Pharmacoeconomical analysis of adverse reactions caused by investigational medical products in russian clinical trials
In recent years, amid the rapid development of the pharmaceutical market, the introduction of new drugs, there has been a trend towards an increase in the number of reports of adverse drug reactions (ADR) sent to Federal Service for Surveillance in Healthcare (Roszdravnadzor). The enhancement of adverse drug reactions is an important additional factor in increasing the direct costs of treating a particular disease and can even out the difference in the cost of drug therapy when conducting comparative clinical and economic research. The aim of our study was to conduct an economic assessment of the costs of adverse drug reactions during the drug therapy using the examples (или based on the examples) of domestic clinical and economic research. The search for clinical and economic studies was carried out on the basis of the eLIBRARY. RU database. The key words of the search were: “side effect”, “adverse drug reaction”, “adverse event”, “costs”. Clinical, economic and pharmacoeconomic studies conducted in the territory of the Russian Federation from 2014 to 2017 were selected for the analysis. A total of 44 papers from 754 publications found were selected for the further analysis. Among the main nosologies, the 1st place in the number of studies containing information about ADR was taken by Oncology (16 publications), the 2nd place - “Rheumatology (8 publications), the 3rd place - “Cardiology” (5 publications). When analyzing the costs of correction of the adverse drug reactions, it was revealed that the total costs for the Oncology profile for 1 year amounted to 943,928 rubles, and for the Rheumatology profile - 145,976 rubles. At the same time, the relative costs of correcting such adverse drug reactions amount to only 2-10% of total costs. The cost of the correction of the adverse drug reaction of profile "Cardiology" for 1 year amounted to 76,981 rubles. The conducted literature review demonstrates the importance of estimating the cost of correcting side-effects of adverse drug reactions during drug therapy, since they make a significant contribution to the structure of the direct costs of therapy for various diseases.
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