What is pharmacovigilance?

• A. The science of detecting, assessing, understanding, and preventing adverse drug effects or other drug-related problems.
• B. The process of developing new medications.
• C. The regulatory framework for approving drugs.
• D. A method for evaluating the manufacturing quality of medications.

Answer: (A)

Pharmacovigilance is the ongoing practice of ensuring medicine safety by detecting, assessing, understanding, and preventing adverse drug effects and other drug-related problems. It involves collecting reports of adverse events, analyzing data to identify safety signals, and taking actions to reduce risk—such as updating labeling, issuing safety communications, or removing a drug from the market if needed. This field focuses on what happens after a drug is in use, emphasizing post-marketing surveillance and risk management to protect patients.

This is distinct from developing new medications, which is drug development; from the regulatory framework for approving drugs, which governs how a drug gets authorized for use; and from evaluating manufacturing quality, which deals with manufacturing processes and product quality control.