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