COVID-19与标签外用药:伦理观点

Amirahmad Shojaei, Pooneh Salari
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引用次数: 28

摘要

背景:COVID-19疫情在世界范围内迅速蔓延,感染患者死亡。目前还没有经过证实的治疗药物,所以,所有用于治疗的药物都被认为是标签外的。由于没有针对这种情况的具体规定,因此在疫情中未对标签外使用进行监管。目的:在这个简短的交流中,我们旨在描述两种超说明书使用的方式,作为临床实践或研究使用。此外,我们将描述标签外使用的第三种方式,我们将其命名为伪研究,然后我们将陈述标签外使用最可能的伦理挑战,以获得更好的认知和责任。结果:世界卫生组织认为标签外使用是针对国家的。所有国际监管机构都认为标签外处方是医生的责任和法律,需要一些要求。目前还没有国际性的指导方针来规范临床实践中的非说明书用药。结论:有不同类型的方法,没有一种是全面的和结论性的。此外,尊重四项伦理原则需要对临床实践或研究中的超说明书使用进行编纂和严格监管。此外,强烈建议根据伦理原则,特别是非恶意和自主原则,编写一份专门的指导方针,用于灾难中的研究性超说明书使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
COVID-19 and off label use of drugs: an ethical viewpoint.

Background: The COVID-19 outbreak is rapidly spread over the world and kills infected patients. There is no proven medication for its treatment, so, all of the medications used for treatment are considered to be off-label. Off-label uses are not under regulation in the outbreak because there is no specific regulation for this condition.

Objectives: In this short communication we aim at describing two ways of off-label use as clinical practice or investigational use. Further, we will describe the third way of off-label use, we named it pseudo-research and then we will state the most possible ethical challenges of off-label use for better perceptions and responsibility.

Results: The WHO considers off-label uses as country-specific. All international regulatory bodies consider off-label prescription as the physician's responsibility and legal by necessitating some requirements. There is no international guideline for regulating investigational off-label uses as clinical practice.

Conclusion: There are different types of approaches, none of them is comprehensive and conclusive. Furthermore, respecting the four ethical principles necessitates codification and strict regulation of off-label uses either as clinical practice or investigational. Besides, compilation of a special guideline based on ethical principles especially non-maleficence and autonomy for investigational off-label uses in disasters is highly recommended.

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