substance misuse in patients on LOT is more than 30% in some series,[107] UDT and confirmatory testing is used as an additional method of examining for patient substance misuse and adherence to the prescribed regimen. UDTs, used in the appropriate way, help to address safety, fairness, and trust with OT. Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to the false positive and negative rates associated with UDTs.[53] Interpretation of a UDT and confirmatory results requires education and knowledge of the local procedures and clinical scenario. Local education and access to expert interpretation is necessary. UDT results are helpful and can help identify active SUD or possible diversion. Accordingly, clinicians should obtain UDT prior to initiating or continuing LOT and periodically thereafter. When a patient is referred for SUD treatment or is engaged in on-going treatment there should be close communication between the SUD and pain management providers. The ideal approach is an interdisciplinary format (see Recommendation 16). For more information, see Appendix B on UDT and confirmatory testing. ", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient. ", "Future research is needed to ascertain whether abuse deterrent formulations actually reduce OUD when used for chronic pain, and whether said formulations differ across clinical outcomes such as pain, function, and adverse events. ", "Toward augmenting this evidence base, we recommend that future observational research examine age as a continuous predictor of adverse outcomes. Additionally, we recommend that future trials examine which risk mitigation strategies can reduce the additional risk of OUD and overdose in younger patients on LOT. Lastly, a deeper understanding of the mechanisms for addiction to opioids in young brains is needed.", "State database queries for detection of multi-sourcing of controlled substances are used throughout the country. Data comparing states with an implemented state database program to states without one showed 1.55 fewer deaths per 100,000 people.[106] The CDC currently recommends at least quarterly checks of the state database system.[33] ", "All patients who take opioids chronically are at risk for OUD and overdose, but especially those who are younger than 30 years of age. Seven studies were identified that examined age as a predictor of OUD, respiratory/CNS depression, and/or overdose. Four of the seven studies were rated as fair quality evidence,[59,86,88,92] while three were rated as poor quality evidence.[58,62,87] Six of the seven studies demonstrated that age was inversely associated with the risk of OUD and overdose.[59,62,86-88,92] One of the three low quality studies showed that older subjects had a higher HR of overdose.[58] The Work Group’s overall confidence in the quality of the evidence was moderate. ", "Given the increasing use of cannabis among patients with chronic pain and the lack of RCTs comparing outcomes of prescribing LOT versus other therapies for patients with and without cannabis use and cannabis use disorder, future research is needed to optimize care for these patients. Research is also needed to determine which subpopulations of patients with active SUD are at greatest risk of OUD, overdose, and death. Finally, further research is needed on the efficacy of alternative treatments for pain and ways to mitigate risks of opioid-related adverse events in patients with SUD and pain. ", "In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD. " ]

[ "When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community." ]

[ "297" ]

[ "Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.", "The Opioid Taper Decision Tool is designed to assist Primary Care providers in determining if an opioid taper is necessary for a specific patient, in performing the taper, and in providing follow-up and support during the taper.", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Evidence for or history of diversion of controlled substances: The clinician should communicate to patients that drug diversion is a crime and constitutes an absolute contraindication to prescribing additional medications. Because suspicion is subjective and may be based on impression, bias, or prejudice, it is important that providers who suspect diversion base treatment plans on objective evidence. Suspicions may be confirmed by a negative mass spectrometry/liquid chromatography UDT for the substance being prescribed in the absence of withdrawal symptoms in someone who is receiving opioids. A negative UDT for the prescribed opioid could also by itself be a sign of diversion. Signs of diversion may also include frequent requests for early refills or atypically large quantities required to control pain. Routine UDT, however, may not reliably detect synthetic opioids (e.g., methadone, fentanyl, tramadol) or semi-synthetic opioids (e.g., oxycodone, hydrocodone, hydromorphone). When there is evidence that the patient is diverting opioids, discontinue opioids according to Recommendations 14 and 15 and assess for underlying OUD and/or psychiatric comorbidities. Consultation with a pain specialist, psychiatrist, or SUD specialist may be warranted. Also consider consultation with local risk management and/or counsel. For patients with OUD, keep in mind that sudden discontinuation of opioids due to suspected diversion may place them at high risk for illicit opioid use and resulting opioid overdose (see Recommendation 17).", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).", "Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.", "We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules.", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.", "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. " ]

