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biomedical_cpgQA

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Algorithm	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.	What to do if referral/consultation for evaluation and treatment is not indicated?	see if the patient is willing to engage in a comprehensive pain care plan
Background information	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.	What was the aim of the National Pain Strategy?	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
Features and overview	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.	What to do if the veteran is actively suicidal?	consult with mental health provider before beginning taper
Features and overview	Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.	When reducing 16% of morphine SR 90 mg Q8h = 270 MEDD on month 1, what dose should be taken on month six of the slower opioid tapering?	15 mg SR Q12h
Recommendations	Psychological therapies (e.g., cognitive behavioral interventions such as Cognitive Behavioral Therapy [CBT], biofeedback) have been found to be effective for pain reduction in multiple pain conditions.[80-82] Exercise treatments, including yoga, also have evidence of benefit for reducing pain intensity and disability when compared to usual care in the treatment of chronic pain conditions.[83-85] Exercise and psychological therapies may each exert their influence through multiple mechanisms including but not limited to the reduction in fear-avoidance, reduction in catastrophizing, and/or enhancing mood.[80] Similarly, multidisciplinary biopsychosocial rehabilitation (described as a combination of a physical intervention such as graded exercise and a psychological, social, or occupational intervention) has been shown to be more effective than usual care in improving pain and disability.[81] These interventions are safe and have not been shown to increase morbidity or mortality. In light of the low harms associated with exercise and psychological therapies when compared with LOT these treatments are preferred over LOT, and should be offered to all patients with chronic pain including those currently receiving LOT. There is insufficient evidence to recommend psychological over physical therapies or vice versa; the choice of which to try first should be individualized based on patient assessment and a shared decision making process (see Patient Focus Group Methods and Findings).[80]	What kind of intervention has been shown to be more effective than usual care in improving pain and disability?	multidisciplinary biopsychosocial rehabilitation (described as a combination of a physical intervention such as graded exercise and a psychological, social, or occupational intervention)
Features and overview	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.	What kinds of pain education groups should be offered to Veterans?	Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for Pain
Background information	The increasing use of opioids, as well as the accompanying rise in morbidity and mortality associated with opioid use, has garnered increasing attention from federal and local officials as well as other policy makers. This public health issue, which has been labeled an epidemic, became a focus of the President’s National Drug Control Strategy in 2010 and has since remained a focus. Two main goals introduced in the 2010 strategy included curtailing illicit drug consumption in America and improving the health and safety of the American people by reducing the consequences of drug abuse. The 2015 strategy, and an accompanying presidential memorandum on preventing prescription drug abuse and heroin use, released in October 2015, encouraged the improvement of health and safety using evidence-based methods by calling for change in a number of key areas including preventing drug use in communities, seeking early intervention opportunities, and integrating SUD treatment and supporting recovery.	When was the 2015 National Drug Control strategy released?	October 2015
Features and overview	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.	What is the alternative treatment option for autonomic symptoms using Baclofen?	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
Features and overview	Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.	When reducing 5% of morphine SR 90 mg Q8h = 270 MEDD, what dose should be taken on month four of the slowest opioid tapering?	75 mg SR qam, 60 mg noon, 75 mg qpm
Features and overview	As with other CPGs, there are limitations, including significant evidence gaps. Further, there is a need to develop effective strategies for guideline implementation and evaluation of the effect of guideline adherence on clinical outcomes. Thus, as stated in the qualifying statements at the beginning of the CPG, this CPG is not intended to serve as a standard of care. Standards of care are determined on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve. This CPG is based on evidence available by December 2016 and is intended to provide a general guide to best practices. The guideline can assist healthcare providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, for the care of an individual patient.	How are the standards of care determined?	on the basis of all clinical data available for an individual patient and are subject to change as scientific knowledge and technology advance and patterns evolve
Features and overview	When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.	When the risks of continuing the opioid outweigh the risks of a rapid taper, which tapers may be required?	More rapid tapers
