1 th Hour: The 49 th : Pla lanning Considerations and a Medically Responsible Model for r Long-Term Mass Medication Dis ispensing Raymond Puerini, MPH Senior Program Analyst National Association of County and City Health Officials Texas Medical Countermeasures Symposium May 6, 2015 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
2 Acknowledgments • NACCHO would first like to thank and acknowledge all those at the Philadelphia Department of Public Health (PDPH) for their ideas and contributions with the formulation of these planning concepts and analysis and interpretation of research findings found in the following slides, including: • Dr. Steve Alles • Jessica Caum • Natalie Francis • Jose Lojo • Dr. Caroline Johnson • Persons interested in reaching PDPH directly about this topic may contact Dr. Steve Alles (steve.alles@phila.gov) or Jessica Caum (jessica.caum@phila.gov) 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
3 Overview • Explore the planning considerations for a long-term mass medical countermeasure (MCM) response • Describe the potential agents and prophylactic measures that are relevant for a long-term response • Describe the expanded screening methodology and point of dispensing (POD) model used for long-term dispensing • Discuss a dual-model, second visit functional dispensing exercise and the applications of the exercise findings 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
4 Poll Everywhere! Science Preparedness and Response: Respond here: PollEv.com/NACCHO or Text here: 22333 Use your: o Cell phone Text NACCHO to 22333 to Join o Device Post responses at PollEv.com/NACCHO Votes and responses are anonymous 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
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7 Importance of the 49 th Hour • As part of the Cities Readiness Initiative (CRI), participating jurisdictions were tasked with building mass dispensing plans to medicate their population within 48 hours • Based on an aerosolized anthrax scenario, with the incubation period of disease being as soon as 48 hours • As part of this initial dispensing campaign, populations would receive their first 10-day course of antibiotic medication to prevent the onset of disease symptoms 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
Determining the Appropriate 8 Response Timeframe No ASAP • Residential delivery Screening Marginal • CRI public POD model 1-2 days U Screening • Subset of most severe contraindications R G • Long term POD model Expanded Screening 4-10 days • Additional contraindications assessed E • Medication tolerance assessed N • All possible contraindications C Complete Screening with assessed 10-20 days Medical Services • Dose adjustments and lab services Y provided • Think doctor’s visit Unlimited • Full medical history assessed Medical Patient Model • Additional services and Time patient-tailored treatment 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
9 Potential Relevant Agents & MCMs for Long Term Response Agent Recommended Post-Exposure Prophylaxis Anthrax 60-day antibiotics and 3-course series of anthrax vaccine (each dose spaced 2 weeks apart) Tularemia 10-14 day course of ciprofloxacin or 21-day course of doxycycline Brucellosis 21-day course with doxycycline or rifampin Pandemic Influenza Vaccine for potentially pandemic or seasonal influenza strain. Additionally antivirals may be used to lessen disease severity. Prolonged prophylaxis may be provided for at-risk groups. Emerging Infectious Existing or investigatory antimicrobial or antiviral therapies may Diseases provide protection or reduce burden of disease. Engineered Existing or investigatory antimicrobial or antiviral therapies may Bioweapons provide protection or reduce burden of disease. 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
10 Historical Anthrax Post-Exposure Prophylaxis (PEP) Data* • Following the 2001 Anthrax Letter Attacks, ~10,000 persons were offered 60-day PEP antibiotics • Of the 5,343 persons that took at least 1 dose of antibiotics, 57% reported adverse events (ADEs) • 44% fully adhered to long-term regimen • 16% reported seeking medical care for adverse events • 0.3% were found to have serious adverse events • Applied to population of 1,000,000: • 3,000 would have serious adverse events * Shepard CW, Soriano-Gabarro-Soriano M, Zell ER, Hayslett J, Lukacs S, Goldstein S, et al. Antimicrobial postexposure prophylaxis for anthrax: adverse events and adherence. Emerg Infect Dis [serial online] 2002 Oct [ 04/27/15 ]. Available from http://wwwnc.cdc.gov/eid/article/8/10/02-0349 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
11 Long-Term Mass Medication Issues • Potential issues with Doxycycline and Ciprofloxacin include: 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
12 Switching to Amoxicillin for Long-Term PEP • For those with contraindications or tolerance issues, switching to Amoxicillin may be an option, assuming: • Pathogen is sensitive to Amoxicillin (i.e. not resistant) • Amoxicillin is available in the quantities and timeframe needed from the Strategic National Stockpile (SNS) or other available avenues • Person does not have a known allergy or other contraindication to the Penicillin class of antibiotics 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
13 Factors to Consider for Long-Term Response Exposed Population Timeframe Logistics (Medications, Staff, Sites) Role of partner agencies and health department Level of screening 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
14 Planning Assumptions • All potentially exposed persons received a 10-day course of antibiotics in the first 48 hours of response • Doxycycline, Ciprofloxacin, and Amoxicillin are all effective and available in quantities needed to provide 50-day supplies to all exposed individuals • Vaccine is also available to provide first dose to all exposed individuals • Once medications arrive, there will be 5-7 days to carry out long-term dispensing operations • Staff and all other resources will be available in quantities needed Above assumptions allow for an expanded screening model 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
15 Antibiotic Screening Algorithm Steps : 1. Collect contact information 2. Screen for disease symptoms 3. Screen for medication tolerance 4. Screen for contraindications to drug 5. Assign medication 6. Determine dose 7. Screen for renal issues 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
16 Clinic Layout ENTRANCE L Legend Screens for: • Disease symptoms L Line Staff =2 • Antibiotic tolerance Antibiotic C C • Antibiotic S Abx Screener and C Screening C Dispenser =2 contraindications and • Renal disease S Dispensing V Vaccinator =2 S Dispenses: S S D Vaccine Drawer=2 • 50-day antibiotic L regimen Data Collector (Vaccine DC Screener) =2 Screens for: Vaccine • Vaccine V C C V C C C Patient Chairs =8 Screening contraindications and Dispenses: Dispensing • First course of vaccine D D DC DC DC DC EXIT 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
17 Exercise Objective To test a novel dual model mass medication POD to include: • Screening for disease symptoms, medication compliance, adverse events, and certain medication contraindications • Assessing 50-day antibiotic dispensing accuracy • Administering one dose of vaccine • Assessing patient processing time and overall patient throughput 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
18 Exercise Scenario • Aerosolized anthrax attack release in a localized large public setting with large population exposed • e.g., stadium event • This is a follow-up medication clinic to provide a 50-day course of antibiotics and first course of anthrax vaccine 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
19 Exercise Assumptions • Paper-based screening forms used and demographic information was not collected in database during initial encounters • All persons received first medication course, either Doxycycline or Ciprofloxacin • Amoxicillin is effective against anthrax and is available in quantities needed • Same layout and staffing model used as presented earlier 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
20 Exercise Methods • Students at a Jewish boarding school acted as patients to receive mock 50-day pill supplies and first shot of mock anthrax vaccine (flu vaccine actually provided) • 100 scripts were developed based on: • Demographic data • Expected prevalence of antibiotic allergies, certain medication prescriptions, pregnancy, and certain contraindicated medical conditions of interest • A script key was developed that documented the 50-day medication type and dose assignment based on script data 1100 17 th St NW @NACCHOalerts www.naccho.org Washington, DC 20036
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