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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 it guide a patient encounter?
provide specific information
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 migraine headaches (with or without aura), tension-type headaches, occipital neuralgia, or myofascial pain?
LOT
Algorithm
Module B is about treatment with opioid therapy. The treatment of opioid therapy is provided to the candidate for trial of OT with consent (in conjunction with a comprehensive pain care plan). Initiate OT using the following approach: short duration (e.g., 1 week initial prescription; no more than 3 months total), use the lowest effective dose recognizing that no dose is completely safe, long-acting opioids should not be prescribed for opioid-naive individuals, consider alternatives to methadone and transdermal fentanyl, assessment of improvement in pain and functional status and adverse effects, offer overdose education and naloxone distribution (OEND). A strategy of escalating dose to achieve benefit increases risk and has not been shown to improve function. Dose escalation above 20-50 mg MEDD has not been shown to improve function and increase risk. If a patient is medically or psychiatrically unstable, then admit/provide medical and psychiatric treatment to stabilize as indicated. If a patient is not medically or psychiatrically unstable, then see if there is a clinically meaningful improvement in function in the absence of significant risk factors. If there is a clinically meaningful improvement in function in the absence of significant risk factors, then review and optimize comprehensive pain care plan (e.g., non-opioid treatments, self-management strategies). If there is no clinically meaningful improvement in function in the absence of significant risk factors, then taper to discontinuation (consult Module C if needed), exit algorithm and manage with non-opioid modalities. Follow-up frequently based on patient risk factors (e.g., 1-4 weeks with any dose change; up to every 3 months without dose change if clinically and functionally stable). During a follow-up, assess function, risks, and benefits of OT, progress toward functional treatment goals, adverse effects, adherence to treatment plan, complications or co-occurring conditions (e.g., medical, mental health, and/or SUD); complete risk mitigation strategies; review and optimize comprehensive pain care plan. The factors that increase risks of OT are non-adherence, co-occurring conditions, behaviors suggesting OUD, indications for referral. If these factors are present, then consider one or more of the following: shortening prescribing interval, intensifying risk mitigation strategies, increasing intensity of monitoring, referring to interdisciplinary care and consulting with or referring to specialty care. If the factors that increase risks of OT are not present, then see if there are indications to discontinue or taper. If there are indications to discontinue or taper, then taper to reduced dose or taper to discontinuation. If there are no indications to discontinue or taper, then reassess in 1-3 months or more frequently as determined by patient risk factors.
What to do if there are no indications to discontinue or taper?
reassess in 1-3 months or more frequently as determined by patient risk factors
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.
Follow-up for tapering is recommended to be what?
a team function with various team members taking on roles in which they have demonstrated specific competencies
Recommendations
Risk mitigation for LOT should begin before the opioids are prescribed, through an informed consent discussion, reviewing the patient’s history, checking state PDMPs, or instructing patients about using drug take back programs to dispose of unused medication. It should also occur concurrently with the therapy (e.g., ongoing UDT, OEND) and in response to adverse events (e.g., needle exchange programs for those who develop an intravenous drug use disorder). The 2010 OT CPG recommended use of an opioid pain care agreement, monitoring for appropriate opioid use, and, with patients’ consent, obtaining a UDT. A literature search was conducted dating back to the original 2010 recommendation to identify studies comparing the effectiveness of different risk mitigation strategies for patients on or being considered for LOT. One identified study was a systematic review of 11 studies looking at opioid treatment agreements (OTAs) and UDT strategies utilizing opioid misuse risk reduction as the main outcome measure.[99] The study revealed weak evidence to support the use of OTAs and UDT. A second study, a retrospective database study, demonstrated decreased risk of suicide attempts in various cohorts with frequent UDT, regular follow-up (including follow-up within four weeks for patients with new opioid prescription), and rehabilitative services are offered.[61] The confidence in the quality of the evidence was moderate for the outcome of attempted suicide risk. The third study was a retrospective cohort study that looked at the intervention of a clinical pharmacist guidance team versus control.[100] Outcome measures included adverse events, pain management, and quality of life. Details of the actual intervention were vague and did not necessarily include OTAs or UDT. Thus, the confidence in the quality of the evidence was very low. The confidence in the quality of the evidence was moderate for UDT and frequent follow-up and was low for OTAs. The frequency of follow-up and monitoring should be based on patient level of risk as determined by an individual risk assessment.
What is OTAs?
opioid treatment agreements
Background information
On July 22, 2016, the Comprehensive Addiction and Recovery Act (CARA) was enacted with the aim of addressing the epidemic of overdoses from prescription opioids and other prescription drugs and heroin. While this act was primarily focused on opioid abuse treatment and prevention, it also gave specific instruction to the VA in regard to broad aspects of OT including consideration of the CDC guideline in revising the prior VA/DoD OT CPG and adopting it for the VA. There are, however, some important distinctions between the CDC guideline and the VA/DoD OT CPG.
What is CARA?
the Comprehensive Addiction and Recovery Act
Features and overview
Educate the Veteran by using Bio-Psycho-Social Model e.g., PHI’s “Whole Health” approach. Offer Veterans pain education groups [especially Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for Pain, if available]. Clinicians should offer physical therapy and Complementary and Integrative Health (CIH) interventions such as acupuncture, meditation, yoga. Clinicians should offer slow tapering of opioids to reduce opioid risks while not “cutting off” the Veteran. Clinicians should offer non-opioid pain medications when appropriate. Clinicians should commit to working with the Veteran on other options for improved function and some decrease in pain.