Recommendations	Prior to initiating OT, an individualized assessment of potential opioid-related harms relative to realistic treatment goals must be completed. After initiating OT, frequent visits contribute to the appropriate use and adjustment of the planned therapy. The Work Group recommends follow-up at least every three months or more frequently (see Recommendation 7 and Recommendation 11) due to the balance of benefits and harms associated with this recommendation. Although the 2010 OT CPG recommended follow-up every six months, this recommended interval for follow-up and reassessment has not been sufficient to reduce the potential harm associated with LOT or adequately implement comprehensive biopsychosocial pain care. More frequent follow-up is needed in order to increase the impact of risk mitigation strategies and enhance the delivery of comprehensive, biopsychosocial pain care. Frequency of visits should thereafter be based on risk stratification. Similarly, the CDC guideline for OT recommends re-evaluating harms versus benefits within one to four weeks of starting OT or at any dose change, and at least every three months or more frequently if needed.[132]	When to follow up?	at least every three months or more frequently
Recommendations	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).	When may LOT be appropriate?	only if risk mitigation strategies are employed and patients are titrated off LOT as soon as it is appropriate
Features and overview	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.	What can be caused by rapid taper?	withdrawal effects
Recommendations	In addition to benzodiazepines, the addition of other psychoactive medications to LOT must be made with caution. While the evidence for harm associated with the combination of opioids and Z-drugs (e.g., zolpidem, eszopiclone) is not as strong as the evidence for harm associated with the combination of opioids and benzodiazepines, we suggest not prescribing Z-drugs to patients who are on LOT, as moderate quality evidence demonstrates that the combination of zolpidem and opioids increases the AOR of overdose.[66] The evidence reviewed also identifies potential adverse outcomes (e.g., risk of overdose) with the combined use of antidepressants and opioids in patients who do not have depression.[66] This particular study did not differentiate between classes of antidepressants, limiting the ability of the Work Group to recommend for or against prescribing opioids and a specific class of antidepressants. As such, there is no recommendation in this guideline with respect to using specific classes of antidepressants and LOT.	In addition to benzodiazepines, what to do with caution?	the addition of other psychoactive medications to LOT
Recommendations	As outlined in this CPG, there is a rapidly growing understanding of the significant harms of LOT even at doses lower than 50 mg oral morphine equivalent daily dose [MEDD], including but not limited to overdose and OUD. At the same time there is a lack of high quality evidence that LOT improves pain, function, and/or quality of life. The literature review conducted for this CPG identified no studies evaluating the effectiveness of LOT for outcomes lasting longer than 16 weeks. Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, non-opioid treatments are preferred for chronic pain. Patient values, goals, concerns, and preferences must be factored into clinical decision making on a case-by-case basis. When considering the initiation or continuation of LOT, it is important to consider whether LOT will result in clinically meaningful improvements in function such as readiness to return to work/duty and/or measurable improvement in other areas of function, such that the benefits outweigh the potential harms.	Why non-opioid treatments are preferred for chronic pain?	Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms
Recommendations	There is moderate quality evidence that intensification of monitoring helps mitigate the risk of suicide among patients on LOT. Im et al. (2015) found moderate quality evidence that, at the facility level, patients on LOT within facilities ordering more drug screens than the comparison group were associated with decreased risk of suicide attempt (chronic short-acting opioid group: OR: 0.2, 95% CI: 0.1-0.3; chronic long acting opioid group: OR: 0.3, 95% CI: 0.2-0.6). In addition, patients on long-acting opioids within the facilities providing more follow-up after new prescriptions were associated with decreased risk of suicide attempt (OR: 0.2, 95% CI: 0.0-0.7).[61]	Is there any evidence that, at the facility level, patients on LOT within facilities ordering more drug screens than the comparison group were associated with decreased risk of suicide attempt?	Im et al. (2015) found moderate quality evidence
Recommendations	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.	What should clinicians obtain prior to initiating or continuing LOT and periodically thereafter?	UDT
Recommendations	There is a paradigm shift occurring in approaches to ensuring and documenting patient and provider understanding and expectations regarding the risks and benefits of LOT. The 2010 OT CPG reflected prior practice of using opioid treatment (or pain care) agreements. OTAs have been described as coercive rather than therapeutic, lack respect for individual autonomy, can be a barrier to pain care, and may be harmful to the patient-provider relationship.[102-105]	How have OTAs been described in the 2010 OT CPG?	as coercive rather than therapeutic, lack respect for individual autonomy, can be a barrier to pain care, and may be harmful to the patient-provider relationship
Background information	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.	What was the considerations behind the recommendations made in the CPG?	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
