An Overview of Mass Antibiotic Dispensing POD

Management

Glennis P. Gray, RN-BC, BSN, MSNAnn Savwoir, RPhRhonda LeMora, MPAWanda P. Rose, JD, MPH

PRESENTERS

DISCLOSUREI 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.

Define SNS Mission, Assets, and ResponseIdentify what a POD is and Define Mass

Antibiotic Dispensing POD BasicsIdentify Policies, Laws, Resources and

Supplies to Support DispensingDefine POD Management and Ways to

Optimize Flow

Course Objectives

SNS Mission, Assets and Response

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.

The Strategic National Stockpile

SNS supplies countermeasures based on the following Category A threat agents:SmallpoxAnthraxBotulismPlagueTularemiaViral Hemorrhagic FeversNerve agentPandemic Influenza Radiological

Category A Threat Agents

Pharmaceuticals include:Radiation CountermeasuresOral and IV AntibioticsNerve Agent Anti-dotesVaccinesAntitoxins and Anti-Virals

Medical SuppliesIV AdministrationAirway Management Supplies (pediatric and

adult)

Pharmaceuticals and Medical Supplies

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

DSNS Responds in Three Ways

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.

Broad Spectrum Support

Push Pack/12 Hours

Strategic National Stockpile Components

Vendor Managed Inventory/ 24-36 hours

Weights over 50 tons130 Containers maximumFits into a wide-body cargo aircraftConsumes 15,000 sq. ft. of floor space524,000 10-day regimesNumbered and colored coded for easy

identification

12 Hour Push Package

Specific Item SupportManaged InventoryVaccinesBuy Power/ Surge CapacityFederal Medical Stations

Technical Assistance and AdviseEmergency Response Concept

States may also be assisted with the following:

Point of Dispening and Mass Antibiotic Dispensing

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

What is a POD?

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.HospitalsAssisted Living Centers/Nursing HomesBusiness/Industry (Occupational PODs)

Types of PODS

Four Phases of a Dispensing Campaign

• Phase 1 – Notification• Phase 2 – Prophylaxis• Phase 3 – Set- Up• Phase 4 – Public Notification

Pre-Event Policy IssuesSpecial Needs/At Risk PopulationsThe Dispensing ProcessData CollectionPOD Forms DesignPOD Site Selection

Things to Consider Prior to Opening a POD

Setting up POD’s quicklyPutting pills in peopleProviding Health Information

Main Goals of Dispensing

Legal Issues

Public Health EmergencyEmergency Use Authorization (EUA)Public Readiness and Emergency Preparedness

Act

Emergency Determinations and Declarations

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 hoursTerminates 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

Purblic Health Emergency Determination

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

Why Determine a Public Health Emergency

Deploy approved, licensed, or cleared countermeasures from the Strategic National Stockpile

Provide temporary assistance to States and localities to meet health emergencies

What Doesn't need a Public Health Emergency Determination

Provides for the emergency use of “investigational” medical products not yet approved, licensed or cleared by the FDA.

Emergency Use Authorization (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 dispensingInformed 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

Why Issue 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

The Three Steps Necessary for an EUA

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.

Maximum of One YearLength of the Declared Emergency

EUA Termination

Criteria of issuance of the EUA is no longer met

The EUA is no longer necessary to protect the public health or safety

EUA Revocation

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

Public Readiness and Emergency Preparedness Act Declaration

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.

Louisuana Emergency Powers Act 2003

POD Management

StorageClinical AspectsTraffic ManagementParkingStaffMental Health

POD Management

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

Goals of a POD Team

“Weights of Dispensing” LabelingClinical accuracyHours of operationScreening/triagePatient/ EducationMedical RecordsTransportation

Requirements in POD Operations

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 requirementsAppoints or acts as POD spokesperson

POD Manager Responsibilities

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, Regina.Williams@la.gov

Sign in sheets can also be faxed to 225-342-0886 Attention: Regina WilliamsPlease complete online evaluations at http://www. Surveymonkey.com/s/PodManagementPassword: FLOW

Conclusion/Questions

Glennis Gray, RN-BC, BSN, MSN8919 World Ministry Ave., Suite B, Baton

Rouge, LA 70810Glennis. Gray@la.gov

You can learn more about the Strategic National Stockpile at http://www.bt.cdc.gov/stockpile

Contact Information