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i)Opioids with benzodiazepines (compared to patients with no prescription, the odds ratio [OR] and 95% confidence interval [CI] for drug-related death was OR: 14.92, 95% CI: 7.00- 31.77 for patients who filled a prescription for opioids and benzodiazepines; OR: 3.40, 95% CI: 1.60-7.21 for patients who filled only an opioid prescription, and 7.21, 95% CI: 3.33-15.60 for patients who filled only a benzodiazepine prescription) (see Recommendation 5) [66,67], ii)Fentanyl with CYP3A4 inhibitors, iii) Methadone with drugs that can prolong the QT interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) (e.g., CYP450 2B6 inhibitors)	236	What combinations of drugs are dangerous?	Co-administration of a drug capable of inducing fatal drug-drug interactions: Providers should carefully rule out and avoid potential drug interactions prior to initiating LOT. For example, the following combinations are dangerous:[66] i)Opioids with benzodiazepines (compared to patients with no prescription, the odds ratio [OR] and 95% confidence interval [CI] for drug-related death was OR: 14.92, 95% CI: 7.00- 31.77 for patients who filled a prescription for opioids and benzodiazepines; OR: 3.40, 95% CI: 1.60-7.21 for patients who filled only an opioid prescription, and 7.21, 95% CI: 3.33-15.60 for patients who filled only a benzodiazepine prescription) (see Recommendation 5) [66,67], ii)Fentanyl with CYP3A4 inhibitors, iii) Methadone with drugs that can prolong the QT interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) (e.g., CYP450 2B6 inhibitors)
PHI’s “Whole Health” approach	59	What is an example of Bio-Psycho-Social Model?	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.
the best information available at the time of publication	91	What are the guidelines based upon?	The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management.
15 mg SR QHS	974	When reducing 33% of morphine SR 90 mg Q8h = 270 MEDD on day 1, what dose should be taken on day eleven 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.
the VA via Pharmacy Benefits Management	1,041	Who facilitates the distribution of naloxone for the reversal?	Naloxone administration has been identified as a life saving measure following opioid overdose. A systematic review of 22 observational studies provided moderate quality evidence that take home naloxone programs are effective in improving overdose survival and decreasing mortality, with a low rate of adverse events.[108] One meta-analysis of nine studies determined that take home naloxone kits were used approximately nine times within the first three months of follow-up for every 100 individuals trained.[109] Further, studies have shown that naloxone administration has been efficacious whether given by medical personnel or lay people, with more than 26,000 reversals documented by the CDC from 1996-2014.[110,111] In addition, prescription of naloxone rescue and accompanying education has also been found to reduce opioid-related emergency department visits.[112] Distribution of naloxone for reversal is supported by SAMHSA, the American Medical Association (AMA), and other medical societies, and is facilitated through the VA via Pharmacy Benefits Management. Clinical efficacy has been established for its use on short-acting opioids, but not for its use on long-acting opioids such as methadone or exceptionally potent opioids.[108]
Risks for overdose and death	232	What does significantly increase at a range of 20- 50 mg morphine equivalent daily dose?	As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose. Note: Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20- 50 mg morphine equivalent daily dose.
the individual clinician	535	Who must make the ultimate judgement regarding a particular clinical procedure or treatment course?	This guideline is not intended as a standard of care and should not be used as such. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advances and patterns evolve. Today there is variation among state regulations, and this guideline does not cover the variety of ever-changing state regulations that may be pertinent. The ultimate judgement regarding a particular clinical procedure or treatment course must be made by the individual clinician, in light of the patient’s clinical presentation, patient preferences, and the available diagnostic and treatment options. As noted previously, the guideline can assist care providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, in the care for an individual patient.
Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS])	312	What is critical due to the false positive and negative rates associated with UDTs?	As substance misuse in patients on LOT is more than 30% in some series,[107] UDT and confirmatory testing is used as an additional method of examining for patient substance misuse and adherence to the prescribed regimen. UDTs, used in the appropriate way, help to address safety, fairness, and trust with OT. Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to the false positive and negative rates associated with UDTs.[53] Interpretation of a UDT and confirmatory results requires education and knowledge of the local procedures and clinical scenario. Local education and access to expert interpretation is necessary. UDT results are helpful and can help identify active SUD or possible diversion. Accordingly, clinicians should obtain UDT prior to initiating or continuing LOT and periodically thereafter. When a patient is referred for SUD treatment or is engaged in on-going treatment there should be close communication between the SUD and pain management providers. The ideal approach is an interdisciplinary format (see Recommendation 16). For more information, see Appendix B on UDT and confirmatory testing.
exacerbation of severe PTSD symptoms	1,777	What may gradual benzodiazepine taper result in?	There is a large variation in patient preference regarding the concurrent use of benzodiazepines and LOT. This is especially true for patients who are already accustomed to receiving both medications (see Patient Focus Group Methods and Findings). Concurrent benzodiazepine and LOT use is a serious risk factor for unintentional overdose death and should be weighed heavily in the risk-benefit evaluation for tapering versus continuing one or both agents. Once initiated, benzodiazepines can be challenging to discontinue due to symptoms related to benzodiazepine dependence, exacerbations of PTSD, and/or anxiety.[91] Moreover, abrupt discontinuation of benzodiazepines should be avoided, as it can lead to serious adverse effects including seizures and death. Tapering benzodiazepines should be performed with caution and within a team environment when possible (see Recommendation 26 in the VA/DoD SUD CPG).7 Due to the difficulty of tapering or discontinuing benzodiazepines, particular caution should be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain. The VA/DoD PTSD CPG recommends against benzodiazepines for the prevention of PTSD and cautions against their use in treatment of PTSD. Benzodiazepines to treat acute anxiety symptoms after trauma are associated with a higher incidence of PTSD symptoms. For treatment of PTSD, there is evidence of lack of efficacy from small clinical trials and evidence of harm from observational studies of benzodiazepines for PTSD. Although anxiety may initially improve with benzodiazepines, the improvement is short-lived and may result in tolerance to increasing doses and eventual failure of the treatment. Even gradual benzodiazepine taper may result in exacerbation of severe PTSD symptoms. Concomitant use of benzodiazepines is considered a contraindication to initiation of OT.
An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose.	0	How was an age of 30 years chosen as a clinically reasonable threshold?	An age of 30 years was chosen based on how age was categorized in the six studies that showed an inverse relationship between age and OUD or overdose. One of those six studies found that patients with OUD were younger than patients without OUD, but did not find a statistically significant relationship.[87] Two of those six studies examined age as a continuous predictor, and neither reported a specific age where the risk of OUD or overdose changed markedly.[62,92] One study examined age as a dichotomous (<65 and ≥65) predictor.[88] In the two remaining studies, the highest risk included ages ranging from 18 to 30 years.[59,86] As such, the Work Group chose 30 years of age as a clinically reasonable threshold.
treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue	1,969	When the patient is willing to engage in a comprehensive pain care plan, what to educate the patient and family about?	Module A is about determination of appropriateness for opioid therapy. Note: Non-pharmacologic and non-opioid pharmacologic therapies are preferred for chronic pain. If a patient is with chronic pain and has been on daily OT for pain for more than 3 months, then proceed to module D. If a patient is with chronic pain and has not been on daily OT for pain for more than 3 months, then obtain biopsychosocial assessment. Then educate or re-educate on non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment. Then implement and optimize non-opioid treatments for chronic pain (e.g., physical, psychological, and complementary and integrative treatments). If the treatments are effective in managing pain and optimizing function, then exit algorithm; manage with non-opioid modalities. If the treatments are not effective in managing pain and optimizing function, then complete opioid risk assessment and see if patient risks outweigh benefits by considering strength and number of risk factors and patient preference. If patient risk outweighs benefits, then see whether referral/consultation for evaluation and treatment is indicated (e.g., mental health, SUD, more intensive interdisciplinary care). If referral/consultation for evaluation and treatment is indicated, then refer/consult with appropriate interdisciplinary treatments. Then after referral/consultation with appropriate interdisciplinary treatments, see if the patient is willing to engage in a comprehensive pain care plan. If referral/consultation for evaluation and treatment is not indicated, then see if the patient is willing to engage in a comprehensive pain care plan. If the patient is not willing to engage in a comprehensive pain care plan, then exit algorithm; manage with non-opioid modalities. If the patient is willing to engage in a comprehensive pain care plan, then educate the patient and family about treatment options, including education on known risks and unknown long-term benefits of OT, risks of SUD and overdose, need for risk mitigation strategies, naloxone rescue. Then see if adding OT to comprehensive pain therapy is indicated at this time. If adding OT to comprehensive pain therapy is indicated at this time, then see if the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies. If adding OT to comprehensive pain therapy is not indicated at this time, then exit algorithm; manage with non-opioid modalities. If the patient is prepared to accept responsibilities and the provider is prepared to implement risk mitigation strategies, then discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B. If the patient is not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies, then exit algorithm; manage with non-opioid modalities.
