K. N. Koryanova, A. V. Matveev, E. A. Egorova, E. Yu. Bekirova. Features of International and Regional Pharmacovigilance Systems

UDК 314.04:330.322

DOI: https://doi.org/10.15507/2413-1407.112.028.202003.571-597

Introduction. Ensuring the safety of medicines is the basis for the existence and functioning of any pharmacovigilance system as a type of activity aimed at obtaining and processing information about the undesirable consequences of the use of medicines. The objective of the paper is to identify the features of functioning of international and regional pharmacovigilance systems on the basis of the study conducted.

Materials and Methods. To achieve the objective set, the authors have conducted a literature search and performed systemic analysis of the available publications and information presented on the websites of regulatory authorities in different countries. Comparative methods of analysis of the existing pharmacovigilance systems by the types of their organization and functioning in individual countries have been used with further analysis of the indicators of adverse drug reactions reporting.

Results. The performed analysis of the peculiarities of functioning of pharmacovigilance systems has made it possible to identify several types of collecting information on adverse drug reactions (the centralized, decentralized, and mixed types), as well as to determine their strengths and weaknesses. It has been revealed that the maximum indicator of the average number of received spontaneous reports of adverse drug reactions per 1 million people a year was registered in countries practicing the centralized type of pharmacovigilance organization. Lower rates have been observed in countries using the decentralized or mixed pharmacovigilance systems.

Discussion and Conclusion. The revealed features of the described approaches seem to be important for further improvement of the organization of work of the state system for monitoring the safety of medicines in the Russian Federation and the CIS countries. The use of the centralized type of organization of the pharmacovigilance system promotes active involvement of all actors involved in circulation of medicines, as well as helps to achieve a higher level of expert skills in assessing adverse drug reactions reporting, which contributes to the qualitative analysis of the information received and the timely adoption of regulatory decisions in order to improve safety of patients.

Keywords: pharmacovigilance, monitoring safety of medicines, international database of adverse reactions, organization of a pharmacovigilance system, actor involved in circulation of medicines, spontaneous reports of adverse drug reactions

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Submitted 21.05.2020; accepted for publication 26.06.2020; published online 30.09.2020.

About the authors:

Ksenia N. Koryanova, Lecturer, Department of Pharmacology with a Course in Clinical Pharmacology; Head of the Editorial and Publishing Department, Pyatigorsk Medical and Pharmaceutical Institute, branch of Volgograd State Medical University (11 Kalinina Ave., Pyatigorsk 357532, Russia), Ph. D. (Pharmaceutical Sciences), ORCID: https://orcid.org/0000-0003-1571-9301, kskor-16@mail.ru

Alexander V. Matveev, Associate Professor, Department of Internal Medicine No. 1 with a Course in Clinical Pharmacology, Georgievsky Medical Academy, Vernadsky Crimean Federal University (5/7 Lenina Blvd., Simferopol 295051, Russia), Ph. D. (Medical Sciences), ORCID: https://orcid.org/0000-0002-6636-3950, avmcsmu@gmail.com

Elena A. Egorova, Associate Professor, Department of Internal Medicine No. 1 with a Course in Clinical Pharmacology, Georgievsky Medical Academy, Vernadsky Crimean Federal University (5/7 Lenina Blvd., Simferopol 295051, Russia), Ph. D. (Pharmaceutical Sciences), ORCID: https://orcid.org/0000-0003-4012-2523, elena212007@rambler.ru

Elvira Yu. Bekirova, Associate Professor, Department of Dermatovenerology and Cosmetology, Georgievsky Medical Academy, Vernadsky Crimean Federal University (5/7 Lenina Blvd., Simferopol 295051, Russia), Ph. D. (Medical Sciences), ORCID: https://orcid.org/0000-0003-4097-2376, elvira8300@mail.ru

Contribution of the authors:

Ksenia N. Koryanova – choice of research methodology; writing the text of the article; search for analytical materials.

Alexander V. Matveev – statement of the research problem; scientific supervision; revision of the text of the article.

Elena A. Egorova – collection of materials and initiation of the study; critical analysis and revision of the text of the article.

Elvira Yu. Bekirova – choice of research methodology, writing the text of the article; search for analytical materials.

For citation:

Koryanova K.N., Matveev A.V., Egorova E.A., Bekirova E.Yu. Features of International and Regional Pharmacovigilance Systems. Regionology = Russian Journal of Regional Studies. 2020; 28(3):571-597. DOI: https://doi.org/10.15507/2413-1407.112.028.202003.571-597

The authors have read and approved the final version of the manuscript.
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