Pharmacovigilance - drug safety

Medicines may affect the body in unintended, harmful ways. These effects, called side effects, adverse events or adverse reactions, represent risks of medicines.

It is important to identify, as quickly as possible, new risks or changes to the known risks associated with the use of medicines. Actions must be taken to minimise the risks, maximise the benefits and promote safe and effective use of medicines by patients.

These activities are known as pharmacovigilance:

• The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
• An activity contributing to the protection of patients’ and public health.