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GAO report on BTC feasibility inconclusive

3/23/2009

WASHINGTON The U.S. Government Accountability Office, tasked with updating a 1995 report regarding the feasibility behind a third-class of drugs in the United States, on Monday released documents suggesting that its comparable study of behind-the-counter drugs in other countries was inconclusive.

“The impact of restricted nonprescription drug classes on availability is unclear,” the report stated. “Pharmacist-, infrastructure- and cost-related issues would have to be addressed before a BTC drug class could be established in the United States. For example, ensuring that pharmacists provide BTC counseling and that pharmacies have the infrastructure to protect consumer privacy would be important. Issues related to the cost of BTC drugs would also require consideration. For example, the availability of third-party coverage for BTC drugs would affect consumers’ out-of-pocket expenditures and pharmacists’ compensation for providing BTC services would need to be examined.”

Arguments supporting and opposing a BTC drug class in the United States have been based on public health and healthcare cost considerations, according to the GAO report, 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 prescription to nonprescription status, thus reducing consumers’ access to drugs that otherwise would have become available OTC. They also argue that pharmacists might not be able to provide high-quality BTC services.

Proponents of a BTC drug class point to potentially reduced costs through a decrease in the number of physician visits and a decline in drug prices that might result from switches of drugs from prescription to nonprescription status. However, opponents argue that out-of-pocket costs for many consumers could rise if third-party payers elect not to cover BTC drugs.

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