Countermeasures and Emergency Management Considerations 4/21/2017 Countermeasures and Emergency Management Considerations Matthew Minson, MD OPSP/ASPR/OS/USDHHS

Countermeasure Distribution, Dispensing, and Delivery Current strategies for countermeasure delivery are generally classified by the following: - Post Exposure Prophylaxis PEP (Given to the public after exposure or presumed exposure during a window of incubation) - Therapeutic or Corrective (Given once disease has begun, requiring professional administration) This presentation focuses on the former or mass prophylaxis campaigns This is best described in the CRI context

In general the threat consideration is substantial CRI Intelligence In general the threat consideration is substantial Aerial dispersion of anthrax over a large geographic area can be accomplished with commercially-available equipment

Anthrax Exposure: Proportion of Population Saved 4/21/2017 Anthrax Exposure: Proportion of Population Saved DELAY in Initiation DURATION of Campaign Immed. 1 Day 2 Days 3 Days 4 Days 5 Days 6 Days 7 Days 10 Days 84% 78% 71% 62% 54% 45% 36% 28% 7 Days 95% 91% 85% 78% 69% 59% 49% 39% 6 Days 97% 94% 89% 83% 75% 65% 54% 43% 5 Days 98% 96% 92% 87% 80% 71% 60% 49% This model was developed by Dr. Nathaniel Hupert of Weil Medical College at Cornell. It shows how delays in either detection (initiation of a campaign) or the amount of time it takes to provide antibiotics to a population will translate in lives lost in persons exposed to anthrax. For example, if the entire population of your city was exposed to anthrax released in the air, if it took 2 days to identify the exposure and 5 days to get antibiotics to the entire population, 8% of those exposed would die. [Note to presenter: use the actual population figures for the city to calculate the potential number of deaths.] 4 Days 99% 98% 95% 91% 85% 76% 66% 54% 3 Days 100% 99% 97% 94% 89% 81% 72% 60% 2 Days 100% 99% 98% 96 92% 86% 77% 66% 1 Day 100% 100% 99% 97% 94% 89% 82% 72%

Cities Readiness Initiative CRI GOAL: distribute antibiotics to the at-risk population – up to the entire community within 48 hours of the decision to do so, (from time of exposure) Doxycycline, Ciprofloxacin CRI Preparedness Indicators: robust local capability to dispense antibiotics rapidly over a large geographic area

CRI MSA Tables 2006-2007 Table I Combined 36 cities from 2004 - 2006 CRI Table II 36 planning cities for 2006-2007 CRI Atlanta, GA Baltimore, MD Boston, MA Chicago, IL Cincinnati, OH Cleveland, OH Columbus, OH Dallas, TX Denver, CO Detroit, MI District of Columbia Houston, TX Indianapolis, IN Kansas City, MO Las Vegas, NV Los Angeles, CA Miami, FL Milwaukee, WI Minneapolis, MN New York City, NY Orlando, FL Philadelphia, PA Phoenix, AZ Pittsburgh, PA Portland, OR Providence, RI Riverside, CA Sacramento, CA San Antonio, TX San Diego, CA San Francisco, CA San Jose, CA Seattle, WA St. Louis, MO Tampa, FL Virginia Beach, VA Albany, NY Albuquerque, NM Anchorage, AK Baton Rouge, LA Billings, MT Birmingham, AL Boise, ID Buffalo, NY Burlington, VT Charleston, WV Charlotte, NC Cheyenne, WY Columbia, SC Des Moines, IA Dover, DE Fargo, ND Fresno, CA Hartford, CT Honolulu, HI Jackson, MS Little Rock, AR Louisville, KY Manchester, NH Memphis, TN Nashville, TN New Haven, CT New Orleans, LA Oklahoma City, OK Omaha, NE Peoria, IL Portland, ME Richmond, VA Salt Lake City, UT Sioux Falls, SD Trenton, NJ Wichita, KS

Countermeasure Cascade: Generic FED SNS PUSH PACKAGE, MI STATE Receiving Staging Storing L. Dist. Center pod F S L Locals

Cities Readiness Initiative: Goal An initiative to expedite the timeframe to dispense prophylaxis Increase Point of Dispensing (POD) throughput Modified Medical Screening (Non-Medical Model) U.S. Postal Service Delivery Alternate Dispensing Modalities Drive thru clinics Establish PODS with large employers, universities, etc. Using existing delivery services- Meals on Wheels, Home Healthcare, etc. Community strike teams

assumptions Model Staff per shift per POD Staff Campaign staff 4/21/2017 Medical PODs Non-Medical PODs Target Population 1,000,000 PEP duration 2 days 9 days Hours of operation 24 hr/day Number of shifts 2 shifts Patient throughput 500 pts/hr/POD 2,000 pts/hr/POD Number of PODs 42 10 11 Core: Public health 19 2 Core: Non-public health 33 48 Support staff 13 Total 65 60 44 5 76 110 30 23 150 138 1,821 434 3,162 753 1,150 1,246 297 240 6,229 1,484 1,438 assumptions Model Staff per shift per POD Staff Campaign staff

