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lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age	49	Which medical comorbidities can increase risk during opioid therapy?	Medical comorbidities that can increase risk are lung disease, sleep apnea, liver disease, renal disease, fall risk, advanced age. Consider tapering opioids when there is concomitant use of medications that increase risk (e.g., benzodiazepines). Mental health comorbidities that can worsen with opioid therapy are PTSD, depression, anxiety. Prior to any changes in therapy, discuss the risks of continued use, along with possible benefits, with the Veteran. Establish a plan to consider dose reduction, consultation with specialists, or consider alternative pain management strategies. Personal history of SUD includes alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances
37.6	284	In 2012, how many benzodiazepine prescriptions were written by healthcare providers for every 100 persons in the U.S.?	From 2000 through 2010, the proportion of pain visits during which opioid and non-opioid pharmacologic therapies were prescribed increased from 11.3% to 19.6% and from 26% to 29%, respectively. In 2012, for every 100 persons in the United States (U.S.), 82.5 opioid prescriptions and 37.6 benzodiazepine prescriptions were written by healthcare providers. In the emergency department, at least 17% of discharges included prescriptions for opioids.
5% to 20%	597	Most commonly, tapering involves dose reduction of how much every 4 weeks?	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.
close monitoring and consideration for tapering when risks exceed benefits	498	What to recommend for patients less than 30 years of age currently on long-term opioid therapy?	We recommend against the concurrent use of benzodiazepines and opioids. 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. We recommend against long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose. For patients less than 30 years of age currently on long-term opioid therapy, we recommend close monitoring and consideration for tapering when risks exceed benefits.
take back programs	0	What does the National Drug Control Strategy advocate?	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]
a panel of multidisciplinary experts	126	Who developed the guidelines?	This Clinical Practice Guideline is based on a systematic review of both clinical and epidemiological evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation.
Overdose Education and Naloxone Distribution	1,581	What does OEND refer to?	Necessary risk mitigation strategies are OEND, UDT, PDMP, face-to-face follow-up with frequency determined by risk. Indications for tapering and discontinuation are as follows: risks of OT outweigh benefits, patient preference, diversion. Risks of opioid therapy outweigh benefits under the following circumstances: lack of clinically meaningful improvement in function, concomitant use of medications that increase risk of overdose, co-occurring medical or mental health conditions that increase risk, concerns about OUD or other SUD, patient non-compliance with opioid safety measures and opioid risk mitigation strategies, patient non-participation in a comprehensive pain care plan, prescribed dose higher than the maximal recommended dose, pain condition not effectively treated with opioids (e.g., back pain with normal MRI; fibromyalgia), medical or mental health comorbidities that increase risk, improvement in the underlying pain condition being treated, unmanageable side effects. Factors that may indicate need for more frequent follow-up are non-adherence to comprehensive pain care plan (e.g., attendance at appointment), unexpected UDT and PDMP results, non-adherence to opioid prescription (e.g., using more than prescribed and/or running out early), higher risk medication characteristics (e.g., high-dose opioids, combination of opioids and benzodiazepines), patients with mental health, medical, or SUD comorbidities that increase risk for adverse outcomes. MEDD refers to morphine equivalent daily dose; MRI refers to magnetic resonance imaging; OEND refers to Overdose Education and Naloxone Distribution.
the treatment of chronic pain with opioids	247	What was increasing at an alarming rate until recently?	Chronic pain is a national public health problem as outlined in the 2011 study by the National Academy of Medicine (previously the Institute of Medicine [IOM]). At least 100 million Americans suffer from some form of chronic pain. Until recently, the treatment of chronic pain with opioids was increasing at an alarming rate. The increase in prescriptions of these medications has been accompanied by an epidemic of opioid-related adverse events.
immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated	248	What is recommended if take-home opioids are prescribed?	We recommend alternatives to opioids for mild-to-moderate acute pain. We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. If take-home opioids are prescribed, we recommend that immediate-release opioids are used at the lowest effective dose with opioid therapy reassessment no later than 3-5 days to determine if adjustments or continuing opioid therapy is indicated. Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.
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)	224	What does include severe respiratory instability or sleep disordered breathing?	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]
Alcohol use, pregnancy, nursing of infants, and lab abnormalities	267	What may change the risk/benefit calculus for LOT?	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.
screening and treatment is offered for conditions that can complicate pain management	7	What to ensure before initiating an opioid taper?	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.
an ordered sequence of steps of care, recommended observations and examinations, decisions to be considered, actions to be taken	696	What does the algorithm include?	This CPG follows an algorithm that is designed to facilitate understanding of the clinical pathway and decision making process used in management of LOT. The use of the algorithm format as a way to represent patient management was chosen based on the understanding that such a format may promote more efficient diagnostic and therapeutic decision making and has the potential to change patterns of resource use. Although the Work Group recognizes that not all clinical practices are linear, the simplified linear approach depicted through the algorithm and its format allows the provider to assess the critical information needed at the major decision points in the clinical process. It includes an ordered sequence of steps of care, recommended observations and examinations, decisions to be considered, actions to be taken.
progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD	33	What information should be discussed with patients at initiation of OT and continuously thereafter?	Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena.
non-inferior	9	What was the efficacy of long-acting opioids used once-daily compared to twice-daily use?	A second non-inferiority RCT compared once-daily hydromorphone ER to twice-daily oxycodone controlled-release in patients with moderate-to-severe cancer pain. The primary efficacy endpoint was patient assessment of “Brief Pain Inventory (BPI) worst pain in the past 24 hr.” Results demonstrated similar improvements in BPI and that the once-daily hydromorphone formulation was non-inferior to the twice-daily oxycodone formulation. Treatment-emergent adverse events were comparable between the groups as well.[141] The efficacy of long-acting opioids used once-daily is non-inferior to twice-daily use. There was a lack of statistical analysis of the outcomes and a lack of statistical power in both studies, and a small sample size in one study.
from 26% to 29%	163	From 2000 through 2010, what was the increment of the proportion of pain visits during which non-opioid pharmacologic therapies were prescribed?	From 2000 through 2010, the proportion of pain visits during which opioid and non-opioid pharmacologic therapies were prescribed increased from 11.3% to 19.6% and from 26% to 29%, respectively. In 2012, for every 100 persons in the United States (U.S.), 82.5 opioid prescriptions and 37.6 benzodiazepine prescriptions were written by healthcare providers. In the emergency department, at least 17% of discharges included prescriptions for opioids.
to advise the “…Health Executive Council on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration and Military Health System,” by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations	175	What was the mission of the Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG)?	The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the “…Health Executive Council on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration and Military Health System,” by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations. This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with chronic pain who are on or being considered for long-term opioid therapy (LOT).
Re-evaluate the risks and benefits of continuing opioid therapy	138	What to do when there is no pain reduction?	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.
to study and consider the latest information on opioid therapy (OT) and how and whether to incorporate that information or recommendations into their practice	113	When can this guideline be used?	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.
those with other risk factors for QTc prolongation, current or prior electrocardiograms (ECGs) with a prolonged QTc >450 ms, or a history of syncope	376	Which patients may be at risk?	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).
patients who already have had an adequate opioid trial (of sufficient dose and duration to determine whether or not it will optimize benefit) without a positive response	319	It is inadvisable to prescribe opioids to which patients?	Intolerance, serious adverse effects, or a history of inadequate beneficial response to opioids: Serious harm may occur should patients be prescribed additional (or different) opioids if prior administration of opioids led to serious adverse effects or was not tolerated. It is also inadvisable to prescribe opioids to patients who already have had an adequate opioid trial (of sufficient dose and duration to determine whether or not it will optimize benefit) without a positive response.
effective for pain reduction in multiple pain conditions	146	What do psychological therapies help?	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]
Veterans with PTSD who have co-occurring chronic pain	1,070	For whom particular caution should be used when considering initiating benzodiazepines due to the difficulty of tapering or discontinuing benzodiazepines?	There is a large variation in patient preference regarding the concurrent use of benzodiazepines and LOT. This is especially true for patients who are already accustomed to receiving both medications (see Patient Focus Group Methods and Findings). Concurrent benzodiazepine and LOT use is a serious risk factor for unintentional overdose death and should be weighed heavily in the risk-benefit evaluation for tapering versus continuing one or both agents. Once initiated, benzodiazepines can be challenging to discontinue due to symptoms related to benzodiazepine dependence, exacerbations of PTSD, and/or anxiety.[91] Moreover, abrupt discontinuation of benzodiazepines should be avoided, as it can lead to serious adverse effects including seizures and death. Tapering benzodiazepines should be performed with caution and within a team environment when possible (see Recommendation 26 in the VA/DoD SUD CPG).7 Due to the difficulty of tapering or discontinuing benzodiazepines, particular caution should be used when considering initiating benzodiazepines for Veterans with PTSD who have co-occurring chronic pain. The VA/DoD PTSD CPG recommends against benzodiazepines for the prevention of PTSD and cautions against their use in treatment of PTSD. Benzodiazepines to treat acute anxiety symptoms after trauma are associated with a higher incidence of PTSD symptoms. For treatment of PTSD, there is evidence of lack of efficacy from small clinical trials and evidence of harm from observational studies of benzodiazepines for PTSD. Although anxiety may initially improve with benzodiazepines, the improvement is short-lived and may result in tolerance to increasing doses and eventual failure of the treatment. Even gradual benzodiazepine taper may result in exacerbation of severe PTSD symptoms. Concomitant use of benzodiazepines is considered a contraindication to initiation of OT.
to assess the critical information needed at the major decision points in the clinical process	588	What does the simplified linear approach depicted through the algorithm and its format allow?	This CPG follows an algorithm that is designed to facilitate understanding of the clinical pathway and decision making process used in management of LOT. The use of the algorithm format as a way to represent patient management was chosen based on the understanding that such a format may promote more efficient diagnostic and therapeutic decision making and has the potential to change patterns of resource use. Although the Work Group recognizes that not all clinical practices are linear, the simplified linear approach depicted through the algorithm and its format allows the provider to assess the critical information needed at the major decision points in the clinical process. It includes an ordered sequence of steps of care, recommended observations and examinations, decisions to be considered, actions to be taken.
