1. Vaccine Storage and Handling Equipment Recommendations in Tennessee Kelly L. Moore, MD, MPH Medical Director, Tennessee Immunization Program Tennessee Department of Health March 6, 2006

2. Disclaimer I am board certified in Preventive Medicine and Public Health. I am not now, nor have I ever been, formally trained in refrigeration or thermometer technology. However, I have good reasons to be passionate about vaccine quality…

4. Objectives Background of storage issues in Tennessee Policies of storage and handling Storage equipment recommendations

5. Tennessee Vaccine Storage Experience Became medical director in September 2004 November 2004 –County health department had stored all refrigerated vaccine at 3400 recipients –Private pediatric VFC provider using combination refrigerator/freezer repeatedly exposed refrigerated vaccine to freezing temperatures for 3 years; ~3000 recipients –Revaccination recommendations worked out with assistance of Greg Wallace, MD, of NIP Subsequent experience with dozens of practices after administration of compromised vaccine

6. Basic Storage Failure Principles Based on CDC advice, WHO, Australian cold chain guidelines, common sense Refrigerated vaccines exposed to freezing at least one hour (<32.0ºF, <0.0ºC) degrade quickly –Hepatitis B, pertussis components most freeze-sensitive –Aluminum adjuvants break down Exposure of refrigerated vaccine to elevated temperatures causes very gradual degradation; revaccination not normally recommended –Australian guidelines give useful advice Varicella vaccine: case by case Manufacturers’ advice to callers extremely conservative – no data on potency provided – we only call for varicella vaccine

7. Preventing Vaccine Waste and Revaccination Prevent administration of compromised vaccine by educating providers –Use graphing temperature logs 2x daily –If out of range Confirm the temperature Restore proper storage conditions Label “Do not use” until you know it’s okay Call TIP (1-800 #) for recommendations for use Document actions on back of temperature log Prevent compromise of vaccine by using better equipment

8. TIP Equipment Recommendations: Why we created them California Dept of Health storage video CDC does not make equipment recommendations Value of vaccines kept in clinics is skyrocketing Providers in Tennessee were motivated –Revaccination impact on their practices –Demanded to know what to buy and where Mailed to all VFC providers July 2005

9. Recommendations of TIP: Thermometers Certified calibrated (required by VFC) Wide range of certification: 1 year  life Recertification requires shipping to a company, may be expensive (learn terms before buying) Accuracy of thermometers vary – review specifications carefully (recommend at most +/- 1ºC variation) If storing thousands of dollars in vaccines, consider a thermometer with alarm that can call to alert you to a failure before vaccine is compromised

10. Recommendations of TIP: Freezers Strongly Recommended –Commercial- or laboratory-quality free standing or combined with refrigerator (max temp -17ºC) Higher quality components, maintains temperature better Separate compressors – no circulating air between sections Drawback: Most expensive, may be bulky Recommended –Free-standing household freezer (<-15ºC), counter high is convenient (cost $200-400)

11. Recommendations of TIP: Freezers Acceptable –Household combined R/F unit with separate thermostats –Household combined R/F unit with one thermostat ONLY if no temperature-sensitive products are stored in refrigerator Unacceptable –Dorm-style freezer box (inadequate freezing) –Household combined R/F unit with one thermostat and vaccines stored in both sections

12. Recommendations of TIP: Refrigerators Strongly Recommended –Commercial- or laboratory-quality free standing or combined with freezer Higher quality components, maintains temperature better Separate compressors – no circulating air between sections Recommended –Household refrigerator without a freezer unit

13. Recommendations of TIP: Refrigerators Acceptable –Dual thermostat household combined R/F unit –Single thermostat combined R/F unit ONLY if no temperature-sensitive products stored in freezer Unacceptable –Dorm-style refrigerator with freezer box –Single thermostat combined R/F with vaccine in both sections –Beverage cooler during clinic hours Compromise was developed for clinics where vaccine refrigerator is far from clinic rooms.

14. Recommendations of TIP: Where to find equipment www.Globalspec.com online search engine for laboratory- and industrial-grade equipment of all kinds (links to over 14,000 companies) Restaurant supply companies Household appliance retailers

15. Recommendations of TIP: Other Helpful Hints Consider the value of your vaccine inventory when choosing storage units (what risk can you afford?) Confirm the terms of warranties with vendors –Is warranty good for household unit in a business? Discuss proper equipment maintenance –Coils cool more efficiently after cleaning; monitor and adjust thermostat if needed Be sure the new unit works; do not place vaccine in a new unit until it has been working and temperatures are correct and stable for several days Study the CDC Vaccine Storage and Handling Toolkit!

16. National Needs for the Future Publish thermostability data on all vaccines to allow evidence-based decisions on use Vaccine insurance? Increase commitment at national level to address problems of quality vaccine storage –Storage equipment specifications designed to minimize risk of storage failures –Evidence-based ACIP standards on response to storage failures and when to revaccinate

17. Acknowledgments Tennessee Immunization Program Staff –Pam Baggett Program Manager –Jonna Goostree VFC Manager –Charlene Smith VFC/AFIX Coordinator –Mimi Larzelere CDC PHA –Jenny Bilbro Secretary –Becky Loveless Clerk –Allen Hardin Clerk –Barbara West Clerk –Luz Cummings IT registry support –Charles MurffIT registry support –Joe Beaver Sr. CDC PHA (retired, Jan 2006)