Russian pharmacovigilance: ways to improve efficiency
- Authors: Taube A.A.1, Evko I.Y.2, Sinitova S.V.2, Krasheninnikov A.E.3, Zhuravleva M.V.1, Romanov B.K.4, Alyautdin R.N.1
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Affiliations:
- Scientific Centre for Expert Evaluation of Medicinal Products
- Saint Petersburg University of Chemistry and Pharmacy
- National Pharmacovigilance Research Center
- Pirogov Russian National Research Medical University
- Issue: Vol 24, No 1 (2022)
- Pages: 81-90
- Section: Research paper
- URL: https://journals.eco-vector.com/1682-7392/article/view/89665
- DOI: https://doi.org/10.17816/brmma89665
- ID: 89665
Cite item
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.
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About the authors
Alexandra A. Taube
Scientific Centre for Expert Evaluation of Medicinal Products
Email: taubeaa@expmed.ru
ORCID iD: 0000-0001-5594-4859
SPIN-code: 7634-4399
candidate of pharmaceutical sciences
Russian Federation, MoscowIrina Y. Evko
Saint Petersburg University of Chemistry and Pharmacy
Email: irina.Evko@pharminnotech.com
SPIN-code: 9788-4091
Russian Federation, Saint Petersburg
Svetlana V. Sinitova
Saint Petersburg University of Chemistry and Pharmacy
Email: Svetlana.Sinitova@pharminnotech.com
SPIN-code: 9181-9011
Russian Federation, Saint Petersburg
Anatoly E. Krasheninnikov
National Pharmacovigilance Research Center
Email: anatoly.krasheninnikov@drugsafety.ru
ORCID iD: 0000-0002-7791-6071
SPIN-code: 8670-9991
Russian Federation, Moscow
Marina V. Zhuravleva
Scientific Centre for Expert Evaluation of Medicinal Products
Author for correspondence.
Email: zhuravleva@expmed.ru
ORCID iD: 0000-0002-9198-8661
SPIN-code: 6267-9901
Scopus Author ID: 55878917900
Russian Federation, Moscow
Boris K. Romanov
Pirogov Russian National Research Medical University
Email: bkr@yandex.ru
ORCID iD: 0000-0001-5429-9528
SPIN-code: 8453-9166
Russian Federation, Moscow
Renad N. Alyautdin
Scientific Centre for Expert Evaluation of Medicinal Products
Email: Alyautdin@expmed.ru
ORCID iD: 0000-0002-4647-977X
SPIN-code: 1722-1817
Scopus Author ID: 6701792451
ResearcherId: L-9261-2014
doctor of medical sciences, professor
Russian Federation, MoscowReferences
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