Romanian Society of Pharmaceutical Sciences

« Back to Farmacia Journal 6/2023



Department of Pharmaceutical Legislation and Management, Faculty of Pharmacy, “Iuliu Haţieganu” University of Medicine and Pharmacy, 12 Ion Creangă Street, 400010, Cluj-Napoca, Romania

Download Full Article PDF

Community pharmacists are the health professionals that are the most accessible to ambulatory patients, being in the best position to assist them with the safe use of medicines. The aim of our paper was to analyse the legal and professional framework for the community pharmacists’ activity in Romania, to identify ways of expanding their roles in pharmacovigilance. To this end, we carried out documentary research and a thematic analysis in comparison with the Best Practice Paper on Pharmacovigilance and Risk Minimisation, which expresses the Pharmaceutical Group of the European Union (PGEU) policy regarding the European community pharmacists’ roles in pharmacovigilance. The Romanian standards of pharmacy education and training do not include pharmacovigilance among mandatory disciplines, contrary to the development and complexity of this field. The Romanian legislation acknowledges the community pharmacists’ competence, but it does not include all the roles they may play in pharmacovigilance. It only mentions informing patients about risks associated with dispensed medicines, monitoring flu vaccinated patients in community pharmacies and reporting adverse reactions to the competent authority. The ongoing regulatory process regarding pharmaceutical services may be beneficial for expanding the community pharmacists’ roles in pharmacovigilance, by setting specific standards for training and monitoring patient treatments. Building up a culture of pharmacovigilance, with expanded roles for community pharmacists, requires patient-centred education and training, legislation to include pharmaceutical services in the health insurance system and standards of professional ethics in pharmacovigilance.