Methadone is a highly effective medication for opioid use disorder (MOUD). Access to methadone has been historically limited due to federal regulations, zoning laws, and community stigma. Even in communities with opioid treatment programs (OTPs), the requirement to visit the clinic daily poses challenges for patients juggling work and family responsibilities. Proposed legislation aims to increase methadone access by providing more flexibility in visit frequency and allowing community-based prescribing and pharmacy dispensing. Regardless of the outcome of this legislation, it is crucial for primary care clinics to establish relationships with community-based OTPs and understand when and how to refer patients to their services. Likewise, primary care clinics can serve as valuable referral sources for various medical services required by individuals receiving methadone treatment at OTPs.
Methadone, MOUD, and OTPs
There are three medications approved by the Food and Drug Administration (FDA) for treating OUD: buprenorphine, naltrexone, and methadone. Buprenorphine and naltrexone can be prescribed by primary care clinicians and in other office-based settings. However, methadone for OUD treatment is only available in federally licensed facilities called OTPs – even though it can be prescribed for pain in primary care and other office-based settings.
Is methadone treatment effective?
Since the 1960s, methadone maintenance treatment has been evaluated for OUD treatment, with consistent results. Methadone reduces the use of illicit opioids, the risk of overdose and death, and injection drug use and some of the risks associated with it (including the risk HIV and hepatitis C virus (HCV) transmission). Among the three FDA-approved medications for OUD, methadone has shown the most significant benefit in terms of retaining patients in treatment and reducing opioid use compared to nonpharmacologic treatment; at daily doses of 16mg or greater, buprenorphine can achieve similar outcomes.[i]
[i] Wakeman SE. Diagnosis and Treatment of Opioid Use Disorder in 2020. JAMA. 2020 May 26;323(20):2082-2083. doi: 10.1001/jama.2020.4104. PMID: 32329798.
Is methadone treatment accessible?
Due to federal licensing requirements, local zoning laws, and community stigma associated with methadone treatment, access has historically been limited to urban areas. People living in rural counties often must travel long distances to access methadone treatment. A recent study found that individuals in rural counties had an average drive time of 49 minutes to reach an OTP, compared to 8 minutes in urban communities.[i]
[i] Joudrey PJ, Edelman EJ, Wang EA. Drive Times to Opioid Treatment Programs in Urban and Rural Counties in 5 US States. JAMA. 2019 Oct 1;322(13):1310-1312. doi: 10.1001/jama.2019.12562. PMID: 31573628; PMCID: PMC6777265.
How are OTPs regulated? How do they operate?
OTPs must adhere to strict federal guidelines and state monitoring. These regulations govern dosing schedules, visit frequency, medication handling, toxicology testing, and the availability of counseling services. During the initial months of methadone treatment, individuals must visit the OTP at least six days a week to take their medication under supervision. The methadone dose is gradually increased, following federal guidelines. As individuals stabilize and progress in their recovery, they are given more take-home doses, allowing them to visit the clinic less frequently.
How did things change during the pandemic and what’s going on now?
Guidance regarding methadone use has been in flux over the last several years. In response to the COVID-19 pandemic, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued guidance in March 2020 allowing states to relax OTP requirements and provide take-home doses of methadone earlier than before. These pandemic-related changes created an opportunity to explore the safety and efficacy of more relaxed requirements. A recent study examined whether these flexibilities led to an increase in methadone-related overdose deaths, finding no rise in methadone-associated overdoses despite increases in other types of overdose deaths during the same period.[i] SAMHSA provides more detailed guidance on the status of OTP requirements at https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance.
Congress has also been considering ways to expand access to methadone. For example, a bipartisan coalition of lawmakers has reintroduced the Modernizing Opioid Treatment Access Act, which aims to expand access to methadone by allowing more clinicians to prescribe it for OUD treatment and permitting pharmacies to dispense the medication. If passed, these allowances would align more closely with methadone access practices in Canada and Australia, where primary care clinicians already have the authority to prescribe methadone and pharmacies have the authority to dispense it.
[i] Jones CM, Compton WM, Han B, Baldwin G, Volkow ND. Methadone-Involved Overdose Deaths in the US Before and After Federal Policy Changes Expanding Take-Home Methadone Doses From Opioid Treatment Programs. JAMA Psychiatry. 2022;79(9):932–934. doi:10.1001/jamapsychiatry.2022.1776
How can primary care practices partner with OTPs?
Primary care practices can partner with OTPs in various ways, such as:
- Referring patients who prefer methadone or have not responded well to buprenorphine or naltrexone to OTPs.
- Accepting referrals from OTPs for primary care services, perinatal care, HIV treatment, HCV treatment, vaccinations, sexually transmitted infection testing and treatment, and other services provided by the clinic.
- Partnering with an OTP to establish a satellite site at a primary care office, ensuring that all three medication options are available in the primary care setting.[i]
- Co-locating primary care services at the OTP, making it easier for individuals receiving methadone treatment to access primary care services.
[i] Gastala N et al. “Opioid Use Disorder: UI Mile Square/Family Guidance Integrated Methadone Treatment” Program Presentation at ASAM Annual Conference 2023. Saturday, April 15, 2023.