15家医院儿科常用药品说明书儿童用药信息调查分析

发布时间：2018-05-12 21:23

本文选题：儿科 + 常用药品　；参考：《中国药学杂志》2015年16期

【摘要】：目的了解我国15家医院儿科常用药品说明书中儿童用药信息的标注情况并分析其存在的问题,尝试建立药品说明书模板,为进一步规范药品说明书的撰写提供建议。方法采用文本分析法和文献调查法,对我国15家医院儿科常用药品说明书中的儿童用药信息进行统计分析,依据FDA《人用处方药和生物制品说明书儿科资料指导原则(草案)》等参考资料建立药品说明书模板。结果在338个目标药品的660份说明书中,标注儿童适应证、儿童用法用量、儿童相关不良反应、禁忌和注意事项的说明书占比分别为8.0%、56.9%、16.4%、11.7%和45.8%,在"儿童用药"项标注了儿科临床试验、儿童药动学数据等内容的说明书占比仅为2.3%;说明书存在用词不规范、儿童用药信息标注位置分散等问题。结论儿科临床研究缺乏导致药品说明书中儿童用药信息标注不足,缺乏统一的药品说明书模版对企业撰写儿童用药信息进行指导。
[Abstract]:Objective to understand the status of drug information labeling in pediatric drug instructions in 15 hospitals in China and analyze the existing problems, and try to establish a drug instruction template to provide suggestions for further standardizing the writing of drug instructions. Methods by means of text analysis and literature survey, the information of drug use in pediatrics of 15 hospitals in China was analyzed statistically. According to FDA guidelines for pediatric data of prescription drugs and biological products for human use (draft), a drug instruction template was established. Results in 660 instructions of 338 target drugs, the indications of children, the dosage of children's usage, the adverse reactions related to children were marked. The proportions of taboos and notes were 8.0% and 16.4%, respectively. The pediatric clinical trials were marked in the item "drugs for children", and the proportion of instructions for children's pharmacokinetic data was only 2.3%. The information of drug use in children is scattered and so on. Conclusion the lack of pediatric clinical studies leads to insufficient labeling of drug information for children in drug instructions and the lack of uniform template of drug instructions to guide enterprises to write drug information for children.
【作者单位】：北京大学药学院;首都医科大学附属北京儿童医院;
【基金】：国家食品药品监督管理总局2013年委托项目:我国儿科常用药品说明书的研究与分析
【分类号】：R95

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