1. Marshal Bickert, MPH Associate Director Central Ohio Trauma System
Mass Prophylaxis
Marshal Bickert, MPH
Associate Director
Central Ohio Trauma System

2. Today’s Presentation
Discuss and Review Potential Mass Prophylaxis Scenarios
Discuss and Review National, State , and Local Mass Prophylaxis Processes
Pandemic Influenza Related Mass Prophylaxis- Of Course!

3. Mass Prophylaxis Scenarios
Bioterrorism
Naturally Occurring Infectious Disease Outbreaks
Prevention of Disease Secondary to Natural Disasters

4. Bioterrorism Category A Category B Anthrax Plague Tularemia
Brucellosis
Glanders
Melioidosis
Q Fever

5. Prophylaxis Related to Infectious Disease Outbreaks
MRSA
Meningococcal Meningitis
Haemophilus influenzae, Invasive
Pandemic Influenza

6. Prophylaxis Related to Natural Disasters
Vector-borne Diseases- Malaria, Lyme Disease
Waterborne Diseases- Cryptosporidium, Strep, Staph
Cutaneous- Strep, Staph
Shelter Sickness

7. Strategic Stockpiles, Caches, and Systems
Strategic National Stockpile- CDC
State Stockpiles and SNS Integration
Local
Mass Vaccination Clinics/Points Of Distribution
MMRS and HRSA Funded Caches
Cities Readiness Initiative

8. Strategic National Stockpile
Large Quantities of Medicine, Vaccines, Supplies, and Equipment
2 Components
12 Hour Push Pack
Vendor Managed Inventory

9. SNS Components 12 Hour Push Packs Vendor Managed Inventory (VMI)
Caches of pharmaceuticals, antidotes, and supplies
On-site within 12 hours
Vendor Managed Inventory (VMI)
Shipped within hours
Flexible and can be tailored to state/local needs

10. Requesting the SNS Local Health Department
County Emergency Operations Center
Ohio Department of Health
CDC/HHS

11. Receiving the SNS Local Public Health and Healthcare Facilities
State Distribution Site
SNS Warehouse

12. Community Mass Vaccination Response

13. Local POD Site

14. Cities Readiness Initiative
A pilot program to prepare 21 pilot cities and 15 additional U.S. cities to dispense needed drugs and medical supplies within 48 hours of the decision to do so.
Ohio:
Cleveland
Columbus
Cincinnati
CRI is a pilot program whose purpose is to prepare 21 major cities to effectively respond to a large scale bioterrorist event by dispensing antibiotics and other medical supplies to their entire populations, if necessary, within 48 hours of the decision to do so.
It is based on the vulnerability of our citizens to an aerial release of anthrax as this agent and dispersal mechanism requires the most rapid response time to prevent large-scale mortality. If we can supply antibiotics within 48 hours to prevent large-scale casualties from anthrax, we can respond effectively to other biologicals such as plague and tularemia.

15. Cities Readiness Initiative
Non-medical model to dispense
Use of “push” and “pull” mechanisms to dispense medications to the masses
Rapid activation and response
Multi-agency response

16. Assumptions Limited to aerosolized anthrax
Exposed population difficult to determine
Community demand for response

17. Existing Technology
Aerial dispersion of anthrax over a large geographic area can be accomplished with commercially-available equipment.
An area covering several square miles could be covered using off-the-shelf equipment. If released over a major metropolitan area millions of people could be exposed.

18. Anthrax Exposure: Proportion of Population Saved
DELAY in Initiation
DURATION
of Campaign
Immed.
1 Day
1 Day
1 Day
2 Days
2 Days 2
3 Days
3 Days 3
4 Days
4 Days 4
5 Days
5 Days 5
6 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%
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.]
5 Days
98%
96%
92%
87%
80%
71%
60%
49%
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%

19. “PULL”: Points-of-Distribution (PODs)
People leave their homes and go to the site to receive medications

20. Use of Business Partnerships
Large employers
College campuses
Senior living communities
Hospitals
Skilled Nursing Facilities & Assisted Living.

21. PUSH Medications delivered directly to people Examples:
U.S. Postal Service delivery to homes
Medication kits pre-positioned
Independent Courier

22. USPS Option Postal Service routinely delivers to each resident daily
Allows to “shelter in place”
Would supplement more traditional dispensing plans
Security Issues
The postal service is an option for cities that are unable to develop plans to provide antibiotics to all those needing them—up to their entire population—within 48 hours. We expect that most cities will need some form of dispensing beyond the traditional point of dispensing model to meet this goal.
Having people receive medication in their mailbox rather than from a health-care provider is not the first choice. There are good reasons for screening and counseling patients and printed materials and public service announcements. But the postal service provides an alternative to thousands not getting their medicine in time.

