An Overview of Mass Antibiotic Dispensing POD Management

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

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.

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

SNS Mission, Assets and Response

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

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

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)

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

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.

Strategic National Stockpile Components �Push Pack/12 Hours Vendor Managed Inventory/ 24 -36 hours

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, 000 10 -day regimes �Numbered and colored coded for easy identification

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

Point of Dispening and Mass Antibiotic Dispensing

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.

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)

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

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

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

Legal Issues

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

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

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

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

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

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

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

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.

EUA Termination �Maximum of One Year �Length of the Declared Emergency

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

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

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.

POD Management

POD Management �Storage �Clinical Aspects �Traffic Management �Parking �Staff �Mental Health

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

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

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

Conclusion/Questions �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, Regina. Williams@la. gov �Sign in sheets can also be faxed to 225 -342 -0886 Attention: Regina Williams �Please complete online evaluations at http: //www. Surveymonkey. com/s/Pod. Management Password: FLOW

Contact Information �Glennis Gray, RN-BC, BSN, MSN � 8919 World Ministry Ave. , Suite B, Baton Rouge, LA 70810 �Glennis. Gray@la. gov You can learn more about the Strategic National Stockpile at http: //www. bt. cdc. gov/stockpile