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Gabapentin	671	Which can help reduce withdrawal symptoms?	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.
mental health, SUD, primary care, and specialty pain care	329	What maybe included in interdisciplinary services?	When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).
multifaceted	476	How to characterize pain as a symptom?	Pain is defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage…Pain is always subjective…It is unquestionably a sensation in a part or parts of the body, but it is also always unpleasant and therefore also an emotional experience.” All of these facets signify the complexity of pain as a condition by itself and how it relates to both the brain and the body. Pain as a symptom is multifaceted and is described and characterized by many factors such as its quality (e.g., sharp versus dull), intensity, timing, location, and whether it is associated with position or movement.
look for evidence of diversion	706	What to do if the patient does not demonstrate signs or symptoms of SUD?	Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.
Patients who may be at risk include those with other risk factors for QTc prolongation, current or prior electrocardiograms (ECGs) with a prolonged QTc >450 ms, or a history of syncope.	340	Why are ECGs highly advised before and after initiating methadone?	QTc interval >450 ms for using methadone: Unlike most other commonly used opioids, methadone has unique pharmacodynamic properties that can prolong the QTc interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) and precipitate torsades de pointes, a dangerous or fatal cardiac arrhythmia. Patients who may be at risk include those with other risk factors for QTc prolongation, current or prior electrocardiograms (ECGs) with a prolonged QTc >450 ms, or a history of syncope. Therefore, ECGs before and after initiating methadone are highly advised (see Methadone Dosing Guidance).
starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies	99	How to implement 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 (Strong for \| Reviewed, New-replaced)
approximately 65%	992	In a study of civilian patients who had been on opioids for at least 90 days, how many remained on opioids through the 4.8 year follow-up period?	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.
patients who require higher doses of opioids, even in those who benefit from such therapy	500	Who will have other adverse events?	Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered.
sweating, tachycardia, myoclonus	148	What do autonomic symptoms include?	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.
Worsening of some of these factors (e.g., quality of life, change in employment status)	664	What can be associated with pain severity and the presence of psychiatric comorbidities?	A comprehensive pain assessment includes a biopsychosocial interview and focused physical exam. Elements of the biopsychosocial pain interview include a pain-related history, assessment of pertinent medical and psychiatric comorbidities including personal and family history of SUD, functional status and functional goals, coping strategies, and a variety of psychosocial factors such as the patient’s beliefs and expectations about chronic pain and its treatment. Patients with chronic pain may also experience worsened quality of life, mental health, immune system function, physical function, sleep, employment status, and impaired personal relationships. Worsening of some of these factors (e.g., quality of life, change in employment status) seems to also be associated with pain severity and the presence of psychiatric comorbidities. Patients with chronic pain report psychological complaints (e.g., depression, anxiety, poor self-efficacy, poor general emotional functioning) more often than patients without chronic pain. Further, there can be social and psychological consequences such as decreased ability to successfully maintain relationship and career roles and increased depression, fear, and anxiety as a result of pain.
4 mg three times daily, can increase to 8 mg three times daily	1,382	What is the alternative treatment option for autonomic symptoms using Tizanidine?	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.
multiple instances in which confidence in the quality of the evidence was low or very low, while there was marked imbalance of benefits and harms, as well as certain other important considerations arising from the domains of values and preferences and/or other implications	95	Given the relevance of all four domains in grading recommendations, what did the Work Group encounter?	Given the relevance of all four domains in grading recommendations, the Work Group encountered multiple instances in which confidence in the quality of the evidence was low or very low, while there was marked imbalance of benefits and harms, as well as certain other important considerations arising from the domains of values and preferences and/or other implications. In particular, the harms due to the potential for severe adverse events associated with opioids, particularly overdose and OUD, often far outweigh the potential benefits. As such, in accounting for all four domains, these factors contributed to strong recommendations in multiple instances.
risks, benefits and responsibilities for managing therapy	257	What to discuss before starting the treatment?	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.
that drug diversion is a crime and constitutes an absolute contraindication to prescribing additional medications	108	What should the clinician communicate to patients?	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).
75%	445	What percentage of people entering SUD treatment for heroin use started using prescription opioids as their first opioid in the 2000s?	Concurrent with the increase in prescription opioid use, the rate of heroin overdose deaths increased nearly four-fold between 2000 and 2013. According to a survey of patients entering SUD treatment for heroin use, the prescription opioid epidemic has resulted in a marked shift in how and which opioids are abused. In the 1960s, 80% of people entering treatment for heroin use started using heroin as their first opioid, while in the 2000s, 75% of people entering treatment for heroin use started using prescription opioids as their first opioid. This increase in the use of opioids, as well as associated morbidity, mortality, and other adverse outcomes, has called attention to the need for a paradigm shift in pain and in the way it is treated. Consult the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders (VA/DoD SUD CPG) for further information.
