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Antimicrobial stewardship programs and convalescent plasma for COVID-19: A new paradigm for preauthorization?

Published online by Cambridge University Press:  09 September 2020

Michael P. Stevens*
Affiliation:
Healthcare Infection Prevention Department, Virginia Commonwealth University Health System, Richmond, Virginia
Payal K. Patel
Affiliation:
Infectious Diseases Section, Ann Arbor VA Medical Center, Ann Arbor, Michigan University of Michigan, Ann Arbor, Michigan
Priya Nori
Affiliation:
Division of Infectious Diseases, Department of Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York
*
Author for correspondence: Michael P. Stevens, E-mail: michael.stevens@vcuhealth.org
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Abstract

Type
Letter to the Editor
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Copyright
© 2020 by The Society for Healthcare Epidemiology of America. All rights reserved

To the Editor—Antimicrobial preauthorization is a core strategy utilized by antimicrobial stewardship programs (ASPs). Reference Dellit, Owens and McGowan1 ASPs have played an important role in coronavirus disease 2019 (COVID-19) response efforts, including in the preauthorization of novel therapeutic agents such as remdesivir. Reference Stevens, Patel and Nori2,Reference Mazdeyasna, Nori and Patel3 On August 23, 2020, the US Food & Drug Administration (FDA) released an emergency use authorization (EUA) for the use of convalescent plasma in treating hospitalized patients with COVID-19. 4 An important question is what role, if any, ASPs should play in the convalescent plasma distribution process. To our knowledge, ASPs have never been involved in the preauthorization of blood products like convalescent plasma. There are numerous potential advantages and disadvantages to consider regarding ASP involvement in the convalescent plasma preauthorization process (Table 1). The effectiveness of convalescent plasma in the treatment of COVID-19 is still unclear. The data regarding convalescent plasma use are limited. As of June 22, 2020, the Infectious Diseases Society of America (IDSA) COVID-19 treatment guidelines recommend the use of convalescent plasma only in the context of a clinical trial. Reference Bhimraj, Morgan and Shumaker5 Importantly, enrollment in existing trials has been potentially compromised by the EUA announcement. Major scientific organizations will likely continue to support guidelines emphasizing convalescent plasma use only in the context of clinical trials. It is also possible that additional study data will become available that will influence convalescent plasma use. This uncertainty about the optimal role of convalescent plasma supports the use of preauthorization to allow for real-time adjustment of convalescent plasma use in a controlled, optimized fashion.

Table 1. Considerations For and Against Antimicrobial Stewardship Program (ASP) Involvement in COVID-19 Convalescent Plasma Preauthorization

Many ASPs have been responsible for the creation and maintenance of COVID-19 treatment guidelines and are ideally situated to inform frontline clinicians about the optimal use of convalescent plasma relative to other therapies. Preauthorization, coupled with local treatment guidelines, would enhance the optimal use of convalescent plasma. Additionally, the new convalescent plasma EUA may increase demand for convalescent plasma use, resulting in timely access issues. A preauthorization process utilizing the best available evidence would facilitate providing convalescent plasma to patients who may benefit.

Health systems would benefit tremendously from ASP involvement in the COVID-19 convalescent plasma distribution process. ASPs can provide guidance for incorporation of convalescent plasma into local treatment guidelines, can provide insight and guidance based on their experiences with other COVID-19 focused EUAs (including hydroxychloroquine, now revoked 6 , and remdesivir 7 ), and can help develop processes for convalescent plasma eligibility screening and preauthorization. If health systems do not adopt preauthorization for convalescent plasma, we recommend that use be carefully monitored to ensure that this resource is being used optimally. ASPs have proven integral in COVID-19 response efforts—investing in and scaling up ASP resources will assist health systems adapt and respond to evolving pandemic challenges.

Financial support

No financial support was provided relevant to this article.

Conflicts of interest

All authors report no conflicts of interest relevant to this article.

References

Dellit, TH, Owens, RC, McGowan, JE, et al. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis 2007;44:159177.CrossRefGoogle Scholar
Stevens, MP, Patel, PK, Nori, P. Involving antimicrobial stewardship programs in COVID-19 response efforts: all hands on deck. Infect Control Hosp Epidemiol 2020;41:744745.CrossRefGoogle Scholar
Mazdeyasna, H, Nori, P, Patel, P, et al. Antimicrobial stewardship at the core of COVID-19 response efforts: implications for sustaining and building programs. Curr Infect Dis Rep 2020;22:23.CrossRefGoogle Scholar
US Food & Drug Administration website. https://www.fda.gov/media/141477/download. Accessed August 25, 2020.Google Scholar
Bhimraj, A, Morgan, RL, Shumaker, AH, et al. Infectious Diseases Society of America guidelines on the treatment and management of patients with COVID-19. Infectious Diseases Society of America website. https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/. Accessed August 25, 2020.Google Scholar
FDA news release. Coronavirus (COVID-19) update: FDA revokes emergency use authorization for chloroquine and hydroxychloroquine. US Food & Drug Administration website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and. Accessed August 25, 2020.Google Scholar
FDA news release. Coronavirus (COVID-19) update: FDA issues emergency use authorization for possible COVID-19 treatment. US Food & Drug Administration website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment. Accessed August 25, 2020.Google Scholar
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Table 1. Considerations For and Against Antimicrobial Stewardship Program (ASP) Involvement in COVID-19 Convalescent Plasma Preauthorization