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March 16, 2005

Evaluation of Suspected Adverse Drug Reactions

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;293(11):1324-1325. doi:10.1001/jama.293.11.1324-a

To the Editor: We would like to raise some issues regarding the Commentary by Dr Strom about evaluation of suspected adverse drug reactions.1 A “signal” should always involve an element of clinical judgment. Statistical algorithms such as the proportional reporting ratio (PRR) and Bayesian approaches designed for application to spontaneous reports are promising tools, but overconfidence in these methods should be avoided because they not only generate false alarms but may also fail to highlight potential safety issues.2,3 Statistical algorithms should not be considered as an alternative to case-by-case review of all reports submitted to a spontaneous reporting system (SRS). The incremental utility of statistical algorithms relative to clinical approaches is still unknown. We believe that statistical algorithms should only be considered as potential supplements to a comprehensive signal detection strategy founded on rigorous application of clinical and epidemiological knowledge and judgement, including sensible clinical criteria for evaluating cumulative case reports.

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