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Classification of existing problems in the Russian pharmacovigilance system 10.47093/2218-7332_2018.3.59-63

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The pharmacovigilance system currently represents as a complex of interstate, state, departmental and public institutions. This system provides the receipt and processing of information about facts and circumstances that pose a threat to life or health for person who using drugs at all stages of life cycle of drugs. In addition, in the framework of pharmacovigilance activities, a continuous evaluation benefit and risk of the use of registered and developed drugs. On the way to its formation, the Russian pharmacovigilance system is face a challenge with a spectrum of problems, including the fragmentation of the conclusions formulated and the identification of polymorphic "targets" for the subsequent appropriate managerial decisions at pharmacovigilance field. Classification of existing problems at the field of pharmacovigilance is the technique of integration variety of studied objects to several systematized groups for the subsequent high-level review of the way for optimization and the possibilities for increasing its effectiveness. The results of the studies using methods of content analysis of publications of pharmacovigilance, statistical analysis of spontaneous reports and a sociological survey made it possible to identify a number of problems in the Russian pharmacovigilance system that were grouped of five types: political, organizational, information, cultural and personal. These analyzes allow us to determine the way for further research of the possibilities for increasing the effectiveness of the pharmacovigilance system based on the integrated development of ways for optimize the activity of the leading pharmacovigilance subjects in five problem areas.

About the Authors

B. K. Romanov
N.I. Pirogov Russian National Research Medical University; Scientific Center of Expertise of Medical Applications
Russian Federation

A. E. Krasheninnikov
National Pharmacovigilance Research Center
Russian Federation


1. Федеральный закон от 12.04.2010 №61-ФЗ «Об обращении лекарственных средств». Российская газета. 2010; 78.

2. Dal Pan G.J. Ongoing challenges in pharmacovigilance. Drug Saf J 2014; 37 (1): 1-8.

3. Dikshit R.K. Challenges in pharmacovigilance. Indian J Pharmacol 2010; 42 (6): 333.

4. Aljadhey H. A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia. Saudi Med J 2015; 36 (9): 1097-102.

5. Хосева Е.Н., Морозова Т.Е. Проблемные аспекты развития системы фармаконадзора в Российской Федерации на современном этапе (обзор). Качественная клиническая практика. 2013; 3.

6. Прытков В.П. Познавательные функции и типология научных проблем. Теория и практика общественного развития. 2013; 5.

7. Анохин А.М., Веденская Т.Е. Проблемы типологии в экологическом научном знании. Общество: философия, история, культура. 2017; 7. cle/n/problemy-tipologii-v-ekologicheskom-nauchnom- znanii


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ISSN 2218-7332 (Print)
ISSN 2658-3348 (Online)