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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Building a National Capability
to Monitor and Assess Medical
Countermeasure Use During a
Public Health Emergency

GOING BEYOND THE LAST MILE

PROCEEDINGS OF A WORKSHOP

Morgan Boname, Theresa Wizemann, and Justin Snair, Rapporteurs

Board on Health Sciences Policy

Health and Medicine Division

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This project was supported by a contract between the National Academy of Sciences and the U.S. Department of Health and Human Services’ U.S. Food and Drug Administration (Contract No. 1R13FD005495-01). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-46642-4
International Standard Book Number-10: 0-309-46642-3
Digital Object Identifier: https://doi.org/10.17226/24912

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Copyright 2017 by the National Academy of Sciences. All rights reserved.

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Building a national capability to monitor and assess medical countermeasure use during a public health emergency: Going beyond the last mile: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org.10.17226/24912.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

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The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

images

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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PLANNING COMMITTEE ON BUILDING A NATIONAL CAPABILITY TO MONITOR AND ASSESS MEDICAL COUNTERMEASURE USE IN RESPONSE TO PUBLIC HEALTH EMERGENCIES1

BORIS LUSHNIAK (Chair), Dean and Professor, University of Maryland School of Public Health

PHYLLIS ARTHUR, Managing Director, Infectious Diseases and Diagnostics Policy, Biotechnology Innovation Organization

SUZANNE BAKKEN, Alumni Professor of Nursing; Professor of Biomedical Informatics, Columbia University

JEREMY BROWN, Director, Office of Emergency Care Research, National Institute of General Medical Sciences, National Institutes of Health

J. PERREN COBB, Professor, Clinical Surgery; Director, University of Southern California Critical Care Institute; Director, Keck Surgical Intensive Care Unit, University of Southern California

JEFFREY COUGHLIN, Senior Director, Federal and State Affairs, Healthcare Information Management and Systems Society

AMANDA PEPPERCORN, Senior Medical Director, Infectious Diseases Research and Development, GlaxoSmithKline

RICHARD PLATT, Professor and Chair, Department of Population Medicine, Harvard Medical School

KIMBERLEY RICKETTS, Public Health Advisor, U.S. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services

PAUL SELIGMAN, Executive Director, Amgen

UMAIR SHAH, Executive Director, Harris County Public Health and Environmental Services

YON YU, Associate Director, Regulatory Affairs, National Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services

Health and Medicine Division Staff

JUSTIN SNAIR, Senior Program Officer (until September 2017)

SCOTT WOLLEK, Senior Program Officer

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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MORGAN BONAME, Associate Program Officer

ALEXA EDMIER, Research Assistant

ANDREW POPE, Director, Board on Health Sciences Policy

Consultants

LAURA RUNNELS, LAR Consulting

THERESA WIZEMANN, Consulting Writer

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

SUZANNE BAKKEN, Columbia University

JAY C. BUTLER, Alaska Department of Health and Social Services

J. PERREN COBB, University of Southern California

EVA LEE, Georgia Institute of Technology

BORIS LUSHNIAK, University of Maryland School of Public Health

VINIT P. NAIR, Humana

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by LINDA C. DEGUTIS, Henry M. Jackson Foundation. She was responsible for making certain that an independent examination of this proceedings was carried out in accordance with stan-

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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dards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×

Acronyms and Abbreviations

ASPR

Office of the Assistant Secretary for Preparedness and Response (HHS)

BARDA

Biomedical Advanced Research and Development Authority

CBRN

chemical, biological, radiological, nuclear

CDC

U.S. Centers for Disease Control and Prevention

CONOPS

concept of operations

CMS

Centers for Medicare & Medicaid Services

CTSA

Clinical and Translational Science Awards

EHR

electronic health record

EMS

emergency medical services

EUA

Emergency Use Authorization

FDA

U.S. Food and Drug Administration

GSK

GlaxoSmithKline

HHS

U.S. Department of Health and Human Services

HIPAA

Health Insurance Portability and Accountability Act of 1996

IPT

integrated program team

IRB

institutional review board

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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IT

information technology

MCM

medical countermeasure

NCATS

National Center for Advancing Translational Sciences (NIH)

NIAID

National Institute of Allergy and Infectious Diseases (NIH)

NIH

National Institutes of Health

NLM

National Library of Medicine (NIH)

OCR

Office for Civil Rights (HHS)

ONC

Office of the National Coordinator for Health Information Technology

PHE

public health emergency

PHEMCE

Public Health Emergency Medical Countermeasures Enterprise

POD

point of dispensing

SNS

Strategic National Stockpile

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
×
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2017. Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency: Going Beyond the Last Mile: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24912.
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During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication.

As part of the United States’ scientific and research preparedness enterprise, there is an imperative to go “beyond the last mile” of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs (e.g., safety, compliance, clinical benefit) after they have been dispensed during PHEs. To further the discussion on this need, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies. The workshop, sponsored by FDA, was held on June 6–7, 2017, in Washington, DC. Workshop participants discussed the roles and efforts of the federal government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability. This publication summarizes the presentations and discussions from the workshop.

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