physical, psychological, and pain rehabilitation modalities	18	To which modalities should the patient have access?	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]
Chronic pain	0	What is one of the most disabling chronic medical conditions in the U.S.?	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.
non-pharmacologic treatments and non-opioid medications	555	What are the preferred treatments for chronic non-terminal 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.
When a decision is made to taper	0	When must special attention be given to ensure that the Veteran does not feel abandoned?	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.
worsening depressive symptoms	682	LOT has been associated with what kinds of symptoms?	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.
overdose and other adverse events	993	Continuing to prescribe the opioid without providing OUD treatment may increase the risk of what?	Ensure screening and treatment is offered for conditions that can complicate pain management before initiating an opioid taper. Conditions that can complicate pain management are mental health disorders, OUD and other SUD, moral injury, central sensitization, medical complications, sleep disorders. Mental health disorders include PTSD, anxiety disorders, depressive disorders. If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper. The lifetime prevalence for OUD among patients receiving long-term opioid therapy is estimated to be about 41%: approximately 28% for mild symptoms, 10% for moderate symptoms and 3.5% for severe symptoms of OUD. Patients with chronic pain who develop OUD from opioid analgesic therapy need to have BOTH pain and OUD addressed. Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment may increase the risk of overdose and other adverse events.
depression, anxiety, poor self-efficacy, poor general emotional functioning	915	What are some examples of psychological complaints made by patients with chronic pain?	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.
However, continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases.	187	In which cases it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT?	Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to “prevent suicide” in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT. Further research is needed to identify strategies for safely managing patients at elevated risk of suicide who demand opioid medications or become further destabilized during tapering.
15 mg SR QHS	974	When reducing 33% of morphine SR 90 mg Q8h = 270 MEDD on day 1, what dose should be taken on day eight 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.
specific risk factors such as risk for suicide, SUD, and other medical and mental health co-occurring conditions that may complicate the management of pain for these patients	357	Throughout the VA/DoD OT CPG, particular attention is paid regarding which factors?	The VA/DoD OT CPG was developed with a specific patient population in mind—Service Members, Veterans, and their families—that has unique characteristics and needs related to the military culture and communities to which they return. Throughout the VA/DoD OT CPG, attention is paid to the characteristics and needs of these patients, particularly regarding specific risk factors such as risk for suicide, SUD, and other medical and mental health co-occurring conditions that may complicate the management of pain for these patients. Further, these recommendations were made keeping in mind the implications they would have within the VA/DoD healthcare settings, particularly regarding considerations such as resource use, accessibility, and equity related to each recommendation and the urgent need for rigorous attention to the balance of risks and benefits for patients within the VA/DoD specifically.
Age <30 years	31	What is not an absolute contraindication to LOT?	Similar to other risk factors, age <30 years should be weighed heavily in the risk-benefit determination for initiating LOT. Age <30 years is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks of OUD and overdose. Hospitalized patients recovering from battlefield injuries, for example, are known to have less chronic pain, depression, and PTSD when their pain is aggressively managed starting soon after injury.[93] In those cases, LOT may be appropriate only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate (see Recommendations 14 and 15).