Features and overview	Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.	When reducing 16% of morphine SR 90 mg Q8h = 270 MEDD on week 1, what dose should be taken on week four of the faster opioid tapering?	30 mg SR (15 mg x 2) Q8h
Recommendations	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 introduction 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]	What is the stance regarding the abuse deterrent formulations for LOT?	do not recommend for or against
Recommendations	Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from an alternative management strategy: close follow-up and CBT. Jamison et al. (2010) randomized patients at high-risk for OUD (as measured by standard rating scales) to receive either standard pain management or close follow-up with CBT for pain.[114] Both of these groups were compared to a low-risk, chronic pain control group receiving standard management. The authors report that, compared to a matched high-risk group receiving standard care, patients receiving additional monitoring and CBT exhibited significantly reduced illicit substance use over six months (percentage of patients with positive drug misuse index scores: 73.7% versus 26.3% versus 25.0%; p<0.01). At six months, there was no difference between the high-risk group receiving close follow-up and the low-risk group receiving standard therapy. Authors also reported that pain perception was less in the high-risk group receiving additional monitoring and behavior therapy; however, analysis of activity interference reporting reflected no significant difference between study groups.	Who may benefit from an alternative management strategy?	Those patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD
Features and overview	Here is an example of an opioid taper plan for a Veteran. Veteran is currently taking morphine SR 60 mg, 1 tablet every 8 hours. Goal is to reduce the dose of morphine to SR 30 mg every 8 hours using a slow taper. Dose will be reduced by 15 mg every 10 days. Using morphine SR 15 mg tablets, follow the schedule below. From days 1 to 10, take 4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 11 to 20, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening. From days 21 to 30, take 3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 3 tablets = 45 mg in the evening.	How much to take from days 1 to 10, when using morphine SR 15 mg tablets?	4 tablets = 60 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening
Background information	From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.	Depending on age, marital status, race, and living conditions, who were more likely to continue using opioids?	those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting
Features and overview	Use a shared decision-making approach to discuss options for OUD treatment. Medication-Assisted Therapy (MAT) is the first-line treatment for OUD. The preferred OUD treatment is Opioid Agonist Therapy (OAT). Opioid agonist treatment involves taking opioid agonist medications such as buprenorphine/naloxone (Suboxone) or methadone. Methadone must be provided through a federally regulated opioid treatment program for OUD therapy. The alternative OUD treatment is extended-release (ER) injectable naltrexone (Vivitrol). MAT can be provided in a variety of treatment settings including residential SUD treatment, intensive outpatient SUD treatment, regular SUD specialty care clinic, primary care or general mental health clinic, or federally regulated opioid treatment program. Moral injury is an act of transgression that leads to serious inner conflict typically brought on by betrayal, disproportionate violence, incidents involving civilians, within-rank violence. For moral injury, treatment via psychologists or chaplains is available. Central sensitization (e .g., fibromyalgia, chronic headaches, and likely many other types of complex chronic pain). Some examples of medical complications are lung disease, hepatic disease, renal disease, or fall risk. Sleep apnea is a sleep disorder.	How to provide methadone for OUD therapy?	through a federally regulated opioid treatment program for OUD therapy
Background information	A paradigm shift in the use of OT for chronic non-terminal pain has paralleled this transformation in pain care. Prior to the 1980s, OT was rarely used outside of severe acute injury or post-surgical pain, primarily due to concern for tolerance, physical dependence, and addiction. As the hospice and palliative care movement began defining end-of-life care in the U.S. during the 1980s and emphasizing the importance of pain relief, OT increasingly became a mainstay for cancer and end-of-life pain. Efforts to destigmatize the use of prescription opioids for chronic non-terminal pain encompassed primary care providers and the public. The efforts led to an unprecedented increase in opioid prescribing for chronic non-terminal pain. Chronic pain management became synonymous with LOT in the 1990s and the first decade of the 2000s with significant numbers of patients in pain clinics receiving LOT. Despite the absence of long-term safety or efficacy data, OT for chronic non-terminal pain became a mainstay of therapy. However, as observational and epidemiologic data of harm from LOT accumulated, a much more cautious approach to OT for chronic non-terminal pain has emerged in the decade of the 2010s.	When did a more cautious approach to OT for chronic non-terminal pain emerge?	in the decade of the 2010s
Background information	From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.	Among the Veterans, who were more likely to continue their opioid use?	Veterans on higher doses of opioids
Features and overview	Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.	How much opioid to reduce in the slower taper?	5 to 20% every 4 weeks with pauses in taper as needed
