Medical Countermeasure (MCM) Operational Resource Guide Stakeholder Meeting

Medical Countermeasure (MCM) Operational Resource Guide Stakeholder Meeting Kelly Dickinson, MHA Dahna Batts, MD, FACEP CAPT, U.S. Public Health Service Healthcare Preparedness Activity (HPA) January 25, 2017 Office of Public Health Preparedness and Response Division of State and Local Readiness

The Meeting Planning Team Division of State and Local Readiness (DSLR) Kelly Dickinson, MHA, Emergency Management Specialist Dahna Batts, MD, FACEP, CAPT, U.S. Public Health Service and Medical Officer National Emergency Management Association (NEMA) Jessica Byrski, Senior Policy Analyst Trina Sheets, Executive Director

Administrative Announcements Restrooms In Case of Emergency Escorts Wi-Fi Skype Comment Cards

Opening Remarks

Day One Agenda 1. Welcome 2. Meeting Overview 3. Participant Introductions 4. Presentations 5. Overview of Breakout Sessions 6. Breakout Sessions 7. Day One Recap

Meeting Overview Kelly Dickinson, MHA Office of Public Health Preparedness and Response Division of State and Local Readiness

Purpose of the Stakeholder Meeting To provide an opportunity for various state, tribal, and local planners to discuss the content and format of the Medical Countermeasure Operational Resource Guide (the Guide) and recommend improvements.

Stakeholder Meeting Objectives 1. Conduct a review of the guide and identify gaps and recommended improvements 2. Obtain feedback related to the format and distribution of the final product 3. Identify next steps for improving the guide and for proposed future products

Day One Meeting Agenda Morning presentations Pre-meeting activities and preparations Strategic National Stockpile (SNS) current and future actions Regulatory mechanisms Proposed changes to the Public Health Emergency Preparedness (PHEP) Cooperative Agreement Proposed changes to the MCM Operational Readiness Review (ORR) Overview of Breakout Group Activity

Day One Meeting Agenda (continued) Lunch and optional emergency operations center tour First breakout sessions Request Process: Decision Making, Triggers, and Format MCM Partners and Formats for Planning Incorporating Immunizations Review of the Anthrax Annex Healthcare System Needs

Day One Meeting Agenda (continued) Participants move to a second breakout session (different topic) Day One wrap-up

Day Two Meeting Agenda Day One recap/day Two overview Breakout sessions report out Finalize recommendations Lunch and optional Emergency Operations Center (EOC) tour Format and posting location Next steps for federal support: guidance and tools

Participant Introductions Name Organization Position Role in MCM planning Favorite animal and why it s your favorite

Pre-Meeting Activities and Preparation Kelly Dickinson, MHA Office of Public Health Preparedness and Response Division of State and Local Readiness

Project Origin Intent Design a product that aids in developing MCM plans that are operational The Project Team recommended the product: Centralize operational information in one product that includes links to other pertinent material Include more on how to incorporate immunizations and stress improved coordination with the health care sector Be web-based, concise, and easy to update A Planning Guide Work Group was formed with federal, state, and local representation

Purpose of the Guide To serve planners at all levels and in all sectors to include public health, healthcare, and emergency management by providing relevant resources in one product to aid in developing comprehensive, all-hazard response plans

Early Activities Reviewed current written MCM guidance and technical assistance requests from states Created the framework for general chapters and hazard-specific annexes Solicited input from subject matter experts in: Division of State and Local Readiness (DSLR) Division of Strategic National Stockpile (DSNS) CDC Centers, Institutes, and Offices (CIOs) Partner Organizations

Current Table of Contents Federal MCM Activities References, regulatory mechanisms, and adverse event reporting MCM Planning Considerations Decision cycle for requests Receiving, distributing, and dispensing MCM (including vaccines) Deployment to and use in health care settings General Planning Considerations to engage partners and a plan template

Current Table of Contents (Continued) Hazard-specific Annexes Will include one annex for each hazard including Anthrax Botulism Plague Tularemia Smallpox Radiation Chemical Incidents Burn/Blast Incidents Pandemic Influenza Emerging or Novel Infectious Diseases Natural Disasters

