某“三甲”医院2015-2016年超说明书用药调查分析

Investigation and Analysis of Off-label Drug Use in a Third Grade Class A Hospital during 2015-2016

目的:控制超说明书用药风险,为合理用药提供参考。方法:采用分层等比例抽样法抽取某"三甲"医院2015年6月-2016年6月门诊处方,根据国家食品药品监督管理总局发布的最新版药品说明书,筛查出全部超说明书用药处方并进行统计。依据Micromedex工具及相关文献报道、指南,分析超说明书用药的类型、疾病诊断、证据来源及级别,以及相关的严重的药品不良反应(ADR)。结果:在抽取的3 025张门诊处方中,11.2%(339张)的处方涉及超说明书用药,包括超适应证(88.7%)、超给药剂量(6.0%)、超给药途径(3.2%)和超适应人群(2.1%);涉及疾病诊断以胃食管反流病为主(16.0%)。证据主要来源于美国FDA批准的说明书(1.5%)、国际国内指南(83.8%)、专家共识(12.4%)和其他(文献报道等)(2.4%)。13项超说明书用药用法已被Micromedex收录,推荐等级、证据强度各有不同。8种超说明书用药药品有致严重的ADR的报道。结论:该院门诊超说明书用药均有循证医学证据支持,但证据质量有差异。在实践中,医师、药师还应充分权衡超说明书用药利弊。

OBJECTIVE： To control the risk of off-label drug use, and to provide reference for rational drug use. METHODS ： Outpatient prescriptions were selected by stratified equal proportion sampling method from a third grade class A hospital during Jun. 2015-Jun. 2016. According to the latest edition of drug instruction issued by CFDA, the off-label prescriptions were screened and analyzed statistically. According to Micromedex tools and literatures report, guidelines, off-label drug use and related severe ADR were analyzed. RESULTS： Of 3 025 outpatient prescriptions, 11.2% of prescriptions （339 pieces） were considered as off-label prescriptions, including without indication （88.7%） , over dose （6.0%）, beyond route of administration （3.2%） and beyond adapt-to-the-crowd （2.1%）. Gastroesophagedal reflux was the main diagosis （16.0%）. 1.5% of off-label drug use were supported by FDA-approved labels, 83.8% of them were supported by international and national guidelines, 12.4% of them were supported by expert consensus, and 2.4% of them were supported by other literature report. Thirteen items of off-label drug use had been included in Micromedex, recommendation grade and evidence intensity of which varied. Eight drugs of off-label drug use were reported to result in serious ADR. CONCLUSIONS ： All off-label drug use in outpatient department of this hospital is supported by evidence-based medical evidence. But the quality of evidence varies. In the practice, physicians and pharmacists should balance the benefit and risk of off-labed drug use carefully.