What is an example of Bio-Psycho-Social Model?
PHI’s “Whole Health” approach
Background information
Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.
What is SAMHSA?
Substance Abuse and Mental Health Services Administration
Algorithm
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.
Which factors may indicate the need for more frequent follow-up?
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
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.
When to follow-up after each change in dosage?
1 week to 1 month
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 not to use to treat withdrawal symptoms?
an opioid or benzodiazepine
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 demonstrates signs or symptoms of SUD?
see whether the patient is willing to engage in SUD therapy
Background information
Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.
What does the OSI use to identify providers whose prescribing practices do not reflect best evidence so that patient care can be improved?
Veterans Health Administration (VHA’s) electronic health record
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 is Module C about?
tapering or discontinuation of opioid therapy
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.
With whom to follow up during opioid taper?
PACT Team
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.
What are included in the 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
Features and overview
Consider use of adjuvant medications during the taper to reduce withdrawal symptoms. The first-line treatment option for autonomic symptoms such as sweating, tachycardia, myoclonus is clonidine 0.1 to 0.2 mg oral every 6 to 8 hours; hold dose if blood pressure <90/60 mmHg (0.1 to 0.2 mg 2 to 4 times daily is commonly used in the outpatient setting); recommend test dose (0.1 mg oral) with blood pressure check 1 hour post dose; obtain daily blood pressure checks; increasing dose requires additional blood pressure checks; re-evaluate in 3 to 7 days; taper to stop; average duration 15 days. The three alternative treatment options for autonomic symptoms are Baclofen, Gabapentin, Tizanidine. The alternative treatment option for autonomic symptoms using Baclofen is as follows: 5 mg 3 times daily; may increase to 40 mg total daily dose; re-evaluate in 3 to 7 days; average duration 15 days; may continue after acute withdrawal to help decrease cravings; should be tapered when it is discontinued. The alternative treatment option for autonomic symptoms using Gabapentin is as follows: start at 100 to 300 mg and titrate to 1800 to 2100 mg divided in 2 to 3 daily doses; adjust dose if renal impairment. Gabapentin can help reduce withdrawal symptoms and help with pain, anxiety, and sleep. The alternative treatment option for autonomic symptoms using Tizanidine is as follows: 4 mg three times daily, can increase to 8 mg three times daily.
Which can help reduce withdrawal symptoms and help with pain, anxiety, and sleep?
Gabapentin
Features and overview
Rapid Taper is done over days. Rapid tapers can cause withdrawal effects and patients should be treated with adjunctive medications to minimize these effects; may need to consider admitting the patient for inpatient care. If patients are prescribed both long-acting and short-acting opioids, the decision about which formulation to be tapered first should be individualized based on medical history, mental health diagnoses, and patient preference. Data shows that overdose risk is greater with long-acting preparations. In rapid taper, reduce opioid by 20 to 50% of first dose if needed, then reduce by 10 to 20% every day. An example of the rapid taper is given below. During the first day in the rapid taper, 33% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 60 mg SR (15 mg x 4) Q8h. The subsequent daily dosage for the rapid taper is 45 mg SR (15 mg x 3) Q8h for day 2, 30 mg SR (15 mg x 2) Q8h for day 3, 15 mg SR Q8h for day 4, 15 mg SR Q12h for day 5-7, 15 mg SR QHS for day 8-11. Stop rapid tapering after day 11 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.
What may be considered after stopping rapid tapering after day 11?
morphine IR 15 mg ½ tablet (7.5 mg) twice daily
Background information
Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. In the U.S., approximately 100 million adults experience chronic pain, and pain is associated with approximately 20% of ambulatory primary care and specialty visits. Since the late 1990s and early 2000s, the proportion of pain visits during which patients received opioids has increased significantly, as have opioid-related morbidity, mortality, overdose death, and SUD treatment admissions. Approximately one in five patients with non-cancer pain or pain related diagnoses is prescribed opioids in office-based settings. According to the CDC, sales of prescription opioids U.S. quadrupled from 1999 and 2014. The absolute number of deaths associated with use of opioids has increased four-fold since 2000, including by 14% from 2013 to 2014 alone. Between 1999 and 2015, more than 183,000 people died from overdoses related to prescription opioids. In one survey, approximately one-third of patients receiving OT for CNCP (or their family members) indicated thinking that they were “addicted” to or “dependent” on the medication or used the medication for “fun” or to “get high.” From 2000 through 2013, the rate of heroin overdose deaths increased nearly four-fold. In the 2000s, the majority of people entering treatment for heroin use used prescription opioids as their first opioid.
What is the ratio of patients with non-cancer pain or pain-related diagnoses who receive opioid prescriptions in office-based settings?