2004	154	When was the Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered?	The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “…Health Executive Council on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration and Military Health System,” by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations. This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with chronic pain who are on or being considered for long-term opioid therapy (LOT).
an investment of resources	63	What does implementing more extensive risk mitigation strategies entail?	Implementing more extensive risk mitigation strategies entails an investment of resources. Primary care providers may require more time with patients to allow for shared decision making and treatment planning. More frequent follow-up of patients on LOT can affect access to care for all empaneled patients. VHA providers must also follow VHA policy regarding education and signature informed consent when providing LOT for patients with non-cancer pain.[101]
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	1,799	What to do during a follow-up with a patient?	Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.
A recent large retrospective cohort study	119	Is there any evidence that suggests an association with prescribed opioid dose and suicide risk among Veterans receiving OT for CNCP?	A number of studies suggest certain chronic pain conditions represent an independent risk factor for suicide.[123-130] A recent large retrospective cohort study also suggests an association with prescribed opioid dose and suicide risk among Veterans receiving OT for CNCP.[131] Suicide risk is not static, and many factors influence an individual’s risk of suicide at any given point in time, as noted in the VA/DoD Suicide CPG. Thus, ongoing assessment of suicide risk is important whether one is initiating, maintaining, or terminating LOT.
provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation	167	Being developed by a panel of multidisciplinary experts, what does the guideline do?	This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation.
Follow-up for tapering	0	What is recommended to be a team function?	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.
approximately 28%	646	What is the estimation of the lifetime prevalence for mild symptoms of OUD among patients receiving long-term opioid therapy?	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.
review the risk of the taper vs. the benefit of remaining at the current dose	1,015	What to review at each step in the taper?	Follow up in the first 1 to 4 weeks of taper. If Veteran feels supported and is adjusting to the dose reduction, continue the strategy of reducing to morphine SR 30 mg every 8 hours, follow up in 1 to 4 weeks to determine the next step in the taper. If Veteran strongly resists reduction, then request mental health support and consider the possibility of OUD. If the Veteran is resisting further dose reductions, explore the reason for the reluctance. The reasons for the reluctance can be medical (increased pain), mental health (worsening depression, anxiety, etc.), and substance use disorder (SUD)/opioid use disorder (OUD). Refer to OUD Provider Education Guide on VA PBM Academic Detailing SharePoint for more information. https://vaww.portal2.va.gov/sites/ad/SitePages/OUD.aspx . If safe, remain at morphine SR 45 mg every 8 hours for 1 to 2 months then reassess. If possible, the Veteran should be actively involved in skills training and/or have a comprehensive pain care plan. At each step in the taper, review the risk of the taper vs. the benefit of remaining at the current dose, and if necessary, adjust the speed of the taper according to the response of the Veteran.
benefits and risks	198	What to follow up or review before starting opioid therapy?	Use immediate-release (IR) opioids when starting therapy. Prescribe the lowest effective dose. When using opioids for acute pain, provide no more than needed for the condition. Follow up and review benefits and risks before starting and during therapy. If benefits do not outweigh harms, consider tapering opioids to lower doses or taper and discontinue.
multimodal	536	What kind of treatment plan should be integrated into the patient’s care prrior to considering LOT?	While there is currently no evidence in the literature documenting the benefit of LOT that demonstrates improvement in pain and function, we recognize that in a rare subset of individuals a decision to initiate LOT may be considered (e.g., for intermittent severe exacerbations of chronic painful conditions). If a decision is made to initiate LOT, a careful assessment of benefits and risks should be made to ensure that the benefits are expected to outweigh the well-documented risks. In addition, prior to this consideration, a multimodal treatment plan should be integrated into the patient’s care. Once opioid therapy is initiated, all opioid risk mitigation strategies outlined in this guideline (see Recommendation 7) should be put into place.
The strategies and their frequency	231	What should be commensurate with risk factors?	We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for \| Reviewed, New-replaced)
A history of overdose	1,111	What is a red flag in the presence of which providers should proceed with utmost caution when considering LOT for these patients?	Current or history of SUD: For patients with untreated SUD, see Recommendation 4. For patients with diagnosed OUD, see Recommendation 17. Frequent requests for early refills or atypically large quantities required to control pain can signal an emerging SUD as well as diversion (see Evidence for or history of diversion of controlled substances). See the VA/DoD SUD CPG.4 Depression or history of depression: Zedler et al. (2014) reported that among patients being treated by the VHA system that received opioids, a history of depression was significantly associated with opioid-related toxicity/overdose compared to no history of depression.[58] LOT has been associated with worsening depressive symptoms.[63] See the VA/DoD MDD CPG.5 PTSD: Seal et al. (2012) (n=15,676) noted that among patients on OT, a prevalence of self inflicted injuries was significantly higher among patients with a history of PTSD (with or without other mental health diagnoses) as compared to patients with other (or no) mental health diagnoses.[65] For more information, see the VA/DoD PTSD CPG.6 History of drug overdose: A history of overdose is a red flag and providers should proceed with utmost caution when considering LOT for these patients. Under 30 years of age: See Recommendation 6.
