Abstract
Infectious diseases remain one of the main causes of population mortality around the world, therefore the circulation, control over the quality and safety of vaccines in almost all countries is under special state control and is carried out separately from other pharmaceuticals. The quality of vaccines and the effectiveness of the population vaccination process largely depend on compliance with the requirements regarding the temperature regime, which must be flawlessly fulfilled by all participants in the pharmaceutical supply chain – the vaccine manufacturer, transporter, distributor, pharmacy or health care institution, the final consumer of vaccines (patient).
The purpose of the work is to identify the risks present in the vaccine supply chain, in the management of stocks, storage and transportation of vaccines to health care facilities, as well as to investigate the priority of these risks in the supply chain of the COVID-19 vaccine.
The assessment of industry risks in the provision of vaccines against COVID-19 to health care facilities was carried out using the method of analyzing the types, consequences and criticality of failures (FMECA) with the accepted quantitative values of the assessment of the severity of consequences (S), the probability of occurrence (О) and the possibility of detection (D). The quantitative assessment of the risk value (R) was carried out according to the priority value of the RPN risk level. Identification of specific risks was carried out by the method of expert assessments. The method of data collection is a questionnaire.
Categories of general, industry and specific risks were defined. It was established that general risks arise at the national level of risks, and their prevention is in the sphere of public administration. The results of the general assessment of industry risks by the FMECA method indicate that the risk of unfair distribution of vaccines is one of the essential ones for stopping the pandemic and unnecessary deaths of the population (RPN = 40). According to the results of the questionnaire of the expert group, the most critical specific risk was the risk of virus variability (19% of the determined sample).
The obtained data indicate that the priority direction of reducing risks in the management of stocks, storage and transportation of vaccines to health care institutions is the implementation of state programs for building up own capacities for the production of vaccines.
Publisher
The State Expert Center of the Ministry of Health of Ukraine
Subject
Anesthesiology and Pain Medicine
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