Approximately one in five
Background information
Other initiatives are aimed at improving the safe use of opioids, including the OSI Toolkit and the patient guide “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain”. The OSI Toolkit was developed to provide clinicians with materials to inform clinical decision-making regarding opioid therapy and safe opioid prescribing. The toolkit materials can be found at the following link: https://www.va.gov/PAINMANAGEMENT/Opioid_Safety_Initiative_Toolkit.asp. “Taking Opioids Responsibly for Your Safety and the Safety of Others: Patient Information Guide on Long-term Opioid Therapy for Chronic Pain” is aimed at providing information to patients as well as their providers regarding the safe use of opioids. More information can be found at the following link: http://www.healthquality.va.gov/guidelines/Pain/cot/OpiodTheraphyforChronicPainPatientTool20May20 13print.pdf. To further promote safety and patient centered care, the VHA issued a policy in 2014 requiring standardized education and signature informed consent for all patients receiving LOT for non-cancer pain.
What is the aim of the patient guide?
providing information to patients as well as their providers regarding the safe use of opioids
Recommendations
At follow-up visits, a clinician should re-examine the rationale for continuing the patient on OT. Clinicians should take into account changes in co-occurring conditions, diagnoses/medications, and functional status when conducting the risk/benefit analysis for LOT. Alcohol use, pregnancy, nursing of infants, and lab abnormalities may change the risk/benefit calculus for LOT. Ongoing OT prescribing practice may include pharmacy review, informed consent, UDTs, and checking state PDMPs. A clinician should also be mindful of signs of diversion during follow-up (see Risk Factors for Adverse Outcomes of Opioid Therapy). The longer the patient is on opioids, the greater the potential for change in patient status and development of opioid-related harms.
What to do at follow-up visits?
a clinician should re-examine the rationale for continuing the patient on OT
Background information
Chronic pain is defined as pain lasting three months or more. It is often associated with changes in the central nervous system (CNS) known as central sensitization. Whereas acute and subacute pain are thought to involve primarily nociceptive processing areas in the CNS, chronic pain is thought to be associated with alterations in brain centers involved with emotions, reward, and executive function as well as central sensitization of nociceptive pathways across several CNS areas.
Which areas in the CNS are involved in the chronic pain?
chronic pain is thought to be associated with alterations in brain centers involved with emotions, reward, and executive function as well as central sensitization of nociceptive pathways across several CNS areas.
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 treatment modality may result in worsening of the underlying headache condition in patients with migraine headaches, tension-type headaches, occipital neuralgia, or myofascial pain?
LOT
Recommendations
State database queries for detection of multi-sourcing of controlled substances are used throughout the country. Data comparing states with an implemented state database program to states without one showed 1.55 fewer deaths per 100,000 people.[106] The CDC currently recommends at least quarterly checks of the state database system.[33]
What are used throughout the country for detection of multi-sourcing of controlled substances?
State database queries
Features and overview
Slowest taper is done over years. In the slowest taper, reduce opioid by 2 to 10% every 4 to 8 weeks with pauses in taper as needed. Consider the slowest taper for patients taking high doses of long-acting opioids for many years. An example of the slowest taper is given below. During the first month in the slowest taper, 5% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 90 mg SR qam, 75 mg for noon, 90 mg qpm. Continue the taper based on Veteran response. Pauses in the taper may allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration. The subsequent monthly dosage for the slowest taper is 75 mg SR qam, 75 mg noon, 90 mg qpm for month 2; 75 mg SR (60 mg+15 mg) Q8h for month 3; 75 mg SR qam, 60 mg noon, 75 mg qpm for month 4; 60 mg SR qam, 60 mg noon, 75 mg qpm for month 5; 60 mg SR Q8h for month 6; 60 mg SR qam, 45 mg noon, 60 mg qpm for month 7; 45 mg SR qam, 45 mg noon, 60 mg qpm for month 8; 45 mg SR Q8h for month 9. Continue following this rate of taper until off the morphine or the desired dose of opioid is reached.
How may pauses in the slowest opioid taper help the patient?
allow the patient time to acquire new skills for management of pain and emotional distress while allowing for neurobiological equilibration
Recommendations
In addition to non-pharmacological therapies (e.g., exercise, CBT), appropriate mechanism and condition specific non-opioid pharmacologic agents should be tried and optimized before consideration of opioid medications (e.g., gabapentin in neuropathic pain states).[83] Potential contraindications and long-term risks of use should be considered for non-opioid pharmacologic agents as well, as these also can carry risk of harm, depending on the specific patient and chosen medication.
Why should the potential contraindications and long-term risks of use be considered for non-opioid pharmacologic agents as well?
these also can carry risk of harm, depending on the specific patient and chosen medication
Features and overview
The treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea are hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed. Avoid diphenhydramine for Veterans older than 65 years. The treatment options for myalgias are NSAIDs (e.g., naproxen 375 to 500 mg twice daily or ibuprofen 400 to 600 mg four times daily), acetaminophen 650 mg every 6 hours as needed, topical medications like menthol/methylsalicylate cream, lidocaine cream/ointment. For NSAIDs, be cautious for patients with risk of GI bleed, renal compromise, cardiac disease. The treatment option for sleep disturbance is Trazodone 25 to 300 mg orally at bedtime.
What are the treatment options for anxiety, dysphoria, lacrimation, and rhinorrhea?
hydroxyzine 25 to 50 mg three times a day as needed, diphenhydramine 25 mg every 6 hours as needed
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 assess during a follow-up with a patient?
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)
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 suicide risk is high in patients?
consult with mental health provider before beginning taper
Recommendations
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.
