医生对风险评估和缓解战略计划的经验和看法,包括确保安全使用的元素
Ameet Sarpatwari1, Beatrice L Brown1, Sarah A McGraw2
1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America.
PloS one
|July 6, 2023
概括
医生了解Elements to Assure Safe Use (ETASU) 风险评估和缓解策略 (REMS),但发现它们在行政上是繁的. 这些重要的安全计划需要更好地整合到工作流程中,并加强患者数据保护.
科学领域:
- 药监和药物安全 药监和药物安全
- 监管科学 监管科学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 2007年美国FDA修订法案允许对具有重大安全隐患的药物进行风险评估和缓解战略 (REMS) 计划.
- 确保安全使用的要素 (ETASU) 是REMS的一个组成部分,包括患者登记册和发行限制,以减轻风险.
研究的目的:
- 调查医生对特定ETASU REMS程序的经验和看法.
- 了解这些安全计划如何影响临床实践和医生处方行为.
主要方法:
- 一个描述性的现象学研究,利用半结构化的电话采访.
- 对医生对纳塔利祖马布,里奥西瓜特,氧酸盐和维加巴特林ETASU REMS的反应进行定性内容分析.
主要成果:
- 大多数医生理解ETASU REMS的要求,但对临床实践的影响有限.
- 医生报告说,由于监督和改善的患者讨论,特别是非专家,处方的舒适性增加了.
- 担忧包括行政负担和潜在的患者健康信息滥用.
结论:
- 医生们了解ETASU REMS,并从所提供的监督中得到了保证.
- 改善建议包括更好地整合到临床工作流程中,并加强对患者健康信息的保护.
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