Introduction and evaluation of pharmacovigilance for beginners

Pushpraj P. Gawai


Drugs safety profile monitoring is an essential element for the effective use of medicines and for high quality medical care. Pharmacovigilance (PV), is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The PV comes in picture after elixir sulfanilamide tragedy of 1937 and in the late 1950s and early 1960s, more than 10,000 children in 46 countries were born with deformities such as phocomelia as a consequence of thalidomide use has opened the eyes of drug regulators as well as consumers to establish a way to ensure drug safety. The hospitalization due to adverse drug reaction (ADR) in USA is about or more than 10%. In addition, it is estimates that 15-20% of the hospital inpatient suffers from ADRs. Now the pharmacovigilance system is globalised, strengthen and systematized after the establishment of World Health Organization (WHO) Programme for International Drug Monitoring. The patient safety is now becoming the priority area of pharmaceuticals. In this article, we are describing brief history and introduction of PV that will help to understand PV for beginners.


Pharmacovigilance, Adverse drug reaction, Adverse Event, ICSR

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