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
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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 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 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.
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Suggested citation: IOM (Institute of Medicine). 2012. Prepositioning antibiotics for anthrax. Washington, DC: The National Academies Press.
THE NATIONAL ACADEMY
Adviser to the Nation on Science, Engineering, and Medicine
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.
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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.
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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
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
ANDREW M. POPE, Director, Board on Health Sciences Policy
VICTORIA BOWMAN, Financial Associate
DONNA RANDALL, Administrative Assistant
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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
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, University 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 comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
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 potentially 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. Antibiotics 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, prepositioning 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
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 strategies 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 exceptional 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 multifaceted 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
The committee gratefully acknowledges and thanks the many individuals who contributed to this study by sharing their expertise, perspectives, 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 Preparedness and Response. The committee greatly appreciated the insightful discussions 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 affiliations 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 committee would like to extend particular thanks to Greg Burel, Daniel Sosin, Stephanie Dulin, and others at the Centers for Disease Control and Prevention 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.
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.