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Implementation of SARS-CoV-2 Monoclonal Antibody Infusion Sites at Three Medical Centers in the United States: Strengths and Challenges Assessment to Inform COVID-19 Pandemic and Future Public Health Emergency Use

Published online by Cambridge University Press:  14 January 2022

Anastasia S. Lambrou
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA Johns Hopkins University Applied Physics Laboratory, Laurel, MD, USA
John T. Redd*
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Miles A. Stewart
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA Johns Hopkins University Applied Physics Laboratory, Laurel, MD, USA
Kaitlin Rainwater-Lovett
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA Johns Hopkins University Applied Physics Laboratory, Laurel, MD, USA
Jonathan K. Thornhill
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA Johns Hopkins University Applied Physics Laboratory, Laurel, MD, USA
Lynn Hayes
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Gina Smith
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
George M. Thorp
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Christian Tomaszewski
Affiliation:
El Centro Regional Medical Center, El Centro, CA, USA UC San Diego Health, San Diego, CA, USA
Adolphe Edward
Affiliation:
El Centro Regional Medical Center, El Centro, CA, USA UC San Diego Health, San Diego, CA, USA
Natalia Elías Calles
Affiliation:
TMC HealthCare, Tucson, AZ, USA
Mark Amox
Affiliation:
Sunrise Hospital and Medical Center, Las Vegas, NV, USA
Steven Merta
Affiliation:
Sunrise Hospital and Medical Center, Las Vegas, NV, USA
Tiffany Pfundt
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Victoria Callahan
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Adam Tewell
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Helga Scharf-Bell
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Samuel Imbriale
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Jeffrey D. Freeman
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA Johns Hopkins University Applied Physics Laboratory, Laurel, MD, USA
Michael Anderson
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
Robert P. Kadlec
Affiliation:
Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services, Washington, DC, USA
*
Corresponding author: John T. Redd, Email john.redd@hhs.gov.

Abstract

Monoclonal antibody therapeutics to treat coronavirus disease (COVID-19) have been authorized by the US Food and Drug Administration under Emergency Use Authorization (EUA). Many barriers exist when deploying a novel therapeutic during an ongoing pandemic, and it is critical to assess the needs of incorporating monoclonal antibody infusions into pandemic response activities. We examined the monoclonal antibody infusion site process during the COVID-19 pandemic and conducted a descriptive analysis using data from 3 sites at medical centers in the United States supported by the National Disaster Medical System. Monoclonal antibody implementation success factors included engagement with local medical providers, therapy batch preparation, placing the infusion center in proximity to emergency services, and creating procedures resilient to EUA changes. Infusion process challenges included confirming patient severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positivity, strained staff, scheduling, and pharmacy coordination. Infusion sites are effective when integrated into pre-existing pandemic response ecosystems and can be implemented with limited staff and physical resources.

Type
Concepts in Disaster Medicine
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is a work of the US Government and is not subject to copyright protection within the United States. Published by Cambridge University Press on behalf of Society for Disaster Medicine and Public Health, Inc.
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
© The US Department of Health and Human Services and The Author(s), 2022.

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