Dispensing Medical Countermeasures for Public Health Emergencies

Workshop Summary

Miriam Davis, Marnina S. Kammersell, and Bruce M. Altevogt, Rapporteurs

Forum on Medical and Public Health Preparedness for Catastrophic Events

Board on Health Sciences Policy

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
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Miriam Davis, Marnina S. Kammersell, and Bruce M. Altevogt, Rapporteurs Forum on Medical and Public Health Preparedness for Catastrophic Events Board on Health Sciences Policy

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, N.W. • Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Insti- tute of Medicine. This study was supported by contracts between the National Academy of Sciences and the American Association of Blood Banks, the American College of Emergency Physi- cians, the American Hospital Association, the American Medical Association, the Ameri- can Nurses Association, the Association of State and Territorial Health Officials, the Centers for Disease Control and Prevention (Contract No. 200-2005-13434 TOs #6, 10), the Department of Health and Human Services’ Agency for Healthcare Research and Quality (Contract No. HHSP233200800498P), the Department of Health and Human Services’ National Institutes of Health (Contract No. N01-OD-4-2139 TO 198), the De- partment of Homeland Security (Contract No. HSHQDC-07-C-00097), the Department of Veteran Affairs (Contract No. V101(93)P-2136 TO #10), the Emergency Nurses As- sociation, the National Association of Chain Drug Stores, the National Association of County and City Health Officials, the National Association of Emergency Medical Tech- nicians, and the Pharmaceutical Research and Manufacturers of America. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-12096-8 International Standard Book Number-10: 0-309-12096-9 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334- 3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2008 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: IOM (Institute of Medicine). 2008. Dispensing medical countermea- sures for public health emergencies: Workshop summary. Washington, DC: The National Academies Press. The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal gov- ernment on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of out- standing engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engi- neering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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MEDICAL COUNTERMEASURES DISPENSING PLANNING COMMITTEE* LYNNE KIDDER (Co-Chair), Business Executives for National Security, Washington, DC MATTHEW MINSON (Co-Chair), Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, DC ANN M. BEAUCHESNE, Chamber of Commerce of the United States, Washington, DC STEPHANIE DULIN, Strategic National Stockpile, Centers for Disease Control and Prevention, Atlanta, GA PERRY FRI, Healthcare Distribution Management Association, Arlington, VA LYNN GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD JEFFREY HOLMES, PRTM, Washington, DC JASON F. JACKSON, Wal-Mart Stores, Inc., Bentonville, AR LISA KOONIN, Centers for Disease Control and Prevention, Atlanta, GA JON KROHMER, Department of Homeland Security, Washington, DC PATRICK LIBBEY, National Association of County and City Health Officials, Washington, DC CARTER MECHER, White House Homeland Security Council, Washington, DC SCOTT MUGNO, FedEx, Memphis, TN ERIN MULLEN, RX Response, Pharmaceutical Research and Manufacturers of America, Washington, DC CHERYL A. PETERSON, American Nurses Association, Silver Spring, MD PHILLIP SCHNEIDER, National Association of Chain Drug Stores Foundation, Alexandria, VA _________________________________ ∗ IOM 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. v

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IOM Staff BRUCE ALTEVOGT, Project Director ANDREW POPE, Director, Board on Health Sciences Policy MARNINA KAMMERSELL, Research Associate ALEX REPACE, Senior Program Assistant HEATHER KAISER, Intern (until June 2008) vi

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FORUM ON MEDICAL AND PUBLIC HEALTH PREPAREDNESS FOR CATASTROPHIC EVENTS* LEWIS R. GOLDFRANK (Chair), New York University Medical Center, New York, NY ANN M. BEAUCHESNE, Chamber of Commerce of the United States, Washington, DC JOSEPH BECKER, American Red Cross, Washington, DC GEORGES BENJAMIN, American Public Health Association, Washington, DC RICHARD BESSER, Centers for Disease Control and Prevention, Atlanta, GA KATHRYN BRINSFIELD, American College of Emergency Physicians, Washington, DC ROBERT DARLING, Uniformed Services University, Bethesda, MD LAWRENCE DEYTON, Department of Veterans Affairs, Washington, DC JEFFREY DUCHIN, Seattle & King County and University of Washington, Seattle, WA ELLEN EMBREY, Office of Assistant Secretary of Defense for Health Affairs, Department of Defense, Washington, DC LYNN GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD JAMES JAMES, American Medical Association, Chicago, IL HARVEY JOHNSON, Federal Emergency Management Agency, Washington, DC JERRY JOHNSTON, National Association of Emergency Medical Technicians, Clinton, MO ROBERT KADLEC, White House Homeland Security Council, Washington, DC LYNNE KIDDER, Business Executives for National Security, Washington, DC JON KROHMER, Department of Homeland Security, Washington, DC (since August 2008) MICHAEL KURILLA, National Institute of Allergy and Infectious Diseases, Bethesda, MD ________________________ * IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. vii

