84份全身麻醉及其辅助用药说明书中关于给药资质的调查与分析  

Qualification for medication administration in 84 package inserts of general anesthesia and auxiliary drugs

作　　者：胡俊涛 曹凯 钱佩佩 张潇菡 陈静静 赵亮 HU Jun-tao;CAO Kai;QIAN Pei-pei;ZHANG Xiao-han;CHEN Jing-jing;ZHAO Liang(Department of Pharmacy,Xuchang Central Hospital Affiliated to Henan University of Science and Technology,Xuchang Henan 461000)

机构地区：[1]河南科技大学附属许昌市中心医院药学部,河南许昌461000

出　　处：《中南药学》2020年第12期2065-2068,共4页Central South Pharmacy

基　　金：许昌市科技公关项目(No.20160713199)。

摘　　要：目的调查、分析全身麻醉及其辅助用药说明书中给药资质信息标注情况,为临床安全合理用药提供参考。方法收集国内在售全身麻醉及其辅助用药最新版纸质说明书,对说明书中"注意事项""用法用量""警告"项目中涉及药品给药资质信息进行统计分析。结果共查阅84份说明书,涉及22种药品。19份说明书未对给药资质进行描述;65份描述了给药资质的说明书中,9份标注为"专门的专业人员给药"或"专业人士给药",56份规定应由医师或医师指导监督下给药。22种药品中,仅有12种各生产企业说明书对给药资质描述基本一致,剩余10种存在较大差异。结论国内外大部分生产企业对全身麻醉及其辅助用药说明书中给药资质信息进行了标注,但同时也存在同一药品不同生产企业说明书中给药资质描述不一致的情况。建议国家药品监督管理局对此类药品临床应用风险进行充分论证后,对给药资质进行统一规定,各生产企业依据规定对相关药品说明书进行修订。医务人员在使用该类药品时,应仔细阅读说明书,降低医疗风险,促进临床安全合理用药。Objective To investigate and analyze the qualification for medication administration in package inserts of general anesthesia and the auxiliary and to provide reference for safe and rational drug use.Methods The latest version of package inserts of general anesthesia and the auxiliary drugs on market in China were collected.The medication administration qualification information under "precautions" "dosage and administration" and "warnings" in the package inserts were analyzed.Results Totally 84 instructions were analyzed,involving 22 drugs,with 19 instructions not describing the medication administration qualification.Among the 65 instructions that did describe medication administration qualification,9 were labeled as "administration by special professionals" or "administration by professionals",and 56 specified that the drug should be administered by physician or under the guidance and supervision of physicians.Among the 22 drugs,only 12 described medication administration qualification among enterprises similarly,and the remaining 10 greatly varied.Conclusion Most enterprises home and abroad have clearly marked medication information in the instructions,but different descriptions exist in different enterprises’ instructions for the same drug.The national drug supervision and administration should unify regulations on medication administration qualification for such drugs,and enterprises should revise the relevant instructions accordingly.Medical staff should read the instructions carefully to reduce the risk and promote the clinical safety and rational use of drugs.

关 键 词：全身麻醉 麻醉辅助用药 给药资质 医疗风险 合理用药 

分 类 号：R95[医药卫生—药学]