Analysis of the movement of prescription drugs to over-the-counter status.

BACKGROUND The transition of prescription drugs (Rx) to over-the-counter (OTC) status is a very complex and multifaceted process involving many parties and many issues. This article examines the regulatory history and process and presents a review of the issues involved, using recent Rx-to-OTC conversions as examples. FINDINGS Data are presented on the growth of the OTC market and the impact recently switched products have had on this market growth. Drug product characteristics that make drug products amenable to OTC conversion are described. Reasons are presented for why more and more prescription drug products are being reviewed as candidates for OTC conversion. A list of high-profile Rx-to-OTC products is provided, along with a discussion of new proposals for OTC conversions and those products that have not been approved for OTC conversion. CONCLUSION Conversion of prescription products to over-the-counter availability can have an impact on prescription-drug-benefit costs and on total health care costs. There are opportunities and limitations for managed care organizations in the coverage and promotion of OTC products as therapeutic alternatives to prescription-only drugs.