我国现有药品说明书儿童禁用相关信息分析  

Analysis of information related to child‑prohibition in drug labels in China

作　　者：杨钰 黄亚云 张云霞[2] 秦倩倩[2] 薛智民[2] 赵瑞玲[1] 许馨文 王晓玲[4] Yang Yu;Huang Yayun;Zhang Yunxia;Qin Qianqian;Xue Zhimin;Zhao Ruiling;Xu Xinwen;Wang Xiaoling(Office of Clinical Trail Institution,Children's Hospital of Shanxi,Taiyuan 030013,China;Department of Pharmacy,Children's Hospital of Shanxi,Taiyuan 030013,China;Children's Safe Medication Branch of China News of Drug Information Association,Beijing 100044,China;Department of Pharmacy,Beijing Chil-dren's Hospital,Capital Medical University,Beijing 100045,China)

机构地区：[1]山西省儿童医院临床试验机构办公室,太原030013 [2]山西省儿童医院药剂科,太原030013 [3]中国医药新闻信息协会儿童安全用药分会,北京100044 [4]首都医科大学附属北京儿童医院药学部,北京100045

出　　处：《药物不良反应杂志》2023年第5期281-286,共6页Adverse Drug Reactions Journal

基　　金：国家“十三五”科技重大专项增补任务(2017ZX09304029‑001‑001)。

摘　　要：目的分析我国现有药品说明书中儿童禁用相关信息。方法通过“药智网”“丁香园”“医脉通”等网站获取2020年版《中华人民共和国药典》(Ch.P)收载化学药品和生物制品的现有药品说明书,从中提取儿童禁用相关信息。对儿童禁用相关信息表述及存在的问题进行分析。结果Ch.P收载的化学药品和生物制品分别为1741和149种,涉及儿童禁用相关信息的分别为411(23.6%)和6种(4.0%)。药品说明书中关于儿童禁用相关信息的表述包括18种方式,如禁用、不推荐、尽量不用等。不同生产企业对同一药品的说明书存在文字表述不一致,年龄范围描述不一致,是否含苯甲醇信息不全等问题;同一药品说明书存在不同项下儿童禁用年龄范围不一致的问题。结论我国现有药品说明书中的儿童禁用相关信息表述存在不一致、不规范等问题,药品生产企业应根据《化学药品和治疗用生物制品说明书中儿童用药相关信息撰写的技术指导原则(试行)》对药品说明书进行全生命周期管理,不断规范和完善药品说明书儿童禁用信息。Objective:To analyze the information related to child-prohibition in drug labels in China.Methods:The existing drug labels for chemical drugs and biological products included in the China Pharmacopoeia 2020 (Ch. P) were collected through searching websites such as "Yaozhiwang" "Dingxiangyuan" and "Yimaitong", and information related to child-prohibition was extracted. The expression and existing problems of information about child-prohibition were analyzed.Results:A total of 1 741 and 149 chemical and biological products were included in the Ch.P, respectively, of which 411 (23.6%) and 6 (4.0%) products involved information of child-prohibition. Information of child-prohibition was expressed in 18 ways, such as "prohibited" "not recommended" and "try not to", etc. Issues of child-prohibition information in drug labels of the same drug from different manufacturers were inconsistent text descriptions, inconsistent age range, and incomplete information on whether there was benzyl alcohol;issues in the same drug label was different age ranges for child-prohibition in different chapters.Conclusions:There are inconsistencies and non-standard issues in information related to child-prohibition in the existing drug instructions in China. Drug manufacturers should conduct full lifecycle management of drug labels in accordance with the "Technical Guidelines for Writing Information on Children′s Medication in the Instructions of Chemical Drugs and Therapeutic Biological Products (trial)", and continuously standardize and improve the information of child-prohibition.

关 键 词：儿童 药物标签 警示 禁忌 注意事项 

分 类 号：R95[医药卫生—药学]