Physician's guide to pharmacovigilance: Terminology and causality assessment

Abstract 

Adverse drug events can range from mild to life threatening reactions resulting in inconvenience or serious morbidity and mortality besides being a financial burden on the society. However clinicians often do not recognize this drug related harm. The terms used to describe these events with medication use cause much confusion. Moreover manifestations of adverse drug reactions can be non-specific making it difficult to differentiate from current illness. To determine the likelihood of relationship between the drug and the event assessment of causality is done. The purpose of this article is to review and clarify the terms encompassing the discipline of pharmacovigilance and also to outline the steps in causality assessment with the help of an actual case report.

Keywords: Adverse drug events, Drug related harm, Pharmacovigilance, Causality assessment