Why pharmacovigilance is needed in every country:

There are differences among countries (and even regions within countries) in the occurrence of ADRs and other drug-related problems.This may be due to differences in e.g.:

❖ diseases and prescribing practices;
❖ genetics, diet, traditions of the people;
❖ drug manufacturing processes used which influence pharmaceutical quality and composition;
❖ drug distribution and use including indications, dose and availability;
❖ the use of traditional and complementary drugs (e.g. herbal remedies) which may pose specific toxicological problems,when used alone or in combination with other drugs.

Data derived from within the country or region may have greater relevance and educational value and may encourage national regulatory decision-making. Information obtained in one country (e.g. the country of origin of the drug) may not be relevant to other parts of the world, where circumstances may differ. Therefore, drug monitoring is of tremendous value as a tool for detecting ADRs and specifically in relation to counterfeit and substandard quality products. ADR monitoring is to help ensure that patients obtain safe and efficacious products. The results of ADR monitoring have also a very important educational value.