识别令人困惑的药物专有名称:朝着安全的药物使用 - - 斯里兰卡的一项跨部门研究
Manori Jayasinghe1, Thotawaththage Loshadhi Indunika Srilal2, Sewwandi Subasinghe3
1Department of Pharmacy, Faculty of Allied Health Sciences, University of Ruhuna, Karapitiya, Galle, 80000, Sri Lanka. manorijayasinghe@ahs.ruh.ac.lk.
Therapeutic innovation & regulatory science
|August 17, 2023
概括
许多斯里兰卡药品名称令人困惑地相似,对患者的安全构成风险. 一项审查发现,超过64%的专有药品名称存在外观或声音相似的问题,需要采取监管行动.
科学领域:
- 药物监督 药物监督 药物监督
- 药物安全 药物安全
- 监管科学是一种监管科学.
背景情况:
- 长相相似,声音相似 (LASA) 药物具有相似的名称,增加了药物错误的风险.
- 外国产品的存在可能会加剧当地市场的混乱.
- 这项研究调查了斯里兰卡注册专利药品名称的潜在LASA问题.
研究的目的:
- 确定斯里兰卡看起来和听起来相似的专有药品名称的流行情况.
- 评估由于药物名称相似而导致药物错误的风险.
- 为改善药品名称安全的监管策略提供信息.
主要方法:
- 一项横截面研究分析了斯里兰卡注册的专有药品名称.
- 使用微软Excel函数选择了385个姓名的随机样本.
- 两个独立评价者使用逐步的文本过方法和手动检查来识别LASA名称.
主要成果:
- 在385个名字中,138个 (35.84%) 与其他名字没有相似之处.
- 很大一部分,即247个名字 (64.15%),表现出LASA特征.
- 具体来说,91对是相似的,80对是声音相似的.
结论:
- 斯里兰卡的药物注册系统包含许多相同的,看起来和听起来相同的专有名称.
- 建议采用由国家药品监管局 (NMRA) 领导的多因素战略.
- 关键行动包括行业指导,提交前评估和拒绝LASA名称以提高药物安全.
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