安全性与价格在仿制药市场:甲福明
Ben Teasdale, Amber Hudspeth, Kaury Kucera
1Clinical Excellence Research Center, School of Medicine, Stanford University, 453 Quarry Rd #117B, CAM Building, Palo Alto, CA 94304.
The American journal of managed care
|April 11, 2024
概括
通用甲胺提醒降低了致癌物水平,但一些产品仍然超过安全值. 药品价格与杂质水平没有相关性,这表明以相似的成本可获得更安全的选择.
科学领域:
- 制药品质量控制 制药品质量控制
- 药物安全和药物监管
- 药用化学 医学化学
背景情况:
- 包括甲福明在内的仿制药对于患者负担能力至关重要,占美国处方的90%.
- 最近对仿制药的召回,特别是2020年延长释放 (ER) 甲福明的召回,突出了对N-二甲基胺 (NDMA) 等致癌杂质的担忧.
- 确保仿制药的安全性和质量对于公共卫生至关重要.
研究的目的:
- 为了评估在市面上销售的通用甲素即时释放 (IR) 和ER片中存在致癌杂质N-二甲胺 (NDMA) 和N,N-二甲胺 (DMF) 的存在.
- 调查杂质含量与药品定价之间的关联.
- 为了评估2020年FDA召回对美特福林单位价格和处方填充率的影响.
主要方法:
- 来自各种制造商的仿制药物metformin IR和ER片的药品质量测试.
- 在测试样本中分析NDMA和DMF水平.
- 数据库分析以将杂质水平与药品价格相关联,并评估召回对市场动态的影响.
主要成果:
- 在召回后,甲福林ER样本中的NDMA水平显著下降.
- 然而,6.67%的IR甲胺样本仍含有超过FDA值的致癌物质.
- 在NDMA或DMF的存在与IR或ER甲胺产品的价格之间没有发现显著的关联.
- 尽管有召回,但甲福林ER处方填充量增加,而单位价格下降.
结论:
- 甲胺ER有效地降低了NDMA水平,但一些通用甲胺产品仍然受到污染.
- 价格与杂质水平缺乏相关性表明,可能有成本效益更高,更安全的通用甲胺替代品可供选择.
- 持续的警和强有力的质量测试对于确保仿制药的安全至关重要.
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