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. 2025 Sep 10:16:1680239.
doi: 10.3389/fphar.2025.1680239. eCollection 2025.

Pharmacovigilance practice on off-label high-dose of vancomycin in severely ill children

Min Qin  1 , Wenwen Chen  1 , Bin Lu  2 , Yi Deng  1
Affiliations

Pharmacovigilance practice on off-label high-dose of vancomycin in severely ill children

Min Qin et al. Front Pharmacol. .

Abstract

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 of vancomycin treatment in 39 PICU patients from January to June 2020 were conducted.

Findings: Among the 39 patients, 20 (51.3%) received off-label high-dose vancomycin dosing, and only 53.8% (21/39) underwent blood concentration testing. Five patients (25%; 5/20) in the off-label use group experienced vancomycin-associated adverse reactions, including three cases of severe ones. Based on risk factor analysis, we implemented improvement measures such as increasing the monitoring of vancomycin trough serum concentration, providing individualized drug regimens, enhancing 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 observed. 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 providers should pay special attention to this in clinical medication safety practices.

Keywords: acute kidney injury; child; off-label; pharmacovigilance; vancomycin.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
The schematic diagram of included patients.
FIGURE 2
FIGURE 2
The correlation between vancomycin dosage and concentration (r = 0.03, p = 0.85).
See this image and copyright information in PMC

References

    1. Akunne O. O., Mugabo P., Argent A. C. (2022). Pharmacokinetics of vancomycin in critically ill children: a systematic review. Eur. J. Drug Metab. Pharmacokinet. 47, 31–48. 10.1007/s13318-021-00730-z - DOI - PMC - PubMed
    1. Clinical Pharmacology Group of Pediatric Branch of the Chinese Medical Association Subspecialty Group of Pediatric Clinical Pharmacology Society of Pediatrics Chinese Medical Association (2015). Expert consensus on therapeutic drug monitoring for children. Chin. J. Pediatr. 53, 650–659. 10.3760/cma.j.issn.0578-1310.2015.09.005 - DOI
    1. Darko W., Guharoy R. (2003). Mississippi mud no more: cost effectiveness of pharmacokinetic dosage adjustment of vancomycin to prevent nephrotoxicity. Pharmacotherapy 23, 8. 10.1592/phco.23.5.643.32199 - DOI - PubMed
    1. Diorio C., Robinson P. D., Ammann R. A., Castagnola E., Erickson K., Esbenshade A., et al. (2018). Guideline for the management of Clostridium difficile infection in children and adolescents with cancer and pediatric hematopoietic stem-cell transplantation recipients. J. Clin. Oncol. 36, 3162–3171. 10.1200/JCO.18.00407 - DOI - PMC - PubMed
    1. Downes K. J., Cowden C., Laskin B. L., Huang Y.-S., Gong W., Bryan M., et al. (2017). Association of acute kidney injury with concomitant vancomycin and piperacillin/tazobactam treatment among hospitalized children. JAMA Pediatr. 171, e173219. 10.1001/jamapediatrics.2017.3219 - DOI - PMC - PubMed