Proactive safety surveillance

Growth in health information systems presents opportunities to enhance post marketing safety surveillance of medical products. Spontaneous suspected si de effect reports provide the foundation, but we need to 'proactively' impr ove their quality and our strategies to seek signals. In our more familiar 'reactive' mode, we examine hypotheses from inquiries or publicity. Such re sponsive evaluations remain essential but may miss latent information on un suspected risks. Efficient techniques to disclose hidden clusters and assoc iations may emerge through adaptation of approaches from industrial quality control and other disciplines. Data-driven techniques like exploratory ana lysis, control charts, and time series modeling may help in sifting through accumulated data and in screening consecutive submissions to discern hints of new product hazards or of more specific understanding about previously identified potential side effects. We also need to cultivate non-spontaneou s data for hypothesis generation as well as testing, the systematic epidemi ologic evaluation of questions and concerns. This hypothesis testing functi on will assume greater importance if proactive safety surveillance methods yield larger numbers of putatively positive findings. Whether from spontane ous reports or other sources, signals that could have arisen by chance alon e usually represent only clues to potential hazards until or unless they ca n be verified through independent studies. Copyright (C) 2001 John Wiley & Sons, Ltd.