Pharmaco Vigilance and Adverse Drug Reaction Reporting

Abstract

Pharmaco vigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug – related problem. Various types of Adverse Drug Reactions are described, its mechanisms explained and the importance of recognizing it is mentioned. Training programmes to help detect ADRs are needed. The method of providing a proper ADR report is provided.

Monitoring of adverse drug reactions is an ongoing, ceaseless and continuing process. Given the limitation of clinical trials in identifying rare and delayed ADR‘s, and the need for comprehensive safety profiles, the importance of reporting ADR‘s cannot be over-emphasized. Given the limitation of clinical trials in identifying rare and delayed ADR’s, and the need for comprehensive safety profiles, the importance of reporting ADR‘s cannot be over-emphasized. Most of the time the ADRs mentioned in formularies is based on Western experience. ADR‘s in Indian population can differ, and it is important that we know ADR’s in Indian population and this can be known only if the ADR‘s are reported.