pharmacovigilance
- Guideline or reference source
- WHO Glossary
- Definition
- The process and science of monitoring the safety of medicines and taking action to reduce risks and increase benefits from medicines. Pharmcovigilance includes: - Collecting and managing data on the safety of medicines - Looking at the data to detect ‘signals’ (any new or changing safety issue) Evaluating the data and making decisions with regard to safety issues - Acting to protect public health (including regulatory action) Communicating with stakeholders - Audit, both of the outcomes of action taken and of the key processes involved. Those directly involved in pharmacovigilance include: - Patients as the users of medicines - Doctors, pharmacists, nurses and all other healthcare professionals working with medicines and regulatory authorities responsible for monitoring the safety of medicines - Pharmaceutical companies, and companies importing or distributing medicines
- Narrower Term
- undefined data pharmacovigilance
- vaccine pharmacovigilance
- Related Term
- safety
- safety reports
- safety signal
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