PREPOSITIONING
ANTIBIOTICS
FOR ANTHRAX

Committee on Prepositioned Medical Countermeasures for the Public

Board on Health Sciences Policy


Clare Stroud, Kristin Viswanathan, Tia Powell, and Robert R. Bass, Editors

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu



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PREPOSITIONING ANTIBIOTICS FOR ANTHRAX Committee on Prepositioned Medical Countermeasures for the Public Board on Health Sciences Policy Clare Stroud, Kristin Viswanathan, Tia Powell, and Robert R. Bass, Editors

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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 Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance. This study was supported by Contract No. HHSO100201000003A between the National Academy of Sciences and the Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publica- tion are those of the author(s) and do not necessarily reflect the view of the organi- zations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-21808-5 International Standard Book Number-10: 0-309-21808-X 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 2012 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 ad- opted 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). 2012. Prepositioning antibiotics for anthrax. 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 Acad- emy 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 en- gineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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 Sci- ences 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 Coun- cil 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 PREPOSITIONED MEDICAL COUNTERMEASURES FOR THE PUBLIC ROBERT R. BASS (Chair), Maryland Institute for Emergency Medical Services Systems TIA POWELL (Vice Chair), Montefiore-Einstein Center for Bioethics MARGARET L. BRANDEAU, Stanford University Department of Management Science and Engineering BRAD BREKKE, Target Corporation ROBERT L. BURHANS, New York State Department of Health (Retired) LOUIS ANTHONY (TONY) COX, JR., Cox Associates ROBERT S. HOFFMAN, New York City Poison Control Center DANIEL LUCEY, Georgetown University Medical Center KEVIN MASSEY, Evangelical Lutheran Church in America ERIN MULLEN, Pharmaceutical Researchers and Manufacturers of America JOANNE M. NIGG, University of Delaware Department of Sociology HERMINIA PALACIO, Harris County Public Health and Environmental Services, Texas ANDREW PAVIA, University of Utah Health Sciences Center STEPHEN M. POLLOCK, University of Michigan Department of Industrial and Operations Engineering REED V. TUCKSON, UnitedHealth Group JEFFREY S. UPPERMAN, Children’s Hospital Los Angeles Study Staff CLARE STROUD, Study Director BRUCE M. ALTEVOGT, Senior Program Officer NEAL GLASSMAN, Senior Program Officer, Board on Mathematical Sciences and Their Applications KRISTIN VISWANATHAN, Research Associate TONIA E. DICKERSON, Senior Program Assistant THERESA WIZEMANN, Consultant Writer RONA BRIERE, Consultant Editor Board Staff ANDREW M. POPE, Director, Board on Health Sciences Policy VICTORIA BOWMAN, Financial Associate DONNA RANDALL, Administrative Assistant v

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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 published report as sound as possible and to ensure that the report 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 deliberative process. We wish to thank the following individuals for their review of this report: Ned Dimitrov, Naval Postgraduate School Dan Hanfling, Inova Health System Ana-Marie Jones, Collaborating Agencies Responding to Disasters (CARD) Edward H. Kaplan, Yale School of Management Roger J. Lewis, Harbor-UCLA Medical Center Graydon “Gregg” Lord, The George Washington University Medical Center Robert Mauskapf, Virginia Department of Health Matthew Minson, Texas A&M University Alonzo Plough, County of Los Angeles Department of Public Health Jeff Runge, Biologue, Inc. Kent Sepkowitz, Memorial Sloan-Kettering Cancer Center Karen Smith, Napa County Health and Human Services vii

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viii REVIEWERS Penny Turnbull, Marriott Hotels International, Ltd. Dean Wilkening, Stanford University Although the reviewers listed above have provided many constructive 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 Brian L. Strom, Uni- versity of Pennsylvania School of Medicine, and Kristine Gebbie, Flinders University School of Nursing and Midwifery. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review com- ments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface Rapid access to antibiotics can prevent people who are exposed to aerosolized Bacillus anthracis from developing anthrax; once symptoms of anthrax emerge, the disease progresses rapidly and can prove fatal. Since the anthrax attack in 2001, the nation’s public health system has made great strides in developing plans to deliver antibiotics quickly to all poten- tially exposed people. However, concerns remain about the nation’s ability to respond to an anthrax attack scenario of the most dire proportions—for example, a large-scale attack impacting hundreds of thousands of people and carried out in multiple cities. Prepositioning (storage closer to intended users, before an attack occurs) is one of the mechanisms that have been discussed over the past several years for helping to ensure that all members of a community have rapid access to medical countermeasures (MCM) such as antibiotics. Anti- biotics could be prepositioned in many different venues, including local stockpiles, workplace caches, caches in health care settings, and even in the home. The Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, asked the Institute of Medicine (IOM) to convene a committee to examine the potential role of these different prepositioning strategies in the overall MCM dispensing strategy. The committee was tasked to examine a wide range of factors, including benefits, costs, safety, and ethical issues. The committee found that, under particular circumstances, preposition- ing strategies can reduce the time within which individuals in a community can receive prophylactic antibiotics, and certain strategies can help alleviate the burden on the public health dispensing system. Relative to existing, more ix

