Development of organizational technology for drug safety management in medical organizations based on a risk-based approach

  • Authors: Kuznetsova E.V.1, Zhuravleva M.V.2, Mikhailov I.A.3,4,5, Khabriev R.U.4
  • Affiliations:
    1. Research Institute of Healthcare Organization and Medical Management of the Moscow Healthcare Department
    2. Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
    3. Center of Expertise and Quality Control of Healthcare of the Ministry of Health of the Russian Federation
    4. N. A. Semashko National Research Institute of Public Health
    5. Russian Medical Academy for Continuous Professional Education
  • Issue: No 2 (2024)
  • Section: Общественное здоровье и организация здравоохранения
  • URL: http://bulleten-nriph.ru/journal/article/view/2752
  • DOI: https://doi.org/10.25742/NRIPH.2024.02.012
  • Cite item

Abstract


We used the following materials: notifications of an adverse reaction or lack of therapeutic effect of a drug for 2020, 2021 and 2022 (N=3933); questionnaires of experts in the field of pharmacovigilance and drug safety and questionnaires of medical specialists from medical organizations in Moscow (N=140); mathematical modeling results from previous research. During the development, the analytical method, classification analysis and SWOT analysis were used. Statistical processing of the survey results was performed by calculating the Kendall concordance coefficient and the nonparametric Friedman test. The developed standard operating procedure includes 8 main steps. The procedure is based on a step-by-step algorithm for selecting an antibacterial drug with the lowest risk in accordance with the clinical indications for use and the conditions for use of this drug, taking into account minimizing the total risk of these conditions, as well as taking into account the patient’s parameters. The possibilities of the procedure were identified as high prospects for the development of organizational technology by expanding the number of factors described by the mathematical model. The need to assess risks when using medications was most rated by experts (average value — 4.750 out of 5 points). The likelihood of reducing the financial costs of a medical organization by preventing the occurrence of adverse events was assessed as quite high (average value — 3.958 points). The need to assess risks when using medications was most rated by practicing medical specialists (average value — 4.466 points). The developed organizational technologies for managing drug safety in medical organizations based on a risk-based approach are effective and popular tools for ensuring the quality and safety of medical care for the population.


About the authors

Elena V. Kuznetsova

Research Institute of Healthcare Organization and Medical Management of the Moscow Healthcare Department

Author for correspondence.
Email: e.v.kuznetsova132@gmail.com
ORCID iD: 0000-0002-1262-4430

Russian Federation, Moscow, Russian Federation

Marina V. Zhuravleva

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation

Email: zhuravleva@expmed.ru
ORCID iD: 0000-0002-9198-8661

Russian Federation, Moscow, Russian Federation

Ilya A. Mikhailov

Center of Expertise and Quality Control of Healthcare of the Ministry of Health of the Russian Federation;
N. A. Semashko National Research Institute of Public Health;
Russian Medical Academy for Continuous Professional Education

Email: mikhailov@rosmedex.ru
ORCID iD: 0000-0001-8020-369X

Russian Federation, Moscow, Russian Federation; 105064, Moscow, Russian Federation; Moscow, Russian Federation

Ramil U. Khabriev

N. A. Semashko National Research Institute of Public Health

Email: institute@nriph.ru
ORCID iD: 0000-0003-2283-376X

Russian Federation, 105064, Moscow, Russian Federation

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