ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1553221
This article is part of the Research TopicExploring Adverse Drug Reactions, Medication Adherence, and Forensic Markers in Pediatrics and ObstetricsView all 9 articles
Analysis of Off-Label Drug Use and Its Influencing Factors in Pediatric Otolaryngology, Head and Neck Surgery Patients
Provisionally accepted
- Beijing Tongren Hospital, Capital Medical University, Beijing, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Background: To date, there are limited data regarding off-label drug use in pediatric patients undergoing otolaryngology, head, and neck surgery. This study aimed to investigate the prevalence and patterns of off-label drug use among outpatients under 18 years of age in the Otolaryngology, Head, and Neck Surgery department, and to analyze the factors influencing such usage.Methods: A retrospective collection of data was conducted based on outpatient prescriptions for patients under 18 years of age who were visited from November 2023 to October 2024. Clinical pharmacists collected and analyzed off-label drug use. Univariate and multivariate logistic regression were employed to analyze the factors associated with off-label drug use.Results: In total, 22,487 prescriptions were included, of which 2,269 were off-label, resulting in an incidence rate of off-label drug use of 10.09%. Among 2,269 off-label prescriptions, the most common type was off-label population use (2,090 instances), accounting for 92.11%. The 2,269 off-label prescriptions encompassed 2,359 records of off-label drug use. Limonene and Pinene enteric capsules had the highest frequency of off-label use, with 1,523 records, representing 64.56% of all off-label uses. Multivariate logistic regression analysis showed that patients' age (OR = 1.341, 95% CI: 1.324 ~ 1.359, p = 0.000), number of prescribed drugs (OR = 1.597, 95% CI: 1.528 ~1.671, P < 0.001), and physician title were the factors associated with off-label drug use. Attending physicians (OR = 0.555, 95%CI: 0.458 ~ 0.673, p < 0.001), deputy chief physicians (OR = 0.770, 95%CI: 0.637 ~ 0.930, p = 0.007), and chief physicians (OR = 0.419, 95%CI: 0.347 ~ 0.507, p < 0.001) were less likely to have off-label drug use compared to resident physicians.Conclusion: These findings indicate that pediatric patients who are older and receive a greater variety of medications are more likely to use drugs off-label. In addition, resident physicians exhibit a higher susceptibility for off-label drug use compared to attending physicians, deputy chief physicians, and chief physicians.
Keywords: off-label, pediatric patients, Prescription, outpatient, Otolaryngology, Head and Neck surgery, influencing factor
Received: 30 Dec 2024; Accepted: 13 May 2025.
Copyright: © 2025 Ji, Wang and Wang. 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: Zichao Ji, Beijing Tongren Hospital, Capital Medical University, Beijing, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.