Drug safety monitoring Artykuł przeglądowy

Abstrakt

Pharmacovigilance plays a crucial role in ensuring patient safety through the systematic identification, assessment, and management of adverse drug reactions (ADRs), enabling continuous evaluation of drug safety profiles and supporting informed clinical decision-making. Core pharmacovigilance activities include spontaneous ADR reporting by healthcare professionals and patients, as well as the use of international safety databases such as EudraVigilance, FAERS, and VigiBase, which facilitate the detection of rare or long-term reactions that may not emerge during clinical trials. ADRs are defined as harmful and unintended responses to medicinal products and represent a significant clinical and public health concern. They may range from mild and transient symptoms to severe, life-threatening conditions, including hospitalization, disability, or death. ADRs can be classified according to their mechanism and predictability, with some reactions being dose-dependent and pharmacologically predictable, while others are rare, idiosyncratic, and difficult to anticipate. Despite its importance, underreporting remains a major global challenge, particularly in Poland, highlighting the need to increase awareness and engagement among healthcare professionals, especially family physicians who have comprehensive access to patient histories and are well positioned to identify potential ADRs. Additional tools, including Hazard Monitoring Systems and Direct Healthcare Professional Communications (DHPCs), support the dissemination of critical safety information and strengthen signal detection processes, ultimately enabling regulatory actions such as label modifications or drug withdrawals to protect public health.