Medical Countermeasures for the First Responder Presented by John J. Walsh Jr. National Center for Emergency Preparedness, Vanderbilt University Tim Stephens Public Health Advisor, National Sheriffs’ Association Steven D. Bice stevebiceassociates, LLC Presented by John J. Walsh Jr. National Center for Emergency Preparedness, Vanderbilt University Tim Stephens Public Health Advisor, National Sheriffs’ Association Steven D. Bice stevebiceassociates, LLC

Presentation Content Medical Countermeasures System Concept Scope of Practice Parameters Requirements and Procurements Challenges Stockpile, Distribution and Delivery Processes Legal Liability Gaps and Issues Future Considerations for Medical Countermeasures Medical Countermeasures System Concept Scope of Practice Parameters Requirements and Procurements Challenges Stockpile, Distribution and Delivery Processes Legal Liability Gaps and Issues Future Considerations for Medical Countermeasures

Medical Countermeasures (MCM) System Objectives Protection of the First Responder Sector Safeguard our Infrastructure Promote Resilient and Sustainable Communities Protection of the First Responder Sector Safeguard our Infrastructure Promote Resilient and Sustainable Communities

Medical Countermeasures (MCM) Target Population (Country Specific) First Responders - Law Enforcement - Fire - Emergency Medical Service - Emergency Management - Public Works - Public Health First Receivers – Healthcare Professionals First Responders - Law Enforcement - Fire - Emergency Medical Service - Emergency Management - Public Works - Public Health First Receivers – Healthcare Professionals

Government Responsibilities U.S. Framework Local – County Government State / Tribal Government Federal Government Other Framework Structures Cabinet Level Ministries / Secretariats Regional / Local Authority level U.S. Framework Local – County Government State / Tribal Government Federal Government Other Framework Structures Cabinet Level Ministries / Secretariats Regional / Local Authority level

Medical Countermeasures (MCM) Vaccines and Antiviral - Procurement - Storage and Distribution - Protective Measure Protocols Personal Protective Equipment (PPE) Post-Exposure Prophylaxis (PEP) Vaccination (pre and post-exposure) - BioShield, CRI, MMRS and BARDA Program Vaccines and Antiviral - Procurement - Storage and Distribution - Protective Measure Protocols Personal Protective Equipment (PPE) Post-Exposure Prophylaxis (PEP) Vaccination (pre and post-exposure) - BioShield, CRI, MMRS and BARDA Program

Medical Countermeasures System Conceptualization Scope of Practice - Altered Standards of Care Product Manufacturing Procurement Stockpiling and Distribution Process Legal Concerns Scope of Practice - Altered Standards of Care Product Manufacturing Procurement Stockpiling and Distribution Process Legal Concerns

Scope of Practice Parameters Educational Requirements Professional Association Acceptance State Regulatory Requirements State Licensure Requirements Educational Requirements Professional Association Acceptance State Regulatory Requirements State Licensure Requirements

Requirements and Procurement Challenges Lengthy Scientific and Regulatory Approval - FDA Approval Process Financial Commitment First Responder Input Lengthy Scientific and Regulatory Approval - FDA Approval Process Financial Commitment First Responder Input

Stockpile, Distribution and Delivery Process Protection of the First Responder Community - Placement, Distribution and Delivery Process - National Capability and Capacity - Node and Hub Distribution and Delivery Protection of the First Responder Community - Placement, Distribution and Delivery Process - National Capability and Capacity - Node and Hub Distribution and Delivery

Dispensing Modality Strategies Pre-event Placement of Medication in Households Pre-Deployment of Community-Based Caches of Medications Home Delivery of Antibiotics By the US Postal Service Utilization of Points of Dispensing (PODs) Pre-event Placement of Medication in Households Pre-Deployment of Community-Based Caches of Medications Home Delivery of Antibiotics By the US Postal Service Utilization of Points of Dispensing (PODs)

Legal Liability Gaps and Issues Scope of Practice Social and Cultural Issues Development, Manufacturing and Distribution Safeguards State Laws - Worker’s Compensation Protections - Malpractice Federal Regulatory Guidelines Scope of Practice Social and Cultural Issues Development, Manufacturing and Distribution Safeguards State Laws - Worker’s Compensation Protections - Malpractice Federal Regulatory Guidelines

Future Considerations for Medical Countermeasures for the 21 st Century Develop Realistic Practical Medical Countermeasures Program - Protection of the First Responders and First Receivers - Protection of Critical Infrastructure Personnel - Management of System Components Development and Procurement Processes Placement, Distribution and Delivery Mechanisms Conceptual Framework and Operational Guidelines Develop Realistic Practical Medical Countermeasures Program - Protection of the First Responders and First Receivers - Protection of Critical Infrastructure Personnel - Management of System Components Development and Procurement Processes Placement, Distribution and Delivery Mechanisms Conceptual Framework and Operational Guidelines

Future Considerations for Medical Countermeasures for the 21st Century Clearly Establish a First Responder and Critical Infrastructure Framework Incorporate an All-Encompassing, Layered Systemic Approach Addressing Production / Manufacturing, Storage and Delivery Mechanism, Designed for Distribution to Local Responder and Citizen Groups Address Responder Family Concerns Clearly Establish a First Responder and Critical Infrastructure Framework Incorporate an All-Encompassing, Layered Systemic Approach Addressing Production / Manufacturing, Storage and Delivery Mechanism, Designed for Distribution to Local Responder and Citizen Groups Address Responder Family Concerns

Future Considerations for Medical Countermeasures for the 21st Century Provide a Model to Address Aspects Pertaining to: - Federal and State Liability Issues - Children Vaccine Funds - Smallpox Vaccination Plans - Define Specific Doctrines Clearly Outlining Practice Lanes Institute a Strong Private Sector Emphasis in Community Preparedness Address Response Time Issues Utilizing Global Approaches Provide a Model to Address Aspects Pertaining to: - Federal and State Liability Issues - Children Vaccine Funds - Smallpox Vaccination Plans - Define Specific Doctrines Clearly Outlining Practice Lanes Institute a Strong Private Sector Emphasis in Community Preparedness Address Response Time Issues Utilizing Global Approaches

Summary Described the Medical Countermeasures System Concept Outlined the Scope of Practice Parameters Identified Requirements and Procurements Challenges Discussed the Stockpile, Distribution and Delivery Process Identified Legal Liability Gaps and Issues Reviewed Future Considerations for Medical Countermeasures Described the Medical Countermeasures System Concept Outlined the Scope of Practice Parameters Identified Requirements and Procurements Challenges Discussed the Stockpile, Distribution and Delivery Process Identified Legal Liability Gaps and Issues Reviewed Future Considerations for Medical Countermeasures