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biomedical_cpgQA

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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 11 to 20, when using morphine SR 15 mg tablets?	3 tablets = 45 mg in the morning, 3 tablets = 45 mg in the afternoon, 4 tablets = 60 mg in the evening
Recommendations	Opioid medications are potentially lethal and an assessment of current suicide risk should be made at every phase of treatment. The VA/DoD Suicide CPG recommends restricting the availability of lethal means for patients considered to be at intermediate or high acute risk of suicide (determined by presence and severity of suicidal ideation, level of intention to act, existence of risk factors, limited or absent protective factors, etc.). Accordingly, suicidality is considered to be an important risk factor for OT (see Risk Factors for Adverse Outcomes of Opioid Therapy).	For which patients the VA/DoD Suicide CPG recommends restricting the availability of lethal means?	patients considered to be at intermediate or high acute risk of suicide (determined by presence and severity of suicidal ideation, level of intention to act, existence of risk factors, limited or absent protective factors, etc.)
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 there are factors that would require immediate attention?	admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated
Background information	Headache not responsive to other pain treatment modalities: LOT is an ineffective treatment modality for patients with migraine headaches (with or without aura), tension-type headaches, occipital neuralgia, or myofascial pain and may result in worsening of the underlying headache condition through factors such as central sensitization and withdrawal.	What is an ineffective treatment modality for patients with tension-type headaches?	LOT
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.	Name the treatment settings in which MAT can be provided.	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
Background information	Concurrent with the increase in prescription opioid use, the rate of heroin overdose deaths increased nearly four-fold between 2000 and 2013. According to a survey of patients entering SUD treatment for heroin use, the prescription opioid epidemic has resulted in a marked shift in how and which opioids are abused. In the 1960s, 80% of people entering treatment for heroin use started using heroin as their first opioid, while in the 2000s, 75% of people entering treatment for heroin use started using prescription opioids as their first opioid. This increase in the use of opioids, as well as associated morbidity, mortality, and other adverse outcomes, has called attention to the need for a paradigm shift in pain and in the way it is treated. Consult the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders (VA/DoD SUD CPG) for further information.	Where can further information on SUD treatment be found?	the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders (VA/DoD SUD CPG)
Background information	There are many causes of chronic pain. Pain arising from persistent peripheral stimulation could be mechanical or chemical/inflammatory in nature typically leading to well-localized nociceptive mechanism pain. Mechanical or inflammatory pain with a visceral origin may produce a less localized pain. Neuropathic pain due to injury or disease of the central or peripheral nervous system (e.g., spinal cord injury, diabetic neuropathy, radiculopathy) may lead to poorly localized symptoms such as diffuse pain, burning, numbness, or a feeling of skin sensitivity.	Which pain may produce a less localized pain?	Mechanical or inflammatory pain with a visceral origin
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 the patient does not demonstrate signs or symptoms of SUD?	look for evidence of diversion
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.	In which cases it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT?	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.
Recommendations	Take Back Programs: Returning unused opioid medications has been explored as a strategy to reduce the amount of opioids in the community, as it has been estimated that 70% of opioid prescriptions are left unused.[115] Accordingly, the National Drug Control Strategy advocates take back programs as an effective tool.[24] For example, in a 2013 medication take back event in a Michigan community, 3,633 containers containing 345 different prescription medications were collected in four hours. The top five most common medications collected were pain relievers.[116] System-wide efficacy of a nationwide program is unknown.[117]	What does the National Drug Control Strategy advocate?	take back programs
Recommendations	We recommend implementing risk mitigation strategies upon initiation of long-term opioid therapy, starting with an informed consent conversation covering the risks and benefits of opioid therapy as well as alternative therapies. The strategies and their frequency should be commensurate with risk factors and include: Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education (Strong for \| Reviewed, New-replaced)	What should be included in the risk mitigation strategies and their frequency?	Ongoing, random urine drug testing (including appropriate confirmatory testing), Checking state prescription drug monitoring programs, Monitoring for overdose potential and suicidality, Providing overdose education, Prescribing of naloxone rescue and accompanying education
