Analysis of the reasons for contraindication in pediatric patients in drug labels
10.3760/cma.j.cn114015-20240202-00075
- VernacularTitle:药品说明书中儿童禁用的原因分析
- Author:
Yunxia ZHANG
1
;
Qianqian QIN
;
Ruiling ZHAO
;
Xiaoling WANG
Author Information
1. 山西省儿童医院药剂科，太原 030013
- Publication Type:Journal Article
- Keywords:
Child;
Drug labeling;
Contraindications;
Reasons
- From:
Adverse Drug Reactions Journal
2024;26(9):557-562
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the reasons for contraindication of chemical drugs and biological products that were marked as contraindication for children in drug labels in China.Methods:The drugs labeled as contraindication for children in drug labels of chemicals and biological products covered by the China Pharmacopoeia 2020 and the 2023 China′s Basic Medical Insurance, Work-related Injury Insurance and Childbirth Insurance (western medicine) were searched. The reasons of contraindication for children were collected through searching the drug labels, Clinical Medication Instructions of the China Pharmacopoeia 2020, the website of the National Medical Products Administration, and drug labels from the Unite States, and analyzed descriptively.Results:There were 222 drugs were labeled as contraindication for children in the drug labels, involving 20 categories and mainly antibiotics and digestive system drugs. Among 222 drugs, 137(61.7%) had the reasons for contraindication in pediatric patients, and the main reasons were adverse drug reactions (65.7%, 90/137) and lack of effectiveness and safety information yet in children (30.7%, 42/137), followed by the unsafe auxiliary materials (1.5%, 2/137), unsuitable prescription design or ingredients for children (1.5%, 2/137) and unsuitable dosage form for children (0.7%, 1/137). The above reasons were collected from domestic drug instructions (100 drugs), U.S. drug labels (17 drugs), NMPA website instructions revision announcements and popular science knowledge (15 drugs), and Clinical Medication Instructions of the China Pharmacopoeia 2020 (5 drugs).Conclusions:It is relatively common in China to label drugs that are contraindicated for children without specifying the reasons for contraindication or with non-standard explanations in the instructions. Therefore, it is necessary to further standardize the contraindication information for children and apply continuous updates and improvement in order to provide timely and up-to-date drug use information for clinical practice.
