pharmacovigilance
Start with the big picture
Pharmacovigilance brings together information and activities that help identify medicine-related harm, assess its possible causes, and guide steps to reduce risk. The lesson distinguishes adverse drug reactions from other problems such as medication errors, and introduces common ADR categories and sources of safety data, including spontaneous reports, surveillance, health records, registries, and literature. It also outlines international and national monitoring systems, pharmacists’ contributions to reporting and risk minimisation, and tools used for causality assessment. Further topics include signal detection and validation, risk-management measures, periodic safety reports, and ongoing benefit–risk assessment. Together, these concepts show how safety monitoring extends beyond a medicine’s approval and supports informed decisions about its use.
What you'll learn
- Define pharmacovigilance and describe its core aims.
- Distinguish adverse drug reactions from other drug-related problems.
- Identify common sources of pharmacovigilance data and reporting systems.
- Describe pharmacists’ roles in medicine-safety monitoring.
- Recognise the purpose of causality assessment, signal detection, and risk management.
Continue your study
Work through the complete notes and reinforce the topic with the study tools available in the full lesson.