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 the patient is prepared to accept responsibilities?	discuss and complete written informed consent with patient and family, determine and document treatment plan, and proceed to module B
Introductory information	This guideline can be used in a variety of ways. This guideline can be used by general clinicians or specialists to study and consider the latest information on opioid therapy (OT) and how and whether to incorporate that information or recommendations into their practice. It can be used to provide specific information to guide a patient encounter, such as looking up the dosing of a medication used less frequently or the meaning of the urine drug testing (UDT) result. The section on tapering and its accompanying appendix can be used to assist in the development of a framework for guiding an individualized, informed discussion when tapering is being considered. Patients can examine the guideline to educate themselves and better understand their care. A health care system can use the CPG to assure that its clinicians and patients have the resources available to compassionately, effectively, and safely evaluate and deliver LOT in a timely, culturally sensitive manner. The guideline can also be used to suggest specific education for identified gaps.	When tapering is being considered, which section in the guideline can be used to assist in the development of a framework for guiding an individualized, informed discussion?	section on tapering and its accompanying appendix
Features and overview	The current document is an update to the 2010 VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain. The methodology used in developing the 2017 CPG follows the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG. The VA/DoD Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp. This document provides information regarding the process of developing guidelines, including the identification and assembly of the Guideline Champions (“Champions”) and other subject matter experts from within the VA and DoD, known as the “Work Group,” and ultimately, the development and submission of an updated OT CPG. The VA Office of Quality, Safety and Value, in collaboration with the Office of Evidence Based Practice, U.S. Army Medical Command, the proponent for CPGs for the DoD, identified two clinical leaders, Jack Rosenberg, MD, FASAM from the VA and Christopher Spevak, MD, MPH, JD from the DoD, as Champions for the 2017 CPG.	What methodology was used in developing the 2017 CPG?	the VA/DoD Guideline for Guidelines,[1] an internal document of the VA and DoD EBPWG
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.	What are some examples of opioid agonist medications?	buprenorphine/naloxone (Suboxone) or methadone
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 is the estimation of the lifetime prevalence for severe symptoms of OUD among patients receiving long-term opioid therapy?	3.5%
Recommendations	Naloxone administration has been identified as a life saving measure following opioid overdose. A systematic review of 22 observational studies provided moderate quality evidence that take home naloxone programs are effective in improving overdose survival and decreasing mortality, with a low rate of adverse events.[108] One meta-analysis of nine studies determined that take home naloxone kits were used approximately nine times within the first three months of follow-up for every 100 individuals trained.[109] Further, studies have shown that naloxone administration has been efficacious whether given by medical personnel or lay people, with more than 26,000 reversals documented by the CDC from 1996-2014.[110,111] In addition, prescription of naloxone rescue and accompanying education has also been found to reduce opioid-related emergency department visits.[112] Distribution of naloxone for reversal is supported by SAMHSA, the American Medical Association (AMA), and other medical societies, and is facilitated through the VA via Pharmacy Benefits Management. Clinical efficacy has been established for its use on short-acting opioids, but not for its use on long-acting opioids such as methadone or exceptionally potent opioids.[108]	When to administer Naloxone?	as a life saving measure following opioid overdose
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.	How to minimize withdrawal effects in patients caused by rapid tapers?	patients should be treated with adjunctive medications
Recommendations	Implementing more extensive risk mitigation strategies entails an investment of resources. Primary care providers may require more time with patients to allow for shared decision making and treatment planning. More frequent follow-up of patients on LOT can affect access to care for all empaneled patients. VHA providers must also follow VHA policy regarding education and signature informed consent when providing LOT for patients with non-cancer pain.[101]	What does implementing more extensive risk mitigation strategies entail?	an investment of resources
Recommendations	As this guideline is related to LOT, the use of opioids for acute pain is not reviewed in detail. However, because acute OT can be a gateway to LOT, it is part of this CPG. A review of the literature indicates that LOT can result from acute opioid use initially intended for short-term therapy. Further, there is a risk of opioid-related overdose even during acute OT. While it is understood that acute OT for severe pain due to injuries or surgery is the most effective option for many patients, the risks associated with acute therapy must be addressed when opioids are prescribed or considered.	What can can be a gateway to LOT?	acute OT
