Which of the following can only be prescribed at Substance Abuse and Mental Health Services Administration (SAMHSA) accredited Opioid Treatment Programs (OTPs), methadone or buprenorphine?

Methadone Can Only Be Prescribed at SAMHSA-Accredited OTPs

Methadone for opioid use disorder can only be prescribed at SAMHSA-accredited Opioid Treatment Programs (OTPs), while buprenorphine can be prescribed by waivered physicians in office-based settings. 1

Regulatory Framework for Methadone

• Methadone for opioid addiction treatment must be dispensed only by opioid treatment programs certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA) 1
• The FDA label explicitly states that "outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA)" 1
• Methadone treatment is administered only by federally licensed treatment facilities, commonly known as methadone clinics 2

Regulatory Framework for Buprenorphine

• Unlike methadone, buprenorphine can be prescribed in office-based settings by physicians who have obtained a waiver from SAMHSA after completing specialized training 2, 3
• The Drug Addiction Treatment Act of 2000 (DATA 2000) created a new paradigm allowing qualified physicians to prescribe Schedule III, IV, and V medications (including buprenorphine) for opioid addiction treatment outside of the traditional OTP system 3
• Physicians with buprenorphine waivers can initially treat up to 30 patients in year 1 and may increase to 100 patients beginning in year 2, with further increases to 275 patients possible for qualified physicians 2

Clinical Considerations for Medication Selection

• Both medications are effective for treating opioid use disorder, with some evidence suggesting methadone may have better retention rates but similar mortality outcomes 2, 4
• Methadone requires daily observed dosing at an OTP facility, which may limit access due to transportation barriers and geographic limitations 2
• Buprenorphine allows for take-home dosing with less frequent clinic visits, which may be more convenient for some patients 2
• A systematic review found that retention in treatment was better for methadone than for buprenorphine beyond 1 month of treatment 4

Special Circumstances

• For pregnant women with opioid use disorder, both methadone and buprenorphine are acceptable treatment options, though buprenorphine (without naloxone) may reduce the severity of neonatal opioid withdrawal syndrome 2
• In emergency department settings, physicians without a waiver may administer (but not prescribe) buprenorphine for up to 72 hours to treat acute withdrawal while arranging referral for ongoing treatment 2
• Similarly, methadone administration for up to 72 hours to treat acute withdrawal is permitted in emergency settings without OTP certification, though this practice is less common 2

Barriers and Access Considerations

• Despite the ability to prescribe buprenorphine in office-based settings, only about 4% of prescribers had obtained the necessary waiver as of 2016 2
• Barriers to buprenorphine prescribing include lack of institutional support, inadequate mental health and psychosocial support resources, time constraints, lack of specialty backup, and provider confidence issues 2
• Some experts and policymakers have suggested evaluating the possibility of lifting restrictions on office-based distribution of methadone, similar to Canada's approach, which led to increased treatment access 2

In conclusion, the regulatory distinction is clear: methadone for opioid use disorder treatment can only be dispensed at SAMHSA-accredited OTPs, while buprenorphine can be prescribed in office-based settings by appropriately waivered physicians.