Methadone is one of three Food and Drug Administration-approved treatments for opioid use disorder (OUD) and a lifesaving medication: Decades of research show that it reduces overdoses and helps people stay in treatment. But methadone is also one of the most heavily regulated drugs in the U.S.—even more so than the prescription opioids that helped spur the nation’s overdose crisis. It is only available at opioid treatment programs (OTPs), health care facilities governed by federal and state regulations that subject patients to punitive rules—such as limits on take-home doses and frequent urine screens—that are borne out of stigma surrounding addiction.
These burdensome regulations mean that many patients who would benefit from methadone treatment either cannot, or choose not to, take it to treat their OUD. In fact, in 2020 there were approximately 2.7 million people diagnosed with OUD, but only around 311,000 of them were treated with methadone.
Rules proposed in December 2022 would make it easier for people receiving methadone to get take-home doses of the medication, rather than requiring them to make daily clinic visits. But the medication still would not be available outside of OTPs.
Other countries approach methadone treatment differently, including allowing the drug to be dispensed at pharmacies alongside other prescription medications, a fact that’s helped make treatment more available to patients in need. And they do so while continuing to honor their obligations under international drug control treaties, which include ensuring that methadone is dispensed by licensed professionals and that the amount of methadone stocked is reported.
As the Biden administration considers ways to increase access to evidence-based treatment for OUD, policymakers may wish to consider how these other governments regulate methadone.
The table below summarizes key features of methadone delivery in three of these countries: Australia, Canada, and the United Kingdom.
| Allows prescribing outside of specialty treatment settings | Requires specialized training to prescribe | Allows pharmacy dispensing | Limits on take-home doses | |
|---|---|---|---|---|
| Australia | Yes | Yes, training varies by state | Yes | Federal guidelines discourage more than four take-home doses per week. States set specific policies. |
| Canada | Yes | Yes, training varies by province | Yes | Rules vary by province. |
| United Kingdom | Yes | No | Yes | Limited to seven doses (a one-week supply) at a time. |
| United States | No | N/A* | No | Under current rules, the phased schedule increases from one per week in the first 90 days of treatment to a potential maximum of one month after two years’ treatment. Recently proposed rules would allow up to 28 doses for clinically stable patients after just one month in treatment. |
Notes: Conclusions in the table above are a summary of methadone delivery among four countries. Direct comparisons on outcomes between countries is difficult due to different health care systems and variation of rules across states/provinces. *Since the U.S. does not allow prescribing in an office setting, the training requirement is not applicable.
Sources: L. Gowing et al., “National Guidelines for Medication-Assisted Treatment of Opioid Dependence” (2014); K.C. Priest et al., “Comparing Canadian and United States Opioid Agonist Therapy Policies,” International Journal of Drug Policy 74 (2019): 257-65; Government of Canada, “Methadone Program”; Government of Canada Regulations Amending the Narcotic Control Regulations and the New Classes of Practitioners Regulations (Diacetylmorphine (Heroin) and Methadone): Sor/2018-37; Canadian Research Initiative in Substance Misuse, “CRISM National Guideline for the Clinical Management of Opioid Use Disorder”; 42 C.F.R. § 8.12 Federal Opioid Treatment Standards; United Kingdom Department of Health and Social Care, “Drug Misuse and Dependence: UK Guidelines on Clinical Management” (2017); U.S. Department of Health and Human Services, “SAMHSA Proposes Update to Federal Rules to Expand Access to Opioid Use Disorder Treatment and Help Close Gap in Care” (2022)
Learn more about methadone treatment in other countries below.