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JAMES LAWLER, White House Homeland Security Council, Washington, DC (until May 2008) PATRICK LIBBEY, National Association of County and City Health Officials, Washington, DC JAYNE LUX, National Business Group on Health, Washington, DC MARGARET MCMAHON, Emergency Nurses Association, Ponoma, NJ JUDITH MONROE, Association of State and Territorial Health Officials, Arlington, VA ERIN MULLEN, Pharmaceutical Research and Manufacturers of America, Washington, DC TARA O’TOOLE, University of Pittsburgh Medical Center, Pittsburgh, PA GERALD PARKER, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, DC SALLY PHILLIPS, Agency for Healthcare Research and Quality, Rockville, MD STEVEN PHILLIPS, National Library of Medicine, Bethesda, MD JEFFREY RUNGE, Office of the Assistant Secretary for Preparedness and Response, Department of Homeland Security, Washington, DC (until August 2008) PHILLIP SCHNEIDER, National Association of Chain Drug Stores Foundation, Alexandria, VA ROSLYNE SCHULMAN, American Hospital Association, Washington, DC LINDA STIERLE, American Nurses Association, Silver Spring, MD MARGARET VANAMRINGE, The Joint Commission, Washington, DC THERESA WIEGMANN, AABB, Bethesda, MD IOM Staff BRUCE ALTEVOGT, Project Director ANDREW POPE, Director, Board on Health Sciences Policy MARNINA KAMMERSELL, Research Associate ALEX REPACE, Senior Program Assistant HEATHER KAISER, Intern (until June 2008) viii

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BOARD ON HEALTH SCIENCES POLICY* FRED H. GAGE (Chair), The Salk Institute for Biological Studies, La Jolla, CA DONALD S. BURKE, University of Pittsburgh, Pittsburgh, PA C. THOMAS CASKEY, University of Texas, Houston Health Science Center GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, IN JAMES F. CHILDRESS, University of Virginia, Charlottesville, VA DENNIS CHOI, Emory University, Atlanta, GA LINDA C. GIUDICE, University of California, San Francisco LYNN R. GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD LAWRENCE O. GOSTIN, Georgetown University Law Center, Washington, DC MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, MD PAUL E. JARRIS, Association of State and Territorial Health Officials, Arlington, VA DAVID KORN, Association of American Medical Colleges, Washington, DC RICHARD C. LARSON, Massachusetts Institute of Technology, Cambridge, MA ALAN LESHNER, American Association for the Advancement of Science, Washington, DC LINDA B. MILLER, Volunteer Trustees Foundation, Washington, DC E. ALBERT REECE, University of Maryland School of Medicine, Baltimore, MD LINDA ROSENSTOCK, University of California, Los Angeles KEITH A. WAILOO, Rutgers, The State University of New Jersey, New Brunswick, NJ MICHAEL J. WELCH, Washington University School of Medicine, St. Louis, MO OWEN N. WITTE, University of California, Los Angeles _________________________________ * IOM boards do not review or approve individual products. The responsibility for the content of the workshop summary rests with the rapporteurs and the institution. ix

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IOM Staff ANDREW M. POPE, Director AMY HAAS, Board Assistant DONNA RANDALL, Financial Officer x

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Independent Report Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its pub- lished report as sound as possible and to ensure that the report meets in- stitutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confi- dential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Prasith (Sid) Baccam, Innovative Emergency Management (IEM) Linda C. Degutis, Yale Center for Public Health Preparedness, Yale University Jack Herrmann, National Association of County and City Health Officials Nancie McAnaugh, Missouri Department of Health and Senior Services Scott Mugno, Corporate Safety Health and Fire Protection, FedEx Express Eileen Scanlon, Office of Emergency Management, Nassau County Department of Health James Shortal, Cox Communications, Inc. Although the reviewers listed above have provided many construc- tive comments and suggestions, they did not see the final draft of the re- port before its release. The review of this report was overseen by Dr. Kristine M. Gebbie, Columbia University School of Nursing. Ap- pointed by the Institute of Medicine, she was responsible for making cer- xi

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tain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this re- port rests entirely with the authoring committee and the institution. xii

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Contents INTRODUCTION 1 WORKSHOP DEFINITIONS, GOALS, AND OBJECTIVES 2 CURRENT CHALLENGES AND THREATS 4 Distribution of Medical Countermeasures: The Strategic National Stockpile, 5 Dispensing Medical Countermeasures, 6 CURRENT PLANS AND GAPS REGARDING MEDICAL COUNTERMEASURE DISPENSING 7 Dispensing Medical Countermeasures: Time Considerations, 8 POD Models, 10 EMERGING FRAMEWORKS, TECHNOLOGIES, TOOLS, AND INNOVATIONS 18 Adapting Existing Frameworks, 18 Public–Private Partnerships, 20 Closed PODs, 24 Preregistration and Prescreening of Individuals, 26 Staffing Requirements, 27 Security, 28 Communication Systems, 28 LIABILITY PROTECTION FOR CORPORATIONS AND NONPROFIT PARTNERS 29 CONCLUSION 31 xiii

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APPENDIXES A References 33 B Workshop Agenda 35 C Registered Workshop Attendees 53 D Organizations Represented 61 E Biographical Sketches of Invited Speakers, Panelists, Workshop Planning Committee, Forum Members, and Staff 67 xiv