Presentation on theme: "An Overview of Mass Antibiotic Dispensing POD Management"— Presentation transcript:
1 An Overview of Mass Antibiotic Dispensing POD Management
2 PRESENTERS Glennis P. Gray, RN-BC, BSN, MSN Ann Savwoir, RPh Rhonda LeMora, MPAWanda P. Rose, JD, MPH
3 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.
4 Course Objectives Define SNS Mission, Assets, and Response Identify 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
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:SmallpoxAnthraxBotulismPlagueTularemiaViral Hemorrhagic FeversNerve agentPandemic InfluenzaRadiological
8 Pharmaceuticals and Medical Supplies Pharmaceuticals include:Radiation CountermeasuresOral and IV AntibioticsNerve Agent Anti-dotesVaccinesAntitoxins and Anti-ViralsMedical SuppliesIV AdministrationAirway Management Supplies (pediatric and adult)
9 DSNS Responds in Three Ways Rapid delivery of a broad spectrum for an ill defined threatLarge shipments of specific items when a threat is knownTechnical 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.
12 12 Hour Push Package Weights over 50 tons 130 Containers maximum Fits into a wide-body cargo aircraftConsumes 15,000 sq. ft. of floor space524, day regimesNumbered and colored coded for easy identification
13 States may also be assisted with the following: Specific Item SupportManaged InventoryVaccinesBuy Power/ Surge CapacityFederal Medical StationsTechnical Assistance and AdviseEmergency 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 PODSOpen 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)
17 Four Phases of a Dispensing Campaign Phase 1 – NotificationPhase 2 – ProphylaxisPhase 3 – Set- UpPhase 4 – Public Notification
18 Things to Consider Prior to Opening a POD Pre-Event Policy IssuesSpecial Needs/At Risk PopulationsThe Dispensing ProcessData CollectionPOD Forms DesignPOD Site Selection
19 Main Goals of Dispensing Setting up POD’s quicklyPutting pills in peopleProviding Health Information
21 Emergency Determinations and Declarations Public Health EmergencyEmergency 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 hoursTerminates when the Secretary determines that the emergency no longer exists or after 90 days, whichever occurs firstMay 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 distributionDeclare 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 StockpileProvide 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) agentThe 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/outbreakInstitutional 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), orDepartment of Defense (DOD), or Health and Human Service Secretary (HHS), andDeclaration of an Emergency by the US Secretary of Health and Human ServicesIssuance 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; orA 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 TerminationMaximum of One YearLength 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.
34 POD Management Storage Clinical Aspects Traffic Management Parking StaffMental Health
35 Goals of a POD TeamProvide prophylaxis to all people in an area who have been exposed to an agent in order to save lives and prevent illnessSet up and operate a site that runs at maximum efficiency and effectiveness
36 Requirements in POD Operations “Weights of Dispensing”LabelingClinical accuracyHours of operationScreening/triagePatient/ EducationMedical RecordsTransportation
37 POD Manager Responsibilities Setup and Operation of the POD according to the state/regional or local planCoordinates the activities of the management staffInformation flow and reporting requirementsAppoints 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 toAttention: Regina WilliamsPlease complete online evaluations atSurveymonkey.com/s/PodManagementPassword: FLOW
39 Contact InformationGlennis Gray, RN-BC, BSN, MSN8919 World Ministry Ave., Suite B, Baton Rouge, LAGlennis.You can learn more about the Strategic National Stockpile at