New Jersey Emergency Pharmaceutical Preparedness

1. New Jersey Emergency Pharmaceutical Preparedness September 28, 2005

2. New Jersey’s Emergency Preparedness Pharmaceutical System The Commissioner of Health and Senior Services has directed the development and implementation of a plan that ensures New Jersey’s healthcare system is adequately supplied with pharmaceuticals and medical supplies during any emergency. • Federally supplied materials • Strategic National Stockpile • CHEMPACK • New Jersey owned supplies • Strategic State Stockpile • Hospital caches

3. Strategic National Stockpile(SNS) • Mission: To deliver pharmaceuticals and medical materiel to the site of a national emergency

4. For unknown or multiple threat 7-8 truck loads of medical material Prepackaged Delivered in under 12 hours For the known threat Pharmaceuticals and medical materials in quantities specifically requested by the state Delivered within 24 hours NJ received MI during anthrax events Push Package vs. Managed Inventory (MI)

5. Oral Antibiotics Nerve Agent Antidotes SNS Push Package: 130 Containers IV Supplies Airway supplies Med/Surg Supplies (Clear)

11. State Requests Federal Assistance Need for Drugs and Medical Supplies Exceeds Local & State Resources Augments Local/State Medical Materiel Resources CDC Director Deploys SNS Assets SNS How SNS Assets are Deployed In consultation with the Surgeon General, Secretary of HHS, HHS Office of Emergency Preparedness, FEMS and the FBI

12. Assets Deployed in the State RSS Distribution POD POD POD POD

13. Unit of Use Medications in 12-Hr Push Package • Dispensed as unit of use • 10-day • Labeled • Child-proof bottles • Sufficient quantities to protect 200,000 • Designed for the worst case – an anthrax response

14. Unit of use medications in 12-Hr Push Package • 10-day regimens in Push Package (approx. 15% of containers in 12-hr PP) • 88,900 bottles of ciprofloxacin (#20 tab) • 88,900 bottles of doxycycline (#20 tab) • 24,000 bottles of amoxicillin 250mg chewable (#30 tab) for: • Pregnant women • Allergies to ciprofloxacin / doxycycline • Children who cannot swallow whole tabs, but can chew (1,600 bottles of amoxillin 500mg chew tabs (#75 tab) • IND required against anthrax

15. Additional Unit of Use Drugs – Managed Inventory For large-scale events SNS has contracts to repackage - 1 million /day!

16. The toxic effects of nerve agents require immediate pharmaceutical intervention followed by long-term care. This pharmaceutical intervention must be supported in both the pre-hospital and hospital phase. The ability of emergency medical personnel to begin immediate treatment of individuals exposed to nerve agents will directly affect a casualty’s ability to survive the exposure. CHEMPACK PROJECT

17. CHEMPACK MISSION • Implement a nationwide project for the “forward” placement of nerve agent antidotes • Provide state and local governments a “sustainable resource” that increases their capability to respond quickly to a nerve agent event

18. CHEMPACK Assumptions • A deliberate or accidental nerve agent release can occur anywhere • Any major release would probably require large supplies of nerve agent antidotes • The “forward” placement of CHEMPACK assets in various locations (caches) throughout an area will expedite delivery of antidotes to the disaster site

19. CHEMPACK Containers • The CHEMPACK Project provides two types of containers: • Emergency Medical Services (EMS) Container Designed for emergency responders; material packaged mostly in auto-injectors • Hospital Container Designed for hospital dispensing, with multiuse vials, for precision dosing and long term care.

20. CHEMPACK Formulary • Mark 1 Kits • Atropine Sulfate 0.4 mg/ml 20 ml • Diazepam 5 mg/ml auto-injector • Pralidoxime 1 gm inj 20 ml • Diazepam 5 mg/ml vial, 10 ml vial

23. Cities Readiness Initiative(CRI)

24. CRI Goals • Enhance the ability of cities to rapidly dispense life saving drugs to their population • Dispense needed drugs to 100% of each city’s population within a 48-hour timeframe

25. Assumptions • An outside aerosolized release of anthrax. • For the purposes of first year planning “First Responders” are defined as: • Public Health Services • Office of Emergency Management • Law Enforcement • Fire Services • Emergency Medical Services

26. Assumptions – cont…. • Non-medical personnel will be allowed to distribute medications. • The NJDHSS will receive an adequate supply of oral medications. • Medications will not be available in liquid suspension form.

27. CRI – NJ Goals • What are the goals of the program • Distribute medications to targeted population within 48 hrs. • One goal, for the 1st year of the grant is to develop a medication distribution plan targeted at a narrowly defined group of First Responders and their households members.

