Analysis of Drug Use Labeling for Pregnant and Lactating Women in 762 Drug Package Inserts
10.6039/j.issn.1001-0408.2016.07.39
- VernacularTitle:762份药品说明书中孕妇及哺乳期妇女用药标注情况分析
- Author:
Jinru NIU
;
Jun LI
;
Si WU
;
Haijing LIU
- Publication Type:Journal Article
- Keywords:
Drug package insert;
Pregnant women;
Lactating women;
Labeling
- From:
China Pharmacy
2016;27(7):992-994
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To provide reference for drug use labeling for pregnant and lactating women. METHODS:The drug package inserts were collected from Linxi Hospital of Kailuan General Hospital during Jul. 2013-Dec. 2015. The information about drug use labeling for pregnant and lactating women was analyzed statistically. RESULTS:Among 762 drug package inserts,pack-age inserts which were not labeled with or labeled with indefinite drug use information for pregnant and lactating women accounted for 31.89% and 52.76% respectively. Among package inserts of 361 domestic chemical drugs and biological products,339 Chinese patent medicine and 62 imported drug,package inserts which were not labeled or labeled with indefinite drug use information for pregnant and lactating women accounted for 22.99% and 25.21%,44.54% and 88.50%,14.52% and 17.74%,respectively. CON-CLUSIONS:Except for poor drug use labeling for pregnant and lactating women in package inserts package,there still are other problems,such as items listed dispersedly,presentation content not consistent. Compared with imported drugs,the missing informa-tion for pregnant and lactating women are obvious in drug package inserts of domestic chemical drugs and biological products,and severe in those of Chinese patent medicine. It is recommended that drug manufacturers should strengthen drug tracing and monitor-ing after listed,and update and revise related content of package inserts timely;drug administration department should strengthen drug package inserts supervision,and unify and standardize labeled content management of drug use.
