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Evaluation of Suspected Adverse Drug Reactions
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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 . . . [Full Text of this Article]
Manfred Hauben, MD, MPH
manfred.hauben@pfizer.com
Medical Director
Risk Management Strategy
Pfizer Inc
New York, NY
Eugène P. van Puijenbroek, MD, PhD
Netherlands Pharmacovigilance Centre Lareb
s-Hertogenbosch, the Netherlands
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