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Off-label prescriptions in intensive care unit: the Chinese experience

Authors Liu L, Yang H, Lou Y, Miao J, Lu X, Zhao Q, Wang R, Jiang S, Zhang X

Received 14 July 2017

Accepted for publication 21 November 2017

Published 31 January 2018 Volume 2018:14 Pages 195—202

DOI https://doi.org/10.2147/TCRM.S146425

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Hoa Le

Peer reviewer comments 2

Editor who approved publication: Professor Deyun Wang


Lin Liu, Hong-Yu Yang, Yan Lou, Jing Miao, Xiao-Yang Lu, Qing-Wei Zhao, Rong-Rong Wang, Sai-Ping Jiang,* Xing-Guo Zhang*

Department of Pharmacy, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China

*These authors contributed equally to this work


Background and purpose: Off-label prescriptions for critically ill patients pose several ethical and legal dilemmas for intensive care unit (ICU) clinicians. Yet, few data are available on the prevalence of this practice in critical care environment in China. This nationwide survey was performed to evaluate the conditions of off-label prescriptions in ICU within China.
Methods: The survey was performed at the scene of the national ICU conferences in 2016. ICU clinicians attending the congress from 23 provinces across the country were invited. The features of the clinician’s off-label prescription practice were investigated and analyzed.
Results: A total of 1,318 ICU clinicians completed the anonymous questionnaire. Of these, 76.2% prescribed off-label in clinical practice. A significant difference (p<0.005) was observed between the ICU clinicians with different years of working experience and professional levels, respectively. For 69.2% of the ICU clinicians, the proportion of off-label prescriptions did not exceed 10%, while for fewer prescribers (2.9%), the proportion exceeded 25%. The main reasons for off-label prescriptions were life-threatening or terminal medical condition without other substitutes (48.3%), new treatments with strong scientific evidence (38.1%), and limited indications of drug labels (22.7%). Of the ICU clinicians surveyed, 87.5% worried about causing medical disputes, and 26.5% encountered medical disputes caused by off-label prescriptions. The risk of medical disputes was positively associated with the proportion of off-label prescriptions (p=0.009). Among the ICU clinicians, 92.5% expected the national policy for off-label prescriptions in future. Gastrointestinal and respiratory drug classes were noted to have the highest prevalence of off-label use.
Conclusion: Off-label prescriptions have been commonly practiced by ICU clinicians in China. A concerted effort should be made to develop a practical and explicit guidance for off-label prescriptions.

Keywords: off-label prescriptions, intensive care unit, questionnaire, Chinese hospitals

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