目的 调查中国儿童超说明书用药的管理现状及医务人员的认知度,为规范儿童超说明书用药提供依据.方法 以横断面研究设计,在中国大陆每个省至少选择一家具备儿科资质的医疗单位;调查人群:儿科医生、药师、护士和医务科行政人员;由儿科临床专家、药学专家、流行病学专家和药事管理专家组成的工作小组自制《中国儿童超说明书用药调查表》,包括基本信息维度6个条目,所在医院超说明书用药的现状及管理维度11个条目,超说明书用药及其管理的认知和《中国儿科超说明书用药专家共识》知晓情况维度33个条目,行网络问卷调查.结果 全国31省436家医院参与调查,其中儿童专科医院36家,妇幼保健院50家,综合性医院350家;一级医院20家,二级医院185家,三级医院231家.收集到有效问卷2116份,其中医生621名、药师755名、护士531名和医务科行政人员209名;初级职称712名、中级职称894名、高级职称510名.63.8%的医生有开具超说明书用药处方经历,职称越高,超说明书用药的现象越多;18.8%的医生经常超说明书用药,职称越高经常超说明书用药发生概率越大;19.4%的医生超说明书用药时都没有得到药师或护士提醒.药师发现过医生超说明书用药的情况是普遍存在的,不论药师职称的高与低(87.1%~98.3%),不论医院级别(82.1%~94.2%),6.9%~8.8%的护士面对医生超说明书用药拒绝执行医嘱.60.6%的被调查医院针对超说明书用药有统一制度流程,其中三级医院的比例高于一、二级医院,儿童专科医院的比例高于综合医院和妇幼保健院.70%的被调查者认为超说明书用药并不违法,但是80%以上的被调查者肯定超说明书用药存在风险.在医生、药师、护士和医务科行政人员中,2016年中华医学会儿科学分会临床药理学组提出的《中国儿科超说明书用药专家共识》知晓率分别为51.2%、56.8%、35.8%和45.4%.结论 中国大陆儿童超说明书用药现象普遍存在,急需统一有效的管理模式,需要制定出适合中国大陆的超说明书用药流程,加强医务人员培训,推进儿童规范化超说明书用药.%ObjectiveTo investigate current practice, management and awareness of pediatric off-label drug use in China, and provide a reference for the effective management on pediatric off-label drug use.MethodsIt was a cross-sectional study.Pediatricians, pharmacists, nurses and medical section staffs from hospitals with pediatric qualification in 31 provinces of mainland China were recruited in the present study.An online anonymous questionnaire was designed by expert group of pediatricians, pharmacists, epidemiologists and pharmacy administration experts.The questionnaire consisted of 3 sections.The first section focused on participants'' general information (6 questions).The second section focused on practice and management of off-label drug use in the participants'' units (11 questions).The third section focused on awareness of medical professionals regarding off-label drug use and the Chinese Expert Consensus of Pediatric Off-Label Drug Use (33 questions).Results2 116 questionnaires were collected from 436 hospitals from 31 provinces including 36 specialized children''s hospitals, 50 maternal and child health hospitals and 350 general hospitals.The 436 hospitals comprised 20 primary hospitals, 185 secondary hospitals and 231 tertiary hospitals.2 116 respondents included 621pediatricians, 755 pharmacists, 531 nurses and 209 medical section staffs.63.8% of the pediatricians had off-label drug prescription experience and 18.8% of the pediatricians prescribed off-label drugs often.Pediatricians with higher technical titles prescribed off-label drugs more frequently.19.4% of the pediatricians were not reminded by pharmacists or nurses during the prescription.It was common for pharmacists to find off-label prescription regardless of the professional title (87.1%~98.3%) and hospital grade (82.1%~94.2%).6.9%~8.8% of the nurses refused to executive off-label prescription.60.6% of the participating hospitals had established protocols for off-label use.The rates were higher in tertiary hospitals and specialized children''s hospitals.70% of the respondents felt it was not illegal to use off-label drugs.However, more than 80% of the respondents realized that there were potential risks to use off-label drugs.Pharmacists had the highest awareness rate of the "Expert Consensus of Pediatric Off-Label Drug Use" (56.8%).followed by pediatricians (51.2%), medical section staffs (45.4%) and nurses (35.8%).ConclusionPediatric off-label drug use is common in China and there exists gaps in the management of the issue.It is necessary to establish the national guidelines to regulate pediatric off-label drug use with Chinese national conditions and to strengthen the training of medical professional on using off-label drugs.
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