Office of Public Health Preparedness and Response Division of Strategic National Stockpile
Shirley Mabry Logistics Branch Chief, Division of Strategic National Stockpile
Office of Public Health Preparedness and Response
Logistics of the SNS
June 4, 2015
INVENTORY MANAGEMENT
Scope of the SNS Inventory $6.3 billion in MCM assets under management Approximately 900 separate line items Size is approximately equal to that of 6 large Home
Depot/Lowes facilities Some inventory items have been kitted in unique
configurations designed by SNS with other SME input Detailed data on physical location to facilitate deployment Customized Inventory Management System – Stockpile
Resource Planning (SRP)
Inventory Management Requirements Annual 100% Inventory Requirement Annual CFO audit Annual A-123 (OMB Circular) review Comply with Federal Property Regulations Comply with all regulations for product disposal
Product Quality Control Quality Control Unit independent of Logistics
Complies with cGMP requirements (21 CFR)
Regular vendor audits for specific products 3PL providers are registered with FDA as pharma
warehouses Results in FDA inspections
3PL providers are registered with DEA Results in regular DEA inspections
Warehousing meets or exceeds Regulatory requirements Product Label requirements USP requirements
Shelf Life Extension Program (SLEP)
Established in January 1986 between FDA and DoD Participants in SLEP have expanded from the U.S.
military to also include the SNS, and the Department of Veterans Affairs
SNS does not solely determine products eligibility Biologics are not eligible
Shelf Life Extension Program (SLEP) Requires documented environmental controls FDA stability testing Sampled/tested by lot
Product historically relabeled by FDA approved vendors
Current cycle time for testing and extension approval is prolonged FDA resource constraints While under testing, product cannot be released and is
held in quarantine
DEPLOYMENT
State Requests Federal Assistance
2. Need for Drugs and Medical Supplies Exceeds Local & State Resources
1.
4. Federal Officials Deploy SNS Assets
3.
Discussion with key officials: (i.e. HHS, DHS, CDC, State, etc)
Augments Federal, State, Local Medical Materiel Resources
SNS Asset Request Flow
Deployment Considerations Commercial partners transport via most expeditious method
Transportation asset availability is a factor in product source Transportation providers are regularly exercised
Products require varying validated shipping conditions QCU validates trucks for transport where required
Products require variable delivery timelines for clinically effective usage DSNS can meet delivery timeframes and has plans to decrease those State/Local dispensing capacity may not match with an expanded
DSNS capability
Product Configurations to Meet Deployment Needs
Forward placed caches – CHEMPACK
12-hour Push Package SNS Managed Inventory (Vaccines,
anti-virals, antibiotics and other SNS managed inventory) Specialized kitting for response needs
– for example, ventilators
Vendor Managed Inventory Can create deployment challenges
Direct order for non-stocked items
Forward Placed Caches: CHEMPACK
Forward placed due to immediate requirement for administration
Not practical to hold centrally
Requires constant remote monitoring
Product rotated by field teams and returned for disposal or SLEP
Broad Spectrum Support: 12-hour Push Packages
Pre-packed and configured in transport-ready containers
Pre-positioned in secure facilities
Delivered by commercial transport partners
Managed Inventory SNS Managed Inventory Under government immediate control, dispersed throughout
our network to meet delivery requirements
Generally lower costs for inventory management
Commercial 3rd Party Logistics model vs. civil service
Bulk of SNS Assets
Vendor Managed Inventory Under vendor control, not necessarily geographically dispersed
Reliant on vendor to accomplish deployment
Federal Medical Stations (FMS)
Modular deployable medical surge support caches
250 Beds per “station” 50 bed variant created
in 2014 for flexibility Medical supplies,
pharmaceuticals and equipment for 3 days
Designed for non-acute care
Configured for rapid movement
FMS Operational Model
Turns a structure of opportunity into a temporary medical shelter
Accompanied by a DSNS team for set up support
Commercial prime vendor support available for re-supply
HISTORICAL EXAMPLE – H1N1 DEPLOYMENTS
DSNS Response - Spring 2009 Metered Package option 25% of SNS Flu Assets 11M antiviral regimens 25M N95 respirators 14M surgical masks Gloves, gowns, and face shields
Support to Mexico & PAHO 840K antiviral regimens Logistics consultation
DSNS Response - Spring 2009 Successful 7 day “push” to 62 Project Areas Successful local distribution according to state plans Systems developed through collaborative
Federal/State/Local public health planning and exercising largely worked as designed
Highlights ~10,000 pallets of materiel 363 trucks 18 air shipments
DSNS Response - Fall 2009 Deployment in response to commercial supply issues:
535K bottles of Tamiflu suspension in two pushes • In response to a shortage of product in the commercial supply chain • First push was 300K regimens followed by remaining 235K regimens
59.7M N95 respirators • In response to a national shortage of N95 respirators
Peramivir IV Delivered a total of 2,129 regimens by expiration of Public Health
Emergency Declaration and EUA on June 23, 2010
Highlights ~7,000 pallets of materiel 298 trucks 25 air shipments