Department of Pharmacy Practice, College of Pharmacy (Drs. Posen, Keller, Elmes, and Jarrett) and Department of Academic Internal Medicine (Dr. Messmer) and Department of Family and Community Medicine (Drs. Gastala and Neeb), College of Medicine, University of Illinois Chicago jarrett8@uic.edu
Drs. Posen, Keller, Elmes, Messmer, Gastala, and Neeb reported no potential conflict of interest relevant to this article. Dr. Jarrett is a consultant to Trevena, developer of an investigative agent, TRV734, for medication-assisted treatment of opioid use disorder. She receives research funding from the US Health Resources and Services Administration; the Illinois Department of Human Services; the Substance Abuse and Mental Health Services Administration of the US Department of Health and Human Services; the Gordon and Betty Moore Foundation; and the Coleman Foundation.
To further expand access to MAR, the US Department of Health and Human Services updated its practice guidelines in April 2021, allowing clinicians to bypass X-waiver training requirements by applying for a notification-of-intent (NOI) buprenorphine waiver.a However, clinicians are still limited to prescribing buprenorphine for 30 patients at a time. Clinicians who undergo complete X-waiver training may prescribe for 100 patients in the first year and, if eligible, 275 patients thereafter.
In addition, as a component of the Consolidation Appropriations Act of 2023, Congress passed the Mainstreaming Addiction Treatment Act of 2021, or MAT 2021, and Medication Access and Training Expansion Act of 2021, or MATE 2021. MAT eliminated the X-waiver, NOI, and restrictions on the number of patients for whom a provider could prescribe buprenorphine, under federal authority; however, restrictions within one’s state might limit the ability to prescribe buprenorphine. MATE 2021 is an educational requirement for licensing by the DEA (at application and renewal) that will require prescribers to complete 8 hours of training in substance use disorders starting in June 2023.
Patients and their families should be educated that withdrawal symptoms might not feel fully managed in the first few days of methadone therapy.
Use of the monthly injectable extended-release buprenorphine productb is limited by an FDA Risk Evaluation and Mitigation Strategy (REMS) program, which requires specialized training and certification by the prescriber, distributor, and administering clinician. REMS reduces buprenorphine accessibility due to time, cost, and regulatory barriers; although such restrictions have been instituted with the patient’s safety in mind, any limitation to buprenorphine prescribing, apart from controlled substance licensure, serves only to limit access to a primary component of MAR.
Clinical considerations.Due to the competitive nature of buprenorphine and its high affinity for the μ-opioid receptor, the drug can displace other opioid agonists and precipitate acute withdrawal. The withdrawal experience can thereby condition fear and disfavor toward buprenorphine among patients.
It is vital, therefore, that (1) patients’ expectations for treatment be managed appropriately and (2) the treating physician be prepared to provide additional buprenorphine for adequate maintenance doses and utilize adjunct comfort agents (clonidine, nonsteroidal anti-inflammatory drugs, ondansetron) to manage acute withdrawal symptoms. Newer buprenorphine dosing strategies, such as micro-induction and macro-induction, have emerged to curtail these risks.23,24 This is an evolving area of MAR; newer low-threshold initiation strategies25 (see “Low-threshold MOUD prescribing models,” in the text that follows) and evidence that supports micro-induction26 might eliminate the practice of requiring active withdrawal for treatment.
