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biomedical_cpgQA

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Algorithm	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.	Who does assess the critical information needed at the major decision points in the clinical process?	the provider
Features and overview	Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.	When reducing 5% of morphine SR 90 mg Q8h = 270 MEDD, what dose should be taken on month eight of the slowest opioid tapering?	45 mg SR qam, 45 mg noon, 60 mg qpm
Features and overview	Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.	When reducing 33% of morphine SR 90 mg Q8h = 270 MEDD on day 1, what dose should be taken on day eleven of the rapid opioid tapering?	15 mg SR QHS
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 patients ≥65 years old, patients 18-30 years old carried how many times the odds of OUD and overdose?	11
Features and overview	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.	What can be utilized to assist with managing the withdrawal symptoms?	Short-term oral medications
Features and overview	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.	Which withdrawal symptoms in patients with chronic pain may improve over time?	fatigue, mental functioning, pain, and well-being
Algorithm	The components of biopsychosocial assessment are pain assessment, patient functional goals, impact of pain on family, work, life, review of previous diagnostic studies, additional consultations and referrals, coexisting illness and treatments and effect on pain, significant psychological, social, or behavioral factors that may affect treatment, family history of chronic pain, collateral of family involvement, patient beliefs/knowledge of the cause of their pain and their treatment preferences along with the perceived efficacy of various treatment options. For patients already on OT, include assessment of psychological factors related to continuing vs. tapering OT. The psychological factors are beliefs, expectations, fears. Pain assessment includes history, physical exam, comorbidities, previous treatment and medications, duration of symptoms, onset and triggers. Examples of absolute contraindications to initiating opioid therapy for chronic pain are true life-threatening allergy to opioids, active SUD, elevated suicide risk, concomitant use of benzodiazepines. LOT refers to long-term opioid therapy; OT refers to opioid therapy; PDMP refers to Prescription Drug Monitoring Program; SUD refers to substance use disorder; UDT refers to urine drug test; VA/DoD Suicide CPG refers to VA/DoD Clinical Practice Guideline for the Assessment and Management of Patients at Risk for Suicide.	What to assess for patients already on OT?	psychological factors related to continuing vs. tapering OT
Features and overview	Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.	What to do when patients are displaying other aberrant behaviors during the taper?	providing follow-up in a clinic visit may be more optimal than a telephone visit
Features and overview	Use immediate-release (IR) opioids when starting therapy. Prescribe the lowest effective dose. When using opioids for acute pain, provide no more than needed for the condition. Follow up and review benefits and risks before starting and during therapy. If benefits do not outweigh harms, consider tapering opioids to lower doses or taper and discontinue.	When to consider tapering opioids to taper and discontinue?	If benefits do not outweigh harms
Features and overview	Follow-up for tapering should be done with PACT Team. Follow-up for tapering is recommended to be a team function with various team members taking on roles in which they have demonstrated specific competencies. Mental health practitioners may need to be included in the follow-up plan. During the slowest taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the slower taper, follow up with the Veteran 1 to 4 weeks after starting taper then monthly before each reduction. During the faster taper, follow up with the Veteran weekly before each dose reduction. During the rapid taper, follow up with the Veteran daily before each dose reduction or if available offer inpatient admission. The follow-up during the slowest, slower, and faster tapering can be done in the clinic and/or over telephone. The follow-up during the rapid tapering can be done in the hospital, clinic or over telephone. Providers will need to determine whether a telephone or in-clinic appointment is appropriate based on the risk category of the Veteran. A Veteran with high risk due to a medical condition may have decompensation during the taper and may require a clinic visit over telephone follow-up. If there are issues with the Veteran obtaining outside prescriptions or they are displaying other aberrant behaviors during the taper, providing follow-up in a clinic visit may be more optimal than a telephone visit. Follow up on patient function, pain intensity, sleep, physical activity, personal goals, and stress level.	What to do if there are issues with the Veteran obtaining outside prescriptions during the taper?	providing follow-up in a clinic visit may be more optimal than a telephone visit
Recommendations	In a prospective cohort study (not included in the evidence review as it did not include information on acute versus chronic pain in the patient population), Dasgupta et al. (2015) compared residents of North Carolina who had received an opioid prescription in the last year to residents who had not. The study examined the outcome of population-based rates of opioid overdose mortality by opioid dose, without use of a presupposed threshold (Table 3).[135] There was no safe dose of opioid. Among the over nine million individuals followed for one year, 629 died from opioid overdose. Of these 629 individuals, 151 had no record of having been dispensed an opioid. It is possible these opioids were obtained through illicit channels or social sharing/diversion. Of the 478 patients who died from an opioid overdose who were prescribed opioids, 235 (49%) had been prescribed <80 mg MEDD. Overdose incidence rate ratios (IRRs) doubled each time the MEDD ranges increase from 60.0-79.9 mg to 80.0-99.9 mg (IRR 2.9 to 6.2), then to 120-139.9 mg (IRR 14.1), 160-179.9 mg (IRR 29.5), and 350-399.9 mg (IRR 63.2).	Is there any study on the outcome of population-based rates of opioid overdose mortality by opioid dose, without the use of a presupposed threshold?	In a prospective cohort study (not included in the evidence review as it did not include information on acute versus chronic pain in the patient population), Dasgupta et al. (2015) compared residents of North Carolina who had received an opioid prescription in the last year to residents who had not.
