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Expanding Access to Methadone Treatment for Opioid Use Disorder in Carceral Settings

By: Kelly S. Ramsey

Methadone is a lifesaving medication for treating opioid use disorder. However, methadone is still widely underutilized in the general population and specifically in vulnerable settings like carceral facilities. Expanding the availability of methadone to incarcerated persons is a key intervention to preventing fentanyl and other opioid-related overdose deaths and reducing recidivism. A report from the Bloomberg American Health Initiative with support from the Bloomberg Overdose Prevention Initiative in 2022 made recommendations to the Drug Enforcement Agency to expand access. 

Substance Abuse & Mental Health Services Administration (SAMHSA) has issued a final rule on the use of methadone, including in carceral settings, and a concurrent roll-out of federal initiatives are increasing access to treatment.

In this Q&A, Dr. Kelly Ramsey explains this opportunity and how it can be implemented in jails and prisons across the country.

What do the updated final rules of 42 CFR Part 8, recently published by SAMHSA, say about provision of methadone in carceral settings?

“If a correctional facility has registered as a hospital/clinic, a physician or authorized staff may administer or dispense narcotic drugs to maintain or manage withdrawal for an inmate as an incidental adjunct to medical or surgical treatment of conditions other than addiction.”

Interpretation: The revised rules clearly and unequivocally state that a carceral setting may register as a hospital/clinic and use methadone under the exemption available to hospitals/clinics. Under this exemption, the clinic can dispense methadone for opioid withdrawal syndrome and/or treatment of opioid use disorder to patients, provided that they have an additional diagnosis besides opioid withdrawal syndrome and/or opioid use disorder. The guidance does not list or otherwise specify the additional diagnoses that are required to use this option, which gives some leeway to the clinician. There should be clear documentation in the medical record identifying what additional diagnoses the patient has.

What are some factors that county jails and state prisons should consider for utilization of methadone?

Methadone is a long-acting, full agonist at the mu opioid receptor, which is very efficacious for the treatment of opioid use disorder.. In fact, evidence indicates that methadone reduces overdose mortality, reduces all-cause mortality, and reduces recidivism. Due to variability in how methadone is metabolized, and its long-half life, the administration of methadone requires clinical expertise and clinical oversight. Clinicians unfamiliar with methadone should seek support from clinicians with training and expertise in addiction medicine before starting patients on treatment. Clinicians should also consult methadone’s labeling, including instructions for use and warnings.

As a Schedule II medication, methadone carries requirements for registration, storage, inventory, and records under the Controlled Substances Act.

Correctional facilities should check with state regulators about other rules related to methadone that may apply.

What should my carceral setting have in place to make the hospital/clinic approach work?

As a recommended practice, carceral facilities that are interested in the hospital/clinic designation approach to treat persons with opioid use disorder. with methadone should establish and maintain:

  1. Written policies and procedures outlining which conditions would qualify as a “primary condition” that would make an individual with opioid use disorder. eligible for methadone treatment;
  2. Protocols and work flows for initiation and adjustment of the methadone dose;
  3. A protocol and work flow for communicating with patients’ community-based opioid treatment program (if applicable), especially during intake at the carceral setting (for dose verification) and before release;
  4. A protocol and work flow for re-entry planning for persons initiated onto methadone while incarcerated (i.e., the patient has no prior relationship with a community-based opioid treatment program and needs this care established before leaving the carceral setting); the DEA 72-Hour Emergency Rule should be utilized to dispense a 72-hour (3-day) supply to patients leaving the carceral setting to ensure there is no gap in medication access until the patient presents to the opioid treatment program; 
  5. A relationship with an addiction medicine provider to discuss any challenging cases;
  6. A plan to review periodically how well the program is working and how it can be improved;
  7. Written policies and procedures for DEA regulatory compliance and a protocol for the procurement, documentation, and safe storage of methadone. 

On March 28, 2024, the Bloomberg School of Public Health’s Center for Mental Health & Addiction Policy in partnership with the White House Office of National Drug Control Policy co-hosted an event focusing on opportunities to expand access to methadone in correctional facilities, including recent developments with the 2024 Substance Abuse & Mental Health Services Administration (SAMHSA) final rule on the use of methadone. Watch the full video on Youtube:

Read the full FAQ on the SAMHSA final rule here: https://opioidprinciples.jhsph.edu/wp-content/uploads/2024/03/FAQ-Methadone-in-Carceral-Settings.pdf

About the Author:

Kelly S. Ramsey, MD, MPH, MA, FACP, DFASAM is a board certified internal medicine and addiction medicine physician who has treated substance use disorder since 2004. She worked as Medical Director of an academic center-based OTP in the South Bronx before working for nearly a decade for a large FQHC in the Hudson Valley where she created and grew a medication assisted treatment program for opioid use disorder and alcohol use disorder to 10 sites and 1500 patients. Most recently, Dr. Ramsey worked as the Chief of Medical Services at the NYS Office of Addiction Services and Supports (OASAS). 

Dr. Ramsey currently works as an Addiction Medicine and Harm Reduction Consultant as well as providing clinical care in addiction medicine. She has provided expert advice to the New York State Department of Health AIDS Institute, serving on numerous committees for about 15 years, providing expertise in addiction medicine, harm reduction, HIV care, and HCV care. 

Dr. Ramsey was the recipient of the New York State Commissioner’s Special Recognition Award for contributions to drug user health in NYS in December 2018. Dr. Ramsey was the Distinguished Contributions to Behavioral Medicine Award Recipient, awarded by the American College of Physicians (ACP)in April 2023. Dr. Ramsey was awarded the Case Western Reserve University School of Medicine Special Medical Alumni Board Award in October 2023. 

Dr. Ramsey is the President for the NYSAM BOD. In addition, she currently serves as Region I Director on the ASAM Board of Directors.