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an aberrant UDT (detection of a non-prescribed opioid, non-prescribed benzodiazepine, illicit drug, or tetrahydrocannabinol [THC])	245	In comparison to patients in the 20-44 age group, patients in the 45-64 year age group were significantly less likely to have what?	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]
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	1,025	What to do if risks do not outweigh benefits of continuing OT?	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.
60 mg SR Q8h	417	When reducing 16% of morphine SR 90 mg Q8h = 270 MEDD on month 1, what dose should be taken on month two of the slower opioid tapering?	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.
The 2015 outbreak of HIV/hepatitis in rural Indiana and subsequent successful implementation of a needle exchange program	928	What 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?	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]
roughly half	440	What was the amount of risk of developing OUD or overdose in patients 30-39 years old compared to subjects 18-29 years old?	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 rationale for the opioid taper and the opioid taper schedule	819	What to document in the Veteran’s medical record?	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.
admit/provide medical and psychiatric treatment to stabilize as indicated	925	What to do if a patient is medically or psychiatrically unstable?	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.
2 to 10% every 4 to 8 weeks with pauses in taper as needed	73	How much opioid to reduce in the slowest taper?	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.
plan	127	What should be done if an opioid thrapy is discontinued?	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.
over 90%	766	In a study of Veterans with chronic pain who had been on opioids for at least 90 days, how many continued to use opioids one year later?	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.
Re-evaluate the risks and benefits of continuing opioid therapy	138	What to do when there are concerns related to an increased risk of substance use disorder?	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 evidence for harm associated with the combination of opioids and Z-drugs (e.g., zolpidem, eszopiclone)	120	What is not as strong as the evidence for harm associated with the combination of opioids and benzodiazepines?	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.
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	602	What are included in the underlying concepts of the biopsychosocial model 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 evidence of both the safety and efficacy for non-pharmacologic and non-opioid pharmacologic pain therapies	188	What was coupled with the newly cautious approach to LOT?	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.
hours to days	308	How long does it take for early withdrawal symptoms to appear?	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.
opioid and benzodiazepines	243	What should not be prescribed concurrently when possible?	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).
Veteran response	453	Clinicians should continue the slowest taper based on what?	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.
Community-based needle exchange programs	0	What has been an effective risk mitigation strategy for reducing high-risk behaviors and infectious disease transmission among injection drug users?	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]
morphine equivalent daily dose	1,492	What is MEDD?	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.
overdose and other adverse events	993	Tapering the opioid analgesic without providing OUD treatment may increase the risk of what?	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.
the variety of ever-changing state regulations that may be pertinent	364	What does this guideline not cover?	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.
Personal Health Inventory	935	What is PHI?	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.
gabapentin in neuropathic pain states	226	What is an example of opioid medications?	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.
as it can lead to serious adverse effects including seizures and death	695	Why should abrupt discontinuation of benzodiazepines be avoided?	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.
opioid misuse (as suggested by a UDT indicating high-risk medication-related behavior)	46	Younger patients are at a higher risk of what?	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]
withdrawal symptoms and help with pain, anxiety, and sleep	1,234	Gabapentin can help reduce what?	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.
standardized education and signature informed consent for all patients receiving LOT for non-cancer pain	1,060	What are the requirements in the policy issued by the VHA to further promote safety and patient centered care?	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.
the risks of continued use, along with possible benefits	382	Prior to any changes in therapy, what should be discussed with the Veteran?	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
patients currently on long-term opioid therapy	261	For whom ongoing risk mitigation strategies are recommended?	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)
a toxidrome characterized by significant CNS and profound respiratory depression requiring multiple naloxone doses for reversal	218	What can be caused by fentanyl analogs that may be used to create counterfeit opioid analgesic pills?	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]
no later than 3-5 days	345	If take-home opioids are prescribed, when is the opioid therapy reassessment recommended?	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.
Consideration of opioid therapy beyond 90 days	385	What does require reevaluation and discussion of risks and benefits with patients?	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.
a requirement for signature informed consent, consistent with VA policy for other treatments or procedures with a significant risk of complications or morbidity	289	What did VA establish in 2014 regarding OT and treatment alternatives?	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).
OUD and overdose	58	All patients who take opioids chronically are at risk for what?	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.
proceed to module D	263	What to do if a patient is with chronic pain and has been on daily OT for pain for more than 3 months?	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.
exercise and psychological therapies	1,042	Which treatments should be offered to all patients with chronic pain including those currently receiving LOT?	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]
the false positive and negative rates associated with UDTs	441	Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to what?	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.
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)	1,638	On which basis the frequency of follow-ups with a patient on OT should be considered?	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 an opioid allergy is present and OT is being considered	392	When may a consultation with an allergist be helpful?	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.
lowest dose of opioids as indicated by patient-specific risks and benefits	321	If prescribing opioids, what is the recommended dose?	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.