Jeffrey Bratberg co-authors report calling for federal government to allow pharmacies to distribute methadone to treat opioid use disorder

The federal Drug Enforcement Administration and Substance Abuse and Mental Health Services Administration should simplify regulations to allow pharmacies to dispense methadone to people seeking treatment for opioid use disorder, according to URI College of Pharmacy Clinical Professor Jeffrey Bratberg, who co-authored a major report with with researchers from The Heller School for Social Policy and Management at Brandeis University, led by the Legislative Analysis and Public Policy Association.

The move would improve access to medication to those with opioid used disorder, only 18 percent of whom received any medication to treat it in 2023, despite the medications’ proven efficacy in preventing opioid deaths and increasing treatment retention. It would specifically increase access to methadone, one of the three FDA approved medications for opioid use disorder, which may be the most effective medication for treating patients who use unregulated fentanyl. Methadone is currently only accessed through one of just 2,100 federally and state regulated opioid treatment programs (OTPs) across the country. Meanwhile, there are more than 60,000 pharmacies, with most people living within five minutes of a pharmacy. This geographic availability makes pharmacies a convenient access point for methadone.

Globally, pharmacy access to methadone is the standard of care. IN the United States, existing regulations permit the establishment of OTP satellite facilities, called “medication units,” to increase methadone access.

“The lack of medication units across the country…. suggests that current laws and regulations cause enough logistical, administrative, and financial difficulty that OTPs rarely try to establish them,” the report states, noting a new LAPPA report found that few, if any, opioid treatment program medication units are co-located in pharmacies.

The report authors describe four steps federal agencies that regulate methadone for opioid use disorder could take to ease restrictions and increase access to the medication units:

• Simplify the multi-step and lengthy approval processes for a medication unit required by the DEA and SAMHSA.
• Remove DEA rules that require any pharmacy operating a medication unit to employ more stringent storage of methadone for OUD treatment. In general, DEA requires pharmacies to store methadone prescribed for pain and many other controlled substances in a securely locked, substantially constructed cabinet. But pharmacies operating medication units would need to store methadone for OUD in a safe or vault, storage requirements that would entail considerably more expense.
• Clarify DEA rules to allow pharmacies to order methadone with other controlled substances, using the same drug distributor and administrative process, preventing some states from forcing them to obtain methadone from a sole preferred source.
• The DEA could make explicit that pharmacy medication units can use the inventory, recordkeeping, and reporting systems they already use for all other controlled substances they dispense. Current DEA guidelines call for a specific record and inventory system for all activities related to OTPs. For pharmacies operating as OTP medication units, “this appears to duplicate the pharmacy’s already existing records and inventory system,” the report states.

Some states have a chilling effect of pharmacies operating as OTP medication units, especially in those that require a certificate of need, barriers to expansion that usually entail lengthy and costly processes to approve expenditures for new healthcare facilities. The report recommends that states proactively issue rules or laws that clearly allow for “a simple and streamlined” approval process for medication units.

Finally, the report offers advice to Congress should it consider legislation to allow pharmacists to dispense methadone for OUD without requiring any relationship with an OTP. The report recommends that legislative language leave no room for the construction of federal agency rules that could create implementation hurdles, such as onerous storage requirements or strict guidelines for take-home dose eligibility.

The laws and regulations currently governing methadone dispensing direct OTPs to seek approval from federal, state, or local agencies before moving forward with medication units or other pursuits. This leaves many rules and policies up for interpretation by individuals at those agencies, underscoring the need for explicit allowances to minimize barriers to treatment.

“Medications for opioid use disorder save lives,” Bratberg said. “Patients should have convenient access to methadone for their opioid use disorder in the same way they can access methadone for pain relief—from their pharmacy. In this way, pharmacists can provide comprehensive, patient-centered care for their patients with opioid use disorder, by offering all available medications proven to treat it.”