ABSTRACT
OBJECTIVE: To analyze 13 judicial precedents involving off-label drug use and explore the legal interpretation on off-label drug use in China in order to provide experience for establishment of off-label drug use and clinical application. METHODS: Based on the law databases (China Judgements Online, Chinalawinfo, Jufaanli, Itslaw), 13 cases were searched and screened involving legal off-label drug use. The relationship was investigated and discussed between different results and characteristics of the 13 cases. RESULTS: In 13 cases, there are 2 cases probably reasonable for off-label use, 2 cases unreasonable but not correlated with patients′ outcomes, 9 unreasonable and with a causal relationship with patients′ outcomes. In the 9 unreasonable cases, there are 4 cases without sufficient evidence, 3 cases without informed consent, 1 case lack of monitoring after off-label use, 1 case with idiosyncratic reaction, and 1 case not consistent with the label of the drug used. CONCLUSION: Major deficiencies of off-label drug use in China are without sufficient evidence, lack of informed consent and with uncompleted system on off-label drug use. Establishing more completed and detailed system, investigating enough clinical evidence, better informed consent and monitoring after off-label use are important measurements to ensure safety on off-label drug use.
ABSTRACT
The research group has built appraisal system of Examination Quality measurement indices on the basis of the present research result of examination quality and the use of more advanced theory and method of educational measurement and educational statistics.According to the feedbackof examination,the examination quality measurement indices are divided into the measurement of test questions,test paper and test achivement,based on which,the mathematical model of Examination Analysis Quality is developed,and through the research and practice,the easy-to-operate software of the feasible examination quality analysis system is developed to realize the standardization,formatting and scientification of the evaluation of examination quality