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In an effort to increase access to select low-toxicity drugs by eliminating the costs associated with obtaining a physician's prescription, the Food and Drug Administration is considering a third classification, called behind-the-counter (BTC) drugs. These drugs would be available without a physician's prescription but, unlike over-the-counter (OTC) drugs, would not be freely available to patients. Rather, they would be available only in pharmacies and upon consultation with a pharmacist. Although the United States has limited experience with BTC drugs, other countries have introduced the BTC class, and their experiences can provide insight into the potential effects of this new class of drugs. The authors examine the potential effects of introducing BTC drugs by looking at experience with OTC drugs. The results of their analyses suggest that the introduction of BTC drugs in the United States could have varied effects in practice, and it is unclear whether such a policy would increase access to drugs, reduce medical costs, or increase health.

The research in this report was conducted by RAND Health and prepared for the Office of the Assistant Secretary for Planning and Evaluation,United States Department of Health and Human Services.

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