Pharmacovigilance is the the science of detecting, assessing, understanding, responding and preventing adverse drug reactions, including reactions to vaccines. It is now an integral part of the regulation of drug and vaccine safety. Surveillance systems exist at national and international levels to ensure effective monitoring and prompt actions in response to AEFIs.

Pharmacovigilance requires that incidents of adverse events are detected, collected, analyzed and followed up. Some adverse events need to be reported and/or investigated, and you will need to know which to report, how and to whom. Causality assessment procedures also need to be carried out effectively.

This module introduces you to the concept of pharmacovigilance and describes national and international pharmacovigilance systems. It helps you to assess how to report an AEFI in the correct way and explains the procedure of causality assessment. Finally, you will look at the subject of risk/benefit assessment, including the factors that influence the balance between risks and benefits of vaccines, risk evaluation and options analysis.

Module outcomes

By the end of this module you should be able to: