Legislative and regulatory barriers to pharmacies dispensing buprenorphine for OUD.

Introduction: Buprenorphine (BUP) is increasingly recognized and utilized as a valuable medication for the treatment of opioid use disorder. This article focuses on the problem of regulatory restrictions on access to buprenorphine products without naloxone (mono-product), involving patients in one geographic area, but which may represent a more general access problem in the United States.

Design: In response to an audit by the Tennessee Board of Pharmacy, a pharmacy in northeast Tennessee designed a questionnaire to survey patient motivation for traveling long distances to fill their prescriptions for BUP, rather than buprenorphine/naloxone (BNx, combo-product), and to document their satisfaction with treatment with the mono-product.

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

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.