Pre-Meeting Accomplishments Conducted webinar on December 8 to introduce the project (Webinar 1 Dec 8) Provided an initial draft for review Conducted webinar with participants to prepare for this meeting (Webinar 2 Jan 12) Revised the draft of the Guide and meeting activities based on stakeholder input

Questions? For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Centers for Disease Control and Prevention Office of Public Health Preparedness and Response

Strategic National Stockpile Overview Greg Burel, Director Division of Strategic National Stockpile Office of Public Health Preparedness and Response Office of Public Health Preparedness and Response Division of Strategic National Stockpile

CDC s Strategic National Stockpile A$7.05 billion repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs and other life-saving medical material designed to supplement and re-supply state and local public health agencies in the event of an emergency SNS medical material is held in a network of locations positioned to optimize deployment SNS is capable of coordinating requirements for preparedness or response by leveraging operating supply chain capability SNS can deploy support teams to assist state and local officials during a public health emergency

Expansion of Missions and Funding Following 9/11, SNS funds were expanded to increase capabilities Product in SNS has expanded to protect greater numbers from priority threats Formulary expanded to cover emerging threats and include available medical countermeasures Pandemic influenza material acquired through supplemental appropriated funds Development of CHEMPACK program forward placement Development of Federal Medical Station (FMS) equipment packages for rapid deployment and set-up Originally funded under a FEMA Mission Assignment in 2004 All-hazards focus has increased

Strategic National Stockpile Significant Response History 2016 Zika Response and Severe Weather Response 2014 International Ebola Response 2012 Hurricanes Isaac and Sandy 2011 Hurricane Irene 2010 Hurricane Alex, North Dakota Flooding 2009 H1N1 Pandemic Influenza, North Dakota Flooding 2008 Hurricanes Gustav and Ike 2005 Hurricanes Katrina and Rita 2001 World Trade Center Attack and Anthrax Letters Frequent small scale deployments of unique MCM for anthrax, smallpox, and botulism exposure Routine deployments of jointly rotated vaccine stocks to supply Department of Defense Requirements

Division of Strategic National Stockpile STEVE ADAMS Deputy Director GREG BUREL Director SUE GORMAN Science Team RON OTTEM Community Resilience Activity FRAN HARRELL Program Planning and Analysis Branch SHIRLEY MABRY Logistics Branch LISA DILLARD Response Branch

Rationale for Stockpiling Material Stockpiled material is normally held for one or more of the following reasons: A product required is not commercially viable and thus is not commercially available. The U.S. pharmaceutical supply chain runs under a just-in-time model, consequently a commercial product: May not be available in projected quantities required. May be available but cannot reach affected populations in adequate timeframes and/or in adequate quantities Commercial supply chain not optimized to dispense to the population at the level required (time or volume)

Formulary Priorities Bio Terrorism Biological - Smallpox, anthrax, botulism, viral hemorrhagic fevers, plague & tularemia Chemical Nerve agent Radiological /Nuclear Non Bio Terrorism Pandemic influenza

INVENTORY MANAGEMENT

Scope of the SNS Inventory $7.05 billion in material under management Approximately 900 separate line items Volume is approximately equal to that of six super WalMarts Majority of assets have labeled shelf life Many inventory items have been kitted in unique configurations designed by SNS with other subject matter expert input Detailed data on physical location to facilitate deployment Customized inventory management system: Stockpile Resource Planning (SRP)

Product Quality Control Quality Control Unit independent of Logistics Branch Complies with Food and Drug Administration s current Good Manufacturing Practice (cgmp) requirements (21 CFR) Regular vendor audits for specific products 3PL providers are registered with FDA as pharmaceutical warehouses Results in FDA inspections 3PL providers are registered with DEA Results in regular DEA inspections Warehousing meets or exceeds Regulatory requirements Product label requirements USP requirements

DEPLOYMENT

Emergency Response Concept Provide threat-appropriate delivery mechanism Provide rapid delivery of a broad spectrum of support for an ill-defined threat in the early hours of an event Provide specific materiel when a threat is known Provide technical assistance to receive and effectively distribute Strategic National Stockpile materiel

