妇产科医院门诊超药品说明书用药情况调查与分析  

Investigation and Analysis of Off-label Drug Use in Outpatient Department of Obstetrics and Gynecology Hospital

作　　者：王先利[1] 金经[1] 王萌萌[1] 杨振宇[1] WANG Xianli;JIN Jing;WANG Mengmeng;YANG Zhenyu(Dept. of Pharmacy,Obstetrics and Gynecology Hospital Affiliated to Fudan University,Shanghai 200090,China)

机构地区：[1]复旦大学附属妇产科医院药剂科,上海200090

出　　处：《中国药房》2017年第11期1466-1470,共5页China Pharmacy

摘　　要：目的:为规范超说明书用药及保证临床合理用药提供参考。方法:通过等间隔方式抽取我院2016年1-3月门诊处方2 400张进行处方分析,按照药品说明书将超说明书用药分为超适应证用药、超剂量用药、超给药途径用药及超人群用药;通过查阅国内外药品说明书、国内外指南、国内外文献及MICROMEDEX Health Care Series数据库等对超说明书用药进行分析。结果:超说明书用药处方有219张(9.1%),共涉及药品12种、超说明书用药38项,主要表现为超适应证用药219张(100%),其中合并超人群用药4张(1.8%)。各项超说明书用药用法均有证据支持,其中9项(23.7%)超说明书用药用法已被MICROMEDEX收录。最常见超说明书用药的药品为戊酸雌二醇片(22.8%)、盐酸二甲双胍片(17.4%)和炔雌醇环丙孕酮片(12.3%)。结论:我院门诊超说明书用药均有证据支持,但各证据质量存在差异。临床确需超说明书用药时需充分权衡利弊,建立相应的临床应用管理制度与流程,尽量规避医疗风险,保障患者用药安全。OBJECTIVE:To provide reference for standardizing off-label drug use and guaranteeing clinical rational use of drugs.METHODS:2400prescriptions were collected from outpatient department of our hospital during Jan.-Mar.2016at regular interval,and then divided into super-indication drug use,out-of-dose drug use,out-of-administration route drug use and out-of-group drug use.The out-of-label drug use were analyzed by reseaching package inserts,domestic and foreign guideline,domestic and foreign literature,MICROMEDEX Health Care Series database.RESULTS:There were219(9.1%)prescriptions ofoff-label drug use,involving12drug types and38items of off-label drug use.In mainly manifested as out-of-indication drug use(219prescriptions,100%),out-of-group drug use(4prescriptions,1.8%).All off-label drug use were supported by evidence,among which9items(23.7%)of off-label drug use were included in MICROMEDEX.Of all the related off-label drugs,Estradiolvalerate tabletes(22.8%),Metformin hydrochloride tablets(17.4%)and Ethinylestradiol and cyproterone acetate tablets(12.3%)were the most common.CONCLUSIONS:All off-label drug use are supported by evidences in outpatient department of our hospital.There are difference in the quality of those evidence.If off-label drug use is necessary in the clinic,it is suggested to fullyweigh the advantages and disad vantages and establish related clinical management system and procedure to avoid medical risks and guarantee the safety of drug use.

关 键 词：妇产科 处方 超说明书用药 

分 类 号：R969.3[医药卫生—药理学]