Klin Farmakol Farm. 2026;40(3):181-185 | DOI: 10.36290/far.2026.014
Farmakovigilancia: pilier bezpečnej farmakoterapie a jej význam v klinickej praxi
- Ústav farmakológie a klinickej farmakológie LF UK, Bratislava
Farmakovigilancia (PhV) predstavuje v súčasnej medicíne kľúčový proces dohľadu nad bezpečnosťou liekov po ich uvedení na trh. Podľa definície Svetovej zdravotníckej organizácie (WHO) ide o vedu a činnosti zamerané na detekciu, hodnotenie, poznanie a prevenciu nežiaducich účinkov liekov. Hlavným poslaním systému je maximalizácia terapeutických prínosov a minimalizácia rizík pre pacienta. Článok analyzuje metódy identifikácie rizík v klinickej praxi, predovšetkým pasívnu farmakovigilanciu, založenú na spontánnych hláseniach, ako aj aktívne a stimulované formy monitoringu. Práca vychádza zo slovenského regulačného rámca a praxe, zdôrazňuje úlohu Štátneho ústavu pre kontrolu liečiv (ŠÚKL) ako národnej autority Slovenskej republiky integrovanej do medzinárodných sietí pod záštitou Európskej liekovej agentúry a WHO. Globálny prístup k PhV, ktorý využíva analýzu dát z reálnej praxe (Real-World Data), umožňuje včasnú detekciu zriedkavých rizík a prijímanie regulačných opatrení vrátane deregistrácie rizikových liečiv. Funkčný systém farmakovigilancie je nevyhnutným predpokladom bezpečného používania liekov a budovania dôvery verejnosti vo farmakoterapiu.
Klíčová slova: farmakovigilancia, nežiaduce účinky liekov, bezpečnosť pacienta, ŠÚKL, EMA, spontánne hlásenia.
Pharmacovigilance: a pillar of safe pharmacotherapy and its importance in clinical practice
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.
Vloženo: 28. leden 2026; Revidováno: 1. duben 2026; Přijato: 13. duben 2026; Zveřejněno: 14. říjen 2026 Zobrazit citaci
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