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Approaches to evaluating the effectiveness of the pharmacovigilance system in the Republic of Kazakhstan
- Authors: Taube A.A.1, 2 2
- Affiliations:
- Saint-Petersburg State Chemical Pharmaceutical University, Saint-Petersburg, Russian Federation
- Scientific Centre for Expert Evaluation of Medicinal Products, Moscow, Russian Federation
- Issue: No 3 (2023)
- Pages: 207-213
- Section: Articles
- URL: https://remedium-journal.ru/journal/article/view/1655
- DOI: https://doi.org/10.32687/1561-5936-2023-27-3-207-213
- Cite item
Abstract
The aim: based on the analysis of data from the official website of the current system for collecting spontaneous reports of adverse events in the Republic of Kazakhstan, to formulate approaches to the effective functioning of the pharmacovigilance system. Materials and methods. Methods of content analysis, synthesis and analysis, structural-logical, statistical. Materials open data of the official website of the Republic of Kazakhstan on spontaneous reports submitted for the period 2018—2022. Results. An analysis of the dynamics of the number of received spontaneous messages showed the absence of a linear trend in the development of this type of activity in the pharmacovigilance system. The largest number of notifications were submitted at the initial stage of pharmacovigilance development in 2018—2019. The leaders in filing notifications are: Pavlodar region (29 per 100 thousand), Almaty city (21 per 100 thousand), Aktobe region (16 per 100 thousand) and Shymkent city (15 per 100 thousand). The smallest number of messages was received from the Turkestan region (1 per 100 thousand). In first place in terms of the number of notifications submitted in 2022— GSK Kazakhstan LLP — 18%. Analysis of the structure of reports received by manufacturers in general terms is characterized by the predominance of reports of ADRs on drugs imported from non-CIS countries. It was revealed that the pharmacovigilance system of the Republic of Kazakhstan is characterized by harmonization with international pharmacovigilance systems, instability in the number of spontaneous reports received. Every month, the results of identified ARs appear in the public domain on the official website. It was determined that there is no information about submitted yellow cards from pharmacy workers and patients, or these subjects of drug circulation do not participate in the spontaneous reporting system. Conclusion. The greatest contribution to spontaneous reporting systems is made by medical organizations of the Republic of Kazakhstan. It is necessary to create institutional mechanisms to strengthen the work of the system of spontaneous reporting.
About the authors
Aleksandra A. Taube
Saint-Petersburg State Chemical Pharmaceutical University, Saint-Petersburg, Russian Federation
Email: taubeaa@expmed.ru
2
Scientific Centre for Expert Evaluation of Medicinal Products, Moscow, Russian Federation
Email: 002
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