A concept for causality assessment and causal inference of adverse events cases

Abstract

Dear Editor,   Causality assessment of adverse drug events is essential in pharmacovigilance to assess the relationship between the medicine and the event.1,2 Regulatory authorities recommend using standardized methods for causality assessment.3,4 The World Health Organization-Uppsala Monitoring Center (WHO-UMC) system offers generalized criteria for establishing causal relationships.3 In contrast, the Roussel Uclaf Causality Assessment Method (RUCAM) provides a specialized system to assess Drug-Induced Liver Injury (DILI) cases. We systematically reviewed the literature and verified that these systems are among the best tools currently available for signal detection and causality assessment. [...]