[ "When a decision is made to taper, special attention must be given to ensure that the Veteran does not feel abandoned. Prior to any changes being made in opioid prescribing, a discussion should occur between the Veteran, family members/caregivers, and the provider either during a face-to-face appointment or on the telephone. The strategies that will help in the transition are discussion, asking about goals, educating the veteran. Discussion includes listening to the Veteran’s story, letting the Veteran know that you believe that their pain is real, using Motivational Interviewing (MI) techniques to acknowledge the Veteran’s fears about tapering. Include family members or other supporters in the discussion. Asking about goals includes drawing out their goals for life, having the Veteran fill out the PHI, asking how we can support them during the taper. The drawn-out life goals should not be just being pain-free. PHI is the Personal Health Inventory. " ]

[ "298" ]

[ "Opioids are not first-line or routine therapy for chronic pain. Establish treatment goals before starting opioid therapy and a plan if therapy is discontinued. Only continue opioid if there is clinically meaningful improvement in pain and function. Discuss risks, benefits and responsibilities for managing therapy before starting and during treatment.", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132] ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education.", "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Evidence for or history of diversion of controlled substances: The clinician should communicate to patients that drug diversion is a crime and constitutes an absolute contraindication to prescribing additional medications. Because suspicion is subjective and may be based on impression, bias, or prejudice, it is important that providers who suspect diversion base treatment plans on objective evidence. Suspicions may be confirmed by a negative mass spectrometry/liquid chromatography UDT for the substance being prescribed in the absence of withdrawal symptoms in someone who is receiving opioids. A negative UDT for the prescribed opioid could also by itself be a sign of diversion. Signs of diversion may also include frequent requests for early refills or atypically large quantities required to control pain. Routine UDT, however, may not reliably detect synthetic opioids (e.g., methadone, fentanyl, tramadol) or semi-synthetic opioids (e.g., oxycodone, hydrocodone, hydromorphone). When there is evidence that the patient is diverting opioids, discontinue opioids according to Recommendations 14 and 15 and assess for underlying OUD and/or psychiatric comorbidities. Consultation with a pain specialist, psychiatrist, or SUD specialist may be warranted. Also consider consultation with local risk management and/or counsel. For patients with OUD, keep in mind that sudden discontinuation of opioids due to suspected diversion may place them at high risk for illicit opioid use and resulting opioid overdose (see Recommendation 17).", "When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.", "Given the recognized risks of opioid therapy, an optimal approach to care should include a robust, signature informed consent process that is patient-centered and provides patients with information about known benefits and harms of OT and treatment alternatives. In 2014, VA established a requirement for signature informed consent, consistent with VA policy for other treatments or procedures with a significant risk of complications or morbidity. See Appendix A, Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain (found at http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf), and 38 C.F.R. §17.32 (2012). ", "Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder)." ]

[ "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include ongoing, random urine drug testing (including appropriate confirmatory testing), checking state prescription drug monitoring programs, monitoring for overdose potential and suicidality, providing overdose education, prescribing of naloxone rescue and accompanying education." ]

[ "299" ]

[ "The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks. ", "The VA/DoD OT CPG was developed with a specific patient population in mind—Service Members, Veterans, and their families—that has unique characteristics and needs related to the military culture and communities to which they return. Throughout the VA/DoD OT CPG, attention is paid to the characteristics and needs of these patients, particularly regarding specific risk factors such as risk for suicide, SUD, and other medical and mental health co-occurring conditions that may complicate the management of pain for these patients. Further, these recommendations were made keeping in mind the implications they would have within the VA/DoD healthcare settings, particularly regarding considerations such as resource use, accessibility, and equity related to each recommendation and the urgent need for rigorous attention to the balance of risks and benefits for patients within the VA/DoD specifically. ", "We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for | Reviewed, New-replaced) ", "An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold. ", "A number of studies suggest certain chronic pain conditions represent an independent risk factor for suicide.[123-130] A recent large retrospective cohort study also suggests an association with prescribed opioid dose and suicide risk among Veterans receiving OT for CNCP.[131] Suicide risk is not static, and many factors influence an individual’s risk of suicide at any given point in time, as noted in the VA/DoD Suicide CPG. Thus, ongoing assessment of suicide risk is important whether one is initiating, maintaining, or terminating LOT. ", "Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment. ", "Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.", "At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms. ", "Implementing more extensive risk mitigation strategies entails an investment of resources. Primary care providers may require more time with patients to allow for shared decision making and treatment planning. More frequent follow-up of patients on LOT can affect access to care for all empaneled patients. VHA providers must also follow VHA policy regarding education and signature informed consent when providing LOT for patients with non-cancer pain.[101] ", "When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping)." ]