Features and overview	When formulating an opioid taper plan, determine if the initial goal is a dose reduction or complete discontinuation. If the initial goal is determined to be a dose reduction, subsequent regular reassessment may indicate that complete discontinuation is more suitable. Several factors go into the speed of the selected taper. Slower, more gradual tapers are often the most tolerable and can be completed over several months to years based on the opioid dose. The longer the duration of previous opioid therapy, the longer the taper may take. Most commonly, tapering will involve dose reduction of 5% to 20% every 4 weeks. More rapid tapers may be required in certain instances like drug diversion, illegal activities, or situations where the risks of continuing the opioid outweigh the risks of a rapid taper. Document the rationale for the opioid taper and the opioid taper schedule in the Veteran’s medical record. Provide opioid overdose education and prescribe naloxone to patients at increased risk of overdose. Strongly caution patients that it takes as little as a week to lose their tolerance and that they are at risk of an overdose if they resume their original dose. Patients are at an increased risk of overdose during this process secondary to reduced tolerance to opioids and the availability of opioids and heroin in the community.	If the initial goal is determined to be a dose reduction, what may indicate that complete discontinuation is more suitable?	subsequent regular reassessment
Recommendations	Abuse Deterrent Formulations of Opioids: The aim of most abuse deterrent formulations is to present a physical barrier to prevent chewing, crushing, cutting, grating, or grinding of the dosage form, or present a chemical barrier, such as a gelling agent, that will resist extraction of the opioid with use of a common solvent. Alternatively, an opioid antagonist (naloxone or naltrexone) can be added to interfere with, reduce, or defeat the euphoria associated with abuse of an agent intended for oral use when taken nasally or parenterally.[142] While these properties deter abuse they do not fully prevent abuse; no opioid formulation prevents consumption of a large number of intact capsules or tablets which continues to be the most common method of abuse.	What is the most common method of abuse?	consumption of a large number of intact capsules or tablets
Recommendations	For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies, assessment for opioid use disorder, and consideration for tapering when risks exceed benefits. We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder. For patients currently on long-term opioid therapy with evidence of untreated substance use disorder, we recommend close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering.	What is the stance regarding the long-term opioid therapy for pain in patients with untreated substance use disorder?	recommend against
Recommendations	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.	Further research is needed for what?	to identify strategies for safely managing patients at elevated risk of suicide who demand opioid medications or become further destabilized during tapering
Features and overview	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.	What may increase the risk of overdose and other adverse events in patients with chronic pain and OUD?	Either tapering the opioid analgesic or continuing to prescribe the opioid without providing OUD treatment
Recommendations	Harms may outweigh benefits for the concurrent use of benzodiazepines and LOT. There is moderate quality evidence that concurrent use of benzodiazepines with prescription opioids increases the risk of overdose and overdose death.[66] In a retrospective cohort study, the adjusted odds ratio (AOR) for drug overdose was highest for individuals on LOT for chronic pain (without anxiety or PTSD) who also received concurrent long-term benzodiazepine therapy.[66] In another retrospective study that involved over 200,000 participants (not included in the evidence review), Veterans receiving both opioids and benzodiazepines were at an increased risk of death from drug overdose.[90] Furthermore, there is a lack of evidence in favor of long-term therapy with benzodiazepines and opioids for chronic pain.[91]	Who were at an increased risk of death from drug overdose?	Veterans receiving both opioids and benzodiazepines
Algorithm	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.	What to do if the factors that increase risks of OT are not present?	see if there are indications to discontinue or taper
Recommendations	Dual-Mechanism Opioids: Dual-mechanism opioids include formulations of an opioid medication with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI). Two common examples are tramadol and tapentadol. While both are dual-mechanism opioids, they differ in their affinity for the mu opioid receptor, resulting in partial versus full agonist effects, and as such are discussed separately.	What is included in the dual-mechanism opioids?	formulations of an opioid medication with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI)
Algorithm	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).	What maybe included in interdisciplinary services?	mental health, SUD, primary care, and specialty pain care
Background information	Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.	What was launched by the VA as part of the OSI?	the Opioid Overdose Education and Naloxone Distribution (OEND) program
Features and overview	Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.	When reducing 33% of morphine SR 90 mg Q8h = 270 MEDD on day 1, what dose should be taken on day two of the rapid opioid tapering?	45 mg SR (15 mg x 3) Q8h