Exacerbation of severe PTSD symptoms may result from what?
gradual benzodiazepine taper
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]
On which kind of opioids the use of the distribution of naloxone has established clinical efficacy?
short-acting opioids
Background information
The increasing use of opioids, as well as the accompanying rise in morbidity and mortality associated with opioid use, has garnered increasing attention from federal and local officials as well as other policy makers. This public health issue, which has been labeled an epidemic, became a focus of the President’s National Drug Control Strategy in 2010 and has since remained a focus. Two main goals introduced in the 2010 strategy included curtailing illicit drug consumption in America and improving the health and safety of the American people by reducing the consequences of drug abuse. The 2015 strategy, and an accompanying presidential memorandum on preventing prescription drug abuse and heroin use, released in October 2015, encouraged the improvement of health and safety using evidence-based methods by calling for change in a number of key areas including preventing drug use in communities, seeking early intervention opportunities, and integrating SUD treatment and supporting recovery.
Which health issue has been identified as an epidemic?
The increasing use of opioids
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 opioid has unique pharmacodynamic properties that can prolong the QTc interval and precipitate torsades de pointes, a dangerous or fatal cardiac arrhythmia?
methadone
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.
What can be used to study and consider the latest information on opioid therapy (OT) by general clinicians or specialists?
This guideline
Recommendations
Subgroups at higher risk: Risk of prescription opioid overdose is elevated across MEDD dosage levels in patients with co-occurring depression (moderate quality evidence).[66,133] Following an elevated baseline adjusted risk ratio (ARR) of 3.96, depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD had respective odds of overdose of 4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression.[66] Similarly, a history of or active SUD increases risk for serious prescription opioid-related toxicity or overdose across opioid dosages (moderate quality evidence).[58,87,133] A retrospective cohort review of patients with CNCP receiving LOT at least five days per week for 90 days determined that those with a history of non-opioid SUD had 28 times the odds of developing OUD.[87] Each 50 mg increase in MEDD nearly doubled the odds while each 100 mg MEDD increase tripled the risk for OUD. Concurrent prescribing of sedative-hypnotics and benzodiazepines increases risk of fatal or non-fatal opioid overdose 2-10 fold across opioid dose ranges.[66,133,135]
Following an elevated baseline adjusted risk ratio (ARR) of 3.96, what were the odds of overdose in depressed patients taking 1-19 mg, 20 to <50 mg, 50 to <100 mg, and ≥100 mg MEDD?
4.75, 5.47, 6.44, and 7.06, compared to those taking an opioid at the same dosage level without a diagnosis of depression
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.
Where to follow up with the Veteran during the faster taper?
in the clinic and/or over telephone
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 may be required in certain instances like situations where the risks of continuing the opioid outweigh the risks of a rapid taper?
More rapid tapers
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 is the rate of a gradual taper?
5-10% reduction every 4 weeks
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 eight of the rapid opioid tapering?
15 mg SR QHS
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 is no presence of prescribed opioid dose>90 mg MEDD or combined sedating medication that increases risk of adverse events or patient non-participation in a comprehensive pain care plan or other indications for tapering?
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
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.
Based on which factors providers will need to determine whether a telephone or in-clinic appointment is appropriate?
the risk category of the Veteran
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 to monitor for when considering an opioid taper?
conditions that may warrant evaluation
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 since 2000?
a four-fold increase
Recommendations
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.
What is a serious risk factor for unintentional overdose death?
Concurrent benzodiazepine and LOT use
Background information
There were also some differences in the methodology used between the development of the VA/DoD OT CPG and the CDC guideline. Along with a clinical evidence review, during which the evidence was evaluated using GRADE, the CDC guideline developers also considered the findings of a contextual evidence review. Further, the CDC Core Expert Group, which consisted of subject matter experts, representatives of primary care professional societies and state agencies, and an expert in guideline methodology, reviewed recommendations drafted by the CDC and evaluated how the evidence was used in the development of the recommendations, rather than developing the recommendations themselves (as was the VA/DoD OT Work Group’s role in the development of the VA/DoD OT CPG). While experts provided feedback on the CDC recommendations and their development, the CDC determined the final recommendations. CDC also used a review process considering and incorporating feedback from federal partners (e.g., SAMHSA, VA, DoD), stakeholders (e.g., professional organizations, delivery systems, community organizations), and other constituents (e.g., clinicians, prospective patients). The CDC guideline development process included notice in the Federal Register for a public review and comment period as well as peer review. Thus, the recommendations made in the CDC guideline, although similar to those made in this CPG, were likely based on a slightly different evidence base and revised based on the feedback of individuals who were considering a larger group of potential patients relative to the VA/DoD. Thus, while the VA/DoD OT Work Group was aware of the release of the CDC guideline and considered potential implications, the CDC guideline did not form the basis of the deliberations on the strength or direction of these recommendations. The Work Group followed the VA/DoD Guideline for Guidelines, a document that details the process by which VA/DoD guidelines will be developed, including the use of the GRADE methodology. As required by Congress in CARA, the Work Group reviewed and considered the CDC guideline and its inclusion in the VA/DoD OT CPG.
