中国循证儿科杂志2017，Vol.12Issue(4)：289-294,6.DOI:10.3969/j.issn.1673-5501.2017.04.010
中国儿童超说明书用药管理现状及认知度的横断面调查
Current practice, management and awareness of pediatric off-label drug use in China-A questionnaire based cross-sectional survey
梅枚 1王立波 1刘恩梅 2李智平 1郭卓瑶 1张晓波 1徐虹1
作者信息
- 1. 复旦大学附属儿科医院呼吸科 上海,201102
- 2. 重庆医科大学附属儿童医院,重庆 400014
- 折叠
摘要
Abstract
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.关键词
儿童/超说明书用药/管理/认知/调查Key words
Children/Off-label drug use/Management/Awareness/Survey引用本文复制引用
梅枚,王立波,刘恩梅,李智平,郭卓瑶,张晓波,徐虹..中国儿童超说明书用药管理现状及认知度的横断面调查[J].中国循证儿科杂志,2017,12(4):289-294,6.