23. Postal Plan: Delivery of Antibiotics and Instructions Items for Delivery
Information Sheet:
Today in your mailbox you have received a bottle of antibiotics. These antibiotics have been distributed because of a potentially wide scale release of a pathogen in your area. There are risks to your health if you are not treated for this exposure. There are however the risks associated with the antibiotic itself. The following provides guidance for pediatric dosage, and provide instructions for seeking assistance from public health authorities…

24. Delivery of Antibiotics & Instructions
USPS will deliver an information sheet & two ‘unit of use’ pill bottle to each residential delivery point (i.e. mail box)
All deliveries will be performed using a postal vehicle
Security personnel will accompany each postal worker during the delivery of the items
Local Point of Dispensing will still be necessary
Other delivery methods will likely be necessary

25. Alternatives to Postal Plan
Drive thru dispensing
Semi-medical and non-medical PODs
Law Enforcement

26. Local Caches
Health Resources and Services Administration (HRSA) Hospital Bioterrorism Preparedness Program
3 day supply prophylaxis for all hospital employees and their family members
Metropolitan Medical Response System (MMRS) Caches

27. Pandemic Influenza Related Mass Prophylaxis
Antiviral medications are principally used to treat influenza infections
Under certain circumstances, these drugs can also reduce transmission of the virus or even prevent infection..

28. Pandemic Antivirals
Two antiviral drugs are effective against the H5N1 virus in laboratory testing.
Tamiflu, Roche Laboratories, administered as a course of capsules or liquid that is taken orally.
Relenza, manufactured by GlaxoSmithKline, is administered by an inhaler.
Both work by blocking the ability of the virus to multiply beyond the infected host cell.

29. Antiviral Assumptions
Treatment with a neuraminidase inhibitor (oseltamivir [Tamiflu®] or zanamivir [Relenza®]) will
Decreasing risk of pneumonia,
Decrease hospitalization by about half (as shown for interpandemic influenza)
Will also decrease mortality.
Antiviral resistance to the adamantanes (amantadine and rimantadine) may limit their use during a pandemic.
The primary source of antiviral drugs for a pandemic response will be the supply of antiviral drugs that have been stockpiled..
Treating earlier after the onset of disease is most effective in decreasing the risk of complications and shortening illness duration.
35% Attack Rate
Number of priority groups that can be covered will be known at the start of the pandemic
No vaccine 4-6 months

30. National Pan Flu Budget

31. National Antiviral Stockpile
Goal: 25% of Population
50 Million Courses in National SNS
31 Million Courses at state level (purchased at federal discounted rate)

32. Antiviral Purchases

33. Planning Considerations for Pan Flu Prophylaxis
Primary constraints:
Limited supplies
Increasing risk of side effects with prolonged use
Potential emergence of drug-resistant variants of the pandemic strain, particularly with long-term use of M2 inhibitors    
Need will decrease with vaccine availability
Post-exposure prophylaxis might be useful in attempts to control small, well-defined disease clusters (e.g., outbreaks in long-term care facilities
Oseltamivir has demonstrated >70% efficacy as prophylaxis against laboratory-confirmed febrile influenza illness during interpandemic

34. Planning Considerations- Continued
Prophylaxis with amantadine or rimandatine decreased the risk of influenza illness during the 1968 pandemic and the 1977 reappearance of H1N1 viruses
The number of persons who receive prophylaxis with oseltamivir should be minimized, primarily to extend supplies available to treat persons at highest risk of serious morbidity and mortality. 
If a pandemic virus is susceptible to M2 ion channel inhibitors, amantadine and rimantadine should be reserved for prophylaxis, although drug resistance may emerge quickly.
Rimantadine is preferred over amantadine

35. Strategies for Antiviral Prophylaxis
Targeting prophylaxis to priority groups:
Using post-exposure prophylaxis (generally for 10 days) to:
Control small, well-defined disease clusters,
Protect individuals with a known recent exposure (e.g., household contacts of pandemic influenza patients)
When a vaccine becomes available, post-exposure prophylaxis to protect key personnel during the period between vaccination and the development of immunity. 
Strategies for antiviral prophylaxis may be revised

36. Vaccination and Prophylaxis Priority Groups

37. Effectiveness of Neuraminidase Inhibitors for Preventing Staff Absenteeism during Pandemic Influenza

38. ? Staffing Shortages Increased Workforce Demands Loss of Workforce
Internal Factors
Workplace Acquired Illness
Morale
Efficacy
Fear- Self
Facility Security ?
Extremely High Census
Increased Workforce Demands
Loss of Workforce
External Factors
Community Acquired Illness- Self
Fear- For Family
Illness Spouse
Illness Dependents
Transportation
Home/Childcare
Increased Needed Output
High Acuity Illness
Diminishing Resources
PPE Requirements
Security Measures
Catastrophic Workforce Shortages

39. Central Region Staff Survey
Knowledge- Only 11%
Personal/Family Preparedness- 28%
Spousal Illness Effect- 62% (75%)
Dependent Effect- 90% (65%)
Dependent Care- 25% (60%)

40. Central Region Survey Top 3 Concerns: Top 3 Recommendations:
If I go to work, I will make my family sick
I don’t have enough knowledge to keep myself safe
The proper planning has been done.
Top 3 Recommendations:
PPE Training
Bird Flu/Pandemic Education
Bird Flu/Pandemic Planning

41. Monitoring and Data Collection (State and Local Public Health)
Distribution of state or federal supplies of antiviral drugs
Occurrence of adverse events following administration of antiviral drugs
Effectiveness of treatment and prophylaxis
Development of drug resistance

42. Summary Mass Prophylaxis Scenarios Mass Prophylaxis Systems
Bioterrorism
Infectious Disease
Natural Disasters
Mass Prophylaxis Systems
SNS
PODS
CRI
Local Caches
Pandemic Influenza Antiviral Prophylaxis

43. Any Questions! Marshal Bickert, MPH MBickert@goodhealthcolumbus.orgx4