What are differences in the recommendations between the CDC guideline and the CPG?
based on a slightly different evidence base and revised based on the feedback of individuals who were considering a larger group of potential patients relative to the VA/DoD
Features and overview
Slower Taper is done over months or years. In the slower taper, reduce opioid by 5 to 20% every 4 weeks with pauses in taper as needed. Slower taper is the most common taper. An example of the slower taper is given below. During the first month in the slower taper, 16% opioid reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg (60 mg+15 mg)SR Q8h. The subsequent monthly dosage for the slower taper is 60 mg SR Q8h for month 2, 45 mg SR Q8h for month 3, 30 mg SR Q8h for month 4, 15 mg SR Q8h for month 5, 15 mg SR Q12h for month 6, 15mg SR QHS for month 7. Stop slower tapering after month 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.
During the first month in the slower taper what does consist of 16% reduction of morphine SR 90 mg Q8h = 270 MEDD?
75 mg (60 mg+15 mg)SR Q8h
Background information
With the passage of the Patient Protection and Affordable Care Act (PPACA) in March 2010, the Interagency Pain Research Coordinating Committee was created to coordinate pain research efforts throughout federal government agencies. The Committee was tasked with summarizing advances in pain care research, identifying gaps in research, and developing recommendations regarding ways to minimize duplicative efforts, disseminate pain care information, and expand public/private research partnerships and collaborations. The Committee published the National Pain Strategy in March 2016 in response to the call from the National Academy of Medicine to increase awareness of pain as a significant public health issue in the U.S. The strategy made recommendations in a number of areas including prevention and care, professional education and training, and population research. The plan is aimed at decreasing the prevalence of all types of pain (acute and chronic) in the U.S., as well as the disability and morbidity associated with pain.
What was the purpose of Interagency Pain Research Coordinating Committee?
coordinate pain research efforts throughout federal government agencies
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 consider for patients who are actively engaged in skills training?
reduced rate of taper or pause in taper
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 is recommended for mild-to-moderate acute pain?
alternatives to opioids
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 risks do not outweigh benefits of continuing OT?
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
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 ≥70 years old had far less risk of developing OUD or overdose?
subjects 18-29 years old
Features and overview
The shared decision making process for chronic pain treatment planning is based on the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider (Figure 1). The patient-centered assessment incorporates a patient-centered interview, and exploration of patient values, goals, questions, concerns, and expectations. Next, the clinician performs a biopsychosocial assessment and determines clinically appropriate therapeutic options in which benefits are likely to outweigh risks. The process culminates in a shared decision making process to develop a patient-centered treatment plan by the patient selecting from the clinically appropriate treatment options generated in the first two steps.
What is the basis of the shared decision making process for chronic pain treatment planning?
the foundation of a patient-centered assessment of risks and benefits and a clinical synthesis performed by the provider
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 the risks of substance use early in life?
increased risk of abnormalities and addiction
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 associated with prescribed opioid dose?
suicide risk among Veterans receiving OT for CNCP
Recommendations
Given the relevance of all four domains in grading recommendations, the Work Group encountered multiple instances in which confidence in the quality of the evidence was low or very low, while there was marked imbalance of benefits and harms, as well as certain other important considerations arising from the domains of values and preferences and/or other implications. In particular, the harms due to the potential for severe adverse events associated with opioids, particularly overdose and OUD, often far outweigh the potential benefits. As such, in accounting for all four domains, these factors contributed to strong recommendations in multiple instances.
What often far outweighs the potential benefits?
the harms due to the potential for severe adverse events associated with opioids, particularly overdose and OUD
Recommendations
Psychological therapies (e.g., cognitive behavioral interventions such as Cognitive Behavioral Therapy [CBT], biofeedback) have been found to be effective for pain reduction in multiple pain conditions.[80-82] Exercise treatments, including yoga, also have evidence of benefit for reducing pain intensity and disability when compared to usual care in the treatment of chronic pain conditions.[83-85] Exercise and psychological therapies may each exert their influence through multiple mechanisms including but not limited to the reduction in fear-avoidance, reduction in catastrophizing, and/or enhancing mood.[80] Similarly, multidisciplinary biopsychosocial rehabilitation (described as a combination of a physical intervention such as graded exercise and a psychological, social, or occupational intervention) has been shown to be more effective than usual care in improving pain and disability.[81] These interventions are safe and have not been shown to increase morbidity or mortality. In light of the low harms associated with exercise and psychological therapies when compared with LOT these treatments are preferred over LOT, and should be offered to all patients with chronic pain including those currently receiving LOT. There is insufficient evidence to recommend psychological over physical therapies or vice versa; the choice of which to try first should be individualized based on patient assessment and a shared decision making process (see Patient Focus Group Methods and Findings).[80]
Why exercise and psychological therapies are preferred over LOT?
In light of the low harms associated with exercise and psychological therapies when compared with LOT
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 indicate that developing brains (age <30 years) are at increased risk of abnormalities and addiction when exposed to substance use early in life?
Studies in other areas (e.g., use of different substances)
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.
Which taper can cause withdrawal effects?
