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762份药品说明书中孕妇及哺乳期妇女用药标注情况分析
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| 篇名： | 762份药品说明书中孕妇及哺乳期妇女用药标注情况分析 |
| TITLE： | |
| 摘要： | 目的：为孕妇及哺乳期妇女用药标注提供参考。方法：收集开滦总医院林西医院2013年7月－2015年12月使用的药品说明书，对孕妇及哺乳期妇女用药标注情况进行统计、分析。结果：收集的762份药品说明书中，孕妇和哺乳期妇女用药未标注或尚不明确的分别占总数的31.89％和52.76％。在国产化学药及生物制品说明书361份、中成药说明书339份、进口药品说明书62份中，孕妇和哺乳期妇女用药未标注或尚不明确的比例分别为22.99％和25.21％、44.54％和88.50％、14.52％和17.74％。结论：除药品说明书中孕妇及哺乳期妇女用药整体标注情况欠佳外，还存在列项分散、表述内容不一致的问题。与进口药比较，国产化学药及生物制品说明书中孕妇及哺乳期妇女用药信息缺失明显，在中成药说明书中则缺失严重。建议药品生产企业应加强药品上市后的跟踪监测，及时更新修订药品说明书的相关内容；药监部门应加强对药品说明书的监管力度，对用药标注的内容进行统一规范管理。 |
| 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， package 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. CONCLUSIONS： 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 information 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 monitoring 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. |
| 期刊： | 2016年第27卷第7期 |
| 作者： | 牛金茹，李君，吴斯，刘海净 |
| AUTHORS： | NIU Jinru，LI Jun，WU Si，LIU Haijing |
| 关键字： | 药品说明书；孕妇；哺乳期妇女；标注 |
| KEYWORDS： | Drug package insert； Pregnant women； Lactating women； Labeling |
| 阅读数： | 456 次 |
| 本月下载数： | 8 次 |
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