The "prescription-to-OTC switch" movement. Its effects on antifungal vaginitis preparations.

Abstract

More than 600 over-the-counter (OTC) products have ingredients or dosages that were previously available by prescription only. The criteria for switching drugs include a low potential for misuse or abuse, safety and efficacy, and the ability for effective use by the average person. In addition, the conditions the drugs treat should be benign and self-limited. In 1990, the first topical imidazole for candidal vaginitis was approved by the Food and Drug Administration for over-the-counter use. Suggested benefits of this switch were increased patient autonomy and reduced costs. Risks include potential for misdiagnoses, resulting in inappropriate use, unnecessary use, or delay in treatment, which could lead to increased cost and morbidity. Despite the wide use of these products, there is little evidence examining the outcome of the switch. Limited available data suggest that the switch of the antifungal preparations reduces costs with little objective evidence of harm resulting from the switch.