Sins and Risks in Underreporting Suspected Adverse Drug Reactions

The underreporting of suspected adverse drug reactions remains a primary issue for contemporary post-market drug surveillance or pharmacovigilance. Pharmacovigilance pioneer W.H.W. Inman argued that “deadly sins” committed by clinicians are to blame for underreporting. Of these “sins,” ignorance and lethargy are the most obvious and impactful in causing underreporting. However, recent analyses show that diffidence, insecurity, and indifference additionally play a major role. I aim to augment our understanding of diffidence, insecurity, and indifference by arguing that these sins are underwritten by value judgments arising via epistemic risk. I contend that “evidence-based” medicine codifies these sins.