分发药房连锁和直接抗凝剂:与患者结局的潜在关联
Steven Kozlowski1, Ellen Tworkoski2, Sai Dharmarajan1
1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Pharmacoepidemiology and drug safety
|February 16, 2024
概括
药房连锁店可能会影响患者对某些药物的治疗结果. 里瓦罗克萨班在一家连锁店的胃肠道出血和缺血性中风率较低,这表明药房连锁店可能是药物研究中的混因素.
科学领域:
- 药物监督 药物监督 药物监督
- 观察性研究设计研究
- 医疗保健服务研究 医疗服务研究
背景情况:
- 连锁药店在患者群体,非处方产品,服务和实践方面表现出差异.
- 这些差异可以在处方药的观察性研究中引入未测量的混.
- 药房连锁的特点可能会作为未测量的混因素的替代品.
研究的目的:
- 评估单一来源药物是否可以根据分发药房连锁产生不同的患者结果.
- 在观察性药物研究中调查药房连锁店在观察性药物研究中的潜在混作用.
主要方法:
- 对两种抗凝血药物的医疗保险服务费索赔的分析:里瓦罗克萨班和阿皮克萨班.
- 药房供应链与结果之间的关联评估,包括心肌梗塞,中风,出血,胃肠道出血和死亡率.
- 使用治疗权重的逆概率 (IPTW) 进行共变量平衡和考克斯比例危险模型进行结果评估.
主要成果:
- 对于阿皮克萨班使用者的药房连锁店之间没有观察到显著的结果差异.
- 与A连锁药店相比,来自C连锁药店的里瓦罗克萨班接受者显示,胃肠道出血和缺血性中风的发生率较低.
- 在分析中,这些影响随着较长的宽限期 (14日和30天) 减少.
结论:
- 药房连锁店的分发有潜力混药物暴露与观察研究结果之间的关联.
- 需要进一步的研究来探索药房连锁效应作为潜在的混因素.
- 建议进行额外的研究,评估药房连锁对药物的安全性和有效性的影响.
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