B
Workshop Agenda
November 18, 2009
The Keck Center of The National Academies
500 Fifth Street, NW
Washington, DC 20001
Workshop Objectives:
Building on the recent progress in countermeasure delivery and dispensing strategies, the objectives of this workshop are to:
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Provide an overview of the current threats, progress made, and remaining vulnerabilities in the public health system as it pertains to the dispensing of medical countermeasures;
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Discuss policy implications of emergency use authorization (EUA) and strategies to limit potential logistical challenges that could delay the delivery and dispensing of medical countermeasures; and
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Discuss outstanding issues related to EUAs and how these issues are impacting the nation’s preparedness and response capabilities.
Welcome and Introductions
LEWIS GOLDFRANK, Forum Chair
Professor and Chair
Department of Emergency Medicine
New York University School of Medicine
Charge to Workshop Speakers and Participants
GREGORY BUREL, Workshop Co-Chair
Director
Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
SCOTT MUGNO, Workshop Co-Chair
Managing Director
Corporate Safety, Health, and Fire Protection
FedEx Express
SESSION I:
OVERVIEW AND NEW POLICIES TO IMPROVE MEDICAL COUNTERMEASURE DISPENSING
Session Objective: Provide an overview of the current threats, progress made, and remaining vulnerabilities in the public health system as it pertains to the dispensing of medical countermeasures, including both antibiotics and antivirals.
GREGORY BUREL, Session Chair and Workshop Co-Chair
Director
Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
Federal Policy Developments Related to Countermeasure Dispensing
MATTHEW MINSON
Senior Medical Officer for Strategic Initiatives
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
State and Local Opportunities and Challenges
JAMES BLUMENSTOCK
Chief Program Officer for Public Health Practice
Association of State and Territorial Health Officials
JACK HERRMANN
Senior Advisor
Public Health Preparedness
National Association of County and City Health Officials
Dispensing Antibiotic Countermeasures: Progress, Opportunities, and Challenges: Moving Forward from the PREP Act
BROOKE COURTNEY
Associate
Center for Biosecurity of UPMC
Dispensing Antiviral Countermeasures: Progress, Opportunities, and Challenges from the Local Response to H1N1
GREGORY BUREL
Director
Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
A Systems View of POD Operations: Integrating All the Elements
EVA LEE
Director, Center for Operations Research in Medicine and HealthCare
Associate Professor, School of Industrial and Systems Engineering
Georgia Institute of Technology
Discussion with Panelists and Attendees
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How have previous policy decisions prepared the nation for the H1N1 response?
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What are the lessons learned from the H1N1 response to date?
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Do any specific areas require additional attention as we move forward in responding to the next influenza wave or preparing for other biological threats?
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What were some of the differences between state and local MCM allocation plans, and how did these impact the overall effectiveness of their plans?
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What are some key differences between antibiotic and antiviral dispensing plans, and how should these impact future policy discussions?
SESSION II:
EMERGENCY USE AUTHORIZATION: STRATEGIES TO LIMIT POTENTIAL LOGISTICAL CHALLENGES
Session Objective: Explore the impact of EUA and strategies to limit potential logistical challenges that could delay the delivery and dispensing of medical countermeasures.
Understanding the EUA Process: Authorization for Medical Products for a Catastrophic Health Event
CDR CARMEN MAHER
Policy Analyst
Office of Counterterrorism and Emerging Threats
Food and Drug Administration
Panel Discussion: Lessons Learned from Recent EUA Signings: H1N1 and the Minneapolis Postal Plan
SUSAN GORMAN, Panel Chair
Associate Director for Science
Division of Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
SUSAN SHERMAN
Senior Attorney
Office of the General Counsel
Department of Health and Human Services
KEVIN SELL
Pharmacist Consultant
Office of Emergency Preparedness
Minnesota Department of Health and
Minnesota Poison Control System
JUDE PLESSAS
Operations Specialist
United States Postal Service
BRAD LEISSA
Deputy Director
Office of Counter-Terrorism and Emergency Coordination
Center for Drug Evaluation and Research Food and Drug Administration
Discussion with Panelists and Attendees
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What is the “update from the field?”
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Have any previously identified impediments been successfully addressed during the recent activity related to H1N1?
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Have any glaring new problems emerged?
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What remaining impediments related to EUA continue to delay the dispensing of medical countermeasures?
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What strategies or mechanisms can be used to address these impediments, and how can they be implemented?
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What potential solutions should be highlighted?
Panel Discussion: Pre-EUA Issues Related to Communication Strategies
AGGIE LEITHEISER, Panel Chair
Director of Emergency Preparedness
Minnesota Department of Health
GRETCHEN MICHAEL
Communications Director
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
LAURA ROSS
Health Communication Specialist
Division of Strategic National Stockpile
Centers for Disease Control and Prevention
PAMELA BLACKWELL
Director
Center for Emergency Preparedness & Response
Cobb & Douglas Public Health
Discussion with Panelists and Attendees
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What can be done during the pre-EUA process to account for the logistical challenges associated with printing information and disseminating it to the public in a timely manner?
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How can EUAs be modified during an event to facilitate timely communication?
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How can Web 2.0 technologies be leveraged to alleviate challenges related to disseminating information to the public in a timely manner?
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How do we prepare for issues such as producing materials in multiple languages or for people with low literacy?
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How do we deal with guidance that may change every day, as was the case with H1N1?
Panel Discussion: Workforce Protection
KATHRYN BRINSFIELD, Panel Chair
Associate Chief Medical Officer
Office of Component Services
Office of Health Affairs
Department of Homeland Security
TIM STEPHENS
Public Health Advisor
National Sheriffs’ Association
LAURA EIKLENBORG
Director
Solutions Development
OptumHealth Public Sector
TIMOTHY CONLEY
Director
Preparedness and Planning
Department of Fire/EMS Services and Emergency Management Village of Western Springs, IL
Discussion with Panelists and Attendees
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How should priorities be set and what are the best mechanisms to ensure that workers get the protection they need?
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How can we effectively communicate with workers prior to an emergency?
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What operational issues need to be considered to ensure that the workforce is protected?
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What are the respective responsibilities of public and private stakeholders, and how should they function together?
SESSION III:
GENERAL DISCUSSION WITH WORKSHOP PARTICIPANTS AND ATTENDEES
Session Objective: Discuss opportunities and constraints identified during the workshop. What new ideas have surfaced in this meeting today that should be explored further? What issues remain related to EUAs and their impact on the nation’s preparedness and response, and how should these issues be addressed?
Panel Discussion: Remaining Areas That Require Attention (e.g., workforce, liability, security, logistics, communications)
SCOTT MUGNO, Session Chair and Workshop Co-Chair
Managing Director
Corporate Safety, Health, and Fire Protection
FedEx Express
GLORIA ADDO-AYENSU
Health Director
Fairfax County Health Department, Virginia
ATKINSON (JACK) LONGMIRE
Medical Officer
Office of Occupational Medicine
Occupational Safety and Health Administration
MITCHEL ROTHHOLZ
Chief of Staff
American Pharmacists Association
DARRELL KLEIN
Assistant Agency Counsel
Nebraska Department of Health and Human Services
Discussion with Panelists and Attendees
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What other issues related to EUA have not yet been discussed during the workshop, for example, issues regarding liability, security, and logistics?
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What strategies, mechanisms, or solutions can be used to address these issues, and how can they be implemented?
Closing Remarks
GREGORY BUREL, Workshop Co-Chair
Director
Strategic National Stockpile
Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
SCOTT MUGNO, Workshop Co-Chair
Managing Director
Corporate Safety, Health, and Fire Protection
FedEx Express