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Considerations and a Medically Responsible Model for r Long-Term - - PowerPoint PPT Presentation

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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

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@NACCHOalerts www.naccho.org 1100 17th St NW Washington, DC 20036

The 49th

th Hour:

: 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

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@NACCHOalerts www.naccho.org 1100 17th St NW Washington, DC 20036

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)

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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

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Use your:

  • Cell phone  Text NACCHO to 22333 to Join
  • Device  Post responses at PollEv.com/NACCHO

Votes and responses are anonymous

Science Preparedness and Response:

Respond here: PollEv.com/NACCHO

  • r Text here: 22333

Poll Everywhere!

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Importance of the 49th 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

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Determining the Appropriate Response

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  • Residential delivery

No Screening

  • CRI public POD model
  • Subset of most severe contraindications

Marginal Screening

  • Long term POD model
  • Additional contraindications assessed
  • Medication tolerance assessed

Expanded Screening

  • All possible contraindications

assessed

  • Dose adjustments and lab services

provided

Complete Screening with Medical Services

  • Think doctor’s visit
  • Full medical history assessed
  • Additional services and

patient-tailored treatment

Medical Patient Model

U R G E N C Y Timeframe ASAP 1-2 days 4-10 days 10-20 days Unlimited Time

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Potential Relevant Agents & MCMs for Long Term Response

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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 Diseases Existing or investigatory antimicrobial or antiviral therapies may provide protection or reduce burden of disease. Engineered Bioweapons Existing or investigatory antimicrobial or antiviral therapies may provide protection or reduce burden of disease.

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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

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* 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

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Long-Term Mass Medication Issues

  • Potential issues with Doxycycline and Ciprofloxacin include:

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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

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Factors to Consider for Long-Term Response

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Exposed Population Timeframe Logistics (Medications, Staff, Sites) Role of partner agencies and health department Level of screening

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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

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Antibiotic Screening Algorithm

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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
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Clinic Layout

ENTRANCE EXIT

L L S S S S V V D D

DC DC DC DC

C C C C C C C C

Antibiotic Screening and Dispensing Vaccine Screening and Dispensing Legend

Line Staff =2 Abx Screener and Dispenser =2 Vaccinator =2 Vaccine Drawer=2 Data Collector (Vaccine Screener) =2 Patient Chairs =8

L S V D

DC

C

Screens for:

  • Disease symptoms
  • Antibiotic tolerance
  • Antibiotic

contraindications

  • Renal disease

Dispenses:

  • 50-day antibiotic

regimen Screens for:

  • Vaccine

contraindications Dispenses:

  • First course of vaccine

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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

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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

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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

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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

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Exercise Methods (continued)

  • Accuracy of dispensing was assessed by comparing the

medication assignment in the database to the script key

  • Throughput was measured by looking at number of persons

processed per hour

  • Processing times were estimated from medication and

vaccine database time stamps.

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@NACCHOalerts www.naccho.org 1100 17th St NW Washington, DC 20036

Exercise Process

Patients Enter Clinic

  • Patients

receive script

Screening/Dispensing

  • Screeners ask patients

questions to determine medication assignment

  • Screeners provide

extended course of antibiotics

  • Screeners document

patient answers and medication type and dose provided in database

Data Collection/Vaccination

  • Data Collectors screen

patients for vaccine contraindications and document patient and vaccine information

  • Vaccinators provide

vaccine to patients

Patients Exit

  • Patients

leave clinic having received both extended course antibiotics and a vaccination

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Throughput & Accuracy Results

  • From 1:00 – 3:00PM, 185 persons were processed
  • Line was fully saturated from 1:00 – 2:51PM:
  • 111 minutes
  • 175 persons processed in that time
  • 94.6 persons processed/hour
  • Over 4 pill screening and dispensing stations
  • 23.7 persons/station/hour
  • Over 2 vaccination stations
  • 47.3 persons/station/hour
  • Antibiotic screening and dispensing accuracy
  • 182 of 185 persons received the correct medication and dose

(98.4% correct)

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Processing Times During Fully Saturated Clinic

