四川省部分医疗卫生机构超说明书用药调研

Survey on Off-label Drug Use in Some Medical Institutions of Sichuan Province

目的:为国家制定超说明书用药相关规定、指南及法规,规范医疗卫生机构的医疗行为提供参考。方法:依据超说明书用药的内涵制订医疗卫生机构"超说明书用药调查表",内容包括药品名称、治疗疾病、超说明书使用类型、超说明书使用证据等,并向四川省参加"临床药师实践技能培训班"的药师发放调查表,收集其所在医疗卫生机构超说明书用药相关信息,对数据进行统计分析,进而提出建议。结果:共发放调查表150份,回收有效调查表124份,有效回收率为82.7%;受访药师来自22家医疗卫生机构,其中三级医院18家、二级医院4家;涉及超说明书用药信息128条,其中14条(10.9%)填报信息不完整。114条相对规范、完整的超说明书用药信息类型以超适应证和超给药途径为主,分别有61条(53.5%)和43条(37.7%),其他尚有超剂量(8条,7.0%)、超适应人群(2条,1.8%)等。超说明书用药涉及药物类别主要包括抗感染药物(34条,29.8%)、抗肿瘤药物(16条,14.0%)、中药注射剂(8条,7.0%)等;品种相对集中的有甲硝唑、地塞米松、庆大霉素、甲氨蝶呤、阿奇霉素、伊立替康、万古霉素、制霉菌素等。部分医疗卫生机构对超说明书用药缺乏有效的监管措施。结论:四川省医疗卫生机构超说明书用药现象比较常见,其中部分超说明书用药存在明显的用药风险。建议尽快制定超说明书用药相关规定、指南及法规,赋予超说明书用药法律效力;医务人员对于无循证医学证据支持、不合理甚至不必要的超说明书用药应尽量避免;药品生产企业应加强与医疗卫生机构的交流与沟通,随时关注并收集临床用药相关信息,及时更新药品说明书,从而维护患者用药的合法权益和医务人员的自身利益。

OBJECTIVE： To provide reference for formulating related provisions, guidelines and regulations for off-label drug use, standardizing medical behavior in medical health institutions. METHODS ： According to the connotation of off-label drug use, ＂Questionnaire for off-label drug use＂ was developed for medical institutions, in which drug name, treatment disease, the type and use evidence of ＂off-label drug use＂ were included. The questionnaires were delivered to pharmacists who participated ＂Clinical phar- macist practice skills training＂ in Sichuan province to collect the related information of off-label drug use for statistical analysis, and suggestions were put forward. RESULTS： Totally 150 questionnaires were sent out, 124 were effectively received with effec- tively recovery of 82.7% ; the surveyed pharmacists came from 22 medical institutions, including 18 tertiary hospitals and 4 second- ary hospitals; there were 128 information about off-label drug use, including 14 （10.9%） with incomplete reporting information. The another 114 information were major in＂super indication＂ （61） and ＂super administration＂ （43）, accounting for 53.5% and 37.7%, respectively, and there are 8 other drug overdose （7.0%）, 2 super object （1.8%）. The relevant off-label drug use mainly included anti-infection drugs （34 information, 29.8% ）, anti-tumor drugs （16 information, 14.0% ）, TCM injections （8 informa- tion, 7.0% ）, and etc.; the relative concentration of varieties were metronidazole, dexamethasone, gentamicin, methotrexate, azithromycin, irinotecan, vancomycin, nystatin, etc.. Some medical institutions were absence of effective regulatory measures. CONCLUSIONS ： Off-label drug use is quite common in medical institutions of Sichuan province, some of them exist obvious med- ication risk. It is suggested that the state should be as soon as possible to develop related provisions, guidelines and regulations for off-label drug use, endowing legal force for off-label drug use; medical staff should avoid no evidence-based drug use, unreason- able or even unnecessary off-label drug use; pharmaceutical production enterprises should strengthen communication with medical institutions and pay attention to collect information related to the clinical medication, timely update the drug instructions to ensure the legitimate rights for patients and the interests for medical staff.