Countermeasures: PODS

Medical PODs vs. Non-Medical PODs 4/21/2017 Medical PODs vs. Non-Medical PODs Medical PODs Non-Medical PODs Target Population 1,000,000 PEP duration 2 days Hours of operation 24 hr/day Number of shifts 2 shifts Patient throughput 500 pts/hr/POD 2,000 pts/hr/POD Number of PODs 42 11 Core: Public health 19 2 Core: Non-public health 33 48 Support staff 13 10 Total 65 60 44 5 76 110 30 23 150 138 1,821 3,162 1,150 1,246 240 6,229 1,438 assumptions Model Staff per shift per POD Staff Campaign staff

CRI Challenges/Issues Staffing (Volunteer) State/Local Leadership Resistance to Planning (Difficult) Security Resources Assessment Process Population Dynamics (Cooperation) Untried Scenario (Battle Conditions)

CRI: Dispensing/Delivery PODS POD Standards Project- ASPR, RAND and the DSNS are working together to establish core standard for POD planning and operations MedKit: 8 month study indicated . 97% efficacy First Responders, Clinic, Corporate FDA working in parallel to address ‘commercialization’ of MedKits CRI/Postal: Postal Option is only “one component of a mass prophylaxis plan, … meant to buy time for a more thorough Public Health response” Greater questions facing the Emergency Management community is how SNS assets will be distributed in a POD structure. Federal, Corporate, Open and Closed PODs 2008, Institute of Medicine Forum for Public Health and Medical Disasters

Countermeasures USPS STRIKE

Countermeasure Distribution and Dispensing: USPS Delivery 3 Exercises Operational Development: MSP/MN (pilot) Collaborative Dependent on Home stockpiling requirement by the USPS volunteers Threat Designation (DHS), PHED (HHS), EUA (FDA): Oct, 2008 Future Cities have expressed interest

USPS and Public Health Emergency Response During the recent combined ice storm debilitation of some communication resources and the need to inform the public of the potential for contaminated peanut products, the USPS successfully delivered print material to residences thus protecting the population of three Midwestern states.

HOME STOCKPILING MEDKIT Countermeasures HOME STOCKPILING MEDKIT

97% efficacy First Responders, Clinic, Corporate Countermeasure Distribution, Dispensing, and Delivery: Personal Stockpiling MedKit: 8 month study . 97% efficacy First Responders, Clinic, Corporate FDA/BARDA working in parallel to address ‘commercialization’ of MedKits NBSB rendered opinion: Formalized kit preferable to Discretionary Prescriptions

CRI MEDKIT

CRI First Responder Issues Based on discussions with the USPS Carrier Union Leadership and Service Management certain requirements for participation were determined PPE (per OSHA/NIOSH) Physical Security (LE) In advance provisioning of Antibiotics for Carrier Volunteers and their families

Medkit (Home Antibiotic Kits) USPS (HHS Lead) EUA Countermeasure Distribution, Dispensing, and Delivery: Personal Stockpiling Medkit (Home Antibiotic Kits) USPS (HHS Lead) EUA HHS Responder (HHS Lead) EUA DHS Responder (DHS Lead/HHS Support) EUA Traditional First Responder (as above) EUA Greater Population (HHS Lead) Commercial Strategy :NDA

CRI RESPONDERS Subsequent Discussions with MSP in have indicated that for POD function and USPS strike team preparations that similar considerations should be provided for their local responders Homeland Security Council undertaking specific countermeasure outreach to FR HSC/DOL/DHS/HHS consideration of unique environmental challenges in CRI

Countermeasure Delivery RECENT DEVELOPMENTS

PH SUMMIT Countermeasures Strategy In the Fall of 2007 a Forum to address issues related to a successful countermeasure campaign was conducted It determined that “dispensing, and delivery” held the greatest impediments to success and workshops were scheduled for Spring and Summer of 2008 to address same.

PH SUMMIT Countermeasures Strategy Consensus conclusions rendered included: Reducing impediments to Public- Private Collaboration Liability-PREP ACT Forward positioning of assets- cache, personal stockpiling USPS amplification Enhancing communication strategies

PH SUMMIT Countermeasures Strategy Since the workshop, a multidisciplinary group has continued to meet and work on these issues State and Local HHS-CDC, FDA, ASPR, OGC, DSNS Industry Academia Non-Governmental organizations

PH SUMMIT Countermeasures Strategy Actions: DHS Determination, HHS PH Emergency Declaration, FDA Provision of EUA in October, 2008 MN/MSP/HHS/USPS Operationalizing USPS PREP ACT Declaration Discussion of issues with NBSB, on going Expanded capability at DSNS (first 12 hours)

PH SUMMIT Countermeasures Strategy Continued issues Worker protection Medkit POD EUA Communications Strategies Increased interest and Federal amplification of USPS option (BARDA Modeling Conclusion)

Countermeasures The Future

Countermeasures QUESTIONS? Matt.Minson@hhs.gov