Abstract
Relevance. Surgical treatment of cardiovascular diseases with the use of artificial blood circulation is associated with the need to protect the myocardium. Various cardioplegic solutions are widely used in cardiac surgery to stop and protect the heart. Currently, a significant number of mixtures of drug solutions are used in "open" heart surgery. However, not all of them have been officially registered as cardioplegic solutions and not all have the appropriate indications in the instructions for medical use of the drug, which jeopardizes the safety and quality of medical care for patients. Goal. To study the pharmaceutical market of registered drugs for cardioplegia and to estimate the share of heart operations with the connection of artificial circulation performed without the use of officially registraited drugs for cardioplegia. Materials and methods. The following methods were used in the work: content analysis, statistical, marketing, graphic. The main information sources were: the State Register of Medicines; statistical indicators of surgical interventions in cardiac surgery, information on public procurement of medicines, instructions for the medical use of medicines, regulatory documents. Results. This study presents the results of a marketing analysis of the pharmaceutical market of drugs officially registered for cardioplegia. Three medicines have been registraited in Russia, which, in accordance with the instructions for use, can be used during surgical interventions in the quality of cardioplegic solutions. According to the ATC classification, all of them belong to the subgroup of the fifth level B05XA16 "Cardioplegic solutions". For the period 2018-2020. the volumes of purchases of cardioplegic solutions for the needs of medical organizations have been established and the volumes of drugs for surgical intervention in cardiac surgery during operations on the "open" heart have been determined. The comparison of morbidity rates and the estimated number of surgical interventions of the cardiac surgery service based on the data of public procurement of drugs for cardioplegia, revealed a discrepancy between the volumes of purchased cardioplegic solutions and the care provided. The data analysis shows that at least 23 thousand cardiac surgeries in Russia are performed annually without the use of registraited medicines for cardioplegia. Conclusion. When performing surgical interventions on an "open" heart with the connection of artificial blood circulation, it is necessary to use cardioplegic solutions that have an official indication in the instructions for medical use, in order to ensure the safety of patients and to perform medical interventions of appropriate quality.
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