DEVELOPMENT OF RADIOPROTECTANT CACHES IN PREPARATION FOR RADIOLOGICAL INCIDENTS/EVENTS

1. DEVELOPMENT OF RADIOPROTECTANT CACHES IN PREPARATION FOR RADIOLOGICAL INCIDENTS/EVENTS John J. Lanza, MD, PhD, MPH, FAAPDirector, Florida Department of HealthEscambia County Health DepartmentHealth & Medical Co-chairFlorida Department of Law Enforcement Northwest Florida Regional Domestic Security Task Force Erin Mullen, RPh, PhD Assistant VP for Rx Response, PhRMA Pharmacist, NDMS/Disaster Medical Assistance Team FL-6

2. Objectives • An understanding of the types of radiological incidents/events possible • What are the available pharmaceutical countermeasures to radiation? • Florida Department of Health strategy for deployment of a radioprotectant cache – RADPACK

3. Types of Radiological Incidents/Events • Improvised Nuclear Device incident • Radiological Exposure Device incident • Radiological Dispersal Device incident* -Single/multiple Isotopes -Failed IND • Nuclear Reactor event* • Transportation incident* • Space-launched Vehicle event* *Most likely RADPACK usage

4. National Planning Scenarios The Homeland Security Council (HSC) – in partnership with the Department of Homeland Security (DHS), the federal interagency, and state and local homeland security agencies – has developed fifteen all-hazards planning scenarios for use in national, federal, state, and local homeland security preparedness activities. These scenarios are designed to be the foundational structure for the development of national preparedness standards from which homeland security capabilities can be measured.

5. National Planning Scenario 1: Nuclear Detonation –10-Kiloton Improvised Nuclear Device

6. National Planning Scenario 11:Radiological Attack – Radiological Dispersal Devices

7. Assessment of Health and Medical Care Delivery Rapid Assessment of Community Health/Medical Needs Delivery of Health and Medical Care Pharmaceutical Supply Potable Water, Safe Food, and Sanitation and Hygiene Injury and illness Surveillance Vector Control Solid Waste Hazardous Materials Registry Mental Health Sheltering and Housing Mass Congregation Handling of the Deceased (humans and animals) Staffing Rumor Control Public Service Announcements/ Media Access Local Public Health Issues After ANY Disaster

8. Who is at the scene? • HAZMAT • Fire • Law enforcement • EMS • Public as victims • Health physicists

9. Community Reception Centers • Population monitoring and decontamination sites to assess people for exposure, contamination, and the need for decontamination and/or medical follow-up

10. Community Reception Centers • Equivalent to bio Points of Dispensing (PODs) • Public health staffing – Medical Reserve Corps • 12-24 hours to establish • Screening forms • Portal monitors for screening • Hand-held monitoring for alarms • Contamination forms to be completed • Referral for diagnosis and/or treatment to AMTS vs. hospital

11. Alternative Medical Treatment Sites • Referred from Community Reception Centers- could be co-located • First stop for medical attention (minor injuries) • Staffed by Disaster Medical Assistance Teams, Medical Reserve Corps, hospitals--TBD • Could provide oral/IV/nebulized medication to large numbers of individuals • Most serious exposures would be referred to hospitals for diagnosis and treatment

12. RDD scenario CRI city (Miami, Orlando, Tampa) • 15 to 30 minutes to determine that radiation is present • 30 to 180 minutes to identify isotope using RIID • On-scene injured (injured public and emergency responders), treatment within 2 – 6 hours • For others, 12-24 hours before treatment begins due to need to set up CRC to check for external contamination and AMTS (vs. hospitals) for treatment of ARS or internal contamination

13. Project Bioshield (2004) • The purpose of Project BioShield is to accelerate the research, development, purchase, and availability of effective medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) agents.

