中国药物警戒 ›› 2016, Vol. 13 ›› Issue (6): 341-343.

• 法规与管理研究 • 上一篇    下一篇

我国药品说明书老年人用药标示的问题与对策

范燕, 夏东胜*   

  1. 国家食品药品监督管理总局药品评价中心,北京 100045
  • 收稿日期:2016-07-22 修回日期:2016-07-22 出版日期:2016-06-20 发布日期:2016-07-22
  • 通讯作者: 夏东胜,女,硕士,药品不良反应监测与评价。E-mail:xiadongsheng@cdr-adr.org.cn
  • 作者简介:范燕,女,硕士,药品不良反应监测与评价。

Problems and Countermeasures of Labeling Contents of Using in the Elderly in Medicine Instructions in China

FAN Yan, XIA Dong-sheng*   

  1. Center for Drug Reevaluation, China Food and Drug Administration, Beijing 100045, China
  • Received:2016-07-22 Revised:2016-07-22 Online:2016-06-20 Published:2016-07-22

摘要: 目的 为规范我国药品说明书中关于老年人用药内容提供参考。方法 总结我国药品说明书中老年人用药标示的法规,检索相关文献,分析我国药品说明书关于老年人用药标示现状及问题,并提出相应对策。结果 目前我国部分药品说明书老年人用药项目标示不足或不明确,其原因主要与老年人用药研究不足及企业责任意识相对薄弱等相关。结论 建议在加强老年人用药研究基础上进一步增强企业的主体责任意识,不断规范药品说明书老年人用药内容,进而提高老年人群的用药水平。

关键词: 药品说明书, 老年人, 问题, 对策

Abstract: Objective To provide reference for labeling contents of using in the elderly in medicine instructions in China. Methods The regulations about labeling contents of using in the elderly in medicine instructions in China were summarized and the related literatures were searched. The current status and problems of labeling contents of using in the elderly were comprehensively analyzed. Then the recommendations were proposed. Results Some medicine instructions were insufficient or imprecise in our country, which might be related to many factors, such as insufficient studies of medication for the elderly, lacking of the sense of responsibility among drug manufacturers, etc. Conclusion It is necessary to strengthen the responsibility of drug manufacturers based on studies of medicines used for the elderly, and constantly standardize the labeling contents of using in the elderly in medicine instructions, so as to enhance the medication safety of the elderly.

Key words: medicine instruction, elderly, problem, countermeasure

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