Comparative analysis of the dosage forms and specifications of OTC （chemical drugs ）for children at home and abroad
- VernacularTitle:国内外儿童非处方药（化学药品）剂型与规格的比较分析
- Author:
Jinfen ZHANG
1
;
Ruofei TONG
1
;
Tao HUANG
1
;
Senyi WANG
1
;
Lin YANG
1
;
Yangyang WANG
1
;
Xinling MA
1
;
Xiaoling WANG
2
;
Yanyan SUN
1
Author Information
1. Dept. of Pharmacy，Tianjin Children’s Hospital/Tianjin University Children’s Hospital，Tianjin 300134，China
2. Dept. of Pharmacy，Beijing Children’s Hospital Affiliated to the Capital Medical University，Beijing 100045，China
- Publication Type:Journal Article
- Keywords:
children;
over-the-counter drug;
active ingredients;
dosage forms;
specifications
- From:
China Pharmacy
2022;33(21):2561-2565
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To compare the dosage forms and specifications of over-the-counter drug （OTC）（chemical drugs ） for children at home and abroad ，and to provide reference for the addition of new dosage forms and specifications of OTC for children in China . METHODS Data analysis was used to comb the active ingredients of OTC single -ingredient preparation for children in China . The similarities and differences of the dosage forms and specifications of OTC for children with the same active ingredients among China and 8th edition of WHO Model List of Essential Medicines for Children （WHO EMLc ）and US/UK/EU （this article refers specifically to EU countries ）/Japan were analyzed by comparative analysis . RESULTS There were 72 active ingredients of OTC single -ingredient preparation for children in China ，corresponding to 34 dosage forms and 216 specifications； 39 same active ingredients of OTC for children were retrieved in WHO EMLc and US/UK/EU/Japan ，corresponding to 38 dosage forms and 258 specifications. Among OTC for children corresponding to 39 active ingredients ，there were 10 unique dosage forms in China ，and 16 unique dosage forms in WHO EMLc and US/UK/EU/Japan ，of which some dosage forms have advantages for children（such as chewing gums ，gels for external use ，spray for oral liquid ，etc.），were included in the latter while not included in China . There were 107 unique specifications in China ，and 214 unique specifications in WHO EMLc and US/UK/EU/Japan ，of which the division of applicable age groups for specifications was more detailed . In addition ，the dosage forms and specifications corresponding to a few active ingredients （such as ibuprofen ，cetirizine hydrochloride ）were not included in OTC for children in China， while included in UK/EU . CONCLUSIONS The dosage forms and specifications of OTC for children in WHO EMLc and US/UK/EU/Japan are generally more abundant and E-mail：zjfyouyou@163.com flexible than in China . Relevant departments in China should learn from the advanced experience of WHO and foreign countries and increase the research and development of dosage forms and specifications of OTC for children .
