Causality Assessment in Pharmacovigilance

Causality assessment is an essential component of, and routine procedure in, any pharmacovigilance system. Establishing a causal relationship between the suspected drug and the adverse event is a complex process and should consider both patient- and medication-related factors. There are three broad approaches, or categories, of causality assessment adopted for establishing causation in pharmacovigilance. The methods adopted to assess the causal relationship generally consider a few criteria in common. There are multiple criteria or algorithms available for establishing a causal relationship in cases of adverse events. The causality assessment tools help clinicians in identifying the culprit drugs. Establishing a causal relationship is important to incorporate the individual case safety reports in benefit–harm analysis, identification of new adverse drug reactions, and regulatory decision-making process. Causality assessment is a continuous process and has wider applications across various fields including academic research, clinical practice, sponsored clinical research, and regulatory activity. Therefore, knowledge of its applications, and associated challenges, is important in enabling stakeholders to play their role at all levels to improve patient safety.