Presentation on theme: "Glennis P. Gray, RN-BC, BSN, MSN Ann Savwoir, RPh Rhonda LeMora, MPA Wanda P. Rose, JD, MPH."— Presentation transcript:
Glennis P. Gray, RN-BC, BSN, MSN Ann Savwoir, RPh Rhonda LeMora, MPA Wanda P. Rose, JD, MPH
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.
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
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.
SNS supplies countermeasures based on the following Category A threat agents: Smallpox Anthrax Botulism Plague Tularemia Viral Hemorrhagic Fevers Nerve agent Pandemic Influenza Radiological
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)
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
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.
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
Specific Item Support Managed Inventory Vaccines Buy Power/ Surge Capacity Federal Medical Stations Technical Assistance and Advise Emergency Response Concept
Point of dispensing (POD) - a place where a vaccine, antibiotic or other medication is dispensed quickly to a large group of people.
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)
Phase 1 – Notification Phase 2 – Prophylaxis Phase 3 – Set- Up Phase 4 – Public Notification
Pre-Event Policy Issues Special Needs/At Risk Populations The Dispensing Process Data Collection POD Forms Design POD Site Selection
Setting up POD’s quickly Putting pills in people Providing Health Information
Public Health Emergency Emergency Use Authorization (EUA) Public Readiness and Emergency Preparedness Act
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
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
Deploy approved, licensed, or cleared countermeasures from the Strategic National Stockpile Provide temporary assistance to States and localities to meet health emergencies
Provides for the emergency use of “investigational” medical products not yet approved, licensed or cleared by the FDA.
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
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
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 Year Length of the Declared Emergency
Criteria of issuance of the EUA is no longer met The EUA is no longer necessary to protect the public health or safety
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
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.
Storage Clinical Aspects Traffic Management Parking Staff Mental Health
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
“Weights of Dispensing” Labeling Clinical accuracy Hours of operation Screening/triage Patient/ Education Medical Records Transportation
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
Mail Sign in Sheets to Continuing Education Program, DHH/OPH, Nursing Services, Bienville Building, 628 North 4 th St., 3 rd 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
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