Database size and power to detect safety signals in pharmacovigilance

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Database size and power to detect safety signals in pharmacovigilance

Hammond IW, Gibbs TG, Seifert HA, Rich DS

Expert Opin Drug Saf. 2007 Nov;6(6):713-21

Pharmacovigilance relies on signal detection to identify potential associations between drugs and adverse drug reactions (ADRs). Although there is no certainty that the drug in question caused the event, the capture of ADRs provides a potential signal that the reported drug may be associated with an adverse event. Early detection is important to protect public health, yet there currently is no gold standard method for signal detection.

The authors set out to determine which database had the highest statistical power in signal detection by using three large databases, the FDA Adverse Event Reporting System (AERS), the World Health Organization VIGIBASE, and GSKs own OCEANS database. VIGIBASE had the highest number of total ADRs recorded, followed by AERS and lastly, OCEANS. They randomly selected ten GlaxoSmithKline drugs for review across these three databases.

This study used database pairs and found that, instead of the overall size of the database being the determinant, the pair that resulted in the highest statistical power for signal detection had the largest amount of data for the specific drug in question. They were unable to compare ADRs in each database to determine overlap of events as part of the study. However, given their findings on the different rates of ADR reports per country in each database, the authors also conclude that using multiple large databases may be better at signal detection given the higher diversity of ADRs.

The authors recommend that further studies be conducted to confirm these results in other pharmaceutical companies, and also to determine additional factors that can influence the detection of signals in order to develop a gold standard.