Recommendations	We recommend tapering to reduced dose or to discontinuation of long-term opioid therapy when risks of long-term opioid therapy outweigh benefits. Note: Abrupt discontinuation should be avoided unless required for immediate safety concerns. We recommend individualizing opioid tapering based on risk assessment and patient needs and characteristics. Note: There is insufficient evidence to recommend for or against specific tapering strategies and schedules.	It is recommended to individualize opioid tapering based on what?	risk assessment and patient needs and characteristics
Features and overview	Opioids are not first-line or routine therapy for chronic pain. Establish treatment goals before starting opioid therapy and a plan if therapy is discontinued. Only continue opioid if there is clinically meaningful improvement in pain and function. Discuss risks, benefits and responsibilities for managing therapy before starting and during treatment.	What to discuss before starting the treatment?	risks, benefits and responsibilities for managing therapy
Recommendations	We recommend interdisciplinary care that addresses pain, substance use disorders, and/or mental health problems for patients presenting with high risk and/or aberrant behavior. We recommend offering medication assisted treatment for opioid use disorder to patients with chronic pain and opioid use disorder. Note: See the VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders.	What kind of care is recommended that addresses pain, substance use disorders, and/or mental health problems for patients presenting with high risk and/or aberrant behavior?	interdisciplinary
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 intensification of monitoring helps mitigate the risk of suicide among patients on LOT?	There is moderate quality evidence
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.	Which tapers are often the most tolerable?	Slower, more gradual tapers
Recommendations	In 2011, in response to the recognition of pain and its management as a public health problem, the National Academy of Medicine investigated and reported on the state of pain research, treatment, and education in the U.S. The report called for a cultural transformation in the way pain is viewed and treated.[3] Accordingly, the U.S. Department of Health and Human Services (HHS) National Pain Strategy (March 2016) recommends a biopsychosocial approach to pain care that is multimodal and interdisciplinary.[26] The underlying concepts of the biopsychosocial model of pain include the idea that pain perception and its effects on the patient’s function is mediated by multiple factors (e.g., mood, social support, prior experience, biomechanical factors), not just biology alone. With this overall change in construct, a biopsychosocial assessment and treatment plan should be tailored accordingly.	What was the impact of the report on the state of pain research, treatment, and education in the U.S. by the National Academy of Medicine in 2011?	The report called for a cultural transformation in the way pain is viewed and treated.
Background information	QTc interval >450 ms for using methadone: Unlike most other commonly used opioids, methadone has unique pharmacodynamic properties that can prolong the QTc interval (the heart rate’s corrected time interval from the start of the Q wave to the end of the T wave) and precipitate torsades de pointes, a dangerous or fatal cardiac arrhythmia. Patients who may be at risk include those with other risk factors for QTc prolongation, current or prior electrocardiograms (ECGs) with a prolonged QTc >450 ms, or a history of syncope. Therefore, ECGs before and after initiating methadone are highly advised (see Methadone Dosing Guidance).	Which one is a dangerous or fatal cardiac arrhythmia?	torsades de pointes
Features and overview	Opioids are associated with many risks and it may be determined that they are not indicated for pain management for a particular Veteran. Re-evaluate the risks and benefits of continuing opioid therapy when there is no pain reduction, no improvement in function or patient requests to discontinue therapy, severe unmanageable adverse effects, dosage indicates high risk of adverse events, concerns related to an increased risk of SUD (Substance use disorder) (e.g., behaviors, age < 30, family history, personal history of SUD), an overdose event involving opioids, non-adherence to the treatment plan or unsafe behaviors. Examples of severe unmanageable adverse effects are drowsiness, constipation, and cognitive impairment. Examples of dosage that indicate high risk of adverse events are doses of 90 MEDD (Morphine equivalent daily dose) and higher. Examples of unsafe behaviors are early refills, lost/stolen prescription, buying or borrowing opioids, failure to obtain or aberrant UDT.	What to do when there is an overdose event involving opioids?	Re-evaluate the risks and benefits of continuing opioid therapy
Introductory information	This guideline can be used in a variety of ways. This guideline can be used by general clinicians or specialists to study and consider the latest information on opioid therapy (OT) and how and whether to incorporate that information or recommendations into their practice. It can be used to provide specific information to guide a patient encounter, such as looking up the dosing of a medication used less frequently or the meaning of the urine drug testing (UDT) result. The section on tapering and its accompanying appendix can be used to assist in the development of a framework for guiding an individualized, informed discussion when tapering is being considered. Patients can examine the guideline to educate themselves and better understand their care. A health care system can use the CPG to assure that its clinicians and patients have the resources available to compassionately, effectively, and safely evaluate and deliver LOT in a timely, culturally sensitive manner. The guideline can also be used to suggest specific education for identified gaps.	How can a health care system use the CPG?	to assure that its clinicians and patients have the resources available to compassionately, effectively, and safely evaluate and deliver LOT in a timely, culturally sensitive manner
