The study of risk management activities for quality of medicines at the wholesale stage




quality management system, quality risk management, risk-oriented thinking, wholesale trade of medicines


Aim. To analyze the state of implementation of risk management activities for quality in domestic organizations for wholesale trade of medicines.

Materials and methods. The works of domestic and foreign authors, international professional websites, methods of survey (questionnaire), analysis, systematization, generalization were used.

Results. During 2019-2020, the sociological study was carried out among the drug distribution organizations on the activities of risk management (RM) for quality. The survey showed that 78 % of employees involved in RM activities in the distribution organizations of medicines of Ukraine were specialists in quality management (assurance) subdivisions. 17 % of the respondents were employees of various departments. 5 % of the respondents stated that RM was performed jointly by quality management (assurance) departments and other divisions of the enterprise. More than 70 % of the respondents stated that when organizing RM activities they faced the problem of insufficient information on the methodology and practical aspects of RM in the drug distribution. 33 % of the respondents believed that they received the most important information about RM during thematic workshops, trainings and from external experts, consultants. 16 % of the respondents found the useful information on RM in guidelines and methodological materials, and 11 % of the respondents - in periodicals. Accordingly, 55 % of the respondents considered it necessary to develop comprehensive guidelines for RM methodology, and 28 % of the respondents agreed that these recommendations would be useful. According to 55 % of the respondents, the greatest problems in the implementation and operation of RM procedures were related to the training of the relevant specialists. When asked about the compliance of RM results with the expectations of management 88 % of the respondents answered that management was generally skeptical about this activity, perceiving RM only as a formal job, which presence was required by regulatory requirements.

Conclusions. The main problems with the effectiveness of RM activities are related to the lack of competence of the relevant specialists and their number, the lack of time to perform procedures to identify, analyze, assess and manage risks to the quality of drugs. Based on the data obtained we plan to form a set of proposals for the optimal organization of activities with RM of medicines in the drug distribution organization, in particular, to substantiate the set of competencies of RM specialists, as well as determine scientific and methodological approaches to the regulation and documentation of RM activities.

Author Biographies

N. V. Sukhanova, At Linde Gas Ukraine

Engineer for quality and control of medicines

V. O. Lebedynets, National University of Pharmacy

Doctor of Pharmacy (Dr. habil.), professor, head of the Department of Quality Management

O. V. Tkachenko, National University of Pharmacy

Candidate of Pharmacy (Ph.D.), associate professor of the Department of Quality Management


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Organizational and socio-economic bases of pharmaceutical activities