Overview

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:

• 1describe the basic principles of pharmacovigilancePharmacovigilanceThe science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. and the special considerations that apply to vaccination programmes;
• 2use AEFI case definitions to evaluate which AEFIs should be detected and reported to the National regulatory authority (NRA)National regulatory authority (NRA)The regulatory body that approves procedures to ensure that medicines, including vaccines, are of adequate safety and potency. The vaccine manufacturer is responsible for demonstrating that the vaccine batch produced meets the requirements, based on the test specifications given by the NRA. The NRA is also responsible both for the official vaccine lot release process, based on the data and information provided by the manufacturer and, eventually, for confirmatory testing./Pharmacovigialnce center/Immunisation programme;
• 3describe the principles of risk-benefit analysisRisk-benefit analysisEvaluation and assessment of the relative risks and benefits of an intervention, e.g. the potential benefit of protection from measles and its complications due to vaccination, relative to the potential risk of adverse reactions to the vaccine. relative to the protective effect of immunization and the importance of causality assessmentsCausality assessment (or causality association)The systematic review of data about an AEFI case to determine the likelihood of a causal association between the event and the vaccine(s) received. to evaluate possible links between AEFIs and a vaccine, a specific lot or the immunisation procedure;
• 4explain the value of AEFI investigation and its key steps.