СИСТЕМНЫЙ АНАЛИЗ ПРИЧИН И ФАКТОРОВ НЕЖЕЛАТЕЛЬНЫХ РЕАКЦИЙ ПРИМЕНЕНИЯ ОМАЛИЗУМАБА

Abstract

The article presents a systematic analysis of the causes and factors of adverse reactions to the use of omalizumab. Methods of monitoring appeals, expert assessment, and interviewing medical specialists were applied. The analysis showed that in Russia there is a "declarative passivity" of medical workers and patients in relation to reports of adverse reactions to the use of omalizumab, which is associated with a high workload and reluctance on the part of medical workers to issue a notification, lack of knowledge about the procedure for notification, fear of being punished for possible incorrect actions on the use of the drug; on the part of patients – by not knowing their rights and the procedure for submitting a report, by fear of spoiling relations with the attending physician. Such passivity and closeness hinders the formation of a system for the prevention of drug safety violations. The data obtained in the course of the study (on the frequency and structure of adverse reactions to the use of omalizumab in clinical practice in children and adults; information on the most dangerous combinations of omalizumab with other drugs; The characteristics of the causes and factors of adverse reactions to the use of omalizumab, as well as the untimely submission of notifications about them, have become the theoretical basis for the development of recommendations for improving pharmacovigilance activities to ensure the safety of the use of omalisamab in children and adults, which includes 4 areas: creation of organizational conditions to ensure the safety of the use of omalisamab in children and adults in medical organizations; prevention of adverse reactions to the use of omalizumab at the preclinical stage; optimization of clinical choice and support for decision-making by a medical specialist (doctor) when prescribing omalizumab based on a risk-based approach, taking into account the individual characteristics of the patient and the clinical situation; improving the quality of safety monitoring of the use of omalizumab.