Medical Countermeasures Dispensing

Emergency Use Authorization and the Postal Model

Workshop Summary

Clare Stroud, Lori Nadig, 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.
www.nap.edu



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Medical Countermeasures Dispensing Emergency Use Authorization and the Postal Model Workshop Summary Clare Stroud, Lori Nadig, 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 Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This project was supported by contracts between the National Academy of Sciences and the American College of Emergency Physicians, the American Hospital Association, the American Medical Association, the American Nurses Association, the Association of State and Territorial Health Officials, the Centers for Disease Control and Prevention (Contract No. 200-2005-13434 TO #6), 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 #240), the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (Contract Nos. HHSP233200900680P and HHSP23320042509X1), the Department of Homeland Security’s Office of Health Affairs (Contract No. HSHQDC-07-C-00097), the Department of Homeland Security, Federal Emergency Management Agency (Contract No. HSFEHQ-08-P-1800), the Department of the Army (Contract No. W81XWH-08-P-0934), the Department of Transportation’s National Highway Traffic Safety Administration (DTNH22-10-H- 00287) the Department of Veterans Affairs (Contract No. 101-G09041), the Emergency Nurses Association, the National Association of Chain Drug Stores, the National Association of County and City Health Officials, the National Association of Emergency Medical Technicians, the Pharmaceutical Research and Manufacturers of America, The Robert Wood Johnson Foundation, and the United Health Foundation. The views presented in this publication are those of the editors and attributing authors and do not necessarily reflect the views of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-15803-9 International Standard Book Number-10: 0-309-15803-6 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 2010 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: IOM (Institute of Medicine). 2010. Medical countermeasures dispensing: Emergency use authorization and the postal model: Workshop summary. Washington, DC: The National Academies Press.

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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 government 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 outstanding 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 engineering 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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Workshop Planning Committee* GREG BUREL (Co-Chair), Centers for Disease Control and Prevention, Atlanta, GA SCOTT MUGNO (Co-Chair), FedEx Express, Memphis, TN PAMELA BLACKWELL, Cobb & Douglas Public Health, Marietta, GA BROOKE COURTNEY, Center for Biosecurity of UPMC, Baltimore, MD LYNNE KIDDER, (then) Business Executives for National Security, (currently) Center for Excellence in Disaster Management & Humanitarian Assistance, Washington, DC EVA LEE, Georgia Institute of Technology, Atlanta, GA JAYNE LUX, National Business Group on Health, Washington, DC MATTHEW MINSON, (then) U.S. Department of Health and Human Services, Washington, DC, (currently) Texas A&M University, College Station, TX ERIN MULLEN, Pharmaceutical Research and Manufacturers of America, Washington, DC IOM Staff BRUCE ALTEVOGT, Preparedness Forum Director CLARE STROUD, Program Officer ANDREW POPE, Director, Board on Health Sciences Policy ALEX REPACE, Senior Program Assistant ________________________ ∗ 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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Forum on Medical and Public Health Preparedness for Catastrophic Events* LEWIS GOLDFRANK (Chair), New York University Medical Center, New York DAMON ARNOLD, Association of State and Territorial Health Officials, Arlington, VA GEORGES BENJAMIN, American Public Health Association, Washington, DC D. W. CHEN, Office of Assistant Secretary of Defense for Health Affairs, Department of Defense, Washington, DC ROBERT DARLING, Uniformed Services University, Bethesda, MD VICTORIA DAVEY, Department of Veterans Affairs, Washington, DC JEFFREY DUCHIN, Public Health−Seattle & King County and University of Washington, Seattle, WA ALEXANDER GARZA, Department of Homeland Security, Washington, DC LYNN GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD DAVID HENRY, National Governors Association, Washington, DC JACK HERRMANN, National Association of County and City Health Officials, Washington, DC KEITH HOLTERMANN, Federal Emergency Management Agency, Washington, DC JAMES JAMES, American Medical Association, Chicago, IL JERRY JOHNSTON, National Association of Emergency Medical Technicians, Mt. Pleasant, IA ROBERT KADLEC, PRTM Management Consultants, Washington, DC BRIAN KAMOIE, The White House, Washington, DC LYNNE KIDDER, Business Executives for National Security, Washington, DC 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. vi

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JAYNE LUX, National Business Group on Health, Washington, DC ANTHONY MACINTYRE, American College of Emergency Physicians, Washington, DC ANGELA MCGOWAN, Robert Wood Johnson Foundation, Princeton, NJ MARGARET MCMAHON, Emergency Nurses Association, Williamstown, NJ ERIN MULLEN, Pharmaceutical Research and Manufacturers of America, Washington, DC GERALD PARKER, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services, Washington, DC CHERYL PETERSON, American Nurses Association, Silver Spring, MD SALLY PHILLIPS, Agency for Healthcare Research and Quality, Rockville, MD STEVEN PHILLIPS, National Library of Medicine, Bethesda, MD EDITH ROSATO, National Association of Chain Drug Stores Foundation, Alexandria, VA ROSLYNE SCHULMAN, American Hospital Association, Washington, DC DANIEL SOSIN, Centers for Disease Control and Prevention, Atlanta, GA SHARON STANLEY, American Red Cross, Washington, DC ERIC TONER, University of Pittsburgh Medical Center, Pittsburgh, PA REED TUCKSON, UnitedHealth Group, Minneapolis, MN MARGARET VANAMRINGE, The Joint Commission, Washington, DC GAMUNU WIEJETUNGE, National Highway Traffic Safety Administration, Washington, DC IOM Staff BRUCE ALTEVOGT, Project Director CLARE STROUD, Program Officer ANDREW POPE, Director, Board on Health Sciences Policy ALEX REPACE, Senior Program Assistant vii

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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 summary as sound as possible and to ensure that the summary meets institutional standards for objectivity, evidence, and responsive- ness to the study charge. The review comments and draft manuscript re- main confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this summary: Brooke Courtney, Center for Biosecurity of UPMC Laura Eiklenborg, OptumHealth Public Sector Priscilla Fox, Massachusetts Department of Public Health Amanda Fuller, North Carolina Department of Health and Human Services Mitchell Rothholz, American Pharmacists Association Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the summary before its release. The review of this summary was overseen by Linda C. Degutis, Yale Center for Public Health Preparedness, Yale University. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this summary rests entirely with the authoring committee and the institution. ix

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Contents INTRODUCTION 1 About the Preparedness Forum, 2 Workshop Objectives and Overview, 3 About This Summary, 5 MEDICAL COUNTERMEASURES DISTRIBUTION AND DISPENSING IN RESPONSE TO THE 2009 H1N1 INFLUENZA PANDEMIC 6 Distribution from the Strategic National Stockpile (SNS), 9 Challenges Facing Public Health Departments, 15 Public–Private Partnerships, 18 Liability Protection and the PREP Act, 21 EMERGENCY USE AUTHORIZATION 25 Background, 25 The EUA Process, 27 Successes in the Response to 2009 H1N1, 31 Challenges and Areas for Further Work, 35 Beyond EUAs, 40 Summary, 41 THE POSTAL MODEL 41 Recent Developments, 42 Logistics, 43 MedKits, 44 Postal Model EUA, 45 Lessons Learned During the EUA Process, 46 xi

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xii CONTENTS Security and Workforce Protection, 48 Areas for Future Work, 49 CONCLUSION 52 APPENDIXES A References 55 B Workshop Agenda 59 C Biographical Sketches of Invited Speakers and Panelists and Workshop Planning Committee Members 67