REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot169610.32687/1561-5936-2024-28-1-4-9Original ArticleAnalysis of drug safety risk factors in medical organizations of Moscow in 2020 2022KuznetsovaElena V.e.v.kuznetsova132@gmail.comZhuravlevaMarina V.zhuravleva@expmed.ruMikhailovIlya A.mikhailov@rosmedex.ruKhabrievRamil U.institute@nriph.ruResearch Institute of Healthcare Organization and Medical Management, Moscow, RussiaScientific Centre for Expert Evaluation of Medicinal Products, Moscow, RussiaCenter of Expertise and Quality Control of Healthcare, Moscow, Russia, N. A. Semashko National Research Institute of Public Health, Moscow, Russian Federation, Russian Medical Academy for Continuous Professional Education, Moscow, RussiaN. A. Semashko National Research Institute of Public Health, Moscow, Russian Federation1512202414915102025Copyright © 2024,2024Aim. To perform a comprehensive analysis of drug safety risk factors over time in medical organizations in Moscow in 2020 2022. Materials and methods. We used the following materials notifications of an adverse reaction or lack of therapeutic effect of a drug for 2020 2021 and 2022 3933 pieces. The study took place in 2 stages. At the 1st stage of the study we performed a comprehensive analysis of the database of spontaneous reports of adverse reactions arising from the use of drugs for 2020 2021 and 2022 by constructing data distributions in various sections with subsequent assessment of the statistical significance of the identified differences. At the 2nd stage of the study we used regression analysis to identify the most significant factors and indicators that determine the safety of the use of drugs in medical organizations in Moscow and the differences in these factors for 2020 2021 and 2022. We used multivariate regression analysis in a linear model. Results. It was found that more often compared to other adverse reactions were observed in patients aged 19 45 years 285 notifications p 0.0193. The most significant factors determining the safety of the use of drugs in 2020 in medical organizations in Moscow were the trade name and manufacturer of the drug. In 2021 such factors were the medical organization in which the drug was used and the conditions for providing medical care. Such changes in the most significant factors compared to 2020 may be associated with the novel coronavirus infection COVID 19 pandemic. The most significant factors in 2022 there were factors similar to 2021. Conclusion. In the absence of significant organizational changes in the healthcare system under the influence of external factors for example the COVID 19 pandemic drug safety is primarily determined by the factors of the manufacturer and trade name of the drug that is the conditions of production and storage of drugs. And in conditions of significant organizational changes in the healthcare system under the influence of external factors drug safety is determined primarily by the conditions of medical care and the medical organization in which medical care is provided.drug safety, internal quality control and safety of medical activities, risk based approach, pharmacovigilance, drugsлекарственная безопасность, внутренний контроль качества и безопасности медицинской деятельности, риск ориентированный подход, фармаконадзор, лекарственные препараты1.Avtonomov D. L., Ryabchunova L. V., Zakatilova D. A. et al. Undesirable adverse reactions to drugs in a multidisciplinary hospital. Mnogoprofil`ny`j stacionar. 2018;5(1):22—24.2.Demchenkova E. Yu., Gorodetskaya G. I., Mazerkina I. A. et al. Major aspects of detection and monitoring of adverse reactions associated with cephalosporin antibiotic treatment. Safety and Risk of Pharmacotherapy. 2021;9(1):34—42.3.Antropova G. A., Okonenko T. I., Sviridenko M. S. Drug safety: pharmacovigilance in the region. Vestnik Novgorodskogo gosudarstvennogo universiteta. 2021;(1):71—75.4.Glagolev S. V., Gorelov K. V., Chizhova D. A. Russian pharmacovigilance in a newly regulated environment: two-year results and prospects. Remedium. 2019;(3):8—14.5.Krasheninnikov A. E., Matveev A. V., Egorova E. A. Development and implementation of information databases of adverse reactions into the pharmacovigilance system and their importance in improving the safety of medicines. Journal of Volgograd State Medical University. 2018;(3):8—12.6.Kugener V. F., Freedland E. S., Maynard K. I. et al. Enhancing pharmacovigilance from the US experience: current practices and future opportunities. Drug Saf. 2021;44(8):843—852.7.van Leeuwen B., Edwards B. The road to pharmacovigilance outsourcing guidance. Ther. Innov. Regul. Sci. 2021;55(2):408—414.8.Montastruc J.-L., Bondon-Guitton E., Abadie D. et as. Pharmacovigilance, risks and adverse effects of self-medication. Therapie. 2016;71(2):257—262.9.Peters T., Soanes N., Abbas M. et al. Effective pharmacovigilance system development: EFPIA-IPVG consensus recommendations. Drug Saf. 2021;44(1):17—28.10.Kuznetsova E. V., Zhuravleva M. V. Assessment of the functioning of the system for monitoring the effectiveness and safety of pharmacotherapy in medical organizations of the state healthcare system of the city of Moscow. Works of graduate students of the Research Institute of Healthcare Organization and Medical Management: Collection of scientific works of graduate students. Moscow;2023:124—134.11.Hans M., Gupta S. K. Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices. Perspect. Clin. Res. 2018;9(4):170—174.12.Du W., Guo J. J., Jing Y. et al. Drug safety surveillance in China and other countries: a review and comparison. Value Heal J. Int. Soc. Pharmacoeconomics Outcomes Res. 2008;11(Suppl 1):S130—S136.