Enhancing drug safety through active surveillance of observational healthcare data

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Drug safety testing continues to be a major public health concern in the United States, with adverse drug reactions ranking as the 4th to 6th leading cause of death, and resulting in health care costs of $ 3.6 billion annually. Recent media attention and public scrutiny of high-profile drug safety issues have increased visibility and skepticism of the effectiveness of the current post-approval safety surveillance processes. Current proposals suggest establishing a national active drug safety surveillance system that leverages observational data, including administrative claims and electronic health records, to monitor and evaluate potential safety issues of medicines. However, the development and evaluation of appropriate strategies for systematic analysis of observational data have not yet been studied. This study introduces a novel exploratory analysis approach (Comparator-Adjusted Safety Surveillance or COMPASS) to identify drug-related adverse events in automated healthcare data. The aims of the study were: to characterize the performance of COMPASS in identifying known safety issues associated with ACE inhibitor exposure within an administrative claims database; to evaluate consistency of COMPASS estimates across a network of disparate databases; and to explore differential effects across ingredients within ACE inhibitor class.

COMPASS was observed to have improved accuracy to three other methods under consideration for an active surveillance system: observational screening, disproportionality analysis, and self-controlled case series. COMPASS performance was consistently strong within 5 different databases, though important differences in outcome estimates across the sources highlighted the substantial heterogeneity which makes pooling estimates challenging. The comparative safety analysis of products within the ACE inhibitor class provided evidence of similar risk profiles across an array of different outcomes, and raised questions about the product labeling differences and how observational studies should complement existing evidence as part of a broader safety assessment strategy. The results of this study should inform decisions about the appropriateness and utility of analyzing observational data as part of an active drug safety testing process. An improved surveillance system would enable a more comprehensive and timelier understanding of the safety of medicines. Such information supports patients and providers in therapeutic decision-making to minimize risks and improve the quality of drug.