Smallpox Vaccine Logistics: Distribution, Storage and Security WVDHHR/BPH US Department of Health and Human Services Centers for Disease Control and Prevention December 2002 / January 2003

Smallpox Vaccine Logistics: Distribution, Storage and Security Learning Objectives: Describe how the smallpox vaccine will be ordered and shipped Describe the support to be provided by the National Pharmaceutical Stockpile Describe the storage and handling requirements for the smallpox vaccine

National Pharmaceutical Stockpile (NPS) Concept of Operations Provide rapid delivery of a broad spectrum of support for an ill-defined threat in the early hours of an event Provide large shipments of specific material when a threat is known Provide technical assistance to receive and distribute NPS material during an event

NPS Response Options Broad Spectrum Support: Specific Item Support: 12-hour Push Packages Specific Item Support: Vendor Managed Inventory (VMI) Vaccines Buying Power/Surge Capacity

Distribution Vaccine is a licensed product and all ancillary support will be in the kit Each kit provides the capability to inoculate 85-90 persons In actual use, getting 85-90 doses from each vial (kit).

What Do the Shipments Contain? Vaccine Diluents for vaccines that must be reconstituted (1 vial per every vial of vaccine) Bifurcated needles Transfer needles (1 needle for every vial of diluent) Package insert Lot number stickers

What Needs to be Acquired Locally Non-latex gloves Waterless hand cleanser Chux pad 2 X 2 gauze pads, plus cloth tape or paper tape Semi-permeable bandages Needle (21G or smaller)

What Needs to be Acquired Locally Zip lock plastic bags (to provide vaccinated persons with a supply of gauze pads, tape and bandages) Sharps containers Medical waste bags Bleach/spray bottle NOTE: DO NOT procure/use alcohol or alcohol wipes as alcohol inactivates the vaccine

Vaccine Handling “Cold Chain” must be constant during distribution Temperature logging is required to validate that 35 - 46° F (2-8° C) was maintained during movement Vaccine kits will be shipped in approved shipping containers with cold packs and temperature monitor Temperature monitor must be read as soon as vaccine arrives

Vaccine Handling West Virginia State Police have primary responsibility for security & transporting vaccine to local/regional sites State Immunization Program staff will contact State Police for transportation of vaccine kits

Vaccine Handling Regional/local sites must designate Point of Contact (primary & alternate) Name, title, address, phone, fax & directions Delivery Site address & directions Number of vaccination doses needed Desired delivery date of vaccine kits

Vaccine Handling “Cold Chain” must be constant during redistribution Temperature logging is required to validate that 35 - 46° F (2-8° C) was maintained during movement Temperature monitor must be checked as soon as vaccine arrives

Storage All kits must be maintained at 35 - 46° F (2-8° C) Proper refrigeration must be in place at point of delivery A temperature reading log must be maintained on the refrigeration system Check/record storage temperature at least 2 times per day

Security Issues Code of Federal Regulations must be followed (21CFR) Fixed storage facilities Controlled access to both facility and the storage system Surveillance (video) and/or security staff

Reminders Vaccine should NEVER be frozen Normal storage temperature is 35 - 46° F (2-8° C) AFTER reconstitution, vaccine: Must be used within 60 days Maintained at 35 - 46° F (2-8° C)

For More Information West Virginia Immunization Program Jeff Neccuzi, Program Manager 304-558-6426 OR 304-558-2188 800-642-3634

National Pharmaceutical Stockpile For More Information National Pharmaceutical Stockpile Telephone: 404-639-0459 Email: NPS_PPT@cdc.gov

For More Information CDC Smallpox website www.cdc.gov/smallpox National Immunization Program website www.cdc.gov/nip