Klin Farmakol Farm. 2026;40(3):181-185 | DOI: 10.36290/far.2026.014

Pharmacovigilance: a pillar of safe pharmacotherapy and its importance in clinical practice

Monika Laššánová, Jana Tisoňová, Daniel Lutz

Ústav farmakológie a klinickej farmakológie LF UK, Bratislava

Pharmacovigilance (PhV) represents a key process in modern medicine for monitoring drug safety following market authorization. As defined by the World Health Organization (WHO), it encompasses the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs). The primary mission of the system is to maximize therapeutic benefits while minimizing risks to patients. This article analyses risk identification methods in clinical practice, focusing on passive pharmacovigilance based on spontaneous reporting, as well as active and stimulated monitoring. This study is based on the Slovak regulatory framework and practice, and highlights the role of the State Institute for Drug Control (ŠÚKL) as the national authority of the Slovak Republic, integrated into international networks under the auspices of the European Medicines Agency and the WHO. A global approach to PhV, utilizing Real-World Data analysis, facilitates the early detection of rare risks and the implementation of regulatory measures, including the withdrawal of high-risk drugs. An effective pharmacovigilance system is an essential prerequisite for the safe use of medicines and for building public trust in pharmacotherapy.

Keywords: pharmacovigilance, adverse drug reactions, patient safety, ŠÚKL, EMA, spontaneous reporting.

Received: January 28, 2026; Revised: April 1, 2026; Accepted: April 13, 2026; Published: October 14, 2026  Show citation