What is pharmacovigilance?

• A. All scientific and data gathering activities relating to the detection, assessment, understanding, and prevention of adverse events
• B. The daily reporting of blood pressure in clinical trials
• C. The process of manufacturing drug batches
• D. The assessment of efficacy in Phase III trials

Answer: (A)

Pharmacovigilance is the science and activities that focus on medicine safety after they are used by patients. It covers all scientific and data gathering efforts related to detecting, assessing, understanding, and preventing adverse events. The goal is to identify safety signals, evaluate whether a drug caused an adverse reaction, understand the risk, and take steps to minimize harm, such as updating labeling, informing health professionals and patients, or implementing risk management plans. This safety monitoring extends beyond the confines of a clinical trial into real-world use, including spontaneous reports, post-marketing surveillance, and ongoing risk-benefit assessment.

The other activities listed don’t align with this safety-centered, ongoing monitoring and prevention focus. For example, tracking a single variable like daily blood pressure in a trial is a specific data collection task within a study, manufacturing drug batches is quality control, and assessing efficacy in Phase III trials is about therapeutic benefit rather than safety surveillance.