Rapid tapers
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 designed to do?
provide information and assist decision making
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 not prepared to accept responsibilities or the provider is not prepared to implement risk mitigation strategies?
exit algorithm; manage with non-opioid modalities
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 patients may be at risk?
those with other risk factors for QTc prolongation, current or prior electrocardiograms (ECGs) with a prolonged QTc >450 ms, or a history of syncope
Recommendations
As substance misuse in patients on LOT is more than 30% in some series,[107] UDT and confirmatory testing is used as an additional method of examining for patient substance misuse and adherence to the prescribed regimen. UDTs, used in the appropriate way, help to address safety, fairness, and trust with OT. Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to the false positive and negative rates associated with UDTs.[53] Interpretation of a UDT and confirmatory results requires education and knowledge of the local procedures and clinical scenario. Local education and access to expert interpretation is necessary. UDT results are helpful and can help identify active SUD or possible diversion. Accordingly, clinicians should obtain UDT prior to initiating or continuing LOT and periodically thereafter. When a patient is referred for SUD treatment or is engaged in on-going treatment there should be close communication between the SUD and pain management providers. The ideal approach is an interdisciplinary format (see Recommendation 16). For more information, see Appendix B on UDT and confirmatory testing.
What can identify active SUD or possible diversion?
UDT results
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).
Why are ECGs highly advised before and after initiating methadone?
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.
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 was the mission of the Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG)?
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
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.
Who should not be prescribed long-acting opioids?
opioid-naive individuals
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 are some examples of high-risk or dangerous behavior?
overdose event, accidents, and threatening provider
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.
Where to follow up with the Veteran during the rapid taper?
in the hospital, clinic or over telephone
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 does this CPG intend to do?
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)
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 an SUD is not identified?
identify the followings: use of opioids to modulate emotions (i.e., “chemical coping”), untreated or undertreated psychiatric disorder
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).
For patients at risk for overdose, what should be done?
Offer risk mitigation strategies, including naloxone
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]
What does increase the risk of acute post-operative OT progressing into LOT?
a history of depression, SUD, catastrophizing, higher preoperative total body pain, history of back pain, and preoperative use of sedative-hypnotics or antidepressants
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 includes prior medical records?
current prescriber, prior and current UDT, PDMP
Recommendations
As substance misuse in patients on LOT is more than 30% in some series,[107] UDT and confirmatory testing is used as an additional method of examining for patient substance misuse and adherence to the prescribed regimen. UDTs, used in the appropriate way, help to address safety, fairness, and trust with OT. Availability of accurate and timely confirmatory testing (e.g., gas chromatography-mass spectrometry [GCMS]) is critical due to the false positive and negative rates associated with UDTs.[53] Interpretation of a UDT and confirmatory results requires education and knowledge of the local procedures and clinical scenario. Local education and access to expert interpretation is necessary. UDT results are helpful and can help identify active SUD or possible diversion. Accordingly, clinicians should obtain UDT prior to initiating or continuing LOT and periodically thereafter. When a patient is referred for SUD treatment or is engaged in on-going treatment there should be close communication between the SUD and pain management providers. The ideal approach is an interdisciplinary format (see Recommendation 16). For more information, see Appendix B on UDT and confirmatory testing.
What is the format of the ideal approach to communicate between the SUD and pain management providers when a patient is referred for SUD treatment or is engaged in ongoing treatment?
interdisciplinary
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 lead to poorly localized symptoms?
Neuropathic pain due to injury or disease of the central or peripheral nervous system (e.g., spinal cord injury, diabetic neuropathy, radiculopathy)
Background information
The presidential memorandum of October 2015 mandated that executive departments and agencies shall, to the extent permitted by law, provide training on the appropriate and effective prescribing of opioid medications to all employees who are health care professionals and who prescribe controlled substances as part of their federal responsibilities and duties. The DoD Opioid Prescriber Safety Training Program, launched accordingly, includes modules on pain management and opioid prescribing safety, the recent Centers for Disease Control and Prevention (CDC) guideline, and the identification of substance misuse and referral to specialized services. Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury is sponsoring the training and related management support. Training is available online at http://opstp.cds.pesgce.com/hub.php.
What was mandated by the presidential memorandum of October 2015?
executive departments and agencies shall, to the extent permitted by law, provide training on the appropriate and effective prescribing of opioid medications to all employees who are health care professionals and who prescribe controlled substances as part of their federal responsibilities and duties
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.
What called attention to the need for a paradigm shift in pain and its treatment protocols?
increase in the use of opioids, as well as associated morbidity, mortality, and other adverse outcomes
Features and overview
There are electronic tools to facilitate clinical risk assessment and adherence to risk mitigation. Two tools currently used in the VA are the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM). The OTRR allows VA providers to review clinical data related to opioid pain treatment within the electronic medical record (EMR), providing an efficient way of monitoring the data. The STORM tool incorporates co-occurring medical and mental health conditions, SUD, opioid dose, co-prescribed sedatives, and information about prior adverse events and generates estimates of patients’ risk or hypothetical risk when considering initiation of opioid therapy. It quantifies risk for poisoning or suicide-related events and for drug-related events, accidents, falls, and drug-induced conditions over a three-year window. Further, it provides suggestions as to what alternative treatments have not been tried and what risk mitigation strategies need to be applied. Evidence supporting their use is poor but they facilitate providers’ determination of current, past and potential therapies and strategies.
Which electronic tools are currently used in the VA?
the Opioid Therapy Risk Report (OTRR) and the Stratification Tool for Opioid Risk Mitigation (STORM)
Recommendations
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.
What is considered a contraindication to initiation of OT?
Concomitant use of benzodiazepines
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.
When to continue opioid therapy?
if there is clinically meaningful improvement in pain and function
Recommendations
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.
What are associated with a higher incidence of PTSD symptoms?