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 factors can increase the risks of OT?	non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral
Introductory information	This guideline can be used in a variety of ways. This guideline can be used by general clinicians or specialists to study and consider the latest information on opioid therapy (OT) and how and whether to incorporate that information or recommendations into their practice. It can be used to provide specific information to guide a patient encounter, such as looking up the dosing of a medication used less frequently or the meaning of the urine drug testing (UDT) result. The section on tapering and its accompanying appendix can be used to assist in the development of a framework for guiding an individualized, informed discussion when tapering is being considered. Patients can examine the guideline to educate themselves and better understand their care. A health care system can use the CPG to assure that its clinicians and patients have the resources available to compassionately, effectively, and safely evaluate and deliver LOT in a timely, culturally sensitive manner. The guideline can also be used to suggest specific education for identified gaps.	When can this guideline be used?	to study and consider the latest information on opioid therapy (OT) and how and whether to incorporate that information or recommendations into their practice
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?	activate suicide prevention plan
Background information	The U.S. is in the midst of a cultural transformation in the way pain is viewed and treated. The biomedical model of pain care, in which the pain experience is reduced to a pain generator and pain treatment is aimed at fixing or numbing pain with medications, interventions, or surgery, dominated the 1990s and the first decade of the 2000s. As the cost, potential harm, and limited effectiveness of the approach in the biomedical model of pain care to chronic pain was becoming apparent, the National Academy of Medicine issued a call for the transformation of pain care to a biopsychosocial, multimodal, interdisciplinary model.	What happens in the biomedical model of pain care?	the pain experience is reduced to a pain generator and pain treatment is aimed at fixing or numbing pain with medications, interventions, or surgery
Recommendations	The added risk that younger patients using opioids face for OUD and overdose is great. Edlund et al. (2014) found that, compared to patients ≥65 years old, patients 18-30 years old carried 11 times the odds of OUD and overdose. Patients 31-40 years old carried 5 times the odds of OUD and overdose compared to those ≥65 years old.[86] Bohnert et al. (2011) found that, compared to subjects 18-29 years old, patients 30-39 years old had roughly half the risk of developing OUD or overdose (HR: 0.56, 95% CI: 0.27-1.17). Compared to the subjects 18-29 years old, patients ≥70 years old had a far less risk (nearly 1/17) of developing OUD or overdose (HR: 0.06, 95% CI: 0.02, 0.18).[59]	Compared to whom, patients 31-40 years old carried 5 times the odds of OUD and overdose?	those ≥65 years old
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.	When was the Interagency Pain Research Coordinating Committee created?	March 2010
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 recommended for patients currently on long-term opioid therapy with evidence of untreated substance use disorder?	close monitoring, including engagement in substance use disorder treatment, and discontinuation of opioid therapy for pain with appropriate tapering
Recommendations	Recognizing the lack of evidence of long-term benefit associated with LOT used alone and the risks of harms with use of opioids without risk mitigation, dosing determinations should be individualized based upon patient characteristics and preferences, with the goal of using the lowest dose of opioids for the shortest period of time to achieve well-defined functional treatment goals. Understandably, there will be greater mortality, co-occurring medical conditions, and other adverse events in patients who require higher doses of opioids, even in those who benefit from such therapy. When closer follow-up is needed, healthcare resources and patient adherence should be considered.	Who will have greater mortality?	patients who require higher doses of opioids, even in those who benefit from such therapy
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.	Patients receiving opioid analgesics who do not meet DSM-5 criteria for OUD may benefit from what?	an alternative management strategy: close follow-up and CBT
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 a patient is medically or psychiatrically unstable?	admit/provide medical and psychiatric treatment to stabilize as indicated
Introductory information	The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management.	What are the guidelines based upon?	the best information available at the time of publication