166份抗糖尿病药品说明书中妊娠妇女用药信息标注情况调查分析

发布时间：2018-03-13 12:41

本文选题：药品说明书　切入点：抗糖尿病药　出处：《中国药房》2017年16期 　论文类型：期刊论文

【摘要】：目的:为规范抗糖尿病药品说明书中妊娠妇女用药信息标注提供参考。方法:收集丁香园用药助手中收录的所有抗糖尿病药品说明书,分析其中妊娠妇女用药信息标注情况。结果:166份药品说明书中,147份(88.55%)有单独列出"孕妇及哺乳期妇女用药"项,并对妊娠妇女用药信息进行了标注;14份(8.43%)也有列出该项,但仅标注尚无临床资料或临床资料有限,未提示妊娠妇女可否用药;5份(3.01%)无"孕妇及哺乳期妇女用药"项。在无用药指导意见中,指导意见缺失3份(1.81%),临床资料无/有限14份(8.43%);在有用药指导意见中,指导意见为禁用49份(29.52%),不得/不宜/不应使用40份(24.1%),慎用/不推荐/权衡利弊/益处大于风险时使用/向医师咨询49份(29.52%),可用/使用不受限制11份(6.63%)。166份药品说明书中,26份为国外药企药品说明书,均有单独列出"孕妇及哺乳期妇女用药"项,且有妊娠妇女用药指导意见。结论:国内药品说明书标注内容存在妊娠妇女用药相关信息缺失、指导意见表述不统一、更新滞后等问题,应引起药品监督管理部门、药品生产企业的重视。
[Abstract]:Objective: to regulate the anti diabetic drug in pregnant women drug reference information annotation. Methods: all anti diabetic drug instructions included in the collection and new assistant, to analyze the pregnancy information label. Results: 166 drug instructions, 147 (88.55%) are listed separately for pregnant and lactating women medication ", and the information of pregnancy women drug labeling; 14 (8.43%) also list the item, but only indicate no clinical data or clinical data are limited, not that pregnant women can use; 5 (3.01%) non pregnant and lactating women drug". Under the guidance of useless medicine the lack of guidance, 3 (1.81%), the clinical data of 14 non / Co. (8.43%); in the guidance of medication, the guidance for the disabled in 49 (29.52%), may / should not be / should not use 40 copies (24.1%), caution / not recommended / weigh the costs and benefits. Harm / benefits outweigh the risks when used to consult a doctor / 49 (29.52%), available / no constraints on the use of 11 copies (6.63%).166 drug instructions, 26 foreign pharmaceutical companies have separate lists of drug instructions, "pregnant women and lactating women use", and pregnant women with medicine guidance. Conclusion: domestic drug labeling content exist women drug related information missing pregnancy, guiding opinions expressed are not uniform, update lag and other issues, should cause the drug supervision and management departments, pharmaceutical production enterprises.

【作者单位】：天津市东丽区东丽医院药剂科;
【分类号】：R977.15

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