Introductory information	This guideline is not intended as a standard of care and should not be used as such. Standards of care are determined on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advances and patterns evolve. Today there is variation among state regulations, and this guideline does not cover the variety of ever-changing state regulations that may be pertinent. The ultimate judgement regarding a particular clinical procedure or treatment course must be made by the individual clinician, in light of the patient’s clinical presentation, patient preferences, and the available diagnostic and treatment options. As noted previously, the guideline can assist care providers, but the use of a CPG must always be considered as a recommendation, within the context of a provider’s clinical judgment and patient values and preferences, in the care for an individual patient.	How are the standards of care determined?	on the basis of all clinical data available for an individual case and are subject to change as scientific knowledge and technology advances and patterns evolve
Recommendations	If prescribing opioid therapy for patients with chronic pain, we recommend a short duration. (Strong for\| Reviewed, New-replaced) Note: Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits. For patients currently on long-term opioid therapy, we recommend ongoing risk mitigation strategies (see Recommendations 7-9), assessment for opioid use disorder, and consideration for tapering when risks exceed benefits (see Recommendation 14). (Strong for\| Reviewed, New-replaced)	For whom consideration for tapering when risks exceed benefits is recommended?	patients currently on long-term opioid therapy
Recommendations	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.	What is the stance regarding long-term opioid therapy for patients less than 30 years of age secondary to higher risk of opioid use disorder and overdose?	recommend against
Recommendations	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.	What is the stance regarding the concurrent use of benzodiazepines and opioids?	recommend against
Algorithm	Module D is for patients currently on opioid therapy. For patients currently on OT, look for factors that would require immediate attention and possible discontinuation of OT due to unacceptable risk. If there are factors that would require immediate attention, then admit/provide treatment to stabilize, including opioid tapering or SUD treatment as indicated. If there are no factors that would require immediate attention, then obtain a biopsychosocial assessment. If prior medical records including current prescriber, prior and current UDT, PDMP are available for review, then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If unavailable, then address factors related to incomplete data prior to prescribing. Then review data and re-assess risks and benefits of continuing OT and consider strength and number of risk factors. If risks outweigh benefits of continuing OT, then proceed to module C. If risks do not outweigh benefits of continuing OT, then educate/re-educate on the following: non-opioid management, self-management to improve function and quality of life, realistic expectations and limitations of medical treatment options, preferred treatment methods being non-pharmacotherapy and non-opioid pharmacotherapy, new information on risks and lack of benefits of long-term OT. After educating/re-educating the patient, identify if there is presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events (e.g., benzodiazepine) or patient non-participation in a comprehensive pain care plan or other indications for tapering. If any of these are present, then proceed to module C. Otherwise, reassess and optimize preferred non-opioid treatments for chronic pain (e.g., physical and psychological treatments) recognizing that the patient is willing to continue to engage in a comprehensive treatment plan including non-opioid treatments. If the patient is experiencing clear functional improvement with minimal risk, then continue OT using the following approach: shortest duration, using lowest effective dose (recognizing that no dose is completely safe and overdose risk increases at doses > 20-50 mg MEDD), continual assessment of improvement in pain and functional status and adverse effects. Then proceed to follow-up frequently based on patient risk factors. Otherwise, proceed to module C.	What to do if the patient does not participate in a comprehensive pain care plan?	proceed to module C
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]	What was the amount of risk of developing OUD or overdose in patients 30-39 years old compared to subjects 18-29 years old?	roughly half
Background information	The risk factors with the greatest impact on the development of opioid-related adverse events are the duration and dose of opioid analgesic use. Beyond duration and dose of OT, many factors increase the risk of adverse outcomes and must be considered prior to initiating or continuing OT (Box 1). Given the insufficient evidence of benefit for LOT, the clinician must carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment. As patient values and preferences may be impacted by other clinical considerations, some patients with one or more risk factors for adverse outcomes may differ with the clinician’s assessment that the risks of OT outweigh the potential for modest short-term benefits. Thus, it is important to consider patients’ values and concerns, address misconceptions, express empathy, and fully explain to patients with one or more risk factors that they may not benefit from, and may even be harmed by, treatment with OT. Conditions that significantly increase the risk of adverse outcomes from LOT are listed below. Patients for whom LOT is initiated should be carefully monitored, and ongoing assessment of risk should be performed with vigilance for the development of additional risk factors and adverse outcomes (see Recommendations 7-9). Consider consultation with appropriate specialty care providers if there is uncertainty about whether the benefits of OT, such as improved function (e.g., return-to-work), outweigh the risks.	Why must the clinician carefully weigh harms and benefits and educate the patient as well as his or her family or caregiver prior to proceeding with treatment?	Given the insufficient evidence of benefit for LOT
