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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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The Nation’s Medical
Countermeasure Stockpile

Opportunities to Improve the Efficiency,
Effectiveness, and Sustainability of the
CDC Strategic National Stockpile

Workshop Summary

Anna Nicholson, Scott Wollek, Benjamin Kahn, and Jack Herrmann,
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. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
×

THE NATIONAL ACADEMIES PRESS500 Fifth Street, NWWashington, DC 20001

This activity was supported by Contract No. 200-2011-38807 with the Centers for Disease Control and Prevention. 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: 978-0-309-44367-8
International Standard Book Number-10: 0-309-44367-9
Digital Object Identifier: 10.17226/23532

Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Copyright 2016 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2016. The nation’s medical countermeasure stockpile: Opportunities to improve the efficiency, effectiveness, and sustainability of the CDC Strategic National Stockpile: Workshop summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
×

Image

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. Ralph J. Cicerone 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 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.national-academies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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PLANNING COMMITTEE FOR THE NATION’S MEDICAL COUNTERMEASURE STOCKPILE: OPPORTUNITIES TO IMPROVE THE EFFICIENCY, EFFECTIVENESS, AND SUSTAINABILITY OF THE CDC STRATEGIC NATIONAL STOCKPILE—A WORKSHOP1

TARA O’TOOLE (Chair), Senior Fellow and Executive Vice President, In-Q-Tel

ELLEN CARLIN, Principal, Carlin Communications

PERRY FRI, Executive Vice President, Industry Relations, Membership and Education, Healthcare Distribution Management Association

EMILY GORE, Director, Public Health and Preparedness Division, Dallas County Health and Human Services

THOMAS INGLESBY, CEO and Director, Center for Health Security, University of Pittsburgh Medical Center

EVA LEE, Professor, School of Industrial and Systems Engineering and Director, Center for Operations Research in Medicine and Health Care, Georgia Institute of Technology

ERIN MULLEN, Subject-Matter Expert, Healthcare Ready

PAUL PETERSEN, Director, Emergency Preparedness Program, Tennessee Department of Health

IRWIN REDLENER, Professor, Health Policy and Management and Director, National Center for Disaster Preparedness, Mailman School of Public Health, Columbia University

Health and Medicine Division Staff

JACK HERRMANN, Project Director

SCOTT WOLLEK, Program Officer

BENJAMIN KAHN, Research Assistant

THELMA COX, Administrative Assistant

ANDREW M. POPE, Director, Board on Health Sciences Policy

___________________

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 workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Reviewers

This workshop summary has been 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 institution in making its published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this workshop summary:

JULIE ANN P. CASANI, North Carolina Department of Health and Human Services

MICHAEL LOEHR, Washington State Department of Health

PAUL PETERSEN, Tennessee Department of Health

CHRISTOPHER G. SHIELDS, Chicago Department of Public Health

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by LINDA DEGUTIS, Henry M. Jackson Foundation for the Advancement of Military Medicine. She was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
×
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
×

Acronyms and Abbreviations

AMMA

Army Medical Materiel Agreement

ASPR

Assistant Secretary for Preparedness and Response

ASTHO

Association of State and Territorial Health Officials

BARDA Biomedical Advanced Research and Development Authority
CBRN chemical, biological, radiological, and nuclear
CDC

Centers for Disease Control and Prevention

CDER

Center for Drug Evaluation and Research

CERT

Community Emergency Response Teams

CGMP

Current Good Manufacturing Practice

CIADM

Center for Innovation in Advanced Development & Manufacturing

CONOPS

concept of operations

CRI

Cities Readiness Initiative

CTECS

Counter-Terrorism and Emergency Coordination Staff

DEA Drug Enforcement Agency
DHS

Department of Homeland Security

DLA

Defense Logistics Agency

DoD

Department of Defense

DPHP

Directors of Public Health Preparedness

DSLR

Division of State and Local Readiness

DSNS

Division of Strategic National Stockpile

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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EDI electronic data interchange
EID

emerging infectious disease

ESC

Enterprise Senior Council

EUA

Emergency Use Authorization

EVD

Ebola virus disease

FDA Food and Drug Administration
FEMA

Federal Emergency Management Agency

HHS Department of Health and Human Services
IDE investigational device exemption
IND

investigational new drug

IPT

Integrated Program Team

ITRA

Integrated CBRN Terrorism Risk Assessment

LDS local distribution site
MCM medical countermeasure
MCMi

Medical Countermeasures Initiative

MOU

memorandum of understanding

NACCHO National Association of County and City Health Officials
NBSB

National Biodefense Science Board

NIH

National Institutes of Health

OMB Office of Management and Budget
OPHPR

Office of Public Health Preparedness and Response

ORR

Operational Readiness Review

PAHPRA Pandemic and All-Hazards Preparedness Reauthorization Act
PHEMCE

Public Health Emergency Medical Countermeasures Enterprise

PHEP

public health emergency preparedness

PHS

Public Health Service

PI

pandemic influenza

PIB

POD in a box

POD

point of dispensing

PPE

personal protective equipment

PREP Act

Public Readiness and Emergency Preparedness Act

PSMR

Pre-Scripted Mission Request

RAMPEx Rapid Activation for Mass Prophylaxis Exercise
RFID

radio-frequency identification

Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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ROI

return on investment

RSS

receipt, storage, and staging

SIP Strategy and Implementation Plan
SLEP

Shelf Life Extension Program

SLTT

state, local, tribal, and territorial

SNS

Strategic National Stockpile

TOPOFF top officials
VA Department of Veterans Affairs
VHA

Veterans Health Administration

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Page R7
Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Page R8
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
×
Page R9
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
×
Page R10
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
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Page R12
Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
×
Page R13
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2016. The Nation's Medical Countermeasure Stockpile: Opportunities to Improve the Efficiency, Effectiveness, and Sustainability of the CDC Strategic National Stockpile: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/23532.
×
Page R14
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Large catastrophic events, or rare acute events, may cause situations in which a local jurisdiction’s medicines and medical supplies are not sufficient to provide care to the population it serves. In these cases of natural or engineered disasters, such as a terrorist attack, influenza pandemic, or earthquake, state or local authorities can request that the federal government provide assets from the Strategic National Stockpile to augment the state and local jurisdictions’ resources.

The Centers for Disease Control and Prevention’s (CDC’s) Strategic National Stockpile (SNS) is the nation’s repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical materiel designed to supplement and resupply state and local public health agencies in the event of an emergency. The materiel is intended to support national health security and is managed by the Office of Public Health Preparedness and Response’s (OPHPR’s) Division of Strategic National Stockpile (DSNS). The stated mission of the SNS is to prepare and support partners and provide the right resources at the right time to secure the nation’s health.

The National Academies of Sciences, Engineering, and Medicine organized a two-day public workshop to explore opportunities to improve the efficiency, effectiveness, and sustainable methods used by the CDC’s SNS to distribute medical countermeasures and other supplies during disasters and other public health emergencies, especially those which result in disruption of physical infrastructure such as the electrical grid, central roadways, bridges, and tunnels within the impacted community. Participants explored relevant distribution lessons learned from other federal agency stockpiles and the private sector as well as opportunities to develop public-private collaborations in the purchase, warehousing, management, and distribution of medical countermeasures. This report summarizes the presentations and discussions from the workshop.

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