Why postmarketing surveillance and reporting ADR is needed:

The information collected during the pre-marketing phase of drug development is inevitably incomplete with regard to possible ADRs. This is mainly because :

❖ Tests in animals are insufficient to predict human safety;
❖ Patients used in clinical trials are selected and limited in number, the conditions of use differ from those in clinical practice and the duration of trials is limited;
❖ By the time of licensing exposure of less than 5000 human subjects to a drug allows only the more common ADR to be detected;
❖ At least 30,000 people need to be treated with a drug to be sure that you do not miss at least one patient with an ADR which has an incidence of 1 in 10,000 exposed individuals;
❖ Information about rare but serious adverse reactions, chronic toxicity, use in special groups (such as children, the elderly or pregnant women) or drug interactions is often incomplete or not available;

Thus, post-marketing surveillance is important to permit detection of less common, but sometimes very serious ADRs. Therefore health professionals worldwide should report on ADRs as it can save lives of their patients and others.