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Prescription to Over-the-Counter Switching of Drugs

Methodological Issues and Implications for Non-Sedating Antihistamines

  • Review Article
  • Published:
Disease Management & Health Outcomes

Abstract

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.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgments

This study was funded by a grant from Aventis Pharmaceuticals. The authors have no conflicts of interest that are directly relevant to the content of this review.

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Authors and Affiliations

  1. Stony Brook University, Stony Brook, New York, USA

    John A. Rizzo

  2. Institute for Policy Studies, Cornell University, Washington, DC, USA

    Ronald J. Ozminkowski &  Ron Z. Goetzel (Director, Vice President)

  3. Thomson Medstat, Washington, DC, USA

    Ronald J. Ozminkowski

  4. Thomson Medstat, Ann Arbor, Michigan, USA

    Ron Z. Goetzel (Director, Vice President)

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  1. John A. Rizzo
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  2. Ronald J. Ozminkowski
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  3. Ron Z. Goetzel
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Correspondence to Ron Z. Goetzel.

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Rizzo, J.A., Ozminkowski, R.J. & Goetzel, R.Z. Prescription to Over-the-Counter Switching of Drugs. Dis-Manage-Health-Outcomes 13, 83–92 (2005). https://doi.org/10.2165/00115677-200513020-00002

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