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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: • 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 59

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60 MEDICAL COUNTERMEASURES DISPENSING 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

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61 APPENDIX B 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

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62 MEDICAL COUNTERMEASURES DISPENSING 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? o 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

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63 APPENDIX B 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?” o Have any previously identified impediments been successfully addressed during the recent activity related to H1N1? o 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

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64 MEDICAL COUNTERMEASURES DISPENSING 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

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65 APPENDIX B 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

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66 MEDICAL COUNTERMEASURES DISPENSING 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