628份药品说明书中有关儿童用药的调查分析

Investigation of Pediatric Drug Use Stated in 628Package Inserts

目的调查了解药品说明书中有关儿童用药的标注情况,为规范药品说明书、促进儿童合理用药提供参考。方法对南京市某儿童医院常用的628种药品说明书中有关儿童用药项进行统计分析。结果药品说明书中有关儿童用药项的标注情况不容乐观,儿童专用药品短缺。结论应加强对药品说明书的监管,药品生产企业应强化责任意识,提高说明书标注的完整性,医疗机构应即时反馈不良反应信息。

Objective To investigate labeling of pediatric drug use in package inserts, and to provide references for standardizing drug package inserts and promoting rational pediatric drug use. Methods A total of 628 package inserts of drugs commonly prescribed in a childrenrs hospital were randomly sampled for the investigation of the contents and limitations about pediatric drug use. Results Labeling of pediatric drug use in package inserts was not very optimistic and pediatric drugs are short in varieties and amounts. Conclusion Departments concerned should strengthen the supervision and regulation of drug package inserts; drug manufacturing enterprises should reinforce their sense of responsibility and complete the content of labeling in package inserts and medical institutions should make instant feedback on adverse drug reactions.