14. Project Bioshield • Liquid formulation of Potassium Iodide -Needed for pediatric population/others -4.3 million bottles contracted • Calcium and Zinc DTPA -Decorporation agent of transuranics -480k doses delivered to SNS •Treatment for Acute Radiation Syndrome -Radiation-induced neutropenia (CSFs) -100k treatment courses anticipated

15. Strategic National Stockpile (SNS) • Operated by the • Large quantities of medicines and supplies in a public health emergency are available when local supplies are insufficient • NOT a first response tool! • 12 hour Push Packages • Managed Inventory—24-36 hours

16. Strategic National Stockpile

17. SNS Push Packages

18. SNS Delivery

19. Radiological Countermeasures in the Strategic National Stockpile •There are no radiological countermeasures currently in the12-hour Push Package • Countermeasures are available in 24-36 hours as part of the Managed Inventory (MI) • Prussian blue – per CDC, adequate amounts • KI – per CDC, adequate amounts, but time issue • Ca-DTPA and Zn-DTPA – per CDC, adequate amounts to address expected exposures

20. Radiological Internal Blocking/Decorporation Adapted from: http://remm.nlm.gov/int_contamination.htm#blockingagents

21. Intent of RADPACK • Other than KI, very little local availability of selected internal radiological blocking/decorporation agents • Planning guidance from CDC/DSNS is that it may take 24-36 hours for assets in managed inventory to arrive after request (DTPA/PB) • Provide, at minimum, first-dose protection to at-risk emergency responders and public until MI assets arrive & can be distributed • 4 rapidly deployable caches - 2 to 6 hours (rotary, wing or ground), portable, stored in rural or low-risk locations distributed throughout the state (North, Central, South)

22. Planning Assumptions • State RADPACK may only be a one-time purchase, as CDC may develop their own RADPACK based on CHEMPACK program • Colony Stimulating Factors not included • Treatment not as time-sensitive • Some availability in local hospitals & clinics • Storage logistics • Expense

23. Existing Radioprotectants in Florida Potassium iodide (KI) •Local • 7 county health departments near nuclear power plants -> 784k (130 mg); 201.6k (65 mg) doses • State Pharmaceutical Stockpiles – 10 locations statewide - 26,799 doses total (130 mg) (emergency ops control) •Central warehouse - Liquid KI 357k doses (23.8k (30 ml) bottles, 65 mg/ml) for general public/peds - Liquid KI ~90k doses for emergency workers No Prussian blue or DTPA in state stockpiles

24. State of Florida RADPACK(anticipated) Potassium iodide Prussian blue Ca and Zn DTPA Syringes Filter needles Administration needles

25. Characteristics of KI • Stable salt of iodine • Not too concerned with expiration dates • Highly soluble • Small volume (easy to store) • Dose: 1 tablet (130 mg) / day (adults) for 14 days/also liquid; dose based on weight • Inexpensive ($11 / 14-tablet package) • Shelf life 5-7 years • Included for political reasons

26. Characteristics of Prussian Blue • Insoluble ferric hexacyanoferrate(II) • Oral administration; is not absorbed systemically • Chelates cesium and thallium in the gastrointestinal tract • Continued administration reduces biological half-life of radioactive isotopes by ~40% (children & adolescents) to 60-70% (adults) • Dose: 2 – 6 capsules TID for 30 days • ~$80 / 30 (500 mg) capsule bottle • Shelf life ~24 – 36 months

27. Characteristics of DTPA • Calcium and Zinc salts of Diethylenetriamene pentaacetate • Administered by IV or nebulization • Ca-DTPA recommended for first dose only; continue chelation therapy with Zn-DTPA • Dose: 1 gram / day X ? days • ~$750 / box of #10 1gm vials • Shelf life approx 18 – 24 months

28. Large Pelican Case for Delivery via Helicopter

29. Bottom LineFlorida RADPACK of Pharmaceuticals for Radiological Response (Divided into four caches, each to treat 500 emergency responders and victims)

30. Contact Information • John J. Lanza, MD, PhD, MPH, FAAP Florida Department of Health Escambia County Health Department 850.595.6557 john_lanza@doh.state.fl.us www.EscambiaHealth.com