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Institute of Medicine (US) Forum on Medical and Public Health Preparedness for Catastrophic Events. Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model, Workshop Summary. Washington (DC): National Academies Press (US); 2010.

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Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model, Workshop Summary.

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BWorkshop 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:

  • 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;
  • Discuss policy implications of emergency use authorization (EUA) and strategies to limit potential logistical challenges that could delay the delivery and dispensing of medical counter- measures; and
  • 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

  • How have previous policy decisions prepared the nation for the H1N1 response?
  • What are the lessons learned from the H1N1 response to date?
  • Do any specific areas require additional attention as we move forward in responding to the next influenza wave or preparing for other biological threats?
    • What were some of the differences between state and local MCM allocation plans, and how did these impact the overall effectiveness of their plans?
  • 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

  • What is the “update from the field?”
    • Have any previously identified impediments been successfully addressed during the recent activity related to H1N1?
    • Have any glaring new problems emerged?
  • What remaining impediments related to EUA continue to delay the dispensing of medical countermeasures?
  • What strategies or mechanisms can be used to address these impediments, and how can they be implemented?
  • 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

  • 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?
  • How can EUAs be modified during an event to facilitate timely communication?
  • How can Web 2.0 technologies be leveraged to alleviate challenges related to disseminating information to the public in a timely manner?
  • How do we prepare for issues such as producing materials in multiple languages or for people with low literacy?
  • 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

  • How should priorities be set and what are the best mechanisms to ensure that workers get the protection they need?
  • How can we effectively communicate with workers prior to an emergency?
  • What operational issues need to be considered to ensure that the workforce is protected?
  • 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

  • What other issues related to EUA have not yet been discussed during the workshop, for example, issues regarding liability, security, and logistics?
  • 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

Copyright © 2010, National Academy of Sciences.
Bookshelf ID: NBK53133
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