Objectives
To analyze the labeling of drug items for patients with renal insufficiency in our hospital so as to provide reference for rational use of drugs.
Methods
The drug instructions used in No.1 Hospital of Jilin University in 2017 were collected. According to the classification of pharmacology, the instructions of the top 9 drugs system were selected. The annotation of drug items for patients with renal insufficiency in these pharmaceutical instructions was analyzed.
Results
A total of 812 drug instructions were included, in which 72.17% did not mark drug instruction for renal insufficiency patients. According to the administration system, the highest unlabeled rate were digestive system drugs; according to the method of administration, the highest unlabeled rate was external preparation of drugs, accounting for 83.33%; according to production enterprises, the highest unlabeled rate were domestic drugs, accounting for 75.55%. There were only 23.40% of the tagging items having guidance of medication, and some with a certain degree of confusion in the annotation.
Conclusion
The unlabelling situation of drug instructions for renal insufficiency patients is very serious. It should arouse the attention of pharmaceutical manufacturers and the pharmaceutical supervisory department is suggested to strengthen the supervision of drug instructions and regulate the contents of drug labeling in drug instructions, so as to guide the rational use of drugs in clinical practice.
国内、外药企由于生产和实验条件不同，其药品说明书存在一定程度的差异。美国 FDA 及欧盟国家对药品说明书的书写出台了相关法律、指南和原则，将药品说明书可读性纳入到药品注册的法规要求之中，保证了其境内药品说明书的客观性、合理性，使得广大的药品说明书阅读人群从中受益，这对于我国有着良好的借鉴意义。由于我国药品说明书不够完整和规范，很多关键项目缺失，如缺乏临床或非临床试验数据支撑，将造成其科学性不强，在临床实践中指导合理用药的意义不大，说明书形同虚设[16, 17]。我们的调查结果显示与国产药相比，进口药的未标注率较低，说明国外药品说明书的完善程度较好。建议我国相关部门应参考美国 FDA 及欧盟国家先进的管理方式、管理理念和规范宗旨，使药品说明书的信息更准确、规范。
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