我院131份药品说明书【药物-乙醇相互作用】信息标注情况调查

Investigation and Analysis of Information Labeling for“Drug-ethanol Interaction”in 131 Drug Package Inserts of Our Hospital

目的:了解我院药品说明书【药物-乙醇相互作用(DEI)】信息的标注情况,为临床合理用药提供参考。方法:收集我院2017年有使用记录的药品说明书1 587份,根据《药品说明书和标签管理规定》《化学药品和生物制品说明书规范细则》对药品说明书中DEI信息进行统计、分析。结果:含DEI信息的药品说明书131份,其中口服剂型69份、注射剂型57份、外用剂型5份。无任何DEI标注信息的说明书占统计总数的91.75%。DEI信息分散在多个项目中,主要标注在【药物相互作用】和【注意事项】项下,分别占71.76%和21.37%。在DEI警示信息中,其对各系统用药的影响作用包括内分泌系统、心血管系统、中枢神经系统等。结论:建议有关部门在药品说明书标注规范中增加【DEI】专项,规范DEI的标注内容,包括DEI是否会影响药物疗效、DEI潜在安全性问题的警告等信息,为药品使用者提供准确的DEI信息,规避药品不良反应的发生。

OBJECTIVE：To investigate the information labeling for＂Drug-ethanol interaction（DEI）＂in drug package inserts of our hospital,to provide guidance for clinical rational drug use. METHODS：Collected 1 587 prescriptions for use in our hospital in 2017. DEI of drug package inserts were analyzed statistically according to Drug Pakcge Inserts and Label Management Regulation,Regulations for Chemical Drugs and Biological Products for Treatment. RESULTS：There were 131 drug package inserts containing DEI information,including 69 oral dosage forms,57 injection forms and 5 external dosage forms. The drug package inserts without any DEI warning remarks account for 91.75% of the total statistics. The information labeling for DEI was dispersed in multiple projects, mainly tagged in the term of ＂Drug Interaction＂ and ＂Precautions＂, 71.76% and 21.37%respectively. In the DEI warning remarks,its effect on the use of drugs in various systems includes the endocrine system,cardiovascular system, and central nervous system. CONCLUSIONS：It is suggested that the relevant departments should add＂DEI＂in the specification of drug package inserts and standardize the labeling content of DEI,including whether DEI will affect therapeutic efficacy of drugs,potential safety problems warning of DEI;it provides accurate DEI information for drug users and avoids the occurrence of ADR.