四川大学华西第二医院2010年儿科住院患儿超说明书用药情况调查  

Off-label Drug Use in Pediatric Wards of West China Second University Hospital in 2010:A Cross Sectional Study

作　　者：张伶俐[1,2] 李幼平[1] 胡蝶[2,3] 曾力楠[2] 黄亮[2] 陈敏[2,3] 吕娟[2] 杨春松[2] 

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041 [2]四川大学华西第二医院药学部,成都610041 [3]四川大学华西药学院,成都610041

出　　处：《中国循证医学杂志》2012年第2期161-167,共7页Chinese Journal of Evidence-based Medicine

基　　金：十一五国家科技支撑计划重点项目"乡镇卫生院药物配置与物流关键技术研究与产品开发"(编号:2008BAI65B22)

摘　　要：目的回顾性调查2010年四川大学华西第二医院儿科住院患儿超说明书用药现状,分析可能的危险因素,为了解我国儿科超说明书用药现状和制订超说明书用药政策提供基线数据。方法分层随机抽取该院2010年儿科住院患儿的用药医嘱和出院带药医嘱,依据药品说明书,判断其用药医嘱是否超说明书,分析各超说明书用药类型、各年龄段儿童、各类药品、各科室超说明书用药情况以及超说明书用药与年龄、性别和医生级别的关系。结果共抽取住院患儿749例,分析用药医嘱14?374条,涉及药品385种。按患儿、用药医嘱与药品品种计,超说明书用药发生率分别为98.00%、78.96%和88.05%。超说明书用药类型主要包括:未提及儿童用药信息(29.41%)、适应症(18.35%)、剂量(17.61%)及剂量范围(±20%)(13.52%)4种。超说明书用药发生率居前两位的年龄段为青少年(83.56%)和儿童(80.58%)。用药医嘱数居前四位药品的超说明书用药为消化和代谢系统用药(82.28%)、系统用抗感染药(75.06%)、血液和造血系统用药(79.27%)及呼吸系统用药(58.27%)。超说明书用药发生率居前两位的科室为血液儿科(88.27%)与新生儿科(79.12%)。全院儿童和青少年患儿及男性患儿超说明书用药的风险较高,高级职称医师超说明书用药医嘱高于中级职称医生。结论四川大学华西第二医院儿科住院患儿超说明书用药较常见,一方面反映了药品说明书中儿科用药信息严重缺乏,需要药品研发、生产、审批、监管、使用各环节工作者共同努力、采取措施,促进和规范儿童药物临床试验,为儿童用药提供更多的证据,保障儿童用药安全;另一方面反映儿科医院超说明书用药的执业风险高,急需国家制订相关法律法规或指南规范超说明书用药行为,规避医师执业风险。Objective To determine the extent of off-label drug use in Pediatric Wards of West China Second University Hospital in 2010 and analyze its risk factors,so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China,and for making policies of off-label drug use.Methods The proportionate stratified random sampling was conducted to select medical advice and discharge medication for hospitalized children in Pediatric Wards in 2010.According to drug instructions,the off-label drug use of prescriptions of all selected children was analyzed in the following aspects,the category of off-label drug use,age,category of drugs and wards.In addition,a logistic regression was done that modeled the odds of receiving an off-label prescription as a function of the following possible risk factors： age,sex and the rank of doctors.Results The total 749 children were selected,and 14？374 prescriptions involving 385 drugs were analyzed.The rate of off-label drug use was 98.00%,78.96% and 88.05% in children,prescriptions and drug categories,respectively.The main categories of off-label drug use were no pediatric information（29.41%）,indication（18.35%）,dosage（17.61%） and dosage range（±20%）（13.52%）.The top 2 age groups of off-label drug use were adolescents（83.56%） and children（80.58%）.The top 4 drugs of off-label use were those for alimentary tract and metabolism（82.28%）,anti-infectives for systemic use（75.06%）,blood and blood forming organs（79.27%） and respiratory（58.27%）.The top 2 wards of off-label drug use were Pediatric Hematology（88.27%） and Neonates（79.12%）.In hospital,children,adolescents and male patients had higher risk factors of off-label drug use,and doctors with senior rank prescribed more off-label prescriptions than those with intermediate rank.Conclusion The off-label drug use in Pediatric Wards is common in West China Second University Hospital.On the one hand,drug instructions lack the pediatric information,and,o

关 键 词：超说明书用药 儿科 住院患儿 危险因素分析 用药安全 

分 类 号：R197.3[医药卫生—卫生事业管理]