Antivirals for Pandemic Influenza

GUIDANCE ON DEVELOPING A DISTRIBUTION AND DISPENSING PROGRAM

Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic

Board on Population Health and Public Health Practice

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu



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Committee on Implementation of Antiviral Medication Strategies for an Influenza Pandemic Board on Population Health and Public Health Practice

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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 Gov- erning Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engi- neering, 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 study was supported by Contract No. HHSP 23320042509X1, Task Order HHSP 233200700006T between the National Academy of Sciences and the Depart- ment of Health and Human Services. 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: 978-0-309-11866-8 International Standard Book Number-10: 0-309-11866-2 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 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. Suggested citation: IOM (Institute of Medicine). 2008. Antivirals for pandemic influ- enza: Guidance on developing a distribution and dispensing program. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

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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 govern- ment 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 mem- bers, sharing with the National Academy of Sciences the responsibility for advis- ing 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 pro- viding 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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COMMITTEE ON IMPLEMENTATION OF ANTIVIRAL MEDICATION STRATEGIES FOR AN INFLUENZA PANDEMIC JUNE E. OSBORN, M.D. (Chair), President Emerita, Josiah Macy, Jr. Foundation, New York KAREN G. GERVAIS, Ph.D., Director, Minnesota Center for Health Care Ethics, Minneapolis, MN SANDRA R. HERNáNDEZ, M.D., Director and Chief Executive Officer, San Francisco Foundation, CA JAMES G. HODGE, Jr., J.D., LL.M., Associate Professor, Executive Director, Center for Law and the Public’s Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD NICOLE LURIE, M.D., M.S.P.H., Director, RAND Center for Population Health and Health Disparities, Co-Director, RAND Center for Domestic and International Health Security, Arlington, VA ANDREW T. PAVIA, M.D., George and Esther Gross Presidential Professor and Chief, Division of Pediatric Infectious Diseases, University of Utah School of Medicine, Salt Lake City M. PATRICIA QUINLISK, M.D., M.P.H., Medical Director, State Epidemiologist, Iowa Department of Public Health, Des Moines EILEEN SCANLON, R.N., M.S.N., Public Health Nurse III, Nassau County Department of Health, Public Health Emergency Preparedness, Office of Emergency Management, East Meadow, NY Study Staff ALINA BACIU, M.P.H., Study Director AMY GELLER, M.P.H., Senior Health Policy Associate TIA CARTER, Senior Project Assistant (through January 2008) LOUISE JORDAN, Senior Project Assistant (from February 2008) ROSE MARIE MARTINEZ, Sc.D., Director, Board on Population Health and Public Health Practice v

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Reviewers T his 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 published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and respon- siveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report: Susan Allan, Oregon Health Services, Oregon Department of Human Services John Bartlett, Center for Civilian Biodefense Strategies, Johns Hopkins University School of Medicine Ruth Gaare Bernheim, Department of Public Health Sciences, University of Virginia Samuel A. Bozzette, The RAND Corporation Matthew L. Cartter, Connecticut Department of Health Jeffrey S. Duchin, Public Health, Seattle & King County, and Division of Allergy & Infectious Diseases, University of Washington Benjamin Mason Meier, Center for Health Policy, Columbia University vii

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viii REVIEWERS Arnold Monto, Department of Epidemiology, University of Michigan School of Public Health Jonathan D. Moreno, Center for Bioethics, University of Pennsylvania Health System Stephen S. Morse, Mailman School of Public Health, Columbia University Michael Osterholm, Center for Infectious Disease Research & Policy, University of Minnesota Academic Health Center Monica Schoch-Spana, Center for Biosecurity, University of Pittsburgh Medical Center Mary C. Selecky, Washington State Department of Health Philip W. Smith, Section of Infectious Diseases, University of Nebraska Medical Center Keith F. Woeltje, Division of Infectious Diseases, Washington University School of Medicine Although the reviewers listed above have provided many construc- tive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by David R. Challoner, Vice President for Health Affairs, Emeritus, University of Florida and Kristine M. Gebbie, School of Nursing, Columbia University. Appointed by the National Research Council and Institute of Medicine they were responsible for making certain that an independent examina- tion of this report was carried out in accordance with institutional proce- dures and that all review comments were carefully considered. Responsi- bility for the final content of this report rests entirely with the authoring committee and the institution.

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Contents Summary 1 1 Introduction 11 Areas of Uncertainty and Existing Assumptions, 12 Charge to the Committee, 14 2 Antiviral Effectiveness, Safety, and Supply 19 Effectiveness and Safety, 20 Supply, 23 3 Ethics, Decision Making, and Communication 39 Ethics, 39 Making Decisions, Changing Course, 43 Communication, 46 4 Who Should Get Antivirals and Where? 53 Diagnosis and Treatment, 53 Prophylaxis, 57 Dispensing Sites, 68 Information Systems for Monitoring Drug Use and Safety, 80 Exercises and Drills, 84 Closing Observations, 85 References 87 ix

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x CONTENTS APPENDIXES A Summary of Lessons Learned from Other Mass Distribution Events 93 B State Plans 99 C Meeting One Agenda 107 D Meeting Two Agenda 113 E Committee Member Biographies 117