Pharmacovigilance strategies

Pharmacovigilance strategies

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It is an essential component of patient care and rational use of medicines. It is also variously referred to as adverse drug reaction monitoring, drug safety surveillance, side effect monitoring, spontaneous reporting, post-marketing surveillance or variations of these.

Pharmacovigilance involves the safety monitoring of all medicines including herbal and complementary remedies, vaccines and biological substances.

Smart Safety Surveillance (3S): Multi-Country Experience of Implementing the 3S Concepts and Principles

Minimum Requirements for a functional Pharmacovigilance System: 

Pharmacovigilance (PV) is well established in most industrialized countries but its practice in low and middle income countries is variable with some countries having absolutely no systems at all whilst a few have systems comparable to the best in industrialized countries. In view of the importance of pharmacovigilance to all countries, the World Health Organization, upon request from the Global Fund against AIDS, TB and Malaria (Global Fund) and key multilateral and technical agencies, has embarked upon an extensive and wide ranging consultative process to produce a Pharmacovigilance Strategy for use by all countries that are seeking to advance PV systems, through the Global Fund and similar health initiatives. The process includes the identification of (and the specifications for) the minimum requirements for PV. For more information, you can access the document.