呼和浩特某三甲医院骨科门诊超说明书用药调查及相关不良事件分析  

Analysis of off-label drug use and related adverse drug events in orthopedics outpatient prescriptions in a tertiary class A hospital

作　　者：王楠楠[1] 石秀兰[1] 邵艳清[1] 张文兴[2] 

机构地区：[1]内蒙古医科大学第二附属医院药剂科,内蒙古呼和浩特010030 [2]内蒙古医科大学基础医学院机能实验中心,内蒙古呼和浩特010010

出　　处：《中国医院药学杂志》2016年第22期2019-2023,共5页Chinese Journal of Hospital Pharmacy

基　　金：内蒙古医科大学第二附属医院院基金支持项目(编号:2015YJJ18)

摘　　要：目的:分析呼和浩特某三级甲等医院骨科门诊超说明书用药情况,探讨其与临床不良反应/事件的关系,为超说明书用药管理提供参考依据。方法:采用回顾性分析方法,分层随机抽取该院2015年1-12月骨科门诊处方,分类统计超说明书用药类型,结合循证医学报道分析超说明书用药可行性。汇总分析因超说明书用药诱发的不良反应/事件,与同期上报的不良反应发生率相比较。结果:该院骨科门诊超说明书处方比例为9.88%。在用药类型方面以超剂量(疗程)用药(57.42%)最多;在用药科室方面以骨科专家门诊超说明书用药比例(44.26%)最高。所有超说明书用药中仅有8.97%(32/357)有循证医学证据。该院可追踪的因超说明书用药诱发药品不良事件13例次,发生比例为4.76%(13/273)。结论:骨科门诊超说明书用药现象普遍存在,相关各方面应引起重视并加以管理规范,以减少不良事件发生,促进临床合理用药。OBJECTIVE To analyze off-label drug use and adverse drug events （ADE） in orthopedics outpatient prescriptions in a tertiary class A hospital in Huhhot. METHODS Prescriptions of orthopedics outpatients were randomly selected from Jan- uary to December 2015. Off-label drug uses of each prescription were assessed and categorized according to drug specifications, and rationality of drug use was determined by referring to dispensatories and evidences. ADEs caused by off-label drug use were analyzed and compared with incidence of ADEs reported in this hospital. RESULTS Prevalence of off-label drug use in orthope- dics outpatient prescriptions was 9. 88%. Primary type of off-label drug use was over dose （57. 42%）, mostly occurred in aspe- cialist outpatient department （44. 26%）. Within all off-label drug uses, only 8. 97% （32/357） prescriptions were evidence- based, and 4. 76% （13/273） of total off-label drug use prescriptions induced AIDE. CONCLUSION Off-label drug use generally exists in orthopedics outpatient prescriptions of this hospital. Further interventions should be adopted to promote drug rational use.

关 键 词：超说明用药 门诊 骨科 药品不良事件 

分 类 号：R969[医药卫生—药理学]