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Russian pharmacovigilance: ways to improve efficiency

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1. Title Title of document Russian pharmacovigilance: ways to improve efficiency
2. Creator Author's name, affiliation, country Alexandra A. Taube; Scientific Centre for Expert Evaluation of Medicinal Products; Russian Federation
2. Creator Author's name, affiliation, country Irina Y. Evko; Saint Petersburg University of Chemistry and Pharmacy; Russian Federation
2. Creator Author's name, affiliation, country Svetlana V. Sinitova; Saint Petersburg University of Chemistry and Pharmacy; Russian Federation
2. Creator Author's name, affiliation, country Anatoly E. Krasheninnikov; National Pharmacovigilance Research Center; Russian Federation
2. Creator Author's name, affiliation, country Marina V. Zhuravleva; Scientific Centre for Expert Evaluation of Medicinal Products; Russian Federation
2. Creator Author's name, affiliation, country Boris K. Romanov; Pirogov Russian National Research Medical University; Russian Federation
2. Creator Author's name, affiliation, country Renad N. Alyautdin; Scientific Centre for Expert Evaluation of Medicinal Products; Russian Federation
3. Subject Discipline(s)
3. Subject Keyword(s) holders of the registration certificate; safety of medicines; adverse reactions; continuing education; distance learning; authorized person for pharmacovigilance; pharmacovigilance
4. Description Abstract

The paper presents the results of a survey of pharmacovigilance specialists’ awareness of the regulation of reporting on adverse drug reactions, self-assessment of their competencies and readiness for distance learning, creation of a generalized portrait of a pharmacovigilance specialist to create mechanisms for improving pharmacovigilance activities, and continuing education of pharmacovigilance specialists. The results of the correlation analysis of the knowledge of pharmacovigilance specialists with their self-assessment of their position are reflected. Information-analytical and sociological (survey) methods and descriptive statistics were used. A questionnaire consisting of 31 items was developed for the survey. The first part of the questionnaire consisted of general questions, such as on education, work experience in the pharmaceutical field and pharmacovigilance, and position held. The second part focused on the structure of pharmacovigilance in the organization of holders of the registration certificate. The third part consisted of 17 items aimed at identifying the level of knowledge concerning the immediate daily activities in pharmacovigilance and knowledge of the legislative framework. The final element was a question about the attitude to distance learning. Specialists working in the field of pharmacovigilance at enterprises and persons authorized for pharmacovigilance objectively assessed their practical knowledge and skills in the field of drug safety. Moreover, 42 (72%) respondents believe that they do not need to update their knowledge on pharmacovigilance, whereas 51 (87%) people successfully passed the proposed survey on knowledge of current legislation. Employees of senior positions showed higher knowledge in the field of pharmacovigilance. Specialists and senior pharmacovigilance specialists need to increase their level of professional knowledge, and they are aware of the need for further training.

5. Publisher Organizing agency, location Eco-Vector
6. Contributor Sponsor(s) (056-00005-21-02)
7. Date (DD-MM-YYYY) 20.04.2022
8. Type Status & genre Peer-reviewed Article
8. Type Type Research Article
9. Format File format PDF (Rus),
10. Identifier Uniform Resource Identifier https://journals.eco-vector.com/1682-7392/article/view/89665
10. Identifier Digital Object Identifier (DOI) 10.17816/brmma89665
10. Identifier Digital Object Identifier (DOI) (PDF (Rus)) 10.17816/brmma89665-80927
11. Source Title; vol., no. (year) Bulletin of the Russian Military Medical Academy; Vol 24, No 1 (2022)
12. Language English=en ru
13. Relation Supp. Files Fig. 1. Questionnaire for employees of the pharmacovigilance department of organizations holding registration certificates (1MB) doi: 10.17816/brmma89665-61397
Fig. 2. Distribution of survey participants on the self-assessment of the level of knowledge in the field of pharmacovigilance (65KB) doi: 10.17816/brmma89665-61398
Fig. 3. Division of survey participants’ responses by the presence of a pharmacovigilance department (82KB) doi: 10.17816/brmma89665-61399
Fig. 4. Distribution of survey participants by departments conducting pharmacovigilance activities (67KB) doi: 10.17816/brmma89665-61400
Fig. 5. Determination of survey participants by the number of employees in the departments responsible for pharmacovigilance activities (52KB) doi: 10.17816/brmma89665-61401
Fig. 6. Distribution of survey participants by their positions (86KB) doi: 10.17816/brmma89665-61402
Fig. 7. Frequency of the survey participants’ reference to the Decision of the Eurasian Economic Union â„– 87 (52KB) doi: 10.17816/brmma89665-61403
Fig. 8. Distribution by sections to which survey participants most often refer (347KB) doi: 10.17816/brmma89665-61404
Fig. 9. Distribution of survey participants by test results (73KB) doi: 10.17816/brmma89665-61405
Fig. 10. Distribution of results of the survey participants by their positions (173KB) doi: 10.17816/brmma89665-61406
Fig. 11. Distribution of the survey participants by criteria: confidence in their knowledge/number of points scored (138KB) doi: 10.17816/brmma89665-61407
14. Coverage Geo-spatial location, chronological period, research sample (gender, age, etc.)
15. Rights Copyright and permissions Copyright (c) 2022 Taube A.A., Evko I.Y., Sinitova S.V., Krasheninnikov A.E., Zhuravleva M.V., Romanov B.K., Alyautdin R.N.
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