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Learn how smallpox vaccine is ordered, shipped, stored, and handled with National Pharmaceutical Stockpile support. Understand distribution requirements, handling procedures, storage, and security measures.
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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: • 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
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 bechecked 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
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