Federal and State Governments Can Reduce Roadblocks to Methadone Access

In 2023, just 18% of people with an opioid use disorder (OUD) received any medication to treat it, despite the availability of therapies that have proved highly effective in preventing opioid deaths and keeping more people in treatment. Emerging research suggests that methadone—one of the three medications approved by the U.S. Food and Drug Administration for OUD—may be the most effective of the three for treating fentanyl use, a drug more lethal than heroin that is responsible for a spike in drug overdose deaths over the past several years.

However, because access to methadone is largely limited to the approximately 2,100 federal- and state-regulated opioid treatment programs (OTPs) across the country, providing this life-saving medication to people with OUD falls far short of what is needed. Meanwhile, there are more than 60,000 pharmacies, with most people living within five miles of a pharmacy. This geographic availability makes pharmacies a convenient access point for methadone—a practice employed in other countries including Australia, Canada, and the United Kingdom.

One potential solution to the need for greater access is to allow people to receive their methadone in medication units set up in pharmacies that would serve as satellite sites of OTPs. Yet, while this arrangement is currently allowed by federal law, a new report by the Legislative Analysis and Public Policy Association (LAPPA) found that of the less than 100 OTP medication units in the U.S., few, if any, are located in pharmacies. “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.

Recommended federal changes

The report, funded by The Pew Charitable Trusts, describes four steps that the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA)—the federal agencies that regulate methadone for OUD—could take to make medication units a more attractive option for OTPs and pharmacies:

1. Simplify the multistep and lengthy approval processes for a medication unit required by the DEA and SAMHSA.
2. Remove DEA rules that require any pharmacy operating a medication unit to employ more stringent (and costly) storage of methadone for OUD treatment. In general, DEA requires pharmacies to store methadone and other controlled substances prescribed for pain in a securely locked, substantially constructed cabinet. But pharmacies operating medication units would have more rigorous requirements. They’ll need to store methadone for OUD in a safe or vault, with specifications for width of its walls and protection from forced entry—storage requirements that would entail considerably more expense.
3. Clarify DEA rules to allow pharmacies to order methadone with other controlled substances, using the same drug distributor and administrative process. Current DEA and SAMHSA regulations are silent on where OTP medication units can order methadone. It is unclear how many medication units get their methadone from the OTP that set them up as a satellite or through pharmacy distributors. In the absence of clarifying regulatory language, the federal government and/or states may require pharmacies as medication units to obtain methadone for OUD treatment solely from the parent OTP rather than distributors that pharmacies use for other controlled substances, including methadone for pain treatment.
4. DEA could make explicit that pharmacy medication units can use the inventory, recordkeeping, and reporting systems they already use for 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.

Recommended state changes

According to the report, state laws can also have a chilling effect on pharmacies operating as OTP medication units. Most notable are laws in 19 states and Washington, D.C., that require a “certificate of need” to establish any new OTP—a requirement that may, in some states, extend to OTP medication units. Because certificate of need laws usually entail lengthy and costly processes to approve expenditures for new health care facilities, and open the door for competitors and neighborhood groups to challenge the proposals, the LAPPA report notes that they’re seen as barriers to expansion.

Additionally, the report recommends that states proactively issue rules or laws that clearly allow for “a simple and streamlined” approval process for medication units. Previous Pew research found that as of 2021, just 11 states have rules that explicitly allow for the use of medication units. In the absence of such intentional language, “state and local decisionmakers may place roadblocks (intentional or unintentional) that delay or prevent implementation,” the LAPPA report states.

Fine-tuning congressional methadone-dispensing reform efforts

Finally, the report offers cautionary advice to policymakers who may consider legislation or other measures that allow pharmacists to dispense methadone for OUD without requiring any relationship with an OTP. The report recommends that policy strategies be narrowly crafted to preclude federal agency actions that could create implementation hurdles, such as onerous storage requirements or strict guidelines for patients to be eligible for taking doses of methadone at home, rather than having to come to the OTP or medication unit daily.

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 that will minimize barriers to treatment.

Jane Koppelman works on The Pew Charitable Trusts’ substance use prevention and treatment initiative.