Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (1). WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
- Meyboom RHB, Egberts ACG, Gribnau FWJ, Hekster YA. Pharmacovigilance in perspective. Drug Safety 1999; 21(6): 429-447. Abbing HDCR. Legal aspects of medical devices: Study on regulatory mechanisms for safety control. Health Services Research. IOS Press 1993: 358-361. Fracchia GN, Theofilatou M (eds); Mehta U, Milstien JB, Duclos P, and Folb PI. Developing a national system for dealing with adverse events following immunization. Bulletin of the World Health Organization 2000, 78(2), 170-177. Craven BM, Stewart GT, Khan M. Chan TYK. Monitoring the safety of herbal medicines. Drug Safety 1997; 17(4): 209-215.
- Effective communications in Pharmacovigilance. The Erice Report. International Conference on Developing Effective Communications in Pharmacovigilance, Erice, Sicily, 24-27 September 1997, at which a policy statement was drawn up known as The Erice Declaration.