1. An Overview of Mass Antibiotic Dispensing POD Management

2. PRESENTERS Glennis P. Gray, RN-BC, BSN, MSN Ann Savwoir, RPh
Rhonda LeMora, MPA
Wanda P. Rose, JD, MPH

3. DISCLOSURE
I have no financial interests or other relationship with manufacturers of commercial products, suppliers of commercial services, or commercial supporters. My presentation will not include any discussion of the unlabeled use of a product or a product under investigational use.

4. Course Objectives Define SNS Mission, Assets, and Response
Identify what a POD is and Define Mass Antibiotic Dispensing POD Basics
Identify Policies, Laws, Resources and Supplies to Support Dispensing
Define POD Management and Ways to Optimize Flow

5. SNS Mission, Assets and Response

6. The Strategic National Stockpile
The Strategic National Stockpile (SNS) is a national repository of antibiotics, chemical antidotes, vaccines, antidotes, vaccines, antitoxins, life-support- mechanisms, intravenous administration and airway maintenance supplies, and medical/ surgical items.

7. Category A Threat Agents
SNS supplies countermeasures based on the following Category A threat agents:
Smallpox
Anthrax
Botulism
Plague
Tularemia
Viral Hemorrhagic Fevers
Nerve agent
Pandemic Influenza
Radiological

8. Pharmaceuticals and Medical Supplies
Pharmaceuticals include:
Radiation Countermeasures
Oral and IV Antibiotics
Nerve Agent Anti-dotes
Vaccines
Antitoxins and Anti-Virals
Medical Supplies
IV Administration
Airway Management Supplies (pediatric and adult)

9. DSNS Responds in Three Ways
Rapid delivery of a broad spectrum for an ill defined threat
Large shipments of specific items when a threat is known
Technical assistance and advice

10. Broad Spectrum Support
12 Hour Push Packages can deliver Pre-configured SNS material anywhere in the country within 12 hours or less.
The state is responsible for subsequent transportation to treatment centers, dispensing sites, or other distribution nodes.
Each 12 hour push package contains large amounts of pre –packaged, individual regimens of oral antibiotics that come in multi-day, unit of use, labeled , child proof bottles.

11. Strategic National Stockpile Components
Push Pack/12 Hours
Vendor Managed Inventory/ hours

12. 12 Hour Push Package Weights over 50 tons 130 Containers maximum
Fits into a wide-body cargo aircraft
Consumes 15,000 sq. ft. of floor space
524, day regimes
Numbered and colored coded for easy identification

13. States may also be assisted with the following:
Specific Item Support
Managed Inventory
Vaccines
Buy Power/ Surge Capacity
Federal Medical Stations
Technical Assistance and Advise
Emergency Response Concept

14. Point of Dispening and Mass Antibiotic Dispensing

15. What is a POD?
Point of dispensing (POD) - a place where a vaccine, antibiotic or other medication is dispensed quickly to a large group of people.

16. Types of PODS
Open POD- A public location like a University, school, or other large site where medications are dispensed to a large group of people.
Closed PODs – A private location where medications are dispensed to a specific group of people.
Hospitals
Assisted Living Centers/Nursing Homes
Business/Industry (Occupational PODs)

17. Four Phases of a Dispensing Campaign
Phase 1 – Notification
Phase 2 – Prophylaxis
Phase 3 – Set- Up
Phase 4 – Public Notification

18. Things to Consider Prior to Opening a POD
Pre-Event Policy Issues
Special Needs/At Risk Populations
The Dispensing Process
Data Collection
POD Forms Design
POD Site Selection

19. Main Goals of Dispensing
Setting up POD’s quickly
Putting pills in people
Providing Health Information

20. Legal Issues

21. Emergency Determinations and Declarations
Public Health Emergency
Emergency Use Authorization (EUA)
Public Readiness and Emergency Preparedness Act

