Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce risks and increase benefits from medicines. It is a key public health function.
- 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 health care professionals working with medicines
- Regulatory authorities including the EMEA and those in the Member States responsible for monitoring the safety of medicines
- Pharmaceutical companies, and companies importing or distributing medicines