15家医院儿科常用药品说明书儿童用药信息调查分析

Analysis of Information for Children in Package Inserts of Medications Commonly Used in Pediatrics of 15 Hospitals

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。

OBJECTIVE To investigate and analyze the problems in information for children existing in package inserts of medications commonly used in pediatrics in 15 hospitals and try to establish a template and provide reference for standardizing package inserts of medications in China. METHODS The method of text analysis and literature survey were used. Information for children in the package inserts were collected, analyzed and evaluated according to Guidance for Industry and Review Staff： Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling （Draft） issued by U. S. FDA and other references. RESULTS In 660 package inserts of 338 medications, 8.0% , 56.9% , 16.4% , 11.7% and 45.8% contained the information on children＇s indications, dosages and administrations, adverse drug reactions, contraindications and precautions, respectively, while only 2. 3% had information of pediatric clinical trials or children＇s pharmacokinetic data. CONCLUSION The current information for Children in package inserts are insufficient and lack of standards, so further management should be strengthened to improve the situation.