Deployment Considerations Commercial partners transport via most expeditious method Transportation asset availability is a factor in product source Transportation providers are regularly exercised Products require varying validated shipping conditions QCU validates trucks for transport where required Products require variable delivery timelines for clinically effective usage DSNS can meet delivery timeframes and has plans to decrease those State/Local dispensing capacity may not match with an expanded DSNS capability

Product Configurations to Meet Deployment Needs Forward placed caches CHEMPACK 12-hour Push Package SNS Managed Inventory (vaccines, antivirals, antibiotics and other SNS managed inventory) Specialized kitting for response needs for example, ventilators Prophylaxis Package Vendor Managed Inventory Can create deployment challenges Direct order for non-stocked items

Forward Placed Caches: CHEMPACK Nationwide joint venture program Forward placement of nerve agent antidotes Integrated into local hazardous material response Containerized storage Remote monitoring Uniform formulary Two configurations

>1,900 CHEMPACK containers in >1,300 cache sites >90% of U.S. Population within a 1 hour response

Broad Spectrum Support: 12-hour Push Packages Less than 5% of SNS material Pre-packed and configured materiel assembled in transport-ready containers (50 tons) Pre-positioned in secure facilities near major transportation hubs Delivered rapidly by commercial transport partners Color coded and numbered containers for rapid identification by state and local authorities

Managed Inventory Comprises bulk of SNS material Stockpile Managed Inventory Commercial 3PL model vs. civil service Vendor Managed Inventory Where cost effective due to rotation or other considerations

Federal Medical Stations (FMS) Modular deployable medical surge support caches 50-bed and 250-bed stations Medical supplies, pharmaceuticals and equipment for 3 days Designed for non-acute care Configured for rapid movement

ALL HAZARDS ZIKA

Vector Control 90-day period until long term solution is in place Residual spraying for inside and outside homes Spraying for hospitals, schools, etc. Ultra Low Velocity spraying by truck Aerial spraying Community Outreach expertise

Zika Prevention Kits (ZPK) CDC's Strategic National Stockpile (SNS) assembled and delivered an initial 5,000 Zika Prevention Kits to Puerto Rico, the U.S. Virgin Islands and American Samoa. These kits contain items such as insect repellent and mosquito netting -- packed in attractive, reusable bags -- that can help prevent Zika transmission, especially in vulnerable populations like pregnant women.

DSNS 2017 Collaboration with manufacturers, distributors, and commercial partners to expand distribution Improved shipment times related to managed inventory Increased use of the Drop Shipment program as related to CHEMPACK Collaboration with PHEMCE to incorporate state level needs Continued use of contract expertise and broad authorities to assist where no other capability resides Continued exercise support and technical assistance

Questions? www.cdc.gov/phpr/stockpile/stockpile.htm For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov Office of Public Health Preparedness and Response Division of Strategic National Stockpile

Regulatory Mechanisms CAPT Yon Yu Office of Public Health Preparedness and Response Division of State and Local Readiness

Break Office of Public Health Preparedness and Response Division of State and Local Readiness

Public Health Emergency Preparedness (PHEP) Program Review Highlights Todd Talbert Senior Advisor Division of State and Local Readiness MCM Operational Resource Guide Stakeholder Meeting Wednesday, January 25, 2017 Office of Public Health Preparedness and Response Division of State and Local Readiness

PHEP Program Review From April to June 2015, CDC s Office of Public Health Preparedness and Response (OPHPR) enlisted assistance of CDC Centers, Institutes and Offices (CIO) leaders to review the PHEP program and its collaboration with other CDC programs. The committee developed recommendations intended to: 1. Strengthen the day-to-day public health impact of the PHEP program 2. Ensure that PHEP funds are invested in areas that will have the most public health impact 3. Identify opportunities for continued program development, including new and emerging programmatic areas not previously identified

