farmakovigilancija

Farmakovigilancija, or pharmacovigilance, is the science and activities involved in the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. Its primary aim is to ensure the safe and effective use of medicines through ongoing monitoring of their benefits and risks throughout a product’s life cycle.

Key activities include collecting and managing reports of adverse drug reactions (ADRs) from healthcare professionals and patients, maintaining and analyzing national and international safety databases, signal detection, causality assessment, and risk evaluation. Based on safety signals, regulators and sponsors implement risk minimization measures, update labeling, and may suspend or withdraw a product. Pharmacovigilance also encompasses the preparation of periodic safety updates and the management of safety communications to clinicians and the public.

Data sources for pharmacovigilance include spontaneous reporting systems, electronic health records, claims databases, literature reviews, clinical trial data, and patient registries. Common tools for signal detection and assessment include disproportionality analyses and standardized causality scales. Pharmacovigilance interacts with clinical practice, regulatory authorities, pharmaceutical manufacturers, and patients to balance drug benefits with potential harms.

Regulatory frameworks vary by country but share core principles. Globally, the World Health Organization coordinates international pharmacovigilance efforts; in Europe, the European Medicines Agency and national authorities oversee systems such as the EudraVigilance database, pharmacovigilance system master files (PSMF), and periodic safety update reports (PSURs). The field aims to protect public health by identifying risks early and communicating them effectively.