Status Survey and Analysis on Package Inserts of Chinese Patent Drug / 中国中医药信息杂志

ABSTRACT

Objective To put forward suggestions for improving the writing standards of package inserts of Chinese patent drug in China. Methods Totally 84 package inserts of Chinese patent drug were chosen randomly. The labeled items in them would be investigated and analyzed according to legal documents in China. Results The rate of complete labeled items was 0%. Meanwhile, many problems existed in the items which affected medication safety seriously. In addition, there were defects in expression of the content, revision of package inserts of Chinese patent drug and so on. Conclusion It is urgent to improve the writing standards and the completeness of the labeled items as well as the scientificalness on the expressions of package inserts of Chinese patent drug.