Bureau of Community Health Systems National Pharmaceutical

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Transcript Bureau of Community Health Systems National Pharmaceutical

Statewide Advisory Committee for Preparedness October 7, 2004

Jeffrey Blystone Strategic National Stockpile Coordinator Bureau of Community Health Systems PA Department of Health

CDC Enhancements to the Strategic National Stockpile (SNS)

– – Initial “push package” • As of 9/1/2004, push package contains 300,000 unit of use medications.

• Pill counters removed from the “push package” Vendor-managed Inventory (VMI) • Tailored follow-up shipment (based on specific event) • Attempting to have VMI in unit-of-use medications by early 2005.

PA Enhancements to the SNS

• DOH strategy changed from decentralized to a more centralized plan – DOH will be responsible for Receipt, Stage and Store (RSS) site management with personnel assistance from RCTTFs – RCTTFs will be responsible for the Points of Dispensing (PODs). DOH will provide a liaison between the PODs and RSS sites • Full-time SNS Coordinator hired

PA DOH SNS Planning

• SNS Plan is being reviewed and enhanced to reflect the strategy change • Receipt, Storage and Staging (RSS) Site verification by CDC and US Marshal Service • Integrate new programs associated with SNS as part of the enhanced SNS plan: – Cities Readiness Initiative (CRI) – CHEMPACK

Next Steps

• Continue to review and enhance the State SNS Plan • Brief the plan to the RCTTFs • Provide technical assist to the RCTTFs with enhancements to their plan on items such as: – RSS Volunteer requirements – POD designation, volunteer requirements, and flow capacity

CHEMPACK PROJECT Mission

Implement a nationwide project for the “forward” placement of nerve agent antidotes. To provide state and local governments a sustainable resource that increases their capability to respond quickly to a nerve agent event. *

State participation in the CHEMPACK Project is voluntary

CHEMPACK

• Why Pennsylvania?

– SNS Program has a 12-hour response time, too long in the event of a nerve agent attack – Some state and local governments don’t have any nerve agent antidote stocks – Hospitals carry limited supplies of treatments for nerve agent exposures – Nerve agent antidotes have variable shelf lives (are not an easily sustainable resource)

• •

CHEMPACK PILOT

Pilot

– New York City (highly urban) – South Dakota (primarily rural) – Washington State (mixture of urban and rural)

Goals

– Develop and implement the concept of “forward” placement of nerve agent antidotes – Develop basic guidelines and project procedures – Validate cost, time, equipment, and procedures – Refine procedures, processes, guidelines and techniques for nationwide project deployment

ASSUMPTIONS

• Potential terrorist use of chemical weapons will continue to be perceived as a threat to national security • The primary purpose for the CHEMPACK Project is to enhance state and local capabilities to save lives • Sustainability of antidote stocks is a critical concern for state and local governments • Provisions of Shelf Life Extension Program (SLEP) cannot be waived

CHEMPACK EQUIPMENT

SENSAPHONE 2050 CHEMPACK STORAGE CONTAINER

• SNS Program supplies CHEMPACK materials, approved storage containers, and monitoring equipment • Sites provide a secure, environmentally controlled storage area with phone connectivity

STANDARD CONTAINERS

The CHEMPACK Project provides two types of containers: • Emergency Medical Service (EMS) Container: Designed for emergency responders; materiel packaged mostly in auto-injectors.

• Hospital Container: Designed for hospital dispensing, with multiuse vials, for precision dosing and long term care.

• Pralidoxime increase • AtroPens®

PILOT PROJECT OBSERVATIONS

• CHEMPACK Pilot demonstrated a national project is cost effective and feasible • Results indicate CHEMPACK Project has the potential to deliver significant cost savings – Procurement advantages – Shelf-life extension of pharmaceuticals

SHELF LIFE EXTENSION PROGRAM (SLEP)

• FDA program originally established with DoD to extend shelf-life of pharmaceuticals for cost efficiency and longevity • SLEP guidelines provide the quality assurance techniques used to determine the condition of materiel in storage to ensure a ready-for-issue status over the long-term

Statewide Advisory Committee for Preparedness October 7, 2004

Michael Huff Director Bureau of Community Health Systems PA Department of Health

Cities Readiness Initiative (CRI)

• • A pilot program to prepare 21 major U.S. cities to dispense needed drugs and medical supplies within 48 hours City of Pittsburgh • City of Philadelphia • The “best practices,” tools and information developed during CRI will be shared with all American cities and regions • Executive briefing to key participants • Planning assessment to be scheduled • Assessment results will drive funding

Biohazard Detection System (BDS)

• PCR-based technology • Samples air continuously above mail-sorting machine • Test run every 60 minutes • Testing takes ~30 minutes • Limited to

Bacillus anthracis

• Positive “signal” leads to automatic alarm and building evacuation

BDS - Response to Alert

• Confirmatory testing by State Public Health Laboratory, Lionville (LRN) • Decontamination • Antibiotic post-exposure prophylaxis • Environmental testing • Follow-up by public health