RTI International, 3040 East Cornwallis Rd., Durham, NC, 27709, USA.
Office of Prescription Drug Promotion, Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
BMC Public Health. 2024 Oct 11;24(1):2791. doi: 10.1186/s12889-024-20234-0.
Under Sect. 564 of the Federal Food, Drug, and Cosmetic Act, when the US Department of Health and Human Services Secretary issues a declaration based on one of four types of determinations, FDA may authorize an unapproved product or unapproved uses of an approved product for emergency use. It is unclear how much the public and health care providers understand about emergency use authorizations and how that understanding influences perceptions or behavioral intentions. The current study aimed to explore consumer and health care provider perceptions of emergency use authorizations and how promotion of emergency use authorizations has been investigated in the literature.
We conducted a scoping review via PubMed, Embase, Web of Science, and CINAHL for original research published in English from January 1, 2012, through November 10, 2022. We conducted surveillance of the literature through March 2023.
We identified 13 studies reported in 14 publications that addressed public and health care provider attitudes, understanding, and behaviors with regard to products authorized under an emergency use authorization. We did not identify any articles describing research regarding the promotion of emergency use authorization products. Findings suggest gaps in understanding of emergency use authorizations, both for the public and health care providers. Findings also suggest the public and health care providers have concerns about safety or the lack of full FDA approval that may contribute to decreased willingness to receive treatments and vaccines under an emergency use authorization.
Future research should explore how emergency use authorizations have been promoted and how that promotion impacts public and health care provider perceptions.
根据《联邦食品、药品和化妆品法案》第 564 节,如果美国卫生与公众服务部部长根据四种决定之一发布声明,FDA 可以授权未经批准的产品或已批准产品的未经批准用途用于紧急使用。目前尚不清楚公众和医疗保健提供者对紧急使用授权的了解程度,以及这种理解如何影响他们的看法或行为意向。本研究旨在探讨消费者和医疗保健提供者对紧急使用授权的看法,以及文献中如何研究紧急使用授权的推广。
我们通过 PubMed、Embase、Web of Science 和 CINAHL 进行了范围综述,检索了 2012 年 1 月 1 日至 2022 年 11 月 10 日期间以英文发表的原始研究。我们通过 2023 年 3 月进行了文献监测。
我们确定了 13 项研究,这些研究在 14 篇出版物中报告了与根据紧急使用授权授权的产品相关的公众和医疗保健提供者的态度、理解和行为。我们没有发现任何描述有关紧急使用授权产品推广的研究的文章。研究结果表明,无论是公众还是医疗保健提供者,对紧急使用授权的理解都存在差距。研究结果还表明,公众和医疗保健提供者对安全性或缺乏完整的 FDA 批准表示关注,这可能导致他们在紧急使用授权下接受治疗和疫苗的意愿降低。
未来的研究应该探讨紧急使用授权是如何推广的,以及这种推广如何影响公众和医疗保健提供者的看法。