Building a National Capability
to Monitor and Assess Medical
Countermeasure Use During a
Public Health Emergency
GOING BEYOND THE LAST MILE
PROCEEDINGS OF A WORKSHOP
Morgan Boname, Theresa Wizemann, and Justin Snair, Rapporteurs
Board on Health Sciences Policy
Health and Medicine Division
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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This project was supported by a contract between the National Academy of Sciences and the U.S. Department of Health and Human Services’ U.S. Food and Drug Administration (Contract No. 1R13FD005495-01). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-46642-4
International Standard Book Number-10: 0-309-46642-3
Digital Object Identifier: https://doi.org/10.17226/24912
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2017. Building a national capability to monitor and assess medical countermeasure use during a public health emergency: Going beyond the last mile: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org.10.17226/24912.
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PLANNING COMMITTEE ON BUILDING A NATIONAL CAPABILITY TO MONITOR AND ASSESS MEDICAL COUNTERMEASURE USE IN RESPONSE TO PUBLIC HEALTH EMERGENCIES1
BORIS LUSHNIAK (Chair), Dean and Professor, University of Maryland School of Public Health
PHYLLIS ARTHUR, Managing Director, Infectious Diseases and Diagnostics Policy, Biotechnology Innovation Organization
SUZANNE BAKKEN, Alumni Professor of Nursing; Professor of Biomedical Informatics, Columbia University
JEREMY BROWN, Director, Office of Emergency Care Research, National Institute of General Medical Sciences, National Institutes of Health
J. PERREN COBB, Professor, Clinical Surgery; Director, University of Southern California Critical Care Institute; Director, Keck Surgical Intensive Care Unit, University of Southern California
JEFFREY COUGHLIN, Senior Director, Federal and State Affairs, Healthcare Information Management and Systems Society
AMANDA PEPPERCORN, Senior Medical Director, Infectious Diseases Research and Development, GlaxoSmithKline
RICHARD PLATT, Professor and Chair, Department of Population Medicine, Harvard Medical School
KIMBERLEY RICKETTS, Public Health Advisor, U.S. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
PAUL SELIGMAN, Executive Director, Amgen
UMAIR SHAH, Executive Director, Harris County Public Health and Environmental Services
YON YU, Associate Director, Regulatory Affairs, National Center for Emerging and Zoonotic Infectious Diseases, U.S. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
Health and Medicine Division Staff
JUSTIN SNAIR, Senior Program Officer (until September 2017)
SCOTT WOLLEK, Senior Program Officer
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
MORGAN BONAME, Associate Program Officer
ALEXA EDMIER, Research Assistant
ANDREW POPE, Director, Board on Health Sciences Policy
Consultants
LAURA RUNNELS, LAR Consulting
THERESA WIZEMANN, Consulting Writer
Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
SUZANNE BAKKEN, Columbia University
JAY C. BUTLER, Alaska Department of Health and Social Services
J. PERREN COBB, University of Southern California
EVA LEE, Georgia Institute of Technology
BORIS LUSHNIAK, University of Maryland School of Public Health
VINIT P. NAIR, Humana
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by LINDA C. DEGUTIS, Henry M. Jackson Foundation. She was responsible for making certain that an independent examination of this proceedings was carried out in accordance with stan-
dards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
Contents
Workshop Background and Objectives
Organization of This Proceedings of a Workshop
Viewpoint from the U.S. Food and Drug Administration on MCM Monitoring and Assessment During a PHE
Overview of Cross-Cutting Topics Highlighted During Presentations and Discussions
2 SETTING THE STAGE: DEFINING TERMINOLOGIES AND SHARING STAKEHOLDER PERSPECTIVES
Defining Terminologies Used Throughout the Workshop
3 DATA NEEDS, DATA SOURCES, AND COLLECTION METHODOLOGIES FOR STAKEHOLDER DECISION MAKING
Defining and Answering Questions to Inform Data Needs for MCM Distribution and Monitoring
Considerations and Approaches to Data Collection
Integrating Data from Different Sources
Existing Data Sources and Datasets
Boxes, Figures, and Table
BOXES
1-1 Workshop Statement of Task
1-2 H1N1 Influenza as a Case Study in MCM Development, Deployment, Monitoring, and Assessment
2-1 Types of Electronic Health Data
3-2 A Routine, All-Hazards Approach to Data Collection During a PHE in New York State
3-3 Modifying a CDC Database to Meet Evolving Data Needs in the 2009 H1N1 Influenza Pandemic
4-3 MCM Data and HIPAA: Human Subjects Research or Public Health Practice?
4-4 Exercising for Administrative Preparedness in PHEs
FIGURES
1-1 Traditional medical product life cycle
1-2 Timeline of FDA response to the 2009 H1N1 influenza pandemic
TABLE
1-1 Differences Between FDA Product Assessment in a PHE Versus Traditional Research and Development
Acronyms and Abbreviations
ASPR |
Office of the Assistant Secretary for Preparedness and Response (HHS) |
BARDA |
Biomedical Advanced Research and Development Authority |
CBRN |
chemical, biological, radiological, nuclear |
CDC |
U.S. Centers for Disease Control and Prevention |
CONOPS |
concept of operations |
CMS |
Centers for Medicare & Medicaid Services |
CTSA |
Clinical and Translational Science Awards |
EHR |
electronic health record |
EMS |
emergency medical services |
EUA |
Emergency Use Authorization |
FDA |
U.S. Food and Drug Administration |
GSK |
GlaxoSmithKline |
HHS |
U.S. Department of Health and Human Services |
HIPAA |
Health Insurance Portability and Accountability Act of 1996 |
IPT |
integrated program team |
IRB |
institutional review board |
IT |
information technology |
MCM |
medical countermeasure |
NCATS |
National Center for Advancing Translational Sciences (NIH) |
NIAID |
National Institute of Allergy and Infectious Diseases (NIH) |
NIH |
National Institutes of Health |
NLM |
National Library of Medicine (NIH) |
OCR |
Office for Civil Rights (HHS) |
ONC |
Office of the National Coordinator for Health Information Technology |
PHE |
public health emergency |
PHEMCE |
Public Health Emergency Medical Countermeasures Enterprise |
POD |
point of dispensing |
SNS |
Strategic National Stockpile |