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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	83	Which factors require immediate attention and possible discontinuation?	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.”.
over days	20	How long does the rapid taper take?	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.
in the clinic and/or over telephone	819	Where to follow up with the Veteran during the slowest taper?	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.
non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral	2,147	Which factors can increase the risks of OT?	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.
patients currently on long-term opioid therapy	261	For whom consideration for tapering when risks exceed benefits is 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)
20-44 year olds	509	Patients in the 45-64 and ≥65 age groups were significantly less likely than whom to have non-detection of a prescribed opioid (indicating possible diversion)?	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 accumulation of evidence of harms and the absence of evidence of long-term benefits	0	What warranted a cautious approach to LOT prioritizing safety?	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.
taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities	1,499	What to do if there is no clinically meaningful improvement in function in the absence of significant risk factors?	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.
Concurrent prescribing of sedative-hypnotics and benzodiazepines	984	What does increase the risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges?	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]
as a complex multidimensional experience that requires multimodal and integrated care approaches	436	How is pain recognized by the biopsychosocial model of pain?	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.
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.	505	Why is it 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?	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.
Chronic pain	0	What is a national public health problem as outlined in the 2011 study by the National Academy of Medicine?	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.
Re-evaluate the risks and benefits of continuing opioid therapy	138	What to do when there are concerns related to an increased risk of SUD?	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.
sharing needles	461	What is an example of high-risk behaviors?	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]
15 mg SR Q12h	521	When reducing 16% of morphine SR 90 mg Q8h = 270 MEDD on month 1, what dose should be taken on month six 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 combined use of antidepressants and opioids	618	What can have potential adverse outcomes in patients who do not have depression?	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.
as observational and epidemiologic data of harm from LOT accumulated	1,038	How did a more cautious approach to OT for chronic non-terminal pain emerge?	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.
to use a patient-centered care approach that is tailored to the patient’s capabilities, needs, goals, prior treatment experience, and preferences	33	What does VA/DoD CPGs encourage clinicians to do?	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.
discussion, asking about goals, educating the veteran	378	What strategies will help in the transition?	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.
providing follow-up in a clinic visit may be more optimal than a telephone visit	1,372	What to do if there are issues with the Veteran obtaining outside prescriptions during the taper?	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.
the National Academy of Medicine	95	In response to the recognition of pain and its management as a public health problem in 2011, who investigated and reported on the state of pain research, treatment, and education in the U.S.?	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.
patients with OUD (Opioid Use Disorder)	373	Who should be offered medication-assisted treatment?	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).
starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies	98	How to implement the risk mitigation strategies upon initiation of long-term opioid therapy?	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.
subsequent regular reassessment	176	If the initial goal is determined to be a dose reduction, what may indicate that complete discontinuation is more suitable?	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.
The U.S. is in the midst of a cultural transformation in the way pain is viewed and treated	0	What is the trend in pain management and care in the U.S.?	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 lowest dose of opioids as indicated by patient-specific risks and benefits	49	What is the recommended dose of opioids?	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).
duration of opioid use as well as dose	102	To what the prevalence of OUD in patients with CNCP is related?	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).
more than 183,000	879	How many people died between 1999 and 2015 from overdoses related to prescription opioids?	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 adjusted odds ratio (AOR) for drug overdose	268	What was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy?	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]
14%	826	How much has the absolute number of deaths associated with the use of opioids increased from 2013 to 2014?	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.
Re-evaluate the risks and benefits of continuing opioid therapy	138	What to do when there is non-adherence to the treatment plan or unsafe behaviors?	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.
use of adjuvant medications	9	What to consider to reduce withdrawal symptoms during the taper?	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.
Pain arising from persistent peripheral stimulation	39	Which pain could be mechanical or chemical/inflammatory in nature?	There are many causes of chronic pain. Pain arising from persistent peripheral stimulation could be mechanical or chemical/inflammatory in nature typically leading to well-localized nociceptive mechanism pain. Mechanical or inflammatory pain with a visceral origin may produce a less localized pain. Neuropathic pain due to injury or disease of the central or peripheral nervous system (e.g., spinal cord injury, diabetic neuropathy, radiculopathy) may lead to poorly localized symptoms such as diffuse pain, burning, numbness, or a feeling of skin sensitivity.
true life-threatening allergy to opioids, active SUD, elevated suicide risk, concomitant use of benzodiazepines	964	What are some examples of absolute contraindications to initiating opioid therapy for chronic pain?	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.
the combination of zolpidem and opioids	446	What does increase the AOR of overdose?	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.
benefits of continued opioid therapy	159	What benefits are recommended to be evaluated at least every 3 months?	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.
objective	384	On what kind of evidence should the providers who suspect diversion base treatment plans?	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).
Prescription Drug Monitoring Program	1,161	What does PDMP mean?	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.
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.	260	Which opioid risk mitigation strategies should be incorporateed into opioid prescribing for acute pain?	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.
those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting	1,249	Depending on age, marital status, race, and living conditions, who were more likely to continue using opioids?	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.