PHEP Program Review (cont.) The PHEP program review process resulted in refinement of PHEP requirements in partnership with key CDC categorical programs. Proposed changes targeted the following: Senior Health Official (SHO) Input Letter Laboratory Response Network - Biological (LRN-B) Laboratory Response Network Chemical (LRN-C) Electronic Death Registration (EDR) Public Health Informatics At-Risk Populations Tribal Populations Infectious Disease Response Community Assessment for Public Health Emergency Response (CASPER) Radiation Emergency Preparedness Poison Control Centers (PCC) Environmental Public Health Tracking Disaster Epidemiology Emergency Management Assistance Compact (EMAC)

Overview of Proposed Requirements Categorical Engagement Senior Health Official (SHO) Input Letter Laboratory Response Network - Biological (LRN-B) Laboratory Response Network Chemical (LRN-C) Electronic Death Registration (EDR) Public Health Informatics At-Risk Populations Tribal Populations Infectious Disease Response Outcomes and Impact Ensure accountability of PHEP investments through formal epidemiology and laboratory input into jurisdictional PHEP cooperative agreement plans, strategies, and investments. Sustain Standard and Advanced laboratory testing for LRN-B state public health laboratories and ensure coverage for designated High Priority Areas (HPA s = cities generally indexed to Urban Area Security Initiative (UASI). Improve and sustain chemical agent identification and testing through LRN-C instrumentation and equipment updates. Implementing a four-year funding strategy to complete toxic metal and nerve agent metabolite equipment replacement for Level 1 and Level 2 chemical laboratories. Awardees with existing operational EDR systems should prioritize goals that advance the utility and geographic coverage of current EDR systems Awardees that do not have operational EDR systems should prioritize development of scalable plans to implement an EDR system Improve data availability, data quality, system usability, epidemiological surveillance, and timely information sharing between CDC and state/local epidemiology programs in support of the CDC Surveillance Strategy (e.g., NSSP, ELR, NNDSS, etc.) Enhance collaboration between public health, health care systems and first responders for at-risk populations planning in all-hazards preparedness through provision of updated reference material and use of indices, population surveys, and consistent information sharing across jurisdictions. Each applicable awardee must provide a letter signed by the senior health official confirming all federally recognized tribes approve or provided input on PHEP priorities to advance engagement with tribal populations. This should be done through joint planning, establishment of tribal points of contact, and promotion of effective subawardee fiscal allocation strategies. Improve infectious disease management in the health care and public health systems by clarifying lanes of authority, establishing a common operating picture platform, and optimizing coordination between CDC, ASPR, and state and local public health agencies.

Overview of Proposed Requirements (cont.) Categorical Engagement CASPER Radiation Emergency Preparedness Poison Control Centers (PCC) Environmental Public Health Tracking Disaster Epidemiology Emergency Management Assistance Compact (EMAC) PHEP Exercise Program Informatics Field Assignee Pilot Project Outcomes and Impact Increase the number of CASPERs conducted in states to support preparedness and response through enhanced CASPER training and technical assistance. Develop or enhance radiation preparedness plans to demonstrate knowledge, skills, and abilities to exercise a community reception center (CRC) or shelter during a radiological emergency. (Webinars pending.) Expand the availability, quality, accessibility, and use of PCC data through improved collaboration with PCCs. Establish coordinated environmental public health tracking plans between PHEP, NCEH, and ATSDR programs through activities such as provision of essential resources, improving awareness of impact, and expanding and analyzing state tracking network information. Expand the use of disaster epidemiology tools to enhance timeliness and accuracy of epidemiological assessments during public health disasters, including: ATSDR Assessment of Chemical Exposures (ACE) NIOSH Rapid Response Registry (RRR) NIOSH Emergency Responder Health Monitoring and Surveillance System (ERHMS) Enhance mutual aid response coordination through the use of mission ready packages (MRPs) and incorporation of EMAC into training courses and preparedness exercises. Test and strengthen operational readiness of jurisdictions to respond to public health emergencies through a suite of exercise options to meet annual and five- year exercise requirements Pilot project to place up to three field assignees in states to facilitate implementation of CDC Surveillance Strategy informatics goals. These goals include improving data availability, data quality, system usability, epidemiological surveillance, and timely information sharing between CDC and state/local epidemiology programs.

