Methadone treatment is a critical tool in the United States’ response to the overdose epidemic. In an era of unregulated fentanyl and other opioids, this medication may be the most effective way to treat opioid use disorder (OUD) and reduce overdose deaths. While in Canada, Australia, and the United Kingdom this life-saving treatment is available at pharmacies, methadone for OUD in the U.S. is siloed from the rest of the health care system. Patients can only access this medication at Opioid Treatment Programs (OTPs) regulated by the federal Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA). As a result, many people who could benefit from methadone do not receive it. To better understand this disparity and potential solutions, researchers at Heller’s Opioid Policy Research Collaborative have published a new report that provides a comprehensive analysis of the regulations restricting methadone access for OUD from community pharmacies.
Most people in the U.S. live within five miles of one of the country’s over 60,000 pharmacies, compared to the only 2,100 OTPs that are not nearly as geographically widespread. Under current federal law, OTPs could potentially partner with pharmacies to offer methadone treatment through a mechanism called “medication units”; however, in practice, this appears to be extremely rare. The OPRC’s report, led by the Legislative Analysis and Public Policy Association (LAPPA), is among the first to summarize the extensive and opaque regulations that govern OTPs and their ability to partner with pharmacies to offer methadone through pharmacy-based medication units. The authors outline actions federal agencies could take to promote medication units:
- Streamline the approval processes for medication units required by DEA and SAMHSA.
- Remove DEA rules that require pharmacies operating a medication unit to store methadone for OUD separately and even more securely than other controlled substances, such as methadone medications for treating pain.
- Allow pharmacies operating a medication unit to procure methadone with other controlled substances instead of requiring a parallel but separate ordering process.
- Make explicit that pharmacies operating a medication unit can use existing record and inventory management systems for all activities related to the medication unit.
The report also dives into regulations that impact an OTP’s ability to operate a mobile medication unit on pharmacy property. Mobile medication units are an increasingly common practice that can help fill treatment gaps, particularly in rural areas. While both these models involve an OTP partnering with a pharmacy, there is also pending federal legislation that, if passed, may allow board-certified addiction medicine physicians or psychiatrists to prescribe and pharmacies to dispense methadone for OUD like other controlled substances (S.644 Modernizing Opioid Treatment Access Act). The report discusses federal laws and regulation changes necessary to facilitate a methadone delivery model that does not require OTP involvement.
“Pharmacy-based access to methadone for OUD is an essential step in lowering treatment barriers, including for people facing housing insecurity. Furthermore, pharmacy-based models dovetail well with other mobile addiction service models, similar to what we are working on for the Commonwealth, where methadone is not an option on non-OTP mobile units,” said Heller research scientist Cynthia A. Tschampl, PhD’15, who served as the Co-Principal Investigator for the project.
“This landmark report provides the needed direction for federal and state actions to liberate methadone access for patients across the country. Pharmacies are a cornerstone of our healthcare system, and pharmacists are partners in efficient, local care provision,” said Traci Green, Professor and Director of the Opioid Policy Research Collaborative and Co-Principal Investigator. “Our analysis paves the way for policymakers, OTPs, and pharmacies to modernize methadone provision and distills next steps for legal and policy changes that will save lives.”
Co-authors Maureen Stewart, PhD’09, and Sage Feltus were Visiting Scholars at Heller during the production of this report.
Read the full report here.