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x PREFACE centralized distribution and dispensing strategies, however, prepositioning provides less flexibility to change plans following an attack if necessary. For example, prepositioning may not be helpful if an attack occurs in a location other than anticipated or uses a strain of anthrax that is resistant to the prepositioned antibiotic. The committee also found that costs are likely to increase as antibiotics are prepositioned closer to the intended users. In the current climate of dramatic cuts in public health funding, the issue of how communities use their limited resources is critically important. The committee was not asked to address the prioritization of prepositioning strategies and anthrax preparedness relative to other disaster preparedness activities, such as preparing for other kinds of terrorist attacks, natural disasters, and infectious diseases, to say nothing of the broad range of other public health efforts vying for resources and planning efforts. However, the committee recognizes that this is precisely the context in which public health officials will make decisions about which, if any, prepositioning strategies to develop. Indeed, careful stewardship of public health resources is one of the committee’s guiding ethical principles. Recognizing that communities across the nation have differing needs and capabilities, the committee believes their needs will best be served by different strategies. The decision-aiding framework presented in this report is intended to assist public health officials in considering the benefits, costs, and trade-offs involved in developing alternative prepositioning strate- gies appropriate to their particular communities. The committee also has attempted, wherever possible, to comment on which strategies would help strengthen public health infrastructure and capability for other purposes beyond prepositioning and which strategies would not. We note that it was a great pleasure and a privilege to chair this IOM committee. We could not have attempted this project without the excep- tional capability and dedication of the IOM staff, including Clare Stroud, Kristin Viswanathan, and Tonia Dickerson. We also offer our sincere thanks to our fellow committee members for their willingness to serve, for their hard work and dedication, and for their enthusiasm and collegiality. The members brought a remarkable range of expertise and perspectives to this study. In the face of many areas of uncertainty and significant gaps in the evidence, they diligently grappled with this extremely challenging and mul- tifaceted topic to develop evidence-based and well-supported insights and advice that would be useful to public health authorities and others charged with developing plans to protect the health of the nation’s public. Robert R. Bass, Chair Tia Powell, Vice Chair Committee on Prepositioned Medical Countermeasures for the Public

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Acknowledgments The committee gratefully acknowledges and thanks the many indi- viduals who contributed to this study by sharing their expertise, perspec- tives, and time with the committee. Funds for the committee’s work were provided by the Department of Health and Human Services, Office of the Assistant Secretary for Prepared- ness and Response. The committee greatly appreciated the insightful discus- sions with George Korch and Lisa Kaplowitz at the first committee meeting, and the ongoing support and assistance it received from Susan Cibulsky, Chad Hrdina, and Elin Gursky. Many individuals provided important input to the committee’s work at its public workshop and other open sessions; their names and affilia- tions are listed in Appendix B. Many others took the time to share their expertise with committee members through interviews or more informal conversations; they are identified by name throughout the text. The com- mittee would like to extend particular thanks to Greg Burel, Daniel Sosin, Stephanie Dulin, and others at the Centers for Disease Control and Pre- vention for providing important information on the Strategic National Stockpile and its interface with state and local public health systems. The committee thanks the authors of the paper commissioned for this study—James Guyton, Robert Kadlec, Chandresh Harjivan, Shabana Farooqi, Sheana Cavitt, and Joseph Buccina of PRTM Management Consultants—which provided a critical source of information for the committee’s work. The committee also thanks the many individuals who were interviewed by PRTM during the preparation of the commissioned paper; their names are listed in Appendix D. xi

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xii ACKNOWLEDGMENTS Finally, the committee greatly appreciates the valuable contributions of Andrew Pope and Bruce Altevogt of the Institute of Medicine’s Board on Health Sciences Policy; Neal Glassman of the Division on Engineering and Physical Sciences’ Board on Mathematical Sciences and Their Applications; Theresa Wizemann, consultant writer; and Rona Briere, consultant editor.

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Contents SUMMARY 1 1 INTRODUCTION 21 Study Charge, 21 Study Context, 23 Methods and Definitions, 27 Study Approach and Scope, 30 Organization of the Report, 36 References, 37 2 ANTIBIOTICS FOR ANTHRAX POSTEXPOSURE PROPHYLAXIS 41 Antibiotics Approved for Postexposure Prophylaxis of Inhalational Anthrax, 42 The Threat of Antibiotic-Resistant Anthrax, 43 Incubation Period of Inhalational Anthrax: Existing Data and Areas of Uncertainty, 46 Impact of Time to Detection on Dispensing of PEP Antibiotics, 57 Summary, 61 References, 62 3 CURRENT DISPENSING STRATEGIES FOR MEDICAL COUNTERMEASURES FOR ANTHRAX 69 Current MCM Distribution and Dispensing System, 69 Concerns About the Current Dispensing System, 82 xiii

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xiv CONTENTS Legal and Regulatory Issues in MCM Dispensing, 85 Summary, 88 References, 89 4 PREPOSITIONING STRATEGIES 93 Forward-Deployed Medical Countermeasures, 94 Cached Medical Countermeasures, 103 Predispensed Medical Countermeasures, 119 References, 145 5 A DECISION-AIDING FRAMEWORK 153 Assessment of Risk and Current Capabilities, 154 Incorporation of Ethical Principles and Community Values, 164 Evaluation of Potential MCM Prepositioning Strategies for Anthrax, 170 Findings and Recommendations on the Benefits, Costs, and Suitability of Alternative Prepositioning Strategies, 186 References, 204 6 RECOMMENDED ACTIONS FOR MOVING FORWARD 209 Actions for State, Local, and Tribal Public Health Officials, 209 Federal/National-Level Actions, 211 Research Needs, 212 Concluding Remarks, 215 APPENDIXES A Acronyms 217 B Public Meeting Agendas 221 C First-Order Model 237 D Commissioned Paper: A Cost and Speed Analysis of Strategies for Prepositioning Antibiotics for Anthrax 241 E Committee Biosketches 319 INDEX 329