Pharmacovigilance
As per WHO, pharmacovigilance is the science and activities related to the detection, assessment,
understanding and prevention of adverse effects or any other medicine-related problems.
Adverse Event
An adverse event is any unwanted or unexpected sign, symptom or health problem that occurs during a
medicine course or treatment. It does not have to be caused by the medicine, but reporting it helps
determine whether there is a relationship between the event and the medicine.
Why Reporting Matters
Medicines are carefully tested before approval, but some side effects only become known after a medicine
is widely used. Everyone’s body reacts differently; what is rare in clinical trials may appear once
thousands of people use the medicine.
By reporting adverse events, you help us identify issues early, take action to protect patients and
ensure that the benefits of medicines continue to outweigh the risks.
What Is the Minimum Amount of Information Needed for a Report?
- An Identified Reporter
- An Identifiable Patient
- A Suspected Adverse Reaction
- A Suspected Product