对日本老年患者适当使用药物的安全评估和信息提供
Makoto Onohara1, Mamoru Narukawa1
1Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University.
Biological & pharmaceutical bulletin
|October 6, 2024
概括
日本老年患者需要更好的药物安全信息. 这项研究发现,包装插件往往缺乏足够的老年病学数据,阻碍了这种不断增长的人口中安全的药物使用.
科学领域:
- 老年人药理学 老年人药理学
- 药物安全评估 药物安全评估
- 日本的制药政策.
背景情况:
- 日本老年人口正在迅速扩大,原因是寿命延长和出生率下降.
- 这种人口变化需要改善药物开发和老年人安全协议.
- 日本目前的利益相关者很慢地适应了这些不断变化的医疗保健需求.
研究的目的:
- 检查加强为日本老年患者提供药品安全信息的方法.
- 评估针对老年人群的新批准药物包装插件中安全数据和老年人使用信息的充分性.
- 评估老年患者在临床研究中的代表性和不良事件报告.
主要方法:
- 对64种在日本新获批准的药物的包装插件进行分析. 在老年人群中普遍存在.
- 评估老年治疗使用信息,临床研究数据和老年患者的安全数据报告.
- 在临床试验数据中,老年人和年轻患者组之间的不良事件发生率的比较.
主要成果:
- 在64种药物中,只有14种药物提供了基于临床数据的特定老年人使用信息;38种药物具有一般性警告,12种药物缺乏老年人使用信息.
- 虽然大多数药物在试验中符合老年患者 (>100) 的入学建议,但试验比例和现实临床环境之间存在差异.
- 29种药物比较了老年患者和年轻患者的不良事件 (AE) 发生率;25种药物仅报告了整体AE发生率.
结论:
- 包装插件经常缺乏足够的老年特异性安全数据,影响日本老年患者的安全药物使用.
- 需要改善临床试验数据,特别是老年人不良事件概况在药物标签上呈现的方式.
- 营销许可证持有者与监管机构之间的合作至关重要,以确保包装插件中包含针对老年患者的全面安全信息.
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