Protecting Patients from Harm: Terfenadine and Potential Drug Therapy Interactions
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0092-8615198 Copyright 0 1998 Drug Information Association Inc.
PROTECTING PATIENTS FROM HARM: TERFENADINE AND POTENTIAL DRUG THERAPY INTERACTIONS LISA STOCKWELL MORRIS,PHD, RPH Director, Disease Treatment and Outcomes Information Services, IMS America, Plymouth Meeting, Pennsylvania
ANGELINE CARLSON,PHD, RPH Chief Manager/Director of Research, Data Intelligence Consultants, LLC, Eden Prairie, Minnesota
Communication of drug interactions has been the focus of reports surrounding the use of terfenadine. Two studies reported in the literature indicated that coprescription events between tedenadine and contraindicated drugs occurred despite communications to health professionals regarding potential harm. Recent studies have found that pharmacists frequently dispense such drug combinations without concern or appropriate counseling. Throughout 1996, reports in journals and the public press created concern over drug interactions and the practice of pharmacy. The terfenadine case study highlights weak links in the chain of communication of serious medical information. Early warnings to health professionals did not result in the elimination of potential events. Additional communications decreased the rate of coprescription events but did not eliminate them. Current investigations show that these events continue. All health care professionals involved in the distribution of pharmaceuticals should use the experiences related to terfenadine as a means to improve their handling of drug interaction and other medical information. Key Words: Terfenadine; Drug-drug interactions; Contraindicated drugs; Patient counseling; Medication errors
INTRODUCTION CONSIDERABLEINFORMATION ABOUT the actions and adverse effects of pharmaceuticals is learned after a drug product comes to market. On the positive side, new indica-
Presented at the DIA “1996 International Symposium on Drug Interactions,” December 4-5, 1996, Toronto, Ontario, Canada. Reprint address: Lisa Stockwell Moms, PhD, Director, Disease Treatment and Outcomes Information Services, IMS America, 660 West Germantown Pike, Plymouth Meeting, PA 19462.
tions or uses for a product are often identified through real world exposures. Unfortunately, negative information often becomes available in the postmarketing phase. This information can be the result of spontaneous reporting or postmarketing surveillance research. While the clinical development of a product in the premarketing phase is intended to determine safety and efficacy, it is not feasible to uncover all positive and negative effects associated with the use of a particular pharmaceutical. Thus, the value of continuing research after the product is marketed is tremendous.
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Lisa Stockwell Morris and Angeline Carlson
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THE TERFENADINE EXPERIENCE Terfenadine (Seldane@)is an example of a product where negative effects have been identified in the postmarketing phase. When introduced to the United States marketplace in 1985, terfenadine, a lon
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