Questions For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Office of Public Health Preparedness and Response Division of State and Local Readiness

Proposed Changes to CDC s MCM Operational Readiness Review Christopher M Reinold, Team Lead DSLR Measurement, Evaluation and Translation Team MCM Operational Resource Guide Stakeholder Meeting Wednesday, January 25, 2017 Office of Public Health Preparedness and Response Division of State and Local Readiness

Agenda Medical Countermeasure (MCM) Operational Readiness Background Dedicated MCM Funding State and local technical assistance review (TAR) planning review Development of operational readiness review 2012-2015 Development and pilot testing 2015-2016 Baseline data collection MCM Operational Readiness Review going forward (2017-2022) Data collection improvements Technical assistance improvements

2004 2015 Background PHEP has provided ~$678 million in dedicated MCM funding $47.9 million in FY 2016; approximately 8% of total PHEP funding 2004-2012: Division of Strategic National Stockpile Conducted TARs State and local MCM planning 2012: MCM Planning Transitioned to DSLR Internal/external review revealed need for continued improvements Key recommendations: Advance assessment process to be a measure of operational readiness Assure consistency of approach

MCM ORR Purpose Improve state/local readiness for a large-scale MCM mission Evaluate the quality of a jurisdiction's MCM plans Evaluate the jurisdiction s ability to execute its plans Assist states in evaluating local capacity and capability Identify operational gaps and provide technical assistance

Defining Operational Readiness Readiness: The ability to successfully execute a largescale MCM distribution and dispensing mission MCM ORR determines a readiness status for each element Based on criteria outlined in CDC s preparedness capability standards Four levels of readiness: early, intermediate, established, and advanced PHEP program goal By 2022, all 62 PHEP jurisdictions will achieve a status of established for both the planning and operational elements

Development of MCM ORR Tool/Approach Developed with extensive involvement and input from stakeholders: 19 awardee jurisdictions: Arizona, Chicago, Connecticut, Delaware, Georgia, Illinois, Michigan, Minnesota, Missouri, Montana, New Hampshire, New York, North Carolina, Oregon, Tennessee, Texas, Washington, Washington, D.C., and West Virginia ASTHO: ASTHO DPHP Executive Committee; ASTHO emcm Steering Committee NACCHO Other CDC subject matter experts, including: Division of Strategic National Stockpile

2012-2013: Develop v1 of tool Development Timeline 2014-2015: Pilot: 36 awardees and 28 Cities Readiness Initiative (CRI) local planning jurisdictions Evaluation: 9 awardees and 12 CRI local planning jurisdictions participated in formal evaluation Revised ORR process and tool based on feedback 2015-2016: Field MCM tool/process

Medical Countermeasure (MCM) Operational Readiness Review (ORR) 2015-2016 Changes based on 2014-2015 pilot feedback Level and specificity of evidence Improved clarity for state review of locals Use of the MCM ORR tool in 2015-2016 CDC reviewed: o o o o 50 states 70 local planning jurisdictions 4 directly funded localities 8 territories and freely associated states State awardees reviewed 355 local planning jurisdictions

Medical Countermeasure (MCM) Operational Readiness Review (ORR) 2015-2-16 Summary All awardees (state and local) used the tool and had the opportunity to provide feedback to CDC CDC MCM and evaluation experts participated in reviews Midway review with MCM specialists to obtain feedback Reviewed data from 487 submitted reviews Reviewed 81 state and local feedback surveys Results MCM ORR preliminary results Feedback results

Medical Countermeasure (MCM) Operational Readiness Review (ORR) Use of ORR in new project period (2017-2022) Reduce redundancy in data collection Improve reliability across different reviewers Focus on broader review All-hazards Increase capability review to align with cooperative agreement Improve and target technical assistance Measure impact of program Improve data collection Reduce awardee burden Use of MCM Operational Resource Guide

Overview of Breakout Sessions Kelly Dickinson, MHA Office of Public Health Preparedness and Response Division of State and Local Readiness

Breakout Session Format Each session will include a mix of sector and planning level representatives Session one: two hours in which to conduct assigned activity and make recommendations Session two: one hour in which to review recommendations and add others Report-out session on day two: One and a half hours for group input

