This paper briefly reviews the history of prescription (Rx) to over-the-counter (OTC) switches and discusses perspectives of consumers, manufacturers, physicians, pharmacists, and the Food and Drug Administration (FDA) towards these switches. We then discuss the role of epidemiology in supporting Rx to OTC switches and present an example of an epidemiological study used to support the Rx to OTC switch of an anti-fungal medication to treat candidiasis infection in women.
TeminP.Costs and benefits in switching drugs from Rx to OTC. J Health Econ.1983;2: 187–205.
2.
WionAH. Rx-to-OTC switch — The process and procedures. Drug Inf J.1985;19: 119–126.
3.
FreddSB. The OTC drug approval process. Am J Gastroent.1990;85(1):12–14.
4.
MadhavenSSchondelmeyerSW. Taking it over the counter: Part I. Pharm Exec.1987;7: 78–82.
5.
SollerRW. Outlook for OTC switches. Am Pharmacy.1991;NS31(2):38–40.
6.
VickeryDM. A medical perspective. Drug Inf J.1985;19: 155–158.
7.
MadhavenSSchondelmeyerSW. Taking it over the counter: Part II. Pharm Exec.1987;8: 54–60.
8.
RheinsteinPH. Criteria used by the FDA to determine what classes of drugs are appropriate switch candidates. Drug Inf J.1985;19: 139–142.
9.
TilsonHH. Use of adverse reaction data bases and making risk assessments of proposed switch candidates. Drug Inf J.1985;19: 143–149.
10.
GableCBEngelhartLSarmaSHolzerSSSmeltzFSchroederDAFriedmanRB. Mixed vaginal infections — candidiasis and venereal disease — in Medicaid women. Pharmacoepi Drug Safety (in press).
11.
DarrowWW. Social stratification, sexual behavior, and the sexually transmitted diseases. Sex Trans Dis.1979;6: 228–230.
12.
MoranJSAralSOJenkinsWEPetermanTAAlexanderER. Impact of sexually transmitted diseases on minority populations. Public Health Report.1989;104: 560–565.
13.
Congressional Research Service.Medicaid Source Book: Background Data and Analysis.Washington D.C.: U.S. Government Printing Office, 1988.
14.
Health Care Financing Program Statistics.Medicare and Medicaid Data Book 1984. HCFA Pub. No. 03210, 1986.
