某院2016年儿外科门诊超说明书用药现状分析  

Off-Label Drug Use in Pediatric Surgery Outpatients in Our Hospital in 2016

作　　者：高华[1,2] 邓宁[1] 孙维红[1,2] 陆铖 项艳曾 张茜[1] 文友民[1] Gao Hua;Deng Nirlg;Sun Weihong;Lu Cheng,;Xiang Yanzeng;Zhang Xi;Wen Youmin(General Hospital of Ningxia Medical University,Ningxia Yinchuan 750004,China;School of Pharmacy,Ningxia Medical University,Ningxia Yinchuan 750004,China)

机构地区：[1]宁夏医科大学总医院,宁夏银川750004 [2]宁夏医科大学药学院,宁夏银川750004

出　　处：《儿科药学杂志》2018年第10期35-38,共4页Journal of Pediatric Pharmacy

基　　金：宁夏重点研发(科技惠民)项目;编号2016KJHM72

摘　　要：目的:回顾性调查宁夏医科大学总医院儿外科门诊超说明书用药情况,分析超说明书用药发生原因,为了解我国儿科超说明书用药现状和制订相关政策提供基线数据。方法:抽取该院儿外科2016年门诊处方,按照说明书从适应证、禁忌证、用法、用量、用药人群5个方面6个指标综合判断超说明书用药情况,分析超说明书用药发生原因。结果:共分析762张处方,涉及用药医嘱810条,按用药医嘱计超说明书用药发生率为30.12%;超说明书用药各类型中"未提及儿童用药信息"比例最高(36.07%);各年龄段中婴幼儿的超说明书用药发生率较高(50.47%);超说明书用药前3位分别是抗肿瘤药和免疫调节药(75.24%)、神经系统用药(63.41%)、消化道及代谢用药(7.14%)。结论:我院小儿外科门诊存在着超说明书用药现象,临床药师应对儿童用药进行密切关注及合理干预。急需国家出台相关法律法规或指南,规范超说明书用药行为,促进儿童药物临床试验提供更多用药数据,保障儿童用药安全和规避医师职业风险。Objective： To retrospectively investigate the off-label drug use in pediatric surgery outpatients in General Hospital of Ningxia Medical University,and to analyze the causes of off-label drug use,so as to provide baseline data for understanding the current status of pediatric off-label drug use and formulating relevant policies. Methods： Prescriptions in pediatric surgery outpatients in our hospital from Jan. to Dec. 2016 were collected. Off-label drug use was comprehensively judged from the indications,contraindications,usage,dosage and drug use population. And causes of off-label drug use were analyzed. Results： Totally 762 prescriptions were analyzed,and 810 medical orders were involved,the incidence of off-label drug use was 30. 12%. ＂No information on children ＇s medication＂was the most common off-label drug use types（36.07%）. The incidence of off-label drug use for infants was higher than other age groups（50.47%）. The top 3 drugs of off-label drug use were respectively antineoplastic and immunomodulatory drugs（ 75. 24%）,neurological drugs（63.41%）,digestive tract and metabolic drugs（7.14%）. Conclusion： Off-label use in pediatric surgery outpatients has been noted in our hospital,clinical pharmacists should monitor pediatric medication closely and intervene it reasonably. It＇s badly in need of developing relevant legislation,regulations or guidelines to regulate off-label drug use,providing more evidence by conducting clinical trials on pediatric drugs,so as to avoid clinicians＇ professional risk and ensure the safety of pediatric drug use.

关 键 词：超说明书用药 小儿外科 门诊 用药安全 

分 类 号：R969.3[医药卫生—药理学]