Benzodiazepines to treat acute anxiety symptoms after trauma
Background information
The increasing use of opioids, as well as the accompanying rise in morbidity and mortality associated with opioid use, has garnered increasing attention from federal and local officials as well as other policy makers. This public health issue, which has been labeled an epidemic, became a focus of the President’s National Drug Control Strategy in 2010 and has since remained a focus. Two main goals introduced in the 2010 strategy included curtailing illicit drug consumption in America and improving the health and safety of the American people by reducing the consequences of drug abuse. The 2015 strategy, and an accompanying presidential memorandum on preventing prescription drug abuse and heroin use, released in October 2015, encouraged the improvement of health and safety using evidence-based methods by calling for change in a number of key areas including preventing drug use in communities, seeking early intervention opportunities, and integrating SUD treatment and supporting recovery.
In 2010, what was the focus of National Drug Control Strategy?
The increasing use of opioids
Recommendations
Community-based Needle Exchange Programs or Syringe Service Programs: Nearly 80% of new users of injectable opioids had previously used prescription oral opioid pain medication.[118,119] Illicit use of injectable opioids is accompanied by an increased rate of human immunodeficiency virus (HIV) and hepatitis infection. Community-based needle exchange programs have been shown to be an effective risk mitigation strategy for reducing high-risk behaviors (e.g., sharing needles) and infectious disease transmission among injection drug users.[120] For those patients who develop OUD and progress to intravenous drug use, the first recommendation should be for medication assisted treatment (MAT) for OUD (see Recommendation 17). For patients who decline MAT for OUD, clinicians should consider educating the patient regarding sterile injection techniques and community based needle exchange programs, if programs are available. The 2015 outbreak of HIV/hepatitis in rural Indiana and subsequent successful implementation of a needle exchange program is an example of the threat to rural communities from non-prescription opioid use and the potential benefits of needle exchange programs for use as a risk mitigation strategy.[121,122]
What should the clinicians do for patients who decline MAT for OUD?
educating the patient regarding sterile injection techniques and community based needle exchange programs, if programs are available
Background information
Evidence for or history of diversion of controlled substances: The clinician should communicate to patients that drug diversion is a crime and constitutes an absolute contraindication to prescribing additional medications. Because suspicion is subjective and may be based on impression, bias, or prejudice, it is important that providers who suspect diversion base treatment plans on objective evidence. Suspicions may be confirmed by a negative mass spectrometry/liquid chromatography UDT for the substance being prescribed in the absence of withdrawal symptoms in someone who is receiving opioids. A negative UDT for the prescribed opioid could also by itself be a sign of diversion. Signs of diversion may also include frequent requests for early refills or atypically large quantities required to control pain. Routine UDT, however, may not reliably detect synthetic opioids (e.g., methadone, fentanyl, tramadol) or semi-synthetic opioids (e.g., oxycodone, hydrocodone, hydromorphone). When there is evidence that the patient is diverting opioids, discontinue opioids according to Recommendations 14 and 15 and assess for underlying OUD and/or psychiatric comorbidities. Consultation with a pain specialist, psychiatrist, or SUD specialist may be warranted. Also consider consultation with local risk management and/or counsel. For patients with OUD, keep in mind that sudden discontinuation of opioids due to suspected diversion may place them at high risk for illicit opioid use and resulting opioid overdose (see Recommendation 17).
On what kind of evidence should the providers who suspect diversion base treatment plans?
objective
Recommendations
Given the relevance of all four domains in grading recommendations, the Work Group encountered multiple instances in which confidence in the quality of the evidence was low or very low, while there was marked imbalance of benefits and harms, as well as certain other important considerations arising from the domains of values and preferences and/or other implications. In particular, the harms due to the potential for severe adverse events associated with opioids, particularly overdose and OUD, often far outweigh the potential benefits. As such, in accounting for all four domains, these factors contributed to strong recommendations in multiple instances.
What contributed to strong recommendations in multiple instances?
these factors
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 long does the rapid taper take?
over days
Recommendations
We recommend assessing suicide risk and intervening when necessary when considering initiating or continuing long-term opioid therapy. We recommend evaluating benefits of continued opioid therapy and risk for opioid-related adverse events at least every three months. If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits. Note: There is no absolutely safe dose of opioids.
If prescribing opioids, what is the recommended dose?
lowest dose of opioids as indicated by patient-specific risks and benefits
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.
What to document in the Veteran’s medical record?
the rationale for the opioid taper and the opioid taper schedule
Background information
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.
It is inadvisable to prescribe opioids to which patients?
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
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.
What percentage of people entering SUD treatment for heroin use started using prescription opioids as their first opioid in the 2000s?
75%
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.
How long does it take for late withdrawal symptoms to appear?
days to weeks
Recommendations
The following recommendations were made using a systematic approach considering four domains as per the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. These domains include: confidence in the quality of the evidence, balance of desirable and undesirable outcomes (i.e., benefits and harms), patient or provider values and preferences, and other implications, as appropriate (e.g., resource use, equity, acceptability).
Which four domains were considered to make the recommendations?
confidence in the quality of the evidence, balance of desirable and undesirable outcomes (i.e., benefits and harms), patient or provider values and preferences, and other implications, as appropriate (e.g., resource use, equity, acceptability)
Recommendations
a) We recommend against initiation of long-term opioid therapy for chronic pain. (Strong against) b) We recommend alternatives to opioid therapy such as self-management strategies and other non-pharmacological treatments. (Strong for) c) When pharmacologic therapies are used, we recommend non-opioids over opioids. (Strong for) (Reviewed, New-replaced)
When should non-opioids be recommended over opioids?
