FAQ 5: What is Pharmacovigilance?

Pharmacovigilance

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.

The purpose of pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Recently, its concerns have been widened to include:(2)
• herbals
• traditional and complementary medicines
• blood  products
• biologicals
• medical  devices
• vaccines.
Many other issues are also of relevance to the science:
• substandard  medicines
• medication  errors
•  lack of efficacy reports
• use of medicines for indications that are not approved and for which there is inadequate scientific basis
•  case reports of acute and chronic poisoning
• assessment of drug-related mortality
•  abuse and misuse of medicines
•  adverse interactions of medicines with chemicals, other medicines, and food.
The specific aims of pharmacovigilance are to:
•  improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions,
•  improve public health and safety in relation to the use of medicines, •  contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and
• promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.(3)
Pharmacovigilance has developed and will continue to develop in response to the special needs and according to the particular strengths of members of the WHO Programme and beyond. Such active influence needs to be encouraged and fostered; it is a source of vigour and originality that has contributed much to international practice and standards.
References:
  1. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/
  2. 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.
  3. 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.
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