Abstract

Post-marketing surveillance requires the establishment of a system to monitor drug effects in real-world practice, including the collection and analysis of safety data after marketing authorization, known as pharmacovigilance (PV). Healthcare professionals are key elements in PV, as they are directly involved in prescribing, dispensing, and monitoring drug therapy. Their knowledge, clinical experience, and direct access to patients are crucial for the timely detection, assessment, and minimization of risks related to drug use. Objectives: The main objective of our study is to assess the knowledge and attitudes regarding the PV system among active stakeholders - healthcare professionals (medical doctors, pharmacists, and nurses/medical technicians employed in various positions) and medical students. Materials and methods: The research was designed as a descriptive-analytical cross- sectional study with MCQ test prepared for assessing the knowledge and attitudes of healthcare professionals and third-year medical students regarding the PV system. Results: According to this study, employed participants were better informed about the PV system and highly noligable on reporting of adverse reactions, mandatory data in the report as well possible changes in the SmPC and PIL based on reported adverse reactions, and the duties and responsibilities of the QPPV Students demonstrated statistically significantly lower knowledge compared to employed participants, particularly regarding where adverse reactions are reported (75% vs. 100%, p=0.000072), mandatory data in the report (87.76% vs. 100%, p=0.002661), possible changes in SmPC and PIL (73.47% vs. 92.86%, p=0.000381), conditions to report (69.39% vs. 82.86%, p=0.017804), responsibilities of the QPPV (77.55% vs. 95.71%, p=0.016367), and where risk minimization measures are described (65.31% vs. 82.86%, p=0.000271). Conclusion: These findings highlight the need for systematic strengthening of educational content and continuous medical education in PV, with an emphasis on practical examples, simulations, and direct exposure to adverse reaction reporting procedures.

Keywords

healthcare professionals, students, pharmacovigilance system, knowledge and attitudes