| 张胜男,娄鑫,闫聪聪,张萌,王奇巍,王晓玲.我国儿童专用药品说明书调查与分析[J].中国药事,2023,(9):1007-1012 |
| 我国儿童专用药品说明书调查与分析 |
| Investigation and Analysis of the Child-specifi c Medicine Instructions in China |
| 投稿时间：2022-09-19 |
| DOI：10.16153/j.1002-7777.2023.09.004 |
| 中文关键词: 儿童专用药 药品说明书 信息统计 问题分析 合理用药 |
| 英文关键词: child-specifi c medicine drug instructions statistical data investigation and analysis rational drug use |
| 基金项目:国家卫生健康委医管中心委托课题 [编号医管中心药械处（2019）053]；中国医药新闻信息协会儿童安全用药分会（编号 EFHKT22017） |
|
| 摘要点击次数: 698 |
| 全文下载次数: 277 |
| 中文摘要: |
| 目的：了解我国儿童专用药品（化学药品与生物制品）中药品说明书的标注情况及存在问题， 为促进儿童用药信息的完善提供参考。方法：对儿童专用药品进行汇总，并依据药品说明书进行信息表的填写与统计，分析儿童专用药品说明书存在的问题。结果：共收集到儿童专用药品说明书1214份， 其中国产药品1180个（占97.20%），进口药品34个（占2.80%）；儿童专用药品数量最多的为呼吸系统用药（占42.01%）；儿童专用药品口服剂型1094个（占90.11%），注射剂型57个（占4.70%），外用剂型59个（占4.86%），吸入剂型4个（占0.33%）；说明书中标注的剂量调整依据主要为年龄和体重（占 45.80%），只依据年龄进行剂量调整的占41.02%，而7.91%的药品未标注剂量调整依据；说明书中标有儿童用药最大剂量的占17.46%，标有儿童用药疗程的占28.01%，而标有儿童药代动力学的仅有16.72%。 结论：我国儿童专用药品说明书存在标签撰写不规范、内容不完善、同一品规药品说明书差异大等问题，建议相关部门加强药品说明书的规范和管理，加大上市后的监管和数据监查，督促药品生产企业对儿童专用药品说明书中的内容进行完善与改进，提高儿童合理用药水平。 |
| 英文摘要: |
| Objective: To investigate the medication information and existing problems in the instructions of child-specifi c medicine (chemicals and biological products) in our country and provide references for promoting the improvement of drug information for children. Methods: The child-specifi c medicines were summarized, and the information sheet was fi lled and statistically analyzed according to the drug instructions, and the problems existed in the special drug instructions for children were analyzed. Results: A total of 1214 drug instructions for children were collected, including 1180 domestic drugs (97.20%) and 34 imported drugs (2.80%). The largest number of child-specific medicine was respiratory system drugs (42.01%).There were 1094 oral dosage forms (90.11%), 57 injectable dosage forms (4.70%), 59 external dosage forms (4.86%) and 4 inhalation dosage forms (0.33%) for child-specific medicine. The dose adjustment was mainly based on age and weight (45.80%), and only 41.02% of the drugs were adjusted based on age, while 7.91% of the drugs were not labeled with the dose adjustment basis. In the instructions, only 17.46% of the drugs had the maximum dose, 28.01% of the drugs had the course of medication, and 16.72% of the drugs had the pharmacokinetics. Conclusion: The child-specific medicines in our country exist some problems such as non-standard instructions label, imperfect content and great diff erences in the same drug instructions and so on. It is suggested that the relevant departments should strengthen the specifi cation and management of the child-specifi c medicines, strengthen the supervision and monitoring data after listing, and supervise the pharmaceutical production enterprise improve the contents of the child-specifi c medicines and promote the level of rational drug use of children |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
|
|
|