28. STRATEGIC STATE STOCKPILE (SSS)

29. Report: State Strategic Stockpile Subcommittee March 22, 2004

30. Local Medical Inventory Considerations • Threat • Prophylactic medicines and supplies for dealing with those threats • Quantity of medicines and other items needed in local inventory • Location of local inventory convenient to essential personnel when needed

31. Proceedings of the State MEDPREP Committee • Resources Available in the State • Hospitals • MICUs • Military • V.A. • State • Cities

32. Proceedings of the Committee • Possible Scenarios for Chemical, Biological, Radiation, Nuclear and Explosive Events (CBRNE) • High-Risk Locations • Storage • Distribution • Composition • Quantity • Budgetary Concerns and Restrictions • Final Recommendations

33. Quantity To determine the quantity of antidotes needed, we estimated the number of potential victims and selected a methodology to determine the severity of an event

34. To determine numbers of victims we reviewed A) the Tokyo Subway Attack (> 5500) B) the original Med Prep proposal (100,000) C) the U.S. government estimate (>10,000) D) NJ daily and emergency room visits

35. FACT: roughly 8,600 daily emergency room visits to NJ Hospitals • Subcommittee arbitrarily doubled this number, plus added a growth factor to come to a total of 20,000 victims for a chemical event.

36. DETERMINED NEED State Stockpile for 20,000 victims for the first 48 hours after a chemical event

37. TASK • Develop our own model by utilizing a successfully determined model • PROBLEM: there are none • The Committee utilized the model developed by the Federal government for their ChemPak Program.

38. Anticipated injuries in the CHEMPAK model • 30% mild • 40% moderate • 30% severe

39. AGENTS NEEDED IN A CHEMICAL EVENT • Atropine • Pralidoxime • Diazepam • Sodium Thiosulfate

40. AGENTS NEEDED IN A BIOLOGICAL EVENT • Ciprofloxacin • Doxycycline • Clindamycin • Gentamicin • Amoxicillin NOTE: All recommendations will allocate 20% of the total for pediatric patients

41. STORAGE OF STOCKPILE HOSPITALS Chemical -- all hospitals must maintain antidotes for a minimum of 20 patients to a maximum of 200 patients Biological – all hospitals must have the capability of diagnosing and treating at least 2 patients and plans for cohorting and treating at least 20 patients

42. STORAGE OF STOCKPILE • REGIONAL STORAGE SITES • Chemical -- LINCS or PODS HOSPITALS or state-determined locale • Biological -- LINCS or PODS HOSPITALS or state-determined locale

43. FURTHER ACTIONS • MedPrep approves actions and methodology of subcommittee to date • State provides information on budget allocated for stockpile • Trauma/Burns subcommittee provides information on RNE needs • Subcommittee finalizes recommendations based on approved methodology and budgetary information

44. NJ’s SSS Formulary • Potassium Iodide • Received 722,000 doses of potassium iodide (KI) for individuals who live and/or work within ten miles of a nuclear generating station. • Established dispensing sites in the areas surrounding New Jersey’s four nuclear power plants and distributed over 75,000 doses of KI • Distributed fact sheets, medical counseling, and other information relating to nuclear emergencies • Provided area schools, colleges and daycare centers with KI pills and information regarding KI administration • Antibiotics • Antibiotics for the treatment of agents associated with acts of bioterroism are stored in state and acute care hospital facilities • Chemical Antidotes • Acquired and pre-positioned in state • Infection Control Supplies • Respiratory masks, thermometers and gloves in support of communicable respiratory illness response plans

45. Mass Dispensing – Points of Dispensing (POD)

46. POD Site Considerations Determined by: • Number of people exposed/potentially exposed • Who you must treat or prophylax • Site locations • The event determines the number and location of sites

47. Staffing the POD • Types of Staff • Professionals • Volunteers • Management & Support staff

48. Staffing the POD • Sources of Staff • Professional Associations • Licensing agencies • Medical Reserve Corps (MRC)

49. TOPOFF 3 Lessons Learned – RSS Operations • Federal emphasis has been on Push Package, but TOPOFF emphasized Managed Inventory. NJ not prepared to receive MI in sufficient quantities • Need additional floor space for MI materials • LINCS agencies need additional space/ equipment for receiving MI

50. TOPOFF 3 Lessons LearnedRSS Operations • Request process for federal assets needs to be streamlined with consistent information/input needed • Must be prepared to both request and deny assets