Model of a risk-based approach in the implementation of pharmaceutical activities
- Authors: Melnikova O.A.1, Smirnov A.V.2, Marchenko S.D.3, Melnikov M.Y.1
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Affiliations:
- Ural State Medical University
- Sverdlovsk Regional Medical College
- The First Sechenov Moscow State Medical University (Sechenov University)
- Issue: Vol 71, No 2 (2022)
- Pages: 41-48
- Section: Articles
- URL: https://journals.eco-vector.com/0367-3014/article/view/113638
- DOI: https://doi.org/10.29296/25419218-2022-02-07
- ID: 113638
Cite item
Abstract
Introduction. This paper analyzes the general situation of drug supply and builds a mathematical model for improving the quality of pharmaceutical services based on an analysis of licensing requirements and conditions using the Sverdlovsk region as an example. Objective: to identify risk-based points in the implementation of pharmaceutical activities and build a mathematical model of the impact of the quality of education of pharmaceutical specialists on the pharmaceutical services provided. Material and methods. Data from the Unified Register of Licenses of Roszdravnadzor. The analysis was carried out by the method of content analysis. Results. It is shown that in the pharmaceutical market there are certain features, expressed in a legal nature, associated with licensing and the risk-based approach used in organizing inspections. The paper describes situations related to the stages and issues of licensing, and schemes with risk points for obtaining a license for pharmaceutical activities, the possibility of self-assessment of compliance with licensing requirements. The organizational and legal forms and their attractiveness for entering the market of the Sverdlovsk region are described. It is noted that conditionally these requirements can be divided into four stages. The first requirement relates to the assessment of the premises, the organization of their functioning, compliance with sanitary and hygienic requirements. The second requirement relates to the formation of a system for accounting and preparation of equipment for the placement of medicines. The third scheme describes the training of specialists involved in pharmaceutical activities, and the fourth one deals with the validation of the main business processes. A mathematical model has been developed that links consumers, the demand for medicines, and the professional qualifications of a specialist with a pharmaceutical education. It is concluded that licensing requirements set a barrier that improves the quality of drug provision and increases the social well-being of the population. Conclusion. Currently, it is necessary to improve the quality of drug provision by improving the quality of education of pharmaceutical workers through the accreditation procedure.
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About the authors
Olga Alexandrovna Melnikova
Ural State Medical University
Author for correspondence.
Email: newfarmacia@mail.ru
Professor of the Department of Management and Economics of Pharmacy and Pharmacognosy
Alexander Vadimovich Smirnov
Sverdlovsk Regional Medical College
Email: alr.smrnv@gmail.com
Head of the Center for Promotion of Employment of Graduates
Sevara Dzhurabekovna Marchenko
The First Sechenov Moscow State Medical University (Sechenov University)
Email: kafcd@mail.ru
Ph.D., Associate Professor of the Department of Organization and Management in the Sphere of Medicines Circulation, IPO
Mikhail Yurievich Melnikov
Ural State Medical University
Email: sasha-ber73@mail.ru
Associate Professor of the Department of Pharmacy
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