1. Approaches for Safe Vaccine Handling and Management Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases University of Louisville

2. Objectives Review specific activities that help ensure that the vaccine administered had been handled to ensure it safety and potency Identify steps in the handling and management process that places vaccine at risk Explore opportunities to make systems adjustments that ultimately protect the patient (the vaccine recipient)

3. Resources CDC Pink Book www.Immunize.org CDC. Vaccine Storage and Handling Guide 2011. Available at www.cdc.gov/vaccines/recs/storage/default.htm. Will no longer be updated. Refer to Pink Book www.cdc.gov/vaccines/recs/storage/default.htm

4. CDC Pink Book Currently 12 th edition Available in hard copy, pdf or ipad versions A “must have” for all immunization programs

5. The Vaccine Handbook, 4E “The Purple Book” Gary S. Marshall, MD Professor of Pediatrics, University of Louisville School of Medicine

6. Principles of Vaccine Storage and Handling Success against vaccine-preventable diseases is impacted by proper storage and handling of vaccines Errors result in reduced potency and effectiveness It is better NOT to vaccinate than to administer a dose that has been mishandled Why worry about this?

7. National Survey of Practices Survey of APIC Infection Preventionists IRB approval University of Louisville Web-based survey 38 questions 93 response items Aims – Evaluate current healthcare worker immunization practices in US healthcare facilities – Evaluate current vaccine handling and management practices in employee/occupational health departments in US healthcare facilities

8. Minimum “Passing” Score, 70% Median: 47.6%

9. Significant Findings: Vaccine Handling 51% use a refrigerator type specifically contraindicated by CDC guidance 20% use calibrated thermometers 28% report having to discard vaccine due to unsuitable storage temperature events 58% maintain redundant power to the vaccine refrigerator 31% use temperature-stabilizing strategies 2% use a vaccine refrigerator to maintain cold chain when vaccines administered outside the office (e.g., mobile carts)

10. Significant Findings: Program Management 40.2% CIC 2.4% COHN/COHN-S 95% either completely or partially responsible for the immunization program in their facility 45.9% indicated they developed vaccine policy with assistance of others (not physician) 27.2% develop vaccine policy with assistance of physician 86.1% listed CDC/ACIP/Public Health as resources for their programs

11. Cold Chain From manufacturer to administration Proper maintenance of vaccines during transport and storage up to the time of administration Vaccines are fragile and subject to damage by exposure to temperature fluctuations Cumulative effect of temperature changes

12. Frozen Vaccines Between -58°F and +5°F (-50°C to -15°C) Varicella MUST be frozen and MMR MAY be frozen Remove from frozen environment immediately before reconstituting in preparation for administration If necessary, non-reconstituted varicella vaccine may be stored at refrigerated temperatures [35°F and 46°F (-2°C to 8°C)] for up to 72 continuous hours. Must be discarded after that time Must use diluent provided by the manufacturer Diluent does not need to be refrigerated

13. Refrigerated Vaccines Between 35°F and 46°F (-2°C to 8°C) Desired average temperature of 40°F (5°C) Proper environment for all inactivated vaccines as well as some of the live attenuated vaccines – FluMist – Rotavirus – Typhoid (oral and injectable) – Yellow Fever

14. Storage and Handling Plans Ordering and accepting vaccine deliveries Storing vaccines Handling vaccines Managing inventory Managing potentially compromised vaccines Emergency retrieval and storage plan with designated backup location

15. Personnel Training and Education Where and how to order vaccine How to receive, check, log, and store vaccine Organizing within the refrigerator/freezer Temperature monitoring Daily physical inspection Stock rotation Expiration date monitoring Response to temperature fluctuations Overseeing proper vaccine transport Documentation

16. Refrigerator CC strongly recommends stand-alone freezers and refrigerators without freezers If a combination unit sold for home use is used, it must have separate exterior doors and thermostat controls for each compartment. This is acceptable but NOT recommended Dormitory style units are NOT acceptable At least 4 inches between unit and a wall 1-2 inches between bottom of unit and floor No other use except vaccine storage

21. Refrigerator Do not store vaccine in the door Remove drawers, bins and shelves as they impede air circulation Do not store food in with vaccines Daily physical inspection – Temperature – Proper placement of vaccines – Opportunity for air circulation

22. Freezer Stand alone unit, or a combination unit designed to house vaccines Each refrigerated and frozen compartment must have own temperature monitoring process Check door seals and frost regularly. Should be frost-free unit

25. Thermometers Calibrated thermometer Certificate of Traceability and Calibration from an ISO 17025 accredited testing lab or another recognized standards agency – Digital – Bio-safe liquid – Continuous graphic Locate ideal thermometer placement by measuring in various locations to identify cold or hot spots Currently, temperatures must be monitored twice a day, but continuous monitoring recommendations are forthcoming

26. Manual Temperature Log

27. Compromised Vaccine Rapid identification Sequester in a refrigerated or frozen environment Label “Do Not Use” Contact manufacturers for guidance If identified after administration, contact medical oversight and other experts to help determine plan of action. Patient safety first

28. Error Proofing Store vaccines in labeled bins (uncovered) Allow space between bins for air to circulate Separate vaccines that may be confused (e.g., Td and Tdap; Hepatitis vaccines) Keep vaccines in their packages until ready to use. May unpackage small numbers of vaccines that are expected to be used regularly. May keep diluents with refrigerated vaccines (check label requirements), but do not store diluents in freezer

30. Error Proofing Plug unit directly into wall, not into power strip Use plug guard Label wall plug with a “Do Not Unplug” sign Temperature alarm Emergency generator/backup power May keep bottled water in refrigerator and ice packs in freezer to assist with temperature maintenance

34. Expiration Dates Monitor vaccine and diluents Rotate stock Can use through end of day on the expiration date. If expiration listed by month (e.g., 12/13), can use through end of last day of that month Multidose vial can be used until expiration date unless otherwise specified by manufacturer Date when opened Never use expired vaccine or diluent

35. Vaccine Transport to Off Site Clinics Minimize the number of times the vaccine is transported Multidose vial must be used by same user (office) as the one who opened it Maintenance of cold chain is critical If in a cooler, monitor temperature hourly Storage of diluent (room temperature) in cooler will adversely impact the temperature inside the cooler Patients should NEVER transport their own (or anyone else’s) vaccine

39. Vaccine Preparation Filling syringes in advance is discouraged If done, any unused must be discarded at the end of the clinic If filling in advance, limit the number prepared to prevent error and facilitate rapid use Any prefilled syringe that has been “activated” (needle applied) must be used or discarded by the end of the clinic

40. Vaccine Disposal Expired or compromised vaccine may be returnable to the manufacturer Open files or activated pre-filled syringes are likely not returnable For return questions, contact manufacturer For disposal, request guidance from pharmacy partner. Disposal may require placement in accordance with new standards

41. Performance Improvement Know existing processes Evaluate your team’s understanding of the policies/procedures Observe practice When deviation identified, promptly take action Engage others in the process so they can identify defects in the system and correct

42. Objectives Review specific activities that help ensure that the vaccine administered had been handled to ensure it safety and potency Identify steps in the handling and management process that places vaccine at risk Explore opportunities to make systems adjustments that ultimately protect the patient (the vaccine recipient)