Pharmacovigilance

The World Health Organization defines pharmacovigilance (PV) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

The goals of PV are to bolster patient safety concerning medicine use by providing a system to collect, assess, and distribute drug safety data. PV activities involve monitoring approved drugs and investigational medicinal products (IMPs) to:

• Identify previously unknown adverse effects

• Recognize changes in the frequency or severity of known adverse effects

• Assess a drugs risk/benefit to determine if action is required to improve safety

• Ensure the accuracy of information communicated to healthcare professionals and patients, and to ensure information contained in patient information leaflets (PILs) is up to date