Pharmacovigilance - An International Perspective

Dr. Shobha Rani R. H.

Introduction : The first major drug related disaster recorded involved Sulfanilamide elixir responsible for the death of 107 children as early as 1937. This was followed by many more such cases such as that of thalidomide (1961), practolol (1974), phenformin (1982) to mention but a few. It was after the thalidomide incident in 1961 that some systematic efforts began in the direction of addressing issues of drug safety. The 16th World Health Assembly (1963) adopted a resolution that reaffirmed the need for early action in regard to rapid dissemination of information on adverse drug reactions and led, later, to creation of the WHO Pilot Research Project for International Drug Monitoring in 1968. The purpose of this was to develop a system, applicable internationally, for detecting previously unknown or poorly understood adverse effects of medicines. The practice of the science of pharmacovigilance emerged as a result of these modest beginnings.

In this article, an attempt is made to look into the methods of pharmacovigilance and status of pharmacovigilance in the world today.


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