Mechanical or inflammatory pain with a visceral origin	211	Which pain may produce a less localized pain?	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.
patients who require higher doses of opioids, even in those who benefit from such therapy	500	Who will have greater mortality?	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.
Prescribed opioid dosage	295	What is a good predictor of overdose death?	In a nested case-control study of U.S. Veterans (not included in our evidence review as it was published after the end of the search date range), Bohnert et al. (2016) examined the association between prescribed opioid dose as a continuous measure (in 10 mg MEDD increments) and overdose.[134] Prescribed opioid dosage was a moderately good predictor of overdose death, but the study did not reveal a specific dosage cut point or threshold above which risk of overdose increased dramatically. Lower prescribed opioid dosages were associated with reduced risk for overdose, but risk was not completely eliminated at lower doses; approximately 40% of overdoses were observed in patients who were prescribed <50 mg MEDD.
exit algorithm; manage with non-opioid modalities	816	What to do if the treatments are effective in managing pain and optimizing function?	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.
consult with mental health provider before beginning taper	474	What to do if the veteran is actively suicidal?	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.
an overdose	1,130	If the patients under opioid taper pna resume their original dose, they are at risk of what?	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.
help to address safety, fairness, and trust with OT	258	What do UDTs do when used appropriately?	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.
more frequent monitoring for adverse events including opioid use disorder and overdose	49	What is recommended as opioid dosage and risk increase?	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.
5 to 10 days following opioid dose reduction/cessation but may take longer depending on the half-life of the opioid (e.g., methadone)	955	How long does it take to resolve early symptoms?	Short-term oral medications can be utilized to assist with managing the withdrawal symptoms, especially when prescribing fast tapers. Do not treat withdrawal symptoms with an opioid or benzodiazepine. Withdrawal symptoms are not life-threatening and may not be seen with a gradual taper. Early symptoms take hours to days to appear. Early symptoms include anxiety/restlessness, rapid short respirations, runny nose, tearing eyes, sweating, insomnia, and dilated reactive pupils. Late symptoms take days to weeks to appear. Late symptoms include runny nose, tearing eyes, rapid breathing, yawning, tremor, diffuse muscle spasms/aches, piloerection, nausea, vomiting, and diarrhea, abdominal pain, fever, chills, increased white blood cells if sudden withdrawal. Prolonged symptoms take weeks to months to appear. Prolonged symptoms include irritability, fatigue, bradycardia, decreased body temperature, craving, insomnia. Early symptoms generally resolve 5 to 10 days following opioid dose reduction/cessation but may take longer depending on the half-life of the opioid (e.g., methadone). Some symptoms of withdrawal such as dysphoria, insomnia and prolonged craving may take longer. Patients with chronic pain may find that symptoms, such as fatigue, mental functioning, pain, and well-being, improve over time.
Research	482	What is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena?	Patients should be informed that progression from acute to long-term OT is associated with little evidence for sustained analgesic efficacy but a substantial increase in risk for OUD. Providers should discuss this information with patients at initiation of OT and continuously thereafter to ensure that the patient understands the associated risks and benefits of LOT. Fully informed, some patients may desire continuation of OT while others may decline its continued provision. Research is necessary to more accurately determine how long it takes for OUD to occur and whether the nature of the pain is one of the factors that can influence either of this phenomena.
implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose	1,270	What was the purpose of the OEND program?	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.
education and knowledge of the local procedures and clinical scenario	564	What is required by the interpretation of a UDT and confirmatory results?	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.
The VA/DoD Suicide CPG	128	Who recommends restricting the availability of lethal means for patients considered to be at intermediate or high acute risk of suicide?	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).
from 18.9% to 33.4%, an increase of 76.7%	96	What was the increment of the prevalence of opioid prescriptions among Veterans from fiscal years 2004 to 2012?	From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.
An urgent evaluation	552	What is needed when there is a history of internal malignancy that has not been re-staged?	When considering an opioid taper, monitor for conditions that may warrant evaluation and arrange primary care and/or emergency department follow-up when indicated. If a patient is taking more than their prescribed dosage of opioids or showing signs of aberrant behavior, before deciding to change therapy, look for “red flags”. The red flags are progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, history of internal malignancy that has not been re-staged, signs of/risk factors for infection. An urgent evaluation may be needed when there is progressive numbness or weakness, progressive changes in bowel or bladder function, unexplained weight loss, a history of internal malignancy that has not been re-staged, signs of/risk factors for infection such as fever, recent skin or urinary infection, immunosuppression, IV drug use.
11	190	Compared to patients ≥65 years old, patients 18-30 years old carried how many times the odds of OUD and overdose?	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]