Opioid use disorder, which claims 115 lives a day by overdose in the United States, is a complex, chronic medical condition, but one that can be successfully treated with proven medications. And yet, one of the oldest and most effective medications to treat this disorder — methadone — is out of reach for many people, largely due to outdated federal laws.
Of the three medications approved by the Food and Drug Administration to treat opioid use disorder, federal law relegates only methadone to be dispensed in separate clinics apart from the general health care system. It’s not unusual for methadone clinics to be in out-of-the-way locations and often inaccessible by public transportation, especially in rural and suburban communities. When individuals trying to break an addiction to opioids can’t get to a methadone clinic on a daily basis, they can’t get treatment.
The other two federally approved medications, buprenorphine and naltrexone, can be prescribed and administered in primary care settings, where treatment can take place as part of an overall clinical care plan.
Methadone is typically taken daily in a highly structured setting, an approach that benefits many patients. But methadone should be treated no differently than other FDA-approved medications for opioid use disorder. As we write in the New England Journal of Medicine, it’s time for Congress to remove this barrier to treatment and allow methadone to be prescribed in primary care settings, as well as in existing standalone clinics.
Only about 20 percent of Americans who have an opioid use disorder are being treated with buprenorphine, naltrexone, or methadone, a woefully small percentage that shows the extent of the barriers to treatment that we need to remove to stop this public health crisis. Restricting the availability of methadone to designated clinics has contributed to this treatment gap.
Methadone has been available by prescription in primary care clinics in Canada since 1963, in Great Britain since 1968, and in Australia since 1970. In these places, methadone is the most commonly prescribed treatment for opioid use disorder, and it isn’t controversial because it has been shown to benefit the patient, the care team, and the community.
Methadone works. In a 2017 review of all causes of death among people with opioid use disorder, those receiving this medication were one-third less likely to have died during the study period than those not treated with methadone.
Methadone is a synthetic opioid that reduces cravings and withdrawal symptoms for heroin and other opioids. Developed in 1937 as a pain medication, it was first studied as a treatment for heroin addiction in New York City in the 1960s.
By the 1970s, the system for delivering methadone that we know today had been fully developed. Patients visit a designated clinic, typically every day, take methadone under observation, and get specialized, highly structured care, including counseling and periodic drug tests.
The methadone clinic model was carved into law in the United States in 1974, when Congress passed the Narcotic Addiction Treatment Act. The regulations around methadone, driven by fears of accidental overdose and diversion, evolved in such a way that primary care physicians almost never delivered methadone treatment. Stigma and a not-in-my-backyard mentality resulted in the placement of a sizable number of methadone clinics in locations that were hard for many to reach.
The last time Congress expanded access to medication for opioid use disorder in primary care was when it passed the Drug Addiction Treatment Act of 2000. It allowed physicians to prescribe and administer buprenorphine in their offices, making this medication more available to thousands of patients. But the barriers to the delivery of methadone remain intact.
Methadone has saved many lives and could save many more. Several studies have shown that methadone treatment in a primary care setting is both feasible and successful. In rare cases, it has been allowed in primary care offices. Our experience in Boston over a 10-year period with a limited number of patients who received methadone treatment in a primary care setting after being stable in a methadone clinic was excellent, with no adverse incidents.
We call on Congress to allow methadone treatment to be delivered in primary care settings, as well as through special methadone clinics. That would be just the beginning. We also need to enhance physician training about opioid use disorder, create incentives for prescribing medications to treat it, and integrate treatment into existing models of care.
From the federal government down to community partners, we are all desperately searching for solutions to stem the opioid epidemic. Increasing the availability of medications that can effectively treat opioid use disorder — including methadone — will be essential if we are to succeed in saving lives.
Jeffrey Samet, M.D., is the chief of general internal medicine at Boston Medical Center and a professor of medicine at Boston University School of Medicine. Michael Botticelli is the executive director of the Grayken Center for Addiction at Boston Medical Center. Monica Bharel, M.D., is the commissioner of the Massachusetts Department of Public Health.