Can Methadone be Effectively Provided in Primary Care?

Methadone, an FDA-approved medication to treat opioid use disorder (OUD), works as a safer alternative to deadly street opioids like heroin and fentanyl. With its long half-life, methadone smoothens out the highs and lows of OUD. A single morning oral dose of methadone allows patients to get through their day instead of having to inject themselves every several hours to stave off miserable withdrawal symptoms.

When dosed appropriately by a medical provider, methadone does not cause euphoria or drowsiness. Instead, it allows people with OUD to feel physically and mentally well. It also prevents fatal overdose from street opioids. Only one other treatment for OUD offers this mortality benefit: buprenorphine, a less potent opioid which, for some patients, may not relieve cravings as effectively as methadone.

Who Can Prescribe Methadone?

In the US, only designated opioid treatment programs (OTPs), which are certified and licensed at both federal and state levels, can use methadone to treat opioid use disorder. Credentialed OTP staff dispense methadone on site and observe patients as they take the medication. It is illegal for a clinician to write a prescription for methadone for a patient to pick up at a pharmacy to treat OUD. (One caveat is that it is technically legal to prescribe methadone in this manner to treat pain—though this could raise eyebrows at the pharmacy).

The history behind these rules dates to the early 20^th century. After the Civil War, thousands of former soldiers emerged dependent on the morphine and opium painkillers that they had received on the battlefield. Physicians continued to provide opioids with few restrictions until the passage of the 1914 Harrison Narcotics Act. Sometimes cited as the starting point of the war on drugs, this law imposed taxes and regulations on anyone involved in the sale or distribution of controlled substances.

A key question that the Harrison Act left open was whether opioids could be prescribed in the long term to treat addiction. This question would be aggressively interpreted in the negative by the Treasury Department, particularly with Harry Anslinger, the nation’s first drug czar, heading a new Bureau of Narcotics established in 1930. Anslinger essentially prohibited opioid maintenance therapy for OUD. When the FDA approved methadone for this purpose in 1972, decades-old policies had to be circumvented. The workaround took the form of the creation of OTPs.

What if Methadone Were Available Through Primary Care?

While OTPs are the law of the land in the US, other countries make methadone far more accessible. In Australia, Canada, and the United Kingdom, primary care providers can write prescriptions for methadone to be filled at a community pharmacy. Australia, despite requiring that primary care providers undergo specialty training to prescribe methadone, boasts a ratio of 13 patients to 1 prescriber, a stark contrast from the American ratio of 190 to 1. Patient outcomes in all three countries are favorable.

Regulations abroad often stipulate that the pharmacist must supervise the patient’s ingestion of methadone, at least in the early stages of treatment. Still, relative to the US, other countries’ pharmacies face fewer regulatory burdens, and the delivery of treatment in a mainstream setting destigmatizes OUD.

Moreover, unlike with OTPs, the primary care-based model does not require patients to attend counseling in order to receive life-saving medication. Indeed, data shows that making counseling a condition for receiving methadone does not increase success in recovery, including negative urine drug screens as well as retention in treatment.

How Successful Are Primary-Care-Based Models for Methadone Treatment?

Adding to the evidence supporting access to methadone through primary care is a recent randomized controlled trial from Ukraine. The study compared rates of retention in methadone treatment as well as access to general health services between patients who received methadone in primary care settings vs in specialty clinics. With 1,500 participants across 13 cities, the study is the largest of its kind in any low- or middle-income country.

Retention rates in methadone treatment proved comparable between primary care and specialty settings, with 70 percent of patients remaining engaged in care after 24 months in both groups. For patients starting methadone for the first time, retention was slightly better in primary care.

Access to general health services was superior under primary care. Among 17 services measured, which included screenings for cancer and infectious diseases, participants received an average of one or two more services if they were treated in primary care. Taken together, the study’s findings suggest that integrating methadone treatment into primary care can improve preventative health without sacrificing the quality of addiction care.

A distinguishing feature of the Ukrainian primary care model for methadone is its use of telementoring, where addiction specialists provide guidance to primary care providers during weekly hour-long virtual meetings. Described by one investigator as a “lifeline,” telementoring empowered many clinicians who had no experience managing methadone prior to the study to confidently help patients with OUD. This confidence remained steady despite the COVID-19 pandemic and Russia's invasion of the country.

Could the US Learn From Experience Abroad to Expand Methadone Access?

The Modernizing Methadone Treatment Act, introduced in the US Senate in 2023, would expand access to methadone beyond OTPs and into community settings. However, it would mandate any provider prescribing methadone outside of an OTP to hold a specialty certification in addiction medicine. Given the nationwide shortage of specialty addiction providers, the bill would have little effect on the status quo. For every addiction specialist in a given state, the number of patients with OUD ranges from a few hundred to a few thousand.

Borrowing from Ukraine’s telementoring model could allow the US to successfully expand access to methadone. A change to the bill allowing primary care providers to prescribe methadone under the remote supervision of an addiction specialist, coupled with the infrastructure to support that supervision, could make the difference between words and substance. This would mean departing from a regulatory landscape that is deeply entrenched in history in favor of embracing modern evidence to maximize patients’ success in recovery.