22. Purblic Health Emergency Determination
The Secretary may determine, after consultation with such public health officials that:
A disease or disorder presents a public health emergency exists.
Notice to Congress within 48 hours
Terminates when the Secretary determines that the emergency no longer exists or after 90 days, whichever occurs first
May be renewed by the Secretary for additional 90 day periods

23. Why Determine a Public Health Emergency
Access Public Health Emergency Funds ( when funds are available)
Waive certain restrictions on requirements or medical countermeasure distribution
Declare an emergency justifying emergency use of an investigational product

24. What Doesn't need a Public Health Emergency Determination
Deploy approved, licensed, or cleared countermeasures from the Strategic National Stockpile
Provide temporary assistance to States and localities to meet health emergencies

25. Emergency Use Authorization (EUA)
Provides for the emergency use of “investigational” medical products not yet approved, licensed or cleared by the FDA.

26. Why Issue An EUA?
An investigational product may be the best available to meet an emergency involving a Chemical , Biological, Radiological, Nuclear (CBRN) agent
The requirements for clinical investigations are difficult to meet in mass dispensing
Informed Consent process may limit public health ‘s ability to respond and contain the disease/outbreak
Institutional Review Boards are not practical during a rapidly progressive public health emergency

27. The Three Steps Necessary for an EUA
Determination of an Emergency by Secretary of Homeland Security (DHS), or
Department of Defense (DOD), or Health and Human Service Secretary (HHS), and
Declaration of an Emergency by the US Secretary of Health and Human Services
Issuance of EUA by FDA Commissioner

28. Emergency Use Authorizations (EUAs)
If FDA grants a request for an EUA, it is found that:
An approved product may be used in a way inconsistent with the limitations of the approval; or
A product that has not yet been approved may be permitted to be used despite lacking the quantum of data that would be necessary for full approval.

29. EUA Termination
Maximum of One Year
Length of the Declared Emergency

30. EUA Revocation Criteria of issuance of the EUA is no longer met
The EUA is no longer necessary to protect the public health or safety

31. Public Readiness and Emergency Preparedness Act Declaration
Authorizes the Secretary to issue a declaration to provide immunity from liability protection (except for willful misconduct) for medical countermeasure development, distribution and administration protection, and provides national guidance.
Authorizes an emergency fund in the U.S. Treasury for compensation for injuries from covered countermeasures

32. Louisuana Emergency Powers Act 2003
The Louisiana Emergency Powers Act 2003 grants the State Health Officer, the Department of Health and Hospitals (DHH), and DHH OPH exclusive jurisdiction, control and authority to isolate or quarantine and to take such action as is necessary to accomplish the subsidence and suppression of diseases of all kinds in order to prevent their spread.

33. POD Management

34. POD Management Storage Clinical Aspects Traffic Management Parking
Staff
Mental Health

35. Goals of a POD Team
Provide prophylaxis to all people in an area who have been exposed to an agent in order to save lives and prevent illness
Set up and operate a site that runs at maximum efficiency and effectiveness

36. Requirements in POD Operations
“Weights of Dispensing”
Labeling
Clinical accuracy
Hours of operation
Screening/triage
Patient/ Education
Medical Records
Transportation

37. POD Manager Responsibilities
Setup and Operation of the POD according to the state/regional or local plan
Coordinates the activities of the management staff
Information flow and reporting requirements
Appoints or acts as POD spokesperson

38. Conclusion/Questions
Mail Sign in Sheets to Continuing Education Program, DHH/OPH, Nursing Services, Bienville Building, 628 North 4th St., 3rd Floor, Baton Rouge, LA 70802,
C/O Regina Williams,
Sign in sheets can also be faxed to
Attention: Regina Williams
Please complete online evaluations at
Surveymonkey.com/s/PodManagement
Password: FLOW

39. Contact Information
Glennis Gray, RN-BC, BSN, MSN
8919 World Ministry Ave., Suite B, Baton Rouge, LA
Glennis.
You can learn more about the Strategic National Stockpile at