PHARMACOVIGILANCE IN HEMOTHERAPY: MONITORING TRANSFUSION REACTIONS AND PATIENT SAFETY

Resumo

Pharmacovigilance and haemovigilance are complementary and fundamental areas for ensuring
transfusion safety in hemotherapy. This simple abstract addresses the concepts, classification of
transfusion reactions, protocols for reporting and investigation, the role of the clinical pharmacist,
electronic monitoring systems, epidemiological data in Brazil, current challenges, and the guidelines
of ANVISA and the Brazilian Society of Hematology and Hemotherapy (SBHH). The research
includes normative analysis, review of technical-scientific literature, assessment of recent national
epidemiological data, and examination of monitoring systems and emerging technologies. The
regulatory advances of RDC nº 34/2014 and IN nº 196/2022 are highlighted, as are multidisciplinary
approaches, the use of the Notivisa system, the evolution of compliance indicators, challenges related
to underreporting and professional qualification, and international trends such as AI integration in
pharmacovigilance processes. These strategies underpin the continuous improvement of patient safety,
process quality, and national institutional effectiveness