When pharmacologic therapies are used
Background information
From fiscal years 2004 to 2012, the prevalence of opioid prescriptions among Veterans increased from 18.9% to 33.4%, an increase of 76.7%. The groups with the highest prevalence of opioid use were women and young adults (i.e., 18-34 years old). In a sample of non-treatment-seeking members of the military who were interviewed within three months of returning from Afghanistan, 44% reported chronic pain and 15% reported using opioids—percentages much higher than in the general population. Chronic pain was also associated with poorer physical function, independent of comorbid mental health concerns in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans. In a study of Veterans with chronic pain who had been on opioids for at least 90 days, over 90% continued to use opioids one year later and nearly 80% continued to use opioids after completion of the 3.5 year follow-up period; while, in a study of civilian patients who had been on opioids for at least 90 days, approximately 65% remained on opioids through the 4.8 year follow-up period. Rates of continuation in Veterans, based on this study, appeared to be related to age, marital status, race, geography, mental health comorbidity, and dosage. Compared to others, those who were aged 50-65 years, were married, were of a race other than African American, and who lived in a rural setting were more likely to continue using opioids. Veterans on higher doses of opioids were more likely to continue their use. Notably, those with mental health diagnoses were less likely to continue opioids, including those with schizophrenia and bipolar diagnoses.
In a study of Veterans with chronic pain who had been on opioids for at least 90 days, how many continued to use opioids after completion of the 3.5 year follow-up period?
nearly 80%
Features and overview
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
What includes personal history of SUD?
alcohol use disorder (AUD), opioid use disorder (OUD), and/or a use disorder involving other substances
Recommendations
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.
Why should abrupt discontinuation of benzodiazepines be avoided?
as it can lead to serious adverse effects including seizures and death
Recommendations
The Edlund et al. (2014) study of 568,640 commercial health plan patients (see Recommendation 2 and 3) found that those diagnosed with CNCP and an alcohol use or non-opioid drug use disorder had higher rates of OUD (OR: 3.22, 95% CI: 1.79-5.80 for patients with pre-index alcohol use disorder compared to no alcohol use disorder; OR: 8.26, 95% CI: 4.74-14.39 for patients with pre-index non-opioid drug use disorders compared to no non-opioid drug use disorders).[86] Moreover, Huffman et al. (2015) found that the presence of a lifetime history of SUD for patients with CNCP was associated with 28 times increased odds of therapeutic opioid addiction compared to patients with CNCP without a lifetime history of SUD (OR: 28.58, 95% CI: 10.86-75.27).[87]
Who had higher rates of OUD?
those diagnosed with CNCP and an alcohol use or non-opioid drug use disorder
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).
When was the Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered?
2004
Background information
Government agencies, including the VA, DoD, and Substance Abuse and Mental Health Services Administration (SAMHSA), have also launched initiatives to improve the study and treatment of pain and adverse events associated with opioid analgesics such as OUD and overdose. By August 2013, the VA deployed the Opioid Safety Initiative (OSI) requirements to all Veterans Integrated Service Networks (VISNs) with the aim of ensuring opioids are used in a safe, effective, and judicious manner. The goals of the OSI related to such topics as increased education, monitoring, use of safe and effective prescribing and management methods, tool development, collaboration, and use of alternative pain treatment. The OSI uses the Veterans Health Administration (VHA’s) electronic health record to identify patients who may be high-risk for adverse outcomes with use of opioids and providers whose prescribing practices do not reflect best evidence so that patient care can be improved. The OSI requirements include specific indicators (e.g., the number of unique pharmacy patients dispensed an opioid, the unique patients on LOT who have received UDT). As part of the OSI, the VA launched the Opioid Overdose Education and Naloxone Distribution (OEND) program, which was implemented as a risk mitigation strategy aimed at reducing deaths from opioid overdose. The program components included education and training regarding the following topics: opioid overdose prevention, recognition, and rescue response; risk mitigation strategies; and issuing naloxone kits, which can be used as an antidote to opioid overdose.
What does the OSI use to identify patients who may be high-risk for adverse outcomes with use of opioids?
Veterans Health Administration (VHA’s) electronic health record
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 risks outweigh benefits of continuing OT?
proceed to module C
Features and overview
Faster Taper is done over weeks. In faster taper, reduce opioid by 10 to 20% every week. An example of the faster taper is given below. During the first week in the faster taper, 16% reduction of morphine SR 90 mg Q8h = 270 MEDD consists of 75 mg SR Q8h. The subsequent weekly dosage for the faster taper is 60 mg SR (15 mg x 4) Q8h for week 2, 45 mg SR (15 mg x 3) Q8h for week 3, 30 mg SR (15 mg x 2) Q8h for week 4, 15 mg SR Q8h for week 5, 15 mg SR Q12h for week 6, 15 mg SR QHS x 7 days for week 7. Stop faster tapering after week 7 and may consider morphine IR 15 mg ½ tablet (7.5 mg) twice daily.
When reducing 16% of morphine SR 90 mg Q8h = 270 MEDD on week 1, what dose should be taken on week five of the faster opioid tapering?
15 mg SR Q8h