Recommendations	A number of studies suggest certain chronic pain conditions represent an independent risk factor for suicide.[123-130] A recent large retrospective cohort study also suggests an association with prescribed opioid dose and suicide risk among Veterans receiving OT for CNCP.[131] Suicide risk is not static, and many factors influence an individual’s risk of suicide at any given point in time, as noted in the VA/DoD Suicide CPG. Thus, ongoing assessment of suicide risk is important whether one is initiating, maintaining, or terminating LOT.	What is represented by chronic pain conditions?	an independent risk factor for suicide
Recommendations	The risks of acute OT extending into LOT are increased in patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids.[183-185] The risk of acute post-operative OT progressing into LOT is increased with a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants.[186,187]	Who are at an increased risks of acute OT extending into LOT?	patients with mood disorders, those who refill the initial prescription, higher prescribed dose (greater than 120 mg MEDD), and initiation using long acting opioids
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.	Why is continuing LOT not recommended to “prevent suicide” in someone with chronic pain?	an appropriate response if suicide risk is high or increases
Algorithm	Factors requiring immediate attention and possible discontinuation are as follows: untreated SUD, unstable mental health disorder, medical condition that acutely increases opioid risks (e.g., compromised or worsening cognitive or cardiopulmonary status), other factors that acutely increase risk of overdose (recent overdose, current sedation, recent motor vehicle accident), acutely elevated suicide risk. The risks of continuing opioid therapy are as follows: increase in all-cause mortality, increase risk of unintentional overdose death, increase risk of developing OUD, risk of developing or worsening - depression, falls, fractures, sleep disordered breathing, worsening pain, motor vehicle accidents hypogonadism, prolonged pain, nausea, constipation, dry mouth, sedation, cognitive dysfunction, immune system dysfunction, reduction in function, reduction in quality of life. The benefits of continuing opioid therapy are modest short-term improvement in pain, possible short-term improvement in function. Some talking points for education and re-education for patients currently on OT are “Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”.	What are some talking points for educating/re-educating the patients currently on OT?	“Doctors used to think that opioids were safe and effective when used for long periods of time to treat chronic pain.”, “New information has taught us that long-term opioid use can lead to multiple problems including loss of pain relieving effects, increased pain, unintentional death, OUD, and problems with sleep, mood, hormonal dysfunction, and immune dysfunction,”, “We now know that the best treatments for chronic pain are not opioids. The best treatments for chronic pain are non-drug treatments such as psychological therapies and rehabilitation therapies and non-opioid medications.”
Features and overview	Offer risk mitigation strategies, including naloxone for patients at risk for overdose. Review PDMP (Prescription Drug Monitoring Program) data at least every 3 months and perform UDT (Urine Drug Testing) at least annually. Avoid prescribing opioid and benzodiazepines concurrently when possible. Clinicians should offer or arrange MAT (Medication-Assisted Treatment) for patients with OUD (Opioid Use Disorder).	What should be arranged for patients with OUD?	MAT (Medication-Assisted Treatment)
Algorithm	When safety allows, a gradual taper rate (5-10% reduction every 4 weeks) allows time for neurobiological, psychological, and behavioral adaptations. When there are concerns regarding risks of tapering (e.g., unmasked OUD, exacerbation of underlying mental health conditions), consider interdisciplinary services that may include mental health, SUD, primary care, and specialty pain care. Address concerns that may negatively impact taper (e.g., inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD). Patient and treatment characteristics to consider when determining tapering strategy are as follows: opioid dose, duration of therapy, type of opioid formulation, psychiatric, medical and SUD comorbidities and other patient risk factors (e.g., non-adherence, high-risk medication-related behavior, strength of social support, and coping).	What are some examples of concerns that may negatively impact taper?	inability for adequate follow-up, inability to provide adequate treatment for co-occurring medical and mental health conditions and SUD
Background information	The increase in opioid prescribing is matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance use disorders (SUD) treatment admissions from 1999 to 2008. In 2009, drug overdose became the leading cause of injury-related death in the U.S., surpassing deaths from traffic accidents. In 2014, 1.9 million Americans were affected by an OUD related to non-medical use of prescription pain relievers, and in the same year, 18,893 individuals died as a result of a prescription drug overdose. There has been a four-fold increase in the absolute number of deaths associated with use of opioids since 2000, and a 14% increase between 2013 and 2014 alone. In a survey of patients prescribed opioids for chronic non-cancer pain (CNCP) and their family members, 34% of patients reported that they thought they were “addicted” or “dependent” on opioid pain medication, 34% said that they used the medication for “fun” or to “get high,” while 22% used the medication to relieve day-to-day stress.	What kind of increase has there been in the absolute number of deaths associated with the use of opioids between 2013 and 2014 alone?	14% increase
