Bogomolets National Medical University, Kyiv, Ukraine
The State Expert Center of the Ministry of Health of Ukraine, Kyiv, Ukraine
DOI 10.32782/2226-2008-2024-3-14
The rational use of antibacterial agents (ABAs) for systemic use is crucial to the pediatric population, since every year the above-mentioned drugs are most often prescribed to children under two years old, and inappropriate use of ABAs at an early age contributes to an increased risk of comorbidities in children.
The study aimed to analyze the frequency of adverse reactions in children to ABAs (by J01 antibacterial drugs for systemic use) in Ukraine during the period of 2018–2023 and highlight those that have the highest rates of adverse reactions.
Materials and methods. During the study, methods of system analysis, passive pharmacovigilance, spontaneous reports, and methods of statistical data processing were applied. General trends in the development of manifestations of adverse reactions in the form of exponential trends were determined with the calculation of the validity value of approximation. There were analyzed 3207 spontaneous card reports (Form No. 137/o) received by the State Expert Center of the Ministry of Health of Ukraine on cases of adverse drug reactions (ADRs) of ABAs in children during the entire study for 2018–2023.
Results. Analysis of the incidence of ADRs revealed the highest rate in ceftriaxone – 998 cases of ADRs. Ceftriaxone, cefotaxime, azithromycin, and moxifloxacin had a declining tendency of the adverse effects, while levofloxacin had an upward trend. The obtained results justify the necessity of strict control over the usage of antibacterial drugs, that might reduce undesirable adverse reactions from their use.
Key words: pharmacovigilance, pediatrics, adverse drug reactions, antibacterial medicinal agents, drugs safety.
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