Abrupt discontinuation	152	What should be avoided unless required for immediate safety concerns?	We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules.
LOT	60	What is an ineffective treatment modality for patients with occipital neuralgia?	Headache not responsive to other pain treatment modalities: LOT is an ineffective treatment modality for patients with migraine headaches (with or without aura), tension-type headaches, occipital neuralgia, or myofascial pain and may result in worsening of the underlying headache condition through factors such as central sensitization and withdrawal.
patient and treatment characteristics	1,608	What to consider while deciding when to follow up with a patient after each change in dosage or after discontinuation?	Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.
nearly four-fold	103	How much did the rate of heroin overdose deaths increase between 2000 and 2013?	Concurrent with the increase in prescription opioid use, the rate of heroin overdose deaths increased nearly four-fold between 2000 and 2013. According to a survey of patients entering SUD treatment for heroin use, the prescription opioid epidemic has resulted in a marked shift in how and which opioids are abused. In the 1960s, 80% of people entering treatment for heroin use started using heroin as their first opioid, while in the 2000s, 75% of people entering treatment for heroin use started using prescription opioids as their first opioid. This increase in the use of opioids, as well as associated morbidity, mortality, and other adverse outcomes, has called attention to the need for a paradigm shift in pain and in the way it is treated. Consult the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders (VA/DoD SUD CPG) for further information.
Bio-Psycho-Social Model e.g., PHI’s “Whole Health” approach	29	What to use to educate the Veteran?	Educate the Veteran by using Bio-Psycho-Social Model e.g., PHI’s “Whole Health” approach. Offer Veterans pain education groups [especially Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for Pain, if available]. Clinicians should offer physical therapy and Complementary and Integrative Health (CIH) interventions such as acupuncture, meditation, yoga. Clinicians should offer slow tapering of opioids to reduce opioid risks while not “cutting off” the Veteran. Clinicians should offer non-opioid pain medications when appropriate. Clinicians should commit to working with the Veteran on other options for improved function and some decrease in pain.
all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications	233	What should be exhausted before consideration of LOT?	Patient access to physical, psychological, and pain rehabilitation modalities should be considered. In some cases access to care may be limited; all VA and DoD clinics may not have access to multidisciplinary pain services. Still, all avenues for obtaining these treatments (e.g. Internet based CBT) and all appropriate non opioid medications should be exhausted before consideration of LOT.[82]
more frequent monitoring for adverse events including opioid use disorder and overdose	267	What to do with the increment of opioid dosage and risk?	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).
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	235	What should be the duration and dosage when initiatiing opioid thrapy?	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.
to reduce the amount of opioids in the community	88	Returning unused opioid medications has been explored as a strategy for what?	Take Back Programs: Returning unused opioid medications has been explored as a strategy to reduce the amount of opioids in the community, as it has been estimated that 70% of opioid prescriptions are left unused.[115] Accordingly, the National Drug Control Strategy advocates take back programs as an effective tool.[24] For example, in a 2013 medication take back event in a Michigan community, 3,633 containers containing 345 different prescription medications were collected in four hours. The top five most common medications collected were pain relievers.[116] System-wide efficacy of a nationwide program is unknown.[117]
Long-acting opioids	0	What should not be used for treatment of acute pain?	Long-acting opioids, as further discussed below, should not be used for treatment of acute pain, on an as needed basis, or during initiation of LOT (see Short-acting versus Long-acting Opioids). In general, however, no single opioid or opioid formulation is preferred over the others. However, individuals may have a better response, degree of safety, or tolerability depending on their individual characteristics and preferences. Additional information for use when deciding on appropriate pharmacological treatment of pain for a specific patient can be found in Appendix D.
15 mg SR Q8h	923	When reducing 33% of morphine SR 90 mg Q8h = 270 MEDD on day 1, what dose should be taken on day four of the rapid opioid tapering?	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.
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	321	What should be included in the risk mitigation strategies and their frequency?	We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for \| Reviewed, New-replaced)
over 90 mg morphine equivalent daily dose	627	What opioid dose is not recommended for treating chronic pain?	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).