Adverse effects of regulation on buprenorphine prescribing and its impact on the treatment of opioid use disorder

Daniel M. Strickland, MD, FACOG; John Sorboro, MD, DABPN, FASAM

doi:10.5055/jom.2021.0650

Authors

Daniel M. Strickland, MD, FACOG https://orcid.org/0000-0001-8684-9184
John Sorboro, MD, DABPN, FASAM

DOI:

https://doi.org/10.5055/jom.2021.0650

Keywords:

opioid use disorder (OUD), opioid, buprenorphine, naloxone, medication-assisted treatment (MAT), outpatient-based opioid treatment, OBOT, DATA 2000

Abstract

Problem: Drug addiction and misuse is a medical and societal problem that has exacted a heavy toll on the United States, and, indeed, the world. In the United States, opioids are currently the main driver of drug overdose deaths. Despite the proven safety and efficacy of medically assisted therapy (MAT) using buprenorphine for the treatment of opioid use disorder (OUD), as well as the fact that its use is regulated by US Federal Law, many states have enacted separate and often burdensome regulations that restrict the prescribing of buprenorphine beyond those required by the US Drug Enforcement Agency (DEA) under the provisions of the DATA 2000 Act, and unnecessarily reduce the availability of effective treatment of OUD in those states.

Purpose: The purpose of this article is to review the pharmacology of both buprenorphine (and naloxone as an additive) and the risks associated with the misuse of buprenorphine products and to consider if such additional state oversight and restrictions improves or is deleterious to public safety in the face of this national epidemic.

Conclusion: We conclude that the placing of unnecessary and unscientific restraints on the treatment of patients with OUD is inconsistent with the principles of harm reduction, and such restraints should be removed unless/until they can be supported by real evidence.

Author Biographies

Daniel M. Strickland, MD, FACOG

Medical Director, Stepping Stone of North Carolina, Boone, North Carolina

John Sorboro, MD, DABPN, FASAM

Addiction Psychiatrist, Mercy Health - St Elizabeth - Youngstown Hospital, Youngstown, Ohio

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