Due to the difficulty of tapering or discontinuing benzodiazepines	919	Why should particular caution be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain?	There is a large variation in patient preference regarding the concurrent use of benzodiazepines and LOT. This is especially true for patients who are already accustomed to receiving both medications (see Patient Focus Group Methods and Findings). Concurrent benzodiazepine and LOT use is a serious risk factor for unintentional overdose death and should be weighed heavily in the risk-benefit evaluation for tapering versus continuing one or both agents. Once initiated, benzodiazepines can be challenging to discontinue due to symptoms related to benzodiazepine dependence, exacerbations of PTSD, and/or anxiety.[91] Moreover, abrupt discontinuation of benzodiazepines should be avoided, as it can lead to serious adverse effects including seizures and death. Tapering benzodiazepines should be performed with caution and within a team environment when possible (see Recommendation 26 in the VA/DoD SUD CPG).7 Due to the difficulty of tapering or discontinuing benzodiazepines, particular caution should be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain. The VA/DoD PTSD CPG recommends against benzodiazepines for the prevention of PTSD and cautions against their use in treatment of PTSD. Benzodiazepines to treat acute anxiety symptoms after trauma are associated with a higher incidence of PTSD symptoms. For treatment of PTSD, there is evidence of lack of efficacy from small clinical trials and evidence of harm from observational studies of benzodiazepines for PTSD. Although anxiety may initially improve with benzodiazepines, the improvement is short-lived and may result in tolerance to increasing doses and eventual failure of the treatment. Even gradual benzodiazepine taper may result in exacerbation of severe PTSD symptoms. Concomitant use of benzodiazepines is considered a contraindication to initiation of OT.
45 mg SR (15 mg x 3) Q8h	346	When reducing 16% of morphine SR 90 mg Q8h = 270 MEDD on week 1, what dose should be taken on week three of the faster opioid tapering?	Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.
60 mg SR Q8h	878	When reducing 5% of morphine SR 90 mg Q8h = 270 MEDD, what dose should be taken on month six of the slowest opioid tapering?	Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.
patients who are currently prescribed doses over 90 mg morphine equivalent daily dose	113	For whom to evaluate for tapering to reduced dose or to discontinuation?	We recommend against opioid doses over 90 mg morphine equivalent daily dose for treating chronic pain. Note: For patients who are currently prescribed doses over 90 mg morphine equivalent daily dose, evaluate for tapering to reduced dose or to discontinuation. We recommend against prescribing long-acting opioids for acute pain, as an as-needed medication, or on initiation of long-term opioid therapy.
behaviors, age < 30, family history, personal history of SUD	466	Which factors can raise concerns related to an increased risk of substance use disorder?	Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT.
objective, evidence-based information on the management of chronic pain	187	What does the updated CPG include?	Consequently, a recommendation to update the 2010 OT CPG was initiated in 2015. The updated CPG, titled Clinical Practice Guideline for Opioid Therapy for Chronic Pain (OT CPG), includes objective, evidence-based information on the management of chronic pain. It is intended to assist healthcare providers in all aspects of patient care, including, but not limited to, diagnosis, treatment, and follow-up.
the heightened risk for developing OUD	206	What is the utmost concern for patients who receive OT beyond 90 days?	The support for these recommendations is two-fold: a paucity of research showing benefit for LOT and the strength of the evidence demonstrating the potential for life-threatening harm. Of utmost concern is the heightened risk for developing OUD in patients who receive OT beyond 90 days (see Appendix C for Diagnostic and Statistical Manual of Mental Disorders [DSM] 5 diagnostic criteria for OUD).
Continuing OT for longer than 90 days	134	What is not an absolute contraindication to LOT?	Similar to other risk factors, continuing OT beyond 90 days’ duration should be weighed heavily in the risk benefit calculus for LOT. Continuing OT for longer than 90 days is not an absolute contraindication to LOT. There may be some situations where the benefits of LOT clearly outweigh the risks. That must be determined through individual clinical assessment.
Gabapentin	671	Which can help reduce withdrawal symptoms and help with pain, anxiety, and sleep?	Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.
the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM)	140	Which electronic tools are currently used in the VA?	There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.
