Considerations Regarding a Behind-the-Counter Drug Class
GAO-09-245: Published: Feb 20, 2009. Publicly Released: Mar 23, 2009.
In the United States, most nonprescription drugs are available over-the-counter (OTC) in pharmacies and other stores. Experts have suggested that drug availability could be increased by establishing an additional class of nonprescription drugs that would be held behind the counter (BTC) but would require the intervention of a pharmacist before being dispensed; a similar class of drugs exists in many other countries. Although the Food and Drug Administration (FDA) has not developed a detailed proposal for a BTC drug class, it held a public meeting in 2007 to explore the public health implications of BTC drug availability. GAO was asked to update its 1995 report, Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated (GAO/PEMD-95-12). Specifically, GAO is reporting on (1) arguments supporting and opposing a U.S. BTC drug class, (2) changes in drug availability in five countries since 1995 and the impact of restricted nonprescription classes on availability, and (3) issues important to the establishment of a BTC drug class. GAO reviewed documents and consulted with pharmaceutical experts. To examine drug availability across countries, GAO studied five countries it had reported on in 1995 (Australia, Italy, the Netherlands, the United Kingdom, and the United States) and determined how 86 drugs available in all five countries were classified in each country.
Arguments supporting and opposing a BTC drug class in the United States have been based on public health and health care cost considerations, and reflect general disagreement on the likely consequences of establishing such a class. Proponents of a BTC drug class suggest it would lead to improved public health through increased availability of nonprescription drugs and greater use of pharmacists' expertise. Opponents are concerned that a BTC drug class might become the default for drugs switching from presc