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
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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.
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.
This page intentionally left blank.
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.
This page intentionally left blank.
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.
This page intentionally left blank.
Contents
1 INTRODUCTION, BACKGROUND, AND CONTEXT
2 THE STRATEGIC NATIONAL STOCKPILE: ORIGIN, POLICY FOUNDATIONS, AND FEDERAL CONTEXT
Historical and Current Perspectives
SNS and the Federal Medical Countermeasures Enterprise: Federal Program and Agency Partnerships
3 STUDIES AND REPORTS RELATED TO THE STRATEGIC NATIONAL STOCKPILE
Anticipated Responsibilities of the SNS in the Year 2020
A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts
Public Health Emergency Medical Countermeasures Enterprise Review: A Strategic Report
Potential Opportunity to Reexamine the Mission and Scope of SNS
Potential Opportunity for Promoting Visibility of the Public Health Enterprise
Perspectives of Public Health Departments at the State and Local Levels
CDC Strategies for Ensuring Readiness at the Last Mile
MCM Challenges from the State and Local Perspectives
Potential Opportunity for Alternative Distribution and Dispensing Models
Potential Opportunity for Improving Capacity to Reach the Last Mile
Strengthening the Public Health Response Supply Chain
Potential Opportunity for Better Engagement with the Commercial and Pharmaceutical Industries
Potential Opportunity for Improved Electronic Data Interchange
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 |
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 |
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 |
This page intentionally left blank.