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.
【저자키워드】 Emergency use authorization, Electronic health record, Food and Drug Administration, extracorporeal membrane oxygenation, FDAFood and Drug Administration, EUAemergency use authorization, ECMOextracorporeal membrane oxygenation, EHRelectronic health record, HHSDepartment of Health and Human Services, Department of Health and Human Services, MCECMinnesota COVID Ethics Collaborative, Minnesota COVID Ethics Collaborative, MDHMinnesota Department of Health, Minnesota Department of Health, NIAIDNational Institute of Allergy and Infectious Diseases, National Institute of Allergy and Infectious Diseases, SATScience Advisory Team, Science Advisory Team, SHCCCState Health Care Coordination Center, State Health Care Coordination Center, UMNUniversity of Minnesota, University of Minnesota, 【초록키워드】 COVID-19, coronavirus, clinical trial, children, hospital, Human, Ethics, Remdesivir, drug, FDA, EUA, antiviral drug, COVID, pregnant women, Patient, public health emergency, allocation, Guidance, food, Emergency, framework, COVID-19 patient, COVID-19 crisis, state health department, treat, Department, authorization, service, approach, compassionate-use, raised, approved, question, addressed, build, Inc., 【제목키워드】 COVID-19, Ethics, framework, Developing,