某三甲医院五官科门诊药品说明书外用法现状调查  

Investigation on Current Status of Off-Label Uses of Medications in Ophthalmology and Otorhinolaryngology Outpatients in a Tertiary Hospital

作　　者：张帆[1] 蒋陆霞[1] 张宏伟[1] 陈菲[1] 

机构地区：[1]山东省聊城市人民医院,山东聊城252000

出　　处：《中国药业》2016年第12期8-13,共6页China Pharmaceuticals

摘　　要：目的调查某三甲医院五官科门诊药品说明书外用法的现状,探讨相关风险和对策。方法以国家药品食品监督管理总局批准的最新版药品说明书为依据,从适应证、年龄、给药剂量、给药频次、给药途径几方面对该院五官科2014年7月至2015年6月门诊处方中的药品说明书外用法情况进行统计与分析,并根据临床指南、专家共识、循证医学或文献等判断其合理性,提出管理对策。结果有829张处方存在药品说明书外用法,占总处方的26.57%。药品说明书外用法医嘱共1 171条,占总用药医嘱的14.92%。共有75种药品出现药品说明书外用法,占总药品种数的32.89%。超频次是最常见的药品说明书外用法类型,占33.99%,其他依次是超给药途径(27.58%)、超年龄(24.08%)、超剂量(15.63%)和超适应证(1.96%)。药品说明书外用法医嘱最多的为中成药,占27.75%。药品说明书外用法发生率最高的为激素类药物,为58.82%。结论该院五官科门诊药品说明书外用法现象普遍,用药基本合理,但为了保障患者用药安全,应加强药品说明书外用法的规范化管理。Objective To investigate the current status of off- label uses of medication in ophthalmology and otorhinolaryngology outpa- tients in a tertiary hospital, and to provide baseline data for policy- making and strategy for risk management. Methods According to the latest edition of drug instructions authorized China Food and Drug Administration, off- label prescriptions were collected from oph- thalmology and otorhinolaryngology outpatients from July 2014 to June 2015 were analyzed statistically in 5 aspects such as indications, age, dosage, frequency and route of administration. The rationality was evaluated according to clinical guidelines, expert consensus, evi- dence- based medicine or literature,and the management countermeasures were proposed. Results There were 829 off-label prescrip- tions, accounted for 26.57% of all prescriptions, I 171 off-label drug records,accounted for 14. 92% of the total records. 75 drugs off-label,accounted for 32. 89% of the total number of drug varieties. Frequency was the commonest type of the off-label drug use, accounting for 33.99% , followed by route of administration（27.58% ）, age（24. 08% ）, dosage（15.63% ） and indications（1.96% ）. The off-label drug use records most drug types was proprietary Chinese drug（2？.？5% ）.The main categories of off -label drug use was hormonal（58.82% ）. Conclusion The off- label uses phenomenon is widespread in ophthalmology and otorhinolaryngology outpatients,it is basically reasonable. In order to guarantee the safety of patients in medication, the hospital should strengthen the standardized man- agement of off-label uses.

关 键 词：五官科门诊 药品说明书外用法 药品说明书 

分 类 号：R954[医药卫生—药学]