WHO pharmacovigilance indicators: A practice manual for the assessment of pharmacovigilance systems

This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation. This should ensure its routine use in pharmacovigilance establishments.

Pharmacovigilance as a medical discipline is crucial in preventing medicine-related adverse effects in humans, promoting patient safety, and the rational use of medicines. The indicators proposed in this manual are based on the expected functions of pharmacovigilance centers as described in the WHO Minimum Requirements for a Functional Pharmacovigilance System