tetano
Editor, Senior Moderator
Mayo Clin Proc
. 2020 Sep;95(9):1946-1954.
doi: 10.1016/j.mayocp.2020.06.016. Epub 2020 Jun 20.
Developing an Ethics Framework for Allocating Remdesivir in the COVID-19 Pandemic
Sarah Lim[SUP] 1 [/SUP], Debra A DeBruin[SUP] 2 [/SUP], Jonathon P Leider[SUP] 2 [/SUP], Nneka Sederstrom[SUP] 3 [/SUP], Ruth Lynfield[SUP] 4 [/SUP], Jason V Baker[SUP] 5 [/SUP], Susan Kline[SUP] 2 [/SUP], Sarah Kesler[SUP] 2 [/SUP], Stacey Rizza[SUP] 6 [/SUP], Joel Wu[SUP] 2 [/SUP], Richard R Sharp[SUP] 6 [/SUP], Susan M Wolf[SUP] 7 [/SUP]
Affiliations
Abstract
On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). Remdesivir is an investigational drug studied in clinical trials for COVID-19 and is available to children and pregnant women through compassionate-use access but is not yet FDA approved. In early May, the US Department of Health and Human Services began to distribute remdesivir, donated by Gilead Sciences, Inc., to hospitals and state health departments for emergency use; multiple shipments have since been distributed. This process has raised questions of how remdesivir should be allocated. The Minnesota Department of Health has collaborated with the Minnesota COVID Ethics Collaborative and multiple clinical experts to issue an Ethical Framework for May 2020 Allocation of Remdesivir in the COVID-19 Pandemic. The framework builds on extensive ethical guidance developed for public health emergencies in Minnesota before the COVID-19 crisis. The Minnesota remdesivir allocation framework specifies an ethical approach to distributing the drug to facilities across the state and then among COVID-19 patients within each facility. This article describes the process of developing the framework and adjustments in the framework over time with emergence of new data, analyzes key issues addressed, and suggests next steps. Sharing this framework and the development process can encourage transparency and may be useful to other states formulating and refining their approach to remdesivir EUA allocation.
. 2020 Sep;95(9):1946-1954.
doi: 10.1016/j.mayocp.2020.06.016. Epub 2020 Jun 20.
Developing an Ethics Framework for Allocating Remdesivir in the COVID-19 Pandemic
Sarah Lim[SUP] 1 [/SUP], Debra A DeBruin[SUP] 2 [/SUP], Jonathon P Leider[SUP] 2 [/SUP], Nneka Sederstrom[SUP] 3 [/SUP], Ruth Lynfield[SUP] 4 [/SUP], Jason V Baker[SUP] 5 [/SUP], Susan Kline[SUP] 2 [/SUP], Sarah Kesler[SUP] 2 [/SUP], Stacey Rizza[SUP] 6 [/SUP], Joel Wu[SUP] 2 [/SUP], Richard R Sharp[SUP] 6 [/SUP], Susan M Wolf[SUP] 7 [/SUP]
Affiliations
- PMID: 32861338
- DOI: 10.1016/j.mayocp.2020.06.016
Abstract
On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). Remdesivir is an investigational drug studied in clinical trials for COVID-19 and is available to children and pregnant women through compassionate-use access but is not yet FDA approved. In early May, the US Department of Health and Human Services began to distribute remdesivir, donated by Gilead Sciences, Inc., to hospitals and state health departments for emergency use; multiple shipments have since been distributed. This process has raised questions of how remdesivir should be allocated. The Minnesota Department of Health has collaborated with the Minnesota COVID Ethics Collaborative and multiple clinical experts to issue an Ethical Framework for May 2020 Allocation of Remdesivir in the COVID-19 Pandemic. The framework builds on extensive ethical guidance developed for public health emergencies in Minnesota before the COVID-19 crisis. The Minnesota remdesivir allocation framework specifies an ethical approach to distributing the drug to facilities across the state and then among COVID-19 patients within each facility. This article describes the process of developing the framework and adjustments in the framework over time with emergence of new data, analyzes key issues addressed, and suggests next steps. Sharing this framework and the development process can encourage transparency and may be useful to other states formulating and refining their approach to remdesivir EUA allocation.