B.K. Romanov1,2, A.E. Krasheninnikov 3
1 — Federal State Budgetary Educational Institution of Higher Professional Education «Pirogov Russian National Research Medical University». Russian Ministry of Health, Moscow, Russia;
2 — Federal State Budgetary Institution «Scientific Center for Expertise of Medicinal Products», Ministry of Health of Russia, Moscow, Russia;
3 — ANO National Scientific Center for Pharmacovigilance, Moscow, Russia

The pharmacovigilance system is currently a complex of interstate, state, departmental, and public institutions. This system provides obtaining and processing information about facts and circumstances that pose a threat to human life or health during the use of medicines at all stages of the life cycle of a medicinal product. In addition, as part of pharmacovigilance activities, there is an ongoing assessment of the benefit-risk ratio of registered drugs and drugs in development.

The Russian pharmacovigilance system faces a spectrum of problems on its way to the formation, including fragmented formulation of conclusions and identification of polymorphic «targets» for subsequent adoption of appropriate management decisions in the field of pharmacovigilance.

Typologization of existing problems in the field of pharmacovigilance is a method of reducing the variety of objects under study into several systematized groups for subsequent consolidated analysis of directions to optimize the mechanisms of this system and the possibilities of improving its effectiveness.

The results of the study, using methods of content analysis of publications on pharmacovigilance, statistical analysis of spontaneous reports, and a sociological survey allowed us to identify a number of problems in the national system of pharmacovigilance of the Russian Federation, which was grouped into five types: political, organizational, informational, cultural and personal.

These analyses allow us to identify areas for further research on opportunities to improve the effectiveness of the pharmacovigilance system based on the comprehensive development of ways to optimize the activities of the leading actors of pharmacovigilance in five problem areas.

Full text: Typology of problems in the Russian pharmacovigilance system