Recommendations	We recommend alternatives to opioids for mild-to-moderate acute pain. (Strong for). We suggest use of multimodal pain care including non-opioid medications as indicated when opioids are used for acute pain. (Weak for). 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. (Strong for). Note: Patient education about opioid risks and alternatives to opioid therapy should be offered.	What should be offered to patients?	Patient education about opioid risks and alternatives to opioid therapy
Introductory information	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).	What is LOT?	long-term opioid therapy
Introductory information	In 2010, the VA and DoD published the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain (2010 OT CPG), which was based on evidence reviewed through March 2009. Since the release of that guideline, there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans. At the same time, there is a mounting body of research expanding detailing the lack of benefit and severe harms of LOT.	What was the basis for the Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain published in 2010?	evidence reviewed through March 2009
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 should the guidelines not be construed as?	a standard of care
Recommendations	Some may interpret the recommendation to limit opioid use by age as arbitrary and potentially discriminatory when taken out of context; however, there is good neurophysiologic rationale explaining the relationship between age and OUD and overdose. Studies in other areas (e.g., use of different substances) indicate that developing brains (age <30 years) are at increased risk of abnormalities and addiction when exposed to substance use early in life.[95-98]	What kind of rationale is there to explain the the relationship between age and OUD and overdose?	good neurophysiologic rationale
Recommendations	Monitoring standards with administration of OT for acute pain vary depending on a number of factors including the setting, specifics of the painful insult, patient medical factors, and selected medication potency/dose/route of administration/adjunct selection.	Depending on which factors monitoring standards with administration of OT for acute pain vary?	the setting, specifics of the painful insult, patient medical factors, and selected medication potency/dose/route of administration/adjunct selection
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.	Alternatives should be considered for which opioid pain medications?	methadone and transdermal fentanyl
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 treatments are effective in managing pain and optimizing function?	exit algorithm; manage with non-opioid modalities
Background information	The increase in opioid prescribing is matched by a parallel increase in morbidity, mortality, opioid-related overdose death rates, and substance use disorders (SUD) treatment admissions from 1999 to 2008. In 2009, drug overdose became the leading cause of injury-related death in the U.S., surpassing deaths from traffic accidents. In 2014, 1.9 million Americans were affected by an OUD related to non-medical use of prescription pain relievers, and in the same year, 18,893 individuals died as a result of a prescription drug overdose. There has been a four-fold increase in the absolute number of deaths associated with use of opioids since 2000, and a 14% increase between 2013 and 2014 alone. In a survey of patients prescribed opioids for chronic non-cancer pain (CNCP) and their family members, 34% of patients reported that they thought they were “addicted” or “dependent” on opioid pain medication, 34% said that they used the medication for “fun” or to “get high,” while 22% used the medication to relieve day-to-day stress.	How many Americans were affected by an OUD related to non-medical use of prescription pain relievers in 2014?	1.9 million
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 is the preferred OUD treatment?	Opioid Agonist Therapy (OAT)
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 are concerns related to an increased risk of substance use disorder?	Re-evaluate the risks and benefits of continuing opioid therapy
Recommendations	At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms.	What may change the risk/benefit calculus for LOT?	Alcohol use, pregnancy, nursing of infants, and lab abnormalities
Recommendations	Some may interpret the recommendation to limit opioid use by age as arbitrary and potentially discriminatory when taken out of context; however, there is good neurophysiologic rationale explaining the relationship between age and OUD and overdose. Studies in other areas (e.g., use of different substances) indicate that developing brains (age <30 years) are at increased risk of abnormalities and addiction when exposed to substance use early in life.[95-98]	What are at increased risk of abnormalities and addiction when exposed to substance use early in life?	developing brains (age <30 years)
Recommendations	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.	Alternatives to opioids are recommended for what?	mild-to-moderate acute pain
Features and overview	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.	What are the signs of/risk factors for infection?	fever, recent skin or urinary infection, immunosuppression, IV drug use