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biomedical_cpgQA

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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.	What are the limitation of this CPG?	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.
Algorithm	Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C.	What to do if the patient is experiencing clear functional improvement with minimal risk?	continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects
Algorithm	Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.	What to do if there is no evidence of diversion?	look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider)
Background information	The presidential memorandum of October 2015 mandated that executive departments and agencies shall, to the extent permitted by law, provide training on the appropriate and effective prescribing of opioid medications to all employees who are health care professionals and who prescribe controlled substances as part of their federal responsibilities and duties. The DoD Opioid Prescriber Safety Training Program, launched accordingly, includes modules on pain management and opioid prescribing safety, the recent Centers for Disease Control and Prevention (CDC) guideline, and the identification of substance misuse and referral to specialized services. Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury is sponsoring the training and related management support. Training is available online at http://opstp.cds.pesgce.com/hub.php.	What does the DoD Opioid Prescriber Safety Training Program include?	modules on pain management and opioid prescribing safety, the recent Centers for Disease Control and Prevention (CDC) guideline, and the identification of substance misuse and referral to specialized services
Background information	The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development.	What is the aim of the CDC Guideline for Prescribing Opioids for Chronic Pain?	assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT.
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.	What is essential to do when a patient becomes destabilized as a result of a medically appropriate decision to taper or cease LOT?	involve behavioral health to assess, monitor, and treat
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.	Throughout the VA/DoD OT CPG, particular attention is paid regarding which factors?	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
Recommendations	We recommend against the concurrent use of benzodiazepines and opioids. (Strong against \| Reviewed, New-added) Note: For patients currently on long-term opioid therapy and benzodiazepines, consider tapering one or both when risks exceed benefits and obtaining specialty consultation as appropriate (see Recommendation 14 and the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders).	For whom to consider tapering one or both benzodiazepines and opioids when risks exceed benefits and obtaining specialty consultation as appropriate?	patients currently on long-term opioid therapy and benzodiazepines
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 to stop faster tapering?	after week 7
Features and overview	Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.	Who will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran?	Providers
Recommendations	State database queries for detection of multi-sourcing of controlled substances are used throughout the country. Data comparing states with an implemented state database program to states without one showed 1.55 fewer deaths per 100,000 people.[106] The CDC currently recommends at least quarterly checks of the state database system.[33]	According to CDC, what needs to be checked at least quarterly?	the state database system
Recommendations	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.	How do the risks for opioid use disorder increase?	in a dose dependent manner
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).	What should be weighed heavily in the risk-benefit determination for initiating LOT?	Similar to other risk factors, age <30 years
Background information	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.	Since when has there been a significant increment of opioid prescriptions during pain visits?	the late 1990s and early 2000s
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 treatments can be beneficial for reducing pain intensity and disability when compared to usual care in the treatment of chronic pain condition?	Exercise treatments, including yoga
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 there are indications to discontinue or taper?	taper to reduced dose or taper to discontinuation
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.	How much opioid to reduce in the slowest taper?	2 to 10% every 4 to 8 weeks with pauses in taper as needed
Recommendations	Younger patients are also at a higher risk of opioid misuse (as suggested by a UDT indicating high-risk medication-related behavior). Turner et al. (2014) showed that patients in the 45-64 year age group were significantly less likely to have an aberrant UDT (detection of a non-prescribed opioid, non-prescribed benzodiazepine, illicit drug, or tetrahydrocannabinol [THC]) in comparison to patients in the 20-44 age group.[94] Patients in the 45-64 and ≥65 age groups were significantly less likely than 20-44 year olds to have non-detection of a prescribed opioid as well (indicating possible diversion).[94]	Younger patients are at a higher risk of what?	opioid misuse (as suggested by a UDT indicating high-risk medication-related behavior)
Background information	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.	What is a red flag in the presence of which providers should proceed with utmost caution when considering LOT for these patients?	A history of overdose
Recommendations	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.	What to consider at the time of re-examining at a follow-up visit?	changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT
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 suicidal, have high suicide risk or actively suicidal?	If suicidal, then activate suicide prevention plan. If high suicide risk or actively suicidal, consult with mental health provider before beginning taper.
