某三甲妇儿医院注射剂说明书中儿童用药信息标注情况的调查与分析

Investigation and Analysis of Child Medication Information in the Injection Manual of a Third A Women and Children’s Hospital

目的调查某三甲妇儿医院里注射剂药品说明书中关于儿童用药信息的标注情况,分析该院儿童患者临床使用注射剂的用药风险。方法通过医院信息系统统计注射剂品种285种,收集对应说明书,采用文本分析法分析儿童用药信息标注情况。结果对说明书进行统计分析,其中国产药品246种(86.32%),进口药品39种(13.68%)。有儿童用药信息的注射剂共277种,占比97.19%,无儿童用药信息的注射剂共8种,占比2.81%,其中儿童专用注射剂品种仅有2种,占比0.7%。结论注射剂中儿童专用药品较少,儿童临床试验开展极少,导致儿童用药信息标注不充分,儿童用药存在安全隐患。

Objective To investigate the labeling of child medication information in the injection instructions in a third grade women and children’s hospital,and analyze the risk of clinical use of injections in pediatric patients in the hospital.Methods 285 injection varieties were counted through the hospital information system,corresponding instructions were collected and child drug information annotation was analyzed by text analysis.Results Statistical analysis of the instructions,including 246 domestic drugs(86.32%)and 39 imported drugs(13.68%).There were 277 injections with medication information for children,accounting for 97.19%,and 8 injections without child medication information,accounting for 2.81%,including only 2 special injections for children,accounting for 0.7%.Conclusion Few drugs for children,few clinical trials,resulting to insufficient information and safety risks.