Preliminary Results of a Novel Algorithmic Method Aiming to Support Initial Causality Assessment of Routine Pharmacovigilance Case Reports for Medication-Induced Liver Injury: The PV-RUCAM

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Erik ScalfaroDavid Lewis

Abstract

Data incompleteness in pharmacovigilance (PV) health records limits the use of current causality assessment methods for drug-induced liver injury (DILI). In addition to the inherent complexity of this adverse event, identifying cases of high causal probability is difficult. The aim was to evaluate the performance of an improved, algorithmic and standardised method called the Pharmacovigilance-Roussel Uclaf Causality Assessment Method (PV-RUCAM), to support assessment of suspected DILI. Performance was compared in different settings with regard to applicability and differentiation capacity. A PV-RUCAM score was developed based on the seven sections contained in the original RUCAM. The score provides cut-off values for or against DILI causality, and was applied on two datasets of bona fide individual case safety reports (ICSRs) extracted randomly from clinical trial reports and a third dataset of electronic health records from a global PV database. The performance of PV-RUCAM adjudication was compared against two standards: a validated causality assessment method (original RUCAM) and global introspection. The findings showed moderate agreement against standards. The overall error margin of no false negatives was satisfactory, wit...Continue Reading

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Jul 31, 2018·Expert Opinion on Drug Safety·Miren García-CortésUNKNOWN Spanish Group for the Study of Drug-Induced Liver Disease (Grupo de Estudio para las Hepatopatías Asociadas a Medicamentos G
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Aug 14, 2019·Toxicological Sciences : an Official Journal of the Society of Toxicology·Andreas BenesicAlexander L Gerbes
Aug 17, 2019·Frontiers in Pharmacology·Gaby Danan, Rolf Teschke

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