Analysis of information related to child-prohibition in drug labels in China
10.3760/cma.j.cn114015-20220527-00475
- VernacularTitle:我国现有药品说明书儿童禁用相关信息分析
- Author:
Yu YANG
1
;
Yayun HUANG
;
Yunxia ZHANG
;
Qianqian QIN
;
Zhimin XUE
;
Ruiling ZHAO
;
Xinwen XU
;
Xiaoling WANG
Author Information
1. 山西省儿童医院临床试验机构办公室，太原 030013
- Publication Type:Journal Article
- Keywords:
Child;
Drug labeling;
Warnings;
Contraindications;
Precautions
- From:
Adverse Drug Reactions Journal
2023;25(5):281-286
- CountryChina
- Language:Chinese
-
Abstract:
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.
