What exactly is an adverse event?

An adverse event is any undesirable experience associated with the use of a medical product or intervention in a patient. It can range from mild, temporary reactions to serious complications or even death, regardless of causality.

How does an adverse event differ from a side effect?

A side effect is a known, often anticipated, secondary effect of a medication or treatment. An adverse event, however, encompasses any undesirable or harmful incident associated with a medical product, whether expected, unexpected, or directly caused by the treatment.

Who is responsible for reporting adverse events?

Healthcare professionals (doctors, nurses, pharmacists) are primarily responsible for reporting. Patients, consumers, and caregivers can also report adverse events directly to regulatory bodies or through their healthcare providers.

Why is reporting adverse events important?

Reporting adverse events is crucial for patient safety, public health monitoring, and improving medical products. It helps regulatory agencies identify potential risks, update product information, and implement necessary safety measures to protect the public.