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In Reply: Dr Ruck and colleagues propose the use of PCCs and their national database, TESS, as a tool for postmarketing drug surveillance. I have long thought that PCCs are an underused resource for the study of dose-related adverse drug reactions.¹ After all, what better way to study such reactions than in an overdose setting? However, it is important to place this in proper perspective.

First, TESS is not a comprehensive system for drug safety, but a data collection system. Second, TESS remains a surveillance system: it lacks the complete collection of data that would enable the conduct of formal hypothesis-testing epidemiologic studies. Thus, in many ways, this system resembles the MEDWATCH system maintained by the US Food and Drug Administration. Such systems generally can only be used to generate hypotheses, not test them.² In contrast to MEDWATCH, TESS would be less able . . . [Full Text of this Article]

Brian L. Strom, MD, MPH
bstrom@cceb.med.upenn.edu
Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania School of Medicine
Philadelphia

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