Pharmacovigilance is 'the pharmacological science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem according to the World Health Organization (WHO). It is concerned with the post-marketing surveillance of medicines and the use of the information generated for education and effective drug regulation. Spontaneous (voluntary) ADR reporting contributes significantly to successful Pharmacovigilance. ADR- databases obtained from these reporting is enormously significant in ascertainment of the benefit-risk ratio of some drugs as well as in signal detection of unsuspected and unusual ADRs previously undetected in initial evaluation of a drug. This information may be useful in identifying and minimizing preventable ADRs while generally enhancing the knowledge of the prescribers to deal with ADRs more efficiently. At the same time proper ADR database contributes a lot in withdrawal of harmful drugs from the market. Under-reporting however remains a major draw-back of spontaneous reporting. Reasons for under-reporting include lack of knowledge, awareness, and training. Good ADR-database can be generated by encouraging the doctors for spontaneous reporting. Hence, every country needs an effectively functioning Pharmacovigilance programme and knowledge about the programme in health professional
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