Abstract
Drug safety monitoring. Adverse events reporting in Poland – role of general practitioners
Polish Society of Pharmacovigilance, Warsaw, Poland
Collegium Medicum, University of Rzeszow, Rzeszow, Poland
Department of Neurology with Stroke Unit, St. Jadwiga Queen Clinical Hospital, Rzeszow, Poland
Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Poland
Family Medicine & Primary Care Review 2026; 28(3): 343–347
Pharmacovigilance plays a pivotal role in ensuring patient safety by identifying, assessing, and managing adverse drug reactions (ADRs). As every drug with therapeutic potency carries inherent risks, pharmacovigilance serves as a systematic approach to mitigate these risks, enhance understanding of drug safety profiles, and enable informed therapeutic decisions. Key activities include monitoring ADRs through spontaneous reporting by healthcare professionals and patients, maintaining safety databases like EudraVigilance, FAERS, and Vigi Base, and adhering to regulatory frameworks such as Directive 84/2010/EU and national laws. Spontaneous reporting remains a cornerstone of pharmacovigilance, particularly for identifying rare or long-term ADRs not detected in clinical trials. Despite its importance, underreporting is a global challenge, with Poland demonstrating notably low reporting rates. Addressing this issue requires increased awareness and engagement, particularly from family doctors who possess comprehensive patient records and insights into potential ADRs. Tools like the Hazard Monitoring System and Direct Healthcare Professional Communications (DHPCs) enhance the dissemination of critical safety information. Signal detection processes further refine the understanding of ADRs, enabling regulatory actions such as label updates or drug withdrawals. In conclusion, pharmacovigilance ensures the dynamic evaluation of drug safety, emphasizing the critical role of healthcare professionals in reporting ADRs and leveraging safety communications to protect patient health globally.
Keywords
pharmacovigilance, adverse drug reaction reporting systems, drug-related side effects and adverse reactions, primary health care
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