ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1680239
This article is part of the Research TopicPharmacist and patient safety: Focus on drug safetyView all 4 articles
Pharmacovigilance practice on off-label high-doseuse of Vancomycin in Severely Ill ill Children
Provisionally accepted
- School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
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Purpose To investigate the safety of off-label high-dose vancomycin use in severely ill children and explore strategies to control risks. Methods A case of acute kidney injury caused by off-label high-dose vancomycin (exceeding 40 mg/kg/day) in the Pediatric Intensive Care Unit (PICU) was analyzed. A retrospective case-control review The treatment of vancomycin treatment in 39 PICU patients from January to June 2020 were investigatedconducted. Findings Among the 39 patients, 20 (51.3%) received off-label high-dose vancomycin dosing, and only 53.8% (21/39) underwent blood concentration testingvancomycin dosage were off-label, and the blood concentration testing rate was only 53.8% (21/39). Five patients (25%; 5/20) in the vancomycin off-label use group were experienced vancomycin-relatedvancomycin-associated adverse reactions, included including three cases of severe ones. Based on risk 设置了格式: 字体: 非加粗 factor analysis, we implementedproposed improvement measures such as increasing the monitoring rate of vancomycin trough serum concentrationlevels, providing individualized drug regimens, enhancingstrengthening training, and formally documenting off-label drug use. After implementing these measures from July 2020 to December 2022, a total of 86 children in the PICU were treated with vancomycin, and no cases of vancomycin-associated acute kidney injury was observednone of them developed vancomycin-related kidney injury. The monitoring rate of vancomycin blood concentration increased to 88.4% (76/86). Implications There is a risk of renal function damage when using high dosage of vancomycin in severely ill children, and healthcare providerspharmacists should pay special attention to this in clinical medication safety practices.
Keywords: Vancomycin, off-label, Acute Kidney Injury, Child, Pharmacovigilance
Received: 05 Aug 2025; Accepted: 01 Sep 2025.
Copyright: © 2025 Qin, Chen, Lu and Deng. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Wenwen Chen, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
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