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

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.