Studying the risks of drug provision for breast cancer patients in the public procurement system of Russia

Background. Breast cancer is a socially significant disease. In Russia, the drug provision of breast cancer patients at all stages of treatment is carried out within the public procurement (PP) system. A systematic risk analysis of the PPs of anticancer drugs is an essential requirement for the safety and effectiveness of chemotherapy treatment. Objective: identification of the main stages in the PPs of anticancer drugs used in breast cancer therapy; study and assessment of possible risks at each stage, development of a heat map of such risks. Material and methods . The methods of content and comparative analysis of scientific publications, legislative acts and protocols of open auctions, requests for quotations from four Russian oncological hospitals in the Southern and Central Federal Districts were used. In order to obtain a quantitative estimate of the overall risk for each group and to construct a risk heat map, the severity of consequences and the probability of risk occurrence were combined in a multiplicative model. Results . The key stages in the PPs of anticancer drugs were established to include tender planning, PP realization, government contract conclusion, and its implementation. At the stage of tender planning, the following groups of the risks were identified: the risk of delaying the implementation of innovative chemotherapy treatment regimens into the real clinical practice; the risk of prescribing the chemotherapy treatment regimens classified as an increased risk of adverse reactions; the risk of excessive uniformity and/or variety of dosage regiments. At the stage of PP realization and contract conclusion, the risks are related to a cancellation of the purchase and forced procurements of more affordable analogues. The stage of contract implementation involves the risks of reduced patient compliance due to the transfer of tablet drug forms to the ambulatory release; emergence of an urgent need for particular medicines due to changes in the treatment strategy; reduced effectiveness of thermolabile drugs due to a violation of the temperature regime of their transportation. The risk of forced procurements of more affordable analogues was rated as the highest level, while the risks of purchase cancellation and the emergence of an urgent need for medicines were ranked among the lowest. Conclusion . The results obtained may serve as a basis for improving the risk-based approach to PPs through minimizing negative consequences for patients, hospitals and the entire healthcare system.