pharmacovigilanceSystem

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Its principal aim is to ensure patient safety by monitoring medicines throughout their life cycle, from development through post-marketing use. The field focuses on adverse drug reactions (ADRs), drug interactions, medication errors, and quality defects that may affect safety or effectiveness.

Key activities include collecting data from spontaneous reporting systems, conducting active surveillance, and performing signal detection and causality assessment. Information sources include healthcare professionals, patients, clinical trials, electronic health records, medical literature, and regulatory reports. When signals are confirmed, risk assessment informs risk management actions such as labeling changes, safety communications, restricted use, or product withdrawal. Pharmacovigilance also supports benefit-risk evaluation to maintain a favorable therapeutic profile.

Regulatory context involves international and national efforts to coordinate safety monitoring. Worldwide, the World Health Organization coordinates international pharmacovigilance through the Uppsala Monitoring Centre. National agencies such as the U.S. Food and Drug Administration and the European Medicines Agency maintain regional systems like FAERS and EudraVigilance to collect safety reports and issue alerts.

Challenges and importance include under-reporting, data quality, confounding, and timely signal validation across diverse populations. Despite these challenges, pharmacovigilance is essential for detecting rare or long-term safety issues, informing clinicians and patients, and guiding regulatory decisions to minimize risk.