Risks, benefits, and issues in creating a behind-the-counter category of medications

To examine the issues surrounding the development and implementation of a behind-the-counter (BTC) category of medications.

Testimony from organizations submitting comments to the Food and Drug Administration (FDA) panel hearings in November 2007, the 2009 final report of the U. S. General Accounting Office regarding a BTC drug category, literature review of research that has been conducted, experiences from other countries, and publically available information from agencies in charge of regulating medications similar to BTC.

Based on evidence attained from the current work, the following six recommendations regarding a BTC category of medications are provided. (1) Demonstration needs to occur that the risks and/or costs of BTC are outweighed by benefits, positive measurable outcomes, and financial savings to society. (2) Sufficient resources, including personnel, equipment, and facilities, need to be available for the appropriate provision of BTC services and to ensure ongoing monitoring and controls. (3) An appropriate compensation structure needs to be developed. (4) Encounters and outcomes should be documented in an electronic record, the information should be shared with other health care providers involved in patients' care, and interprofessional collaboration and communication should occur. (5) Criteria for designating candidates for transition, ongoing review for safety, and reverse transition must be developed. (6) Applicable lessons learned from other countries should be incorporated into BTC strategies. In addition to implementation recommendations, we also summarize additional evidence that needs to be gathered to optimize the BTC model.

Based on the accumulated evidence, comments to FDA's request, and information from other countries, implementation of a BTC model probably is feasible in the United States. However, the optimal model remains uncertain and various aspects of a program need to be prioritized and rigorously tested.