Breakout Session Requests Be as succinct as possible Allow facilitator to move on with the discussion when necessary Refrain from discussing how to fund programs Use a comment card to capture questions or recommendations not covered in the session Feel free to recommend resources for the project team to research Pick a presenter for the Day Two Report-out

Breakout Session Request Process Focus on how to determine if there is a need for MCM and what is needed in the request Questions to consider: Information needed to make decisions and the source of the information Agencies involved in gathering information and providing input as part of the decision cycle Triggers for requesting MCM for various hazards to include infectious diseases and burn/blast injuries, among others

Breakout Session Planning Focus on how to develop a plan that includes the role of all partners in the incident MCM response Questions to consider: Is there a need to add or modify the partners and their roles and responsibilities in MCM planning? What is needed in a template for plan development? If we provide an example of a plan for a hazard response, what hazard should we use?

Breakout Session Immunizations Focus on how to best coordinate with immunization program leads to incorporate immunizations in a MCM response Questions to consider: How do we encourage coordinated planning between immunization and MCM programs? Does the description of the three planning scenarios for immunizations make sense (i.e., mass vaccinations)? What methods of tracking immunizations will work best in each of the scenarios?

Breakout Session Anthrax Annex Focus on reviewing the draft Anthrax Annex to improve planning considerations for that hazard and format for other annexes Questions to consider: Does the general planning section at the beginning provide enough detail to get planners started? Is it better to keep the MCM split between those likely dispensed in points of dispensing sites and those that go to healthcare settings? What can be removed from the table for each MCM and what can be added?

Breakout Session Healthcare Needs Focus on what health care systems need to know about MCM planning and what other sectors need to know about their response Questions to consider: Is there sufficient information on what MCMs are available for use in healthcare settings and how to request MCM? Is the information on regulatory mechanisms detailed enough for health care administrators to understand the requirements for use and reporting? How should health care systems coordinate the distribution and use of MCMs that are in limited supply?

Lunch Optional EOC Tour starts at 12:15 p.m. Report to Breakout Sessions at 12:45 p.m. Office of Public Health Preparedness and Response Division of State and Local Readiness

Breakout Sessions Office of Public Health Preparedness and Response Division of State and Local Readiness

Day One Conclusions Kelly Dickinson, MHA Office of Public Health Preparedness and Response Division of State and Local Readiness

Highlights from Day One This slide will be populated in the afternoon of Day One

Adjourn Meet your shuttle in the front of the Visitor s Center Office of Public Health Preparedness and Response Division of State and Local Readiness

Medical Countermeasure (MCM) Operational Resource Guide Stakeholder Meeting Kelly Dickinson, MHA Dahna Batts, MD, FACEP CAPT, US Public Health Service Healthcare Preparedness Activity (HPA) January 26, 2017 Office of Public Health Preparedness and Response Division of State and Local Readiness

Day Two Meeting Agenda Day One recap/day Two overview Breakout sessions report out Finalize recommendations Lunch and optional Emergency Operations Center (EOC) tour Format and distribution of final product Next steps for federal support guidance and tools

Recap from Day One This slide will be populated in the evening of Day One

Breakout Sessions Report Out Request Process Decision Making, Triggers, and Format MCM Partners and Formats for Planning Incorporating Immunizations Review of the Anthrax Annex Health care System Needs

Instructions Finalize Recommendations Return to the first session you were assigned to Assist the facilitators in determining the final recommendations from both sessions Be prepared to discuss any next steps These sessions will not be available to those on Adobe Connect

Break Office of Public Health Preparedness and Response Division of State and Local Readiness

Format and Distribution General discussion regarding format and distribution of final product

Next Steps for Federal Support Guidance and Tools General discussion regarding next steps for the Guide General discussion regarding other guidance and tools stakeholders would like to see

Closing Remarks Kelly Dickinson, MHA Dahna Batts, MD, FACEP CAPT, US Public Health Service Office of Public Health Preparedness and Response Division of State and Local Readiness

Adjourn Meet your shuttle in the front of the Visitor s Center Office of Public Health Preparedness and Response Division of State and Local Readiness