VA/DoD CLINICAL PRACTICE GUIDELINE FOR OPIOID THERAPY FOR CHRONIC PAIN

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VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain Table 5. Buprenorphine/Naloxone Formulations [162] Route Dosage Form Buccal Film 2.1 mg/0.3 mg 4.2 mg/0.7 mg 6.3 mg/1.0 mg Sublingual Film 2 mg/0.5 mg 4 mg/1 mg 8 mg/2 mg 12 mg/3 mg Sublingual Tablets 2 mg/0.5 mg 8 mg/2 mg Sublingual Tablets 1.4 mg/0.36 mg 2.9 mg/0.71 mg 5.7 mg/1.4 mg 8.6 mg/2.1 mg 11.4 mg/2.9 mg Abbreviations: hr: hour(s); mg: milligram(s) Methadone Strengths (listed as buprenorphine/naloxone) Brand Name Bunavail® Suboxone® generic Zubsolv® Use Treatment of opioid dependence Treatment of opioid dependence Treatment of opioid dependence Treatment of opioid dependence There is insufficient evidence to recommend methadone over other opioids for the treatment of chronic pain.[163] The only study included in the evidence review was limited to patients with cancer pain and suggested greater adverse effects with methadone than with other opioids.[166] An epidemiologic study suggests that the use of methadone contributes disproportionately to opioid overdose deaths relative to the frequency with which methadone has been prescribed.[164] An analysis of opioid prescriptions by VA from 2010 to 2012 concluded that the prescribing of any longacting/ER opioid medication, including methadone, was predictive of overdose or serious opioid-induced respiratory depression.[165] Studies comparing treatment of pain with methadone to treatment with other opioids describe inconsistent results and indicate that the risks associated with use of methadone vary greatly with treatment settings and management, monitoring, and risk mitigation strategies. A retrospective study of Tennessee Medicaid records (for years 1997 to 2007), documented an increased risk for overdose for non-institutionalized patients with non-cancer pain receiving methadone, including at low dosages.[166] A retrospective cohort study among Oregon Medicaid recipients (for years 2000 to 2004) found no statistically significant differences between methadone and long-acting morphine in risk for death. However, for the subgroup of patients with non-cancer pain, methadone was associated with greater risk of overdose symptoms, but not mortality or hospitalization.[167] A retrospective observational study of a large cohort drawn from VA healthcare databases (for years 2000 to 2007) documents that propensity-adjusted mortality was lower for methadone than for morphine. The study found no evidence of excess all-cause mortality among VA patients who received methadone compared with those who received long-acting morphine.[168] Yet the unique pharmacologic properties of methadone make it particularly risky to prescribe. Methadone carries a risk of cardiac arrhythmia, and risk assessment for QT prolongation and electrocardiographic monitoring is essential. Methadone has a variable half-life with peak respiratory depressant effect February 2017 Page 60 of 192
VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain occurring later and lasting longer than peak analgesic effect. Dose escalation to improve pain relief may lead to unintentional intoxication and corresponding respiratory depression or arrest.[166] Additionally, the metabolism of methadone varies by dose and individual, making dosing unpredictable. Plus, there are medications that interact with methadone and should not be prescribed concurrently (see Table D-2). Only clinicians who are experienced with methadone and who are prepared to implement appropriate precautions, risk mitigation strategies, and patient/caregiver education should initiate, titrate, or taper methadone for chronic pain. Prescribers and patients should be familiar with these unique characteristics and institute appropriate safety precautions. Specific guidance for clinicians about the risks of methadone is summarized below and detailed in Appendix D: • Monitoring for cardiotoxicity [169] • Inform patients of the arrhythmia risk • Ask patients about heart disease, arrhythmia, and syncope • Obtain baseline electrocardiogram (ECG) and regularly thereafter in intervals appropriate to risk/dosage • If the QTc interval is greater than 450 ms, but less than 500 ms, reevaluate and discuss with the patient the potential risks and benefits of therapy and the need for monitoring the QTc more frequently • If the QTc interval exceeds 500 ms, discontinue or taper the methadone dose and consider using an alternative therapy; other contributing factors, such as drugs that cause hypokalemia or QT prolongation, should be eliminated whenever possible • Be aware of interactions between methadone and other drugs that may prolong QTc interval or slow the elimination of methadone, and educate patients about potential drug interactions • Conservative dosing • Methadone should not be initiated in opioid naïve patients in the outpatient setting • Primary care clinicians should never rotate from another opioid to methadone without guidance from an experienced clinician regarding the starting dose of methadone • When initiating or increasing dosage, close follow-up is recommended (e.g., within five to seven days) to assess signs of methadone toxicity, such as excess sedation or delirium • Wait at least one week on a particular dose of methadone before increasing dosage of methadone to make sure that the full effects of the previous dosage are evident February 2017 Page 61 of 192
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DRAFT 3 - DO NOT DISTRIBUTE VA/DoD
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VA/DoD CLINICAL PRACTICE GUIDELINE FOR OPIOID THERAPY FOR CHRONIC PAIN

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