ADDRESSING PHARMACOVIGILANCE IN ROMANIAN LEGISLATION ON VACCINATION IN PHARMACY

Pharmacy-based vaccination services have developed in many countries, particularly in the wake of the COVID-19 pandemic, becoming increasingly regulated by authorities and supported by international pharmacists' organisations. The pharmacovigilance tasks of vaccinating pharmacists are particularly important for monitoring vaccine safety and increasing population confidence in vaccination, as a tool to protect public health. The aim of this paper was to analyse the provisions addressing pharmacovigilance in the Romanian legislation that applies to vaccination in pharmacy, to assess their suitability to this context. We used as materials the texts of the relevant normative acts, and as methods documentary research, thematic analysis and a pluralist method of legal interpretation. The Romanian legislation includes detailed provisions on the authorisation and organisation of influenza vaccination in community pharmacy under a pilot program, theoretical and practical training and evaluation of vaccinating pharmacists, including in pharmacovigilance of influenza vaccines, for patient monitoring and reporting adverse reactions to the competent authorities. Simplifying the reporting, by harmonising the forms and procedures used by the national immunization authority and the national pharmacovigilance authority, could stimulate the involvement of pharmacies in vaccination and in monitoring the safety of vaccines on the Romanian market. Pharmacists' and patients' associations could develop public health campaigns to educate the population about the safety and benefits of influenza vaccination.