Prescription to over-the-counter switching of drugs: Methodological issues and implications for non-sedating antihistamines

Recently, the US FDA has expanded its efforts to move prescribed drugs onto over-the-counter (OTC) status. This approach is consistent with the movement towards 'consumerism' in healthcare, which reflects the belief that enhanced consumer autonomy will increase choice and control costs without adverse consequences for quality of care. Evaluating whether such changes are beneficial involves complex methodological issues and raises questions about consumer information and strategic responses to changing incentives engendered by the OTC switch. This review considers these issues and their implications for the switching of non-sedating antihistamines to OTC status. Switching non-sedating antihistamines to OTC status offers a number of potential benefits, including greater access, the ability to substitute non-sedating antihistamines for sedating antihistamines, and more competition in the OTC market. At the same time, switching may increase the number of people with allergies who are treating their conditions inappropriately and misdiagnosing other conditions related to allergies such as asthma. In evaluating these tradeoffs, blanket recommendations, which are pro or con, will likely lead to poor public policy decisions. The success or failure of these changes hinges on a variety of factors about which there is often considerable uncertainty. The net benefits of switching are likely to be quite specific to the drug as well as the consumer's understanding of the disease it is designed to treat. Moreover, the effects of switching as well as consumer information may change and evolve over time. These considerations pose challenging and important issues for policy makers.