A scoping review of the clinical utility of adverse drug reaction causality analysis tools for use in the hospital setting

Abstract

Introduction: Identification and monitoring of adverse drug reactions (ADRs) and interventions to reduce ADRs are essential for patient safety in hospitals. Causality analysis (CA) is an approach that helps to determine a causal link between medication and patient harm (i.e. an ADR). While numerous CA tools exist, there is no gold standard.

Areas covered: Five online databases were searched to identify studies that evaluated the potential clinical utility of CA tools for ADRs. CA tools were mapped against the Bradford Hill (BH) criteria and included if they adhered to the first seven criteria proposed by BH. Upon the database search, 550 studies were identified, with 41 studies being selected that looked at tools mapped to BH. Thirty-four different CA tools were identified in the included studies.

Expert opinion: Naranjo and WHO-UMC were the most reported CA tools for studies examining inter-rater and intra-rater reliability. Naranjo commonly received a 'fair' agreement level while WHO-UMC received a 'substantial' agreement level between raters. Along with kappa statistics, time using the CA tool was also analyzed, with WHO-UMC being the most time-efficient. There does not appear to be one CA tool that can be applied universally to pharmacovigilance efforts in hospital in-patient settings.

Keywords: Adverse drug reaction; adverse drug event; causality analysis; inter-rater; intra-rater reliability; medication harm.