Model of a risk-based approach in the implementation of pharmaceutical activities

DOI: https://doi.org/10.29296/25419218-2022-02-07
Issue: 
2
Year: 
2022

O.A. Melnikova(1), A.V. Smirnov(3), S.D. Marchenko(2), M.Yu. Melnikov(1)
1-Ural State Medical University, Repina 3, Yekaterinburg, 620028, Russian Federation;
2-I.M. Sechenov First Moscow State Medical University (Sechenov University), st. Trubetskaya, d. 8, building 2, Moscow, 119048, Russian Federation;
3-Sverdlovsk Regional Medical College, Repina 2A, Yekaterinburg, 620014, Russian Federation

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.
Keywords: 
Key words: Licensing
drug supply
accreditation
pharmaceutical organization.
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