Re-evaluate the risks and benefits of continuing opioid therapy	138	What to do when dosage indicates high risk of adverse events?	Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT.
high prescribed dose, history of SUD, and history of mental health concerns	160	Which factors increase overdose risk when opioids are used for acute pain?	In addition, the risk of overdose includes the use of opioids for acute pain. Factors that increase overdose risk when opioids are used for acute pain include high prescribed dose, history of SUD, and history of mental health concerns. While the risk of overdose increases at doses above 20 mg MEDD or greater, this risk increases even further as doses increase to over 50 or 100 mg MEDD.[58,59,188]
summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations	263	What was the tasks of Interagency Pain Research Coordinating Committee?	With the passage of the Patient Protection and Affordable Care Act (PPACA) in March 2010, the Interagency Pain Research Coordinating Committee was created to coordinate pain research efforts throughout federal government agencies. The Committee was tasked with summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations. The Committee published the National Pain Strategy in March 2016 in response to the call from the National Academy of Medicine to increase awareness of pain as a significant public health issue in the U.S. The strategy made recommendations in a number of areas including prevention and care, professional education and training, and population research. The plan is aimed at decreasing the prevalence of all types of pain (acute and chronic) in the U.S., as well as the disability and morbidity associated with pain.
signs of diversion	528	What to be aware of during follow-ups?	At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms.
do not recommend for or against	3	What is the stance regarding the abuse deterrent formulations for LOT?	We do not recommend for or against abuse deterrent formulations for LOT. Our searches identified two RCTs in which the benefits of co-prescribing of naloxone with opioids were examined.[143,144] However, both RCTs were rated as low to very low quality with short-term follow-up. One open-label RCT enrolling 453 patients with chronic low back pain considered the safety and tolerability of an abuse deterrent formulation of oxycodone/naloxone relative to oxycodone or morphine at 12-week follow-up.[143] Another RCT considered the safety and efficacy of oxycodone/naloxone prolonged-release relative to oxycodone prolonged-release in 184 patients with moderate-to-severe chronic cancer pain at four-week follow-up.[144] An observational study (not included in the evidence review) suggested that the Introductory information of abuse deterrent opioid formulations did not help reduce abuse of opioids as a class and that patients may switch from one opioid to another based on the availability or the lack of availability of abuse deterrent formulations.[145]
the understanding that such a format may promote more efficient diagnostic and therapeutic decision making and has the potential to change patterns of resource use	247	The use of the algorithm format as a way to represent patient management was chosen based on what?	This CPG follows an algorithm that is designed to facilitate understanding of the clinical pathway and decision making process used in management of LOT. The use of the algorithm format as a way to represent patient management was chosen based on the understanding that such a format may promote more efficient diagnostic and therapeutic decision making and has the potential to change patterns of resource use. Although the Work Group recognizes that not all clinical practices are linear, the simplified linear approach depicted through the algorithm and its format allows the provider to assess the critical information needed at the major decision points in the clinical process. It includes an ordered sequence of steps of care, recommended observations and examinations, decisions to be considered, actions to be taken.
Because a comprehensive review of the evidence related to LOT was not feasible	351	Why only nine key questions (KQs) were prioritized from many possible KQs?	The systematic review conducted for the update of this CPG encompassed interventional studies (primarily randomized controlled trials [RCTs]) published between March 2009 and December 2016 and targeted nine key questions (KQs) focusing on the means by which the delivery of healthcare could be optimized for patients on or being considered for LOT. Because a comprehensive review of the evidence related to LOT was not feasible, the nine selected KQs were prioritized from many possible KQs. Therefore, many of the 2010 OT CPG recommendations were considered for inclusion in the updated version of the guideline without an updated review of the evidence. The section on Recommendations delineates whether or not the current CPG recommendations were based on an updated evidence review. Appendix H delineates whether the 2010 OT CPG recommendations were considered for inclusion in the update based on an updated evidence review or based on the evidence included in the 2010 OT CPG. The section on Recommendation Categorization further describes the methodology used for the categorization.
close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering	239	What is recommended for patients currently on long-term opioid therapy with evidence of untreated substance use disorder?	We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. (Strong against) For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering (see Recommendation 14 and Recommendation 17). (Strong for) (Reviewed, Amended)