Development of Pharmacovigilance Culture

Abstract

The history of international pharmacovigilance goes back as much as fifty years, with the thalidomide tragedy in the early 1960s, in which many thousands of congenitally deformed infants were born as the result of in utero exposure to a medicine. As a result, the Sixteenth World Health Assembly in 1963 adopted a resolution (WHA 16.36) that reaffirmed the need for early action with regard to the rapid dissemination of information on adverse drug reactions. This resolution led to the creation of the WHO Pilot Research Project for International Drug Monitoring in 1968. Since its inception, the project has evolved into the WHO Program for International Drug Monitoring, which is coordinated by the Uppsala Monitoring Centre in Uppsala, Sweden, and has 118 official member states, and 29 associate member states. The last few decades have also seen a major increase in the public availability and access to medical and biopharmaceutical information in many respects pharmacovigilance. The WHO defines pharmacovigilance as “the science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines”. Effective Communications in pharmacovigilance is a “public health activity with profound implications that depend on the integrity and collective responsibility of all parties – consumers, health professionals, researchers, academia, media, biopharmaceutical industry, drug regulators, governments and international organisations – working together. “Together the best practices described within each of these phases of pharmacovigilance combine to form a ‘Gold Standard’ of a robust pharmacovigilance system.