Organisation of the Russian Pharmacovigilance System: Survey of Pharmacovigilance Officers

Abstract

Ensuring the safety of pharmacotherapy is a priority of the national regulatory health policy and is enshrined in the international and federal legislation. Survey of qualified pharmacovigilance experts on current problems in pharmacovigilance is one of the tools for improving the pharmacovigilance system efficiency. The aim of the study was to analyse the Russian pharmacovigilance system organisation based on the results of a survey of pharmacovigilance officers. Materials and methods: the authors carried out a survey of 26 pharmacovigilance officers from pharmaceutical companies. Results: the majority of the respondents (50%) had short work experience in this area and combined pharmacovigilance duties with other functions in the company. At the same time, 73.08% of the respondents noted the lack of full-time pharmacovigilance staff in the company. According to the respondents, one of the most important problems in organising pharmacovigilance in the Russian Federation is a low level of staff qualification, which stems from the lack of specific pharmacovigilance courses at medical universities. The lack of qualified staff hinders the preparation of periodic and routine pharmacovigilance reports (according to 67.1% of the respondents) as well as the implementation of critical pharmacovigilance processes, e.g., risk management, and organisation of the pharmacovigilance quality management system. In addition, the paper discusses the issues of state support of private pharmacovigilance activities and the creation of a consolidated system for promoting consumer awareness about pharmacovigilance. Conclusions: the improvement of the pharmacovigilance system should be based on: state oversight of the authorised regulatory and supervisory bodies, marketing authorisation holders, and professional communities; joint efforts on the part of professional communities and educational institutions in order to train staff in practical pharmacovigilance aspects — as part of post-graduate and professional education programmes; adequate reflection of pharmacovigilance problems and potential solutions in the mass media.