Background information	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.	What warranted a cautious approach to LOT prioritizing safety?	The accumulation of evidence of harms and the absence of evidence of long-term benefits
Recommendations	Synthetic opioids such as fentanyl analogs, potent opioid receptor agonists, are responsible for a recent rise in death rates. Fentanyl analogs that may be used to create counterfeit opioid analgesic pills can cause a toxidrome characterized by significant CNS and profound respiratory depression requiring multiple naloxone doses for reversal.[113]	What can be caused by fentanyl analogs that may be used to create counterfeit opioid analgesic pills?	a toxidrome characterized by significant CNS and profound respiratory depression requiring multiple naloxone doses for reversal
Recommendations	Given the recognized risks of opioid therapy, an optimal approach to care should include a robust, signature informed consent process that is patient-centered and provides patients with information about known benefits and harms of OT and treatment alternatives. In 2014, VA established a requirement for signature informed consent, consistent with VA policy for other treatments or procedures with a significant risk of complications or morbidity. See Appendix A, Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain (found at http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf), and 38 C.F.R. §17.32 (2012).	Given the recognized risks of opioid therapy, what should be included in an optimal approach to care?	a robust, signature informed consent process that is patient-centered and provides patients with information about known benefits and harms of OT and treatment alternatives
Recommendations	Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment.	What should be done before the opioids are prescribed?	Risk mitigation for LOT should begin
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.	What is not the intention of this guideline?	to serve as a standard of care
Features and overview	The shared decision making process for chronic pain treatment planning is based on the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider (Figure 1). The patient-centered assessment incorporates a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations. Next, the clinician performs a biopsychosocial assessment and determines clinically appropriate therapeutic options in which benefits are likely to outweigh risks. The process culminates in a shared decision making process to develop a patient-centered treatment plan by the patient selecting from the clinically appropriate treatment options generated in the first two steps.	What does the patient-centered assessment incorporate?	a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations
Features and overview	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.	What is included in the discussion?	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
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.	Which can help with pain, anxiety, and sleep?	Gabapentin
Features and overview	Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).	How often the urine drug testing needs to be performed?	at least annually
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.	Which approach to follow when initiating OT?	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)
Features and overview	Use immediate-release (IR) opioids when starting therapy. Prescribe the lowest effective dose. When using opioids for acute pain, provide no more than needed for the condition. Follow up and review benefits and risks before starting and during therapy. If benefits do not outweigh harms, consider tapering opioids to lower doses or taper and discontinue.	Should you prescribe the highest or lowest effective dose when starting therapy?	lowest
Algorithm	Module C is on tapering or discontinuation of opioid therapy. If there is indication to taper to reduced dose or taper to discontinuation, repeat comprehensive biopsychosocial assessment. Then see if the patient demonstrates signs or symptoms of SUD. If the patient demonstrates signs or symptoms of SUD, then see whether the patient is willing to engage in SUD therapy. If the patient is willing to engage in SUD therapy, then access specialized SUD care with monitoring and follow-up appropriate for the patient’s needs (e.g., MAT, treatment for comorbidities), see VA/DoD SUD CPG, exit algorithms and manage with non-opioid modalities. If the patient does not demonstrate signs or symptoms of SUD, then look for evidence of diversion. If there is evidence of diversion, then immediately discontinue opioid therapy. If there is no evidence of diversion, then look for high-risk or dangerous behavior (e.g., overdose event, accidents, and threatening provider). If there is high risk or dangerous behavior or the patient is not willing to engage in SUD therapy or immediately after discontinuing OT, then address safety and misuse, assess for withdrawal symptoms and offer expedited taper, immediate discontinuation or detox as indicated, continue to monitor for SUD and mental health comorbidities and offer treatment as indicated (see VA/DoD SUD CPG and Academic Detailing Tapering Document), exit algorithm and manage with non-opioid modalities. If there is no high risk or dangerous behavior, then develop an individualized tapering treatment plan (including pace of tapering, setting of care) based on patient and treatment characteristics. Follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics. At each interaction with patient, consider the followings: educate on self-management and risks of OT, optimize whole person approach to pain care, optimize treatment of co-occurring mental health conditions, optimize non-opioid pain treatment modalities, reassess for OUD and readiness for OUD treatment as indicated. If the patient is resistant to taper or there is high risk or dangerous behaviors or there is an increase in patient distress, then repeat comprehensive biopsychosocial assessment and see if an SUD is identified. If an SUD is identified, then find out if the patient is willing to engage in SUD therapy. If an SUD is not identified, then identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder. If an SUD is not identified and there is use of opioids to modulate emotions or an untreated or undertreated psychiatric disorder, then engage the patient in appropriate behavioral and/or psychiatric treatment, ideally in an interdisciplinary setting, consider reduced rate of taper or pause in taper for patients actively engaged in skills training. If the patient is fearful and/or anxious about taper and ability to function on lower dose or without opioids, then provide additional education about whole person pain care and LOT and reassurance that the patient will not be abandoned, consider more frequent follow-up using the expanded care team (registered nurse, clinical pharmacist, health coach, mental health provider), consider reduced rate of taper or pause in taper for patients actively engaged in skills training, reassess for OUD throughout the taper. If there is concern for diversion, then immediately discontinue opioid therapy. If there is no concern for diversion, then follow-up 1 week to 1 month after each change in dosage and after discontinuation considering patient and treatment characteristics.	What to do if there is evidence of diversion?	immediately discontinue opioid therapy
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 is VISNs?	Veterans Integrated Service Networks
Background information	Duration and dose of OT: See Recommendation 2 for more guidance on duration of OT and Recommendations 10-12 for more guidance on dosing of OT. Severe respiratory instability or sleep disordered breathing: This would include any co-occurring condition that significantly affects respiratory rate or function such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia, sleep apnea, or a neuromuscular condition (e.g., amyotrophic lateral sclerosis). Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death.[58,59]	Who showed a weak but positive association with opioid-related toxicity/overdose and overdose-related death?	Two large observational studies of patients with a history of COPD and sleep apnea who were prescribed opioids
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.	Should the opioid-naive individuals be prescribed long-acting opioids?	long-acting opioids should not be prescribed for opioid-naive individuals
Background information	The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development.	When did the CDC released its Guideline for Prescribing Opioids for Chronic Pain?	March 15, 2016
Background information	The CDC released its Guideline for Prescribing Opioids for Chronic Pain, directed toward primary care physicians, on March 15, 2016. The aim of the guideline is to assist primary care providers in offering safe and effective treatment for patients with chronic pain in the outpatient setting (not including active cancer treatment, palliative care, or end-of-life care). It is also aimed at improving communication between providers and patients and decreasing adverse outcomes associated with LOT. The CDC guideline, similar to the VA/DoD OT CPG, covered topics including initiation and continuation of OT, management of OT, and risk assessment and use of risk mitigation strategies. It also used the GRADE system to assign a grade for the strength for each recommendation which includes assessment of the quality of the evidence and consideration of the balance of desirable and undesirable outcomes, patient values and preferences, and other considerations (e.g., resource use, equity) during recommendation development.	Who are the targeted individuals for the CDC Guideline for Prescribing Opioids for Chronic Pain?	primary care physicians
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 can UDT results do?	help identify active SUD or possible diversion
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 can happen with a strategy of escalating dose during OT?	A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function.