从常用药品说明书中儿童用药内容看我国儿童用药现状

摘要

Objective:To analyze the situation of the medicines used for children in China and provide references for clinical ra-tional use of pediatric drugs by investigating "the package inserts of commonly used medicines in our hospital ". Methods:Pediatric Use,Dosage,Pharmacokinetics studies,and other Items of package inserts of 314 commonly used drugs in our hospital were ana-lyzed according to“Regulations Concerning the labels and package inserts of drugs”and other related documents. Results:The part of the drugs suitable for children in the prescription drugs is very low while the proportion of the drugs children can use in the over - the - counter drugs is high. However,the proportion of package inserts which are clearly in usage and dosage is low,which the proportion of the drugs children can use in prescription drugs is 96. 3% ,while the proportion of the drugs children can use in Over - the - counter drugs is 28. 4% . The package inserts which are clearly in Pharmacokinetics studies is 2. 22% .“Children can cut down according to the circumstance”、“Follow the doctor’s advice”is often described in the package inserts. Conclusion:The package inserts for children is incomplete and the expression is not clear,which can easily cause drug safety hidden trouble. The phenomenon should cause the attention of various aspects,the standardization of the drug instructions should be improved. The package inserts should be a guide to the rational use of drugs.%目的：调查本院314份常用药品说明书中儿童用药内容，分析我国儿童用药现状，为儿童的临床合理用药提供参考。方法：依据《药品说明书和标签管理规定》及配套文件对本院常用的314份药品说明书中“儿童用药”、“用法用量”、“药代动力学研究”等内容进行分析。结果：处方药中儿童可用药比例较低，非处方药儿童可用药比例较高，但是明确标注“用法用量”的比例非常低，标注为儿童可用药的比例高达96.3%，而标注儿童用法用量的仅为28.4%。314份药品说明书中明确标注儿童药代动力学研究的仅为2.22%。在儿童用法用量换算上，出现“小儿酌减”、“遵医嘱”等模糊表述的较多。结论：目前儿童用药说明书中存在儿童用药内容不完整与用语模糊等现象，易引起用药安全隐患，应当引起各方面的重视，提高药品说明书的规范化，使其成为合理用药的指南。