Pharmacovigilance: An Overview

PV was officially introduced in December 1961 with the publication of a letter in The Lancet by Dr. William McBride, the Australian obstetrician who first suspected a causal link between serious fatal deformities (phocomelia), thalidomide used during pregnancy: Thalidomide was used as an anti-emetic and sedative agent in pregnant women. In 1968, the WHO promoted the ‘Programme for International Drug Monitoring’ a pilot project aimed to centralize world data on Adverse Drug Reactions (ADRs). In particular, the main aim of the “WHO Programme” was to identify the earliest possible PV signals. The term PV was proposed in the mid-70s by a French group of pharmacologists and toxicologists to define the activities promoting ‘The assessment of the risks of side effects potentially associated with drug treatment’. WHO defines PV as ‘the pharmacological science relating to the detection, assessment, understanding and prevention of ADRs, particularly long-term and short-term ADRs of medicines. PV serves various roles such as identification, quantification and documentation of drug-related problems which are responsible for drug-related injuries. PV is mainly the post marketing surveillance (phase-4 study) of drug development; the main objective of PV is to quantify previously Abstract