Analysis of drug safety risk factors in medical organizations of Moscow in 2020 2022

  • Authors: Kuznetsova E.V.1, Zhuravleva M.V.2, Mikhailov I.A.3, Khabriev R.U.4
  • Affiliations:
    1. Research Institute of Healthcare Organization and Medical Management, Moscow, Russia
    2. Scientific Centre for Expert Evaluation of Medicinal Products, Moscow, Russia
    3. Center 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, Russia
    4. N. A. Semashko National Research Institute of Public Health, Moscow, Russian Federation
  • Issue: No 1 (2024)
  • Pages: 4-9
  • Section: Articles
  • URL: https://remedium-journal.ru/journal/article/view/1696
  • DOI: https://doi.org/10.32687/1561-5936-2024-28-1-4-9
  • Cite item

Abstract


Aim. 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.

About the authors

Elena V. Kuznetsova

Research Institute of Healthcare Organization and Medical Management, Moscow, Russia

Email: e.v.kuznetsova132@gmail.com

Marina V. Zhuravleva

Scientific Centre for Expert Evaluation of Medicinal Products, Moscow, Russia

Email: zhuravleva@expmed.ru

Ilya A. Mikhailov

Center 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, Russia

Email: mikhailov@rosmedex.ru

Ramil U. Khabriev

N. A. Semashko National Research Institute of Public Health, Moscow, Russian Federation

Email: institute@nriph.ru

References

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