an overview of mass antibiotic dispensing pod management
DESCRIPTION
An Overview of Mass Antibiotic Dispensing POD Management. PRESENTERS. Glennis P. Gray, RN-BC, BSN, MSN Ann Savwoir, RPh Rhonda LeMora, MPA Wanda P. Rose, JD, MPH. DISCLOSURE. - PowerPoint PPT PresentationTRANSCRIPT
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, [email protected]
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. [email protected]
You can learn more about the Strategic National Stockpile at http://www.bt.cdc.gov/stockpile
Contact Information