Abstract

REVIEW ARTICLE ON CAUSALITY ASSESSMENT IN PHARMACOVIGILANCE

Sreejanya Athul and Ajith Babu T. K.*

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Abstract

Adverse drug reactions (ADRs) are a major cause of morbidity, hospital admission, and even death. Hence it is essential to recognize ADRs and to establish a causal relationship between the drug and the adverse event. An adequate causality classification of ADRs, especially in institutions providing high complexity assistance, may contribute to their early recognition, prevention of recurrence and optimization of drug therapy, thus improving the quality of patient care. There are some available tools with applicability for this classification, as algorithms, probabilistic approaches and global introspection methods. The World Health Organization-Uppsala Monitoring Center (WHO-UMC) system has been considered one of the most adequate method for establishing causal relationship in hospitalized patients.

Keywords: Adverse drug reactions, causality assessment, pharmacovigilance.