Методика Оценки Риска Снижения Качества Лекарственных Средств В Территориальном Сегменте Сферы Обращения Лекарственных Средств На Примере Свердловской Области

Abstract

Abstract. Introduction. At the present stage of the development of the drugs quality control system in the Russia, studies of the balance of control measures for the movement of goods and the qualitative characteristics of certain types of activities in the field of drug circulation are of interest. The purpose of the study is a situational analysis of the balance of the drugs quality control system measures at the stages of drug distribution in the segment of the regional pharmaceutical market on the example of the Sverdlovsk region by forming a risk transfer matrix to diagnose the risk of drug quality reduction at the regional level. Materials and methods. Structural and functional analysis of medicines quality control system. Content analysis of normative documentation. Results and discussion. Identification and procedural structuring of the key processes of the system were carried out, a risk transfer matrix was formed, its key characteristics were developed and justified. The existing approach to selective control does not take into account the points of concentration of turnover, which leads to an unbalanced coverage of control measures between wholesale and retail agents of the pharmaceutical market. Conclusion. The existing approach to the selection of control objects in the territorial segment of the medicines quality control system can be harmonized by shifting the emphasis towards wholesale pharmaceutical activities with increased validation of product-oriented procedures of intra-company quality management system of wholesale trade enterprises. In the Sverdlovsk region, there are prerequisites for strengthening the qualification measures of the quality management system with the involvement of an additional regional laboratory complex of the medicine's quality control.