108份抗菌药物药品说明书调查研究

Survey and Analysis of 108 Copies of Drug Instructions of Antibacterial Drug

目的为进一步规范抗菌药物药品说明书提供参考。方法收集马鞍山市疾病预防控制中心、上海杨思医院和马鞍山市中心医院2016年1月至8月的108份抗菌药物药品说明书,对其标注项信息进行汇总和分析。结果药品名称、成分、性状、适应证、规格、用法用量、贮藏、包装、有效期、执行标准、批准文号、生产企业等项的标注率均达100.00%;不良反应、禁忌、注意事项、孕妇及哺乳期妇女用药、老年用药、药物相互作用、药理作用、药代动力学等项虽标注率较高,但有些项缺乏具体说明内容;儿童用药、药物过量、毒理、警示语等项的标注率均偏低;临床试验项均未标注。结论部分抗菌药物药品说明书的项目内容不完整,修改不及时,书写不规范,难以满足使用者的需求,也难以保证用药安全。生产企业应尽可能将抗菌药物药品说明书项目内容标注完整,并及时修改、补充、规范和完善。

Objective To provide the reference for the further standardization of the drug instructions of antibacterial drug . Methods 108 copies of the drug instructions of antibacterial drug were collected from M Maanshan Municipal Center for Disease Pre-vention and Control,Shanghai Yangsi Hospital and Maanshan Central Hospital from January to August 2016. The information of marked item was summarized and analyzed. Results Among the 108 drug instructions of antibacterial drug,the mark rates of drug names,main ingredients,character,indications,specification,usage and dosage,reposition,package,term of validity,operative norm,license number,manu-facturing enterprise and other items all reached 100. 00%. Although the mark rates of ADR,contraindication,precaution,drug use of pregnant women and nursing mothers,drug interactions,pharmacokinetics,drug use of the elderly,storage and other items were relatively high,some items lacked the specific description of the content. The label rates of children＇s drug use,drug excess,toxicology and warn-ing were very low,and the clinical trials were not marked. Conclusion Some drug instructions of antibacterial drug were not revised timely and not completed in content and non-standard in writing,which could not meet the needs that clinical pharmacists and patients get enough drug safety information from the drug instructions of antibacterial drug. Manufacturing enterprise is suggested to label the content of package inserts completely,verify and supplement related content,standardize and improve the drug instructions of antibacterial drug.