0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 1-1:30 pm 1:30-2pm 2-2:30pm 2:30-3pm

Processing Time (minutes)

Time Interval

Medication Screening Time Vaccine Processing Time Total Processing Time

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Limitations

  • Scripted population with a limited number of conditions

listed in non-emergency setting

  • Scripts did not simulate those with limited English

proficiency or those with functional or access needs

  • Screening algorithm did not encompass all possible

medication contraindications

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Resource and Throughput Extrapolations

Applicable Setting Number of Dual-Step Processing Units Used* Estimated Throughput (Persons/ Hour)** Estimated Population Served in Timeframe*** Number

  • f Laptops

Needed Number of Staff for Dual- Step Processing Units**** Number of Staff Needed***** Rural LHD 1 47 3,948 4 6 9 Small City LHD 10 473 39,480 40 60 90 Large City LHD 100 4,730 394,800 400 600 900

* 1 dual-step processing unit is equivalent to 2 antibiotic screeners/dispensers, 2 vaccine screeners, 1 vaccinator, and 1 vaccine drawer (6 total staff). ** Assuming a fully saturated model. ***Assuming a 7-day timeframe is available for long-term mass medication dispensing. ****Staffing model assumes each person used to staff the clinic will work on a rotating 12-hour-on, 12-hour-off basis ***** Staff estimates based on 2:1 ratio of staff at stations (screeners/dispensers, data collectors, drawers, and vaccinators) to other staff in POD (leadership staff and line staff)

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Potential Model Modifications

  • Reduce the population needing follow-up medication
  • Increase response capacity
  • Limit interventions and/or screening questions
  • Limit data collection

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Potential Applications of Model

  • Model may have applicability to responses that require any

combination of:

  • Extended screening PODs to provide medications with many

contraindications (e.g. dispensing for smaller-sized population)

  • Dual intervention dispensing (e.g. non-serogroup B meningococcal disease

– one dose of Cipro and one dose of vaccine provided)

  • Multi-course intervention dispensing (e.g. influenza vaccine dispensing

with a multi-series vaccine schedule or prolonged antiviral prophylaxis course dispensing)

  • Database: Long-term follow-up of patient symptoms and/or adverse

events is needed for large populations (e.g. Smallpox, Ebola, or when using investigational products)

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Conclusions

  • Preliminary data collected informed dual POD model

throughput, accuracy, staffing, and other resource estimates

  • Model can be expanded to serve larger populations
  • The window of time between initial post-exposure

dispensing and the second visit provides an opportunity to implement enhanced screening methods

  • Healthcare providers will be overwhelmed in a large event

and patient safety could be compromised

  • Identifying roles of public health and other response

partners (healthcare and Closed PODs) and training to those roles is critical before an event.

  • Adjusting the level of medical screening taking into account

the timeframe of response, resources available, and potential health impacts will be critical when implementing this model

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Article in Health Security

Title: The 49th Hour: Analysis of a Follow-Up Medication and Vaccine Dispensing Field Test Citation: Puerini Raymond, Caum Jessica, Francis Natalie, and Alles

  • Steven. Health Security. January/February 2015, 13(1): 54-63.

doi:10.1089/hs.2014.0078. Link: goo.gl/mZgwzy

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Preparedness Workgroups

  • Preparedness Workgroups provide leadership, guidance, and

direction to NACCHO’s Preparedness portfolio

  • Members are local health department officials and public

health preparedness professionals

  • Workgroups usually meet about once per month
  • Applications are accepted each year in March
  • More information on workgroups:
  • http://www.naccho.org/about/committees/index.cfm

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April 19-22, 2016 Dallas, Texas

Planning Today for Rebuilding Tomorrow: Focusing on Resiliency and Recovery in the 21st Century

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Questions

Raymond Puerini, MPH Senior Program Analyst Medical Countermeasures and Strategic National Stockpile Portfolio National Association of County and City Health Officials 202-507-4257 rpuerini@naccho.org Twitter: @Are_You_Ray_Dy

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Antibiotic Screening Database (1/2)

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Antibiotic Screening Database (2/2)

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Vaccine Screening Database (1/2)

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