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Zhang, Y., Sun, X., Wang, D., Hua, Y., Wang, G. & Ramalho, N. (2025). Exploring pediatricians’ off-label prescribing behavior in China: A theory of planned behavior-based study. International Journal of Clinical Pharmacy. 47 (6), 2072-2082

Y. Zhang et al.,  "Exploring pediatricians’ off-label prescribing behavior in China: A theory of planned behavior-based study", in Int. Journal of Clinical Pharmacy, vol. 47, no. 6, pp. 2072-2082, 2025

@article{zhang2025_1764931215329,
	author = "Zhang, Y. and Sun, X. and Wang, D. and Hua, Y. and Wang, G. and Ramalho, N.",
	title = "Exploring pediatricians’ off-label prescribing behavior in China: A theory of planned behavior-based study",
	journal = "International Journal of Clinical Pharmacy",
	year = "2025",
	volume = "47",
	number = "6",
	doi = "10.1007/s11096-025-02032-9",
	pages = "2072-2082",
	url = "https://link.springer.com/journal/11096"
}

TY  - JOUR
TI  - Exploring pediatricians’ off-label prescribing behavior in China: A theory of planned behavior-based study
T2  - International Journal of Clinical Pharmacy
VL  - 47
IS  - 6
AU  - Zhang, Y.
AU  - Sun, X.
AU  - Wang, D.
AU  - Hua, Y.
AU  - Wang, G.
AU  - Ramalho, N.
PY  - 2025
SP  - 2072-2082
SN  - 2210-7703
DO  - 10.1007/s11096-025-02032-9
UR  - https://link.springer.com/journal/11096
AB  - Introduction
Off-label prescribing, use of medications outside approved indications, dosages, administration routes, or age groups is common in pediatric clinical practice, largely because of the lack of high-quality clinical trials in children. Although such prescriptions can meet urgent therapeutic needs, particularly in complex or rare pediatric conditions, they also raise significant concerns regarding safety, effectiveness, and medicolegal liability. Limited research has examined the behavioral factors that influence pediatricians’ decisions to prescribe off-label drugs.
Aim
This study aimed to identify the behavioral determinants of pediatricians’ off-label drug use in Chinese hospitals by applying the Theory of Planned Behavior (TPB) to assess how behavior attitudes, subjective norms, and perceived behavioral control influence prescribing intentions and behaviors.
Method
A cross-sectional survey was conducted among pediatricians from 40 hospitals across seven provinces and municipalities in China. A TPB-based questionnaire was developed and refined through expert panel review and pilot testing. Structural equation modeling (SEM) was used to test the hypothesized relationships among the TPB constructs.
Results
A total of 350 questionnaires were distributed, of which 320 were returned (response rate: 91.4%). Most pediatricians acknowledged the necessity (82.4%) and risks (78.9%) of off-label use. Attitudes reflecting perceived benefits, safety concerns, and cost implications significantly predicted behavioral intention (? = 0.51, P < 0.01). Perceived behavioral control, including barriers such as outdated labeling, lack of pediatric formulations, and limited data, also predicted intention (? = 0.26, P < 0.01), but not behavior directly (? = 0.00, P = 0.12). Subjective norms such as institutional expectations and peer influence were positively associated with intention (? = 0.07, P < 0.01). Behavioral intention was the strongest predictor of actual off-label prescription behaviors (? = 0.16, P < 0.001). Most pediatricians (85.2%) supported pharmacists’ involvement in evidence reviews, documentation, and prescription oversight.
Conclusion
Pediatric off-label prescribing in China is largely intention-driven and shaped by behavior attitudes, perceived control, and professional norms. Interventions targeting these behavioral domains, along with institutional policies and pharmacist collaboration, may enhance the safety, consistency, and regulatory oversight of off-label drug use in pediatric care.
ER  -