1. 1 The Perceived Importance of Vaccine Storage Problems and Variability of Storage and Handling Policies Among Immunization Programs in the US Kelly L. Moore, MD, MPH Medical Director, Tennessee Immunization Program & Katelyn Wells, MS Research Coordinator Association of Immunization Managers (AIM)

2. 2 The Association of Immunization Managers (AIM) Non-profit, created in 1999, funded through cooperative agreement with CDC Members include all 64 state, city and territorial NCIRD immunization grantees (“programs”). Standing committees and working groups include: Vaccine Storage and Handling Finance Epidemiology/Surveillance Registry Vaccine Management Programmatic Research

3. 3 The Problem Every day Immunization Programs make difficult decisions –Vaccine storage equipment choices What are the best options? –Vaccine storage failures Is the vaccine ruined? Is revaccination needed? Little evidence based guidance available

4. 4 Available resources - ACIP CDC-ACIP General Recommendations (2006) –On storage failures: “After the vaccine has been moved, determine if the vaccine is still useable by contacting the manufacturer or state/local health department.” –On revaccination: “As a general rule, vaccines that have been mishandled or stored at inappropriate temperatures should not be administered. Guidance for specific situations is available from the state health department or CDC.”

5. 5 Available resources - Other Vaccine Manufacturers –Data for their recommendations is typically proprietary –Recommendations may conflict with those given in the past or with data in other sources Other Sources –WHO Temperature Stability of Vaccines (2006) –Research articles (e.g., in the journal Vaccine)

6. 6 AIM Vaccine Storage and Handling (VSH) Working Group Early 2006, AIM established the VSH Working Group Discuss and advocate for solutions to VSH challenges First step: characterize programs’ needs

7. 7 Objectives of 2008 AIM VSH Survey Characterize the range of VSH policy and procedures across immunization programs Characterize support for more evidence- based standards or national policies for VSH Characterize the importance of VSH issues to programs

8. 8 Survey Methods Questions developed and reviewed by AIM Research Coordinator and VSH Working Group Survey Monkey questionnaire to all 64 AIM member projects January 2008 Data cleaned; basic descriptive data reported

9. 9 Survey Response 55 of 64 programs responded –48 of 50 state programs –6 of 6 city programs –1 of 8 territories Aggregate data presented here includes only state and city respondents (n=54)

10. 10 Vaccine Storage Equipment

11. 11 Current Practice: What guidelines do programs give providers about storage units? (n=54)

12. 12 Need for Guidance: Storage Units (n=54) Scale mean=3.90 mean=3.65

13. 13 Vaccine Storage Failures and Vaccine Compromise

14. 14 Current Practice: What guidance do programs give concerning vaccine storage failures? 52 of 54 (96%) have written guidance for providers

15. 15 Current Practice: What resources are used to determine if vaccine is compromised?

16. 16 Current Practice: Who makes decision that vaccine is compromised?

17. 17 Respondents’ perception of the impact of common out-of- range temperatures (< 24 hours) on vaccine potency (n=52 of 54) mean=4.27 mean=4.65 Scale

18. 18 Respondents’ perception of the impact of common out-of- range temperatures (< 24 hours) on vaccine potency (n=52 of 54) mean=3.42 mean=2.73Scale

19. 19 Need for additional evidence-based standards to determine vaccine compromise in the following conditions (n=54) Scale mean=4.24 mean=4.00 mean=4.26

20. 20 The need for consistent national policy for process of determining vaccine viability (n=54 of 54) Scale mean=4.07 mean=4.45 mean=4.39

21. 21 28 of 53 programs are concerned about legal liability issues when making a decision to consider a vaccine usable following exposure to out-of-range temperatures One reason for desiring consistent national policy:

22. 22 Revaccination

23. 23 28% (15 of 54) have specific written guidelines, others do not Current Practice: Who determines if revaccination is recommended? (n=54)

24. 24 Current Practice: What resources are used to determine if a recipient should be revaccinated? (n=54)

25. 25 If revaccination is recommended, do you require providers to notify recipients or parents of this recommendation? (n=54) 54% (29) Yes 17% (9) No 6% (3) Do not know 24% (13) Various other remarks

26. 26 Need for Better Evidence-Base and National Policy for Revaccination (n=54) mean=4.33 mean=4.20

27. 27 Overall: How critical are these VSH issues to your program? (n=54) mean=4.9 mean=4.6 mean=4.8

28. 28 Conclusions Diversity of policies, resources used and decision makers among state and local AIM member programs Programs see a critical need for better evidence to make scientifically sound and defensible decisions Strong demand for consistent national policies for these issues More work and research are needed

29. 29 Acknowledgments Katelyn Wells Research Coordinator, AIM Others: Claire Hannan, Exec Director, AIM Helen Fox Fields (AIM) Greg Wallace, MD (CDC) Tony Richardson (CDC) Howard Backer, MD (CA) AIM VSH Working Group Members –Lynn Bahta (MN) –Matt Gilman (OR) –Sandra Jo Hammer (CA) –Jan Hicks-Thompson (WA) –Dan Hopfensperger (WI) – Mike Hudgens (AL) –Marnell Kretschmer (IA) –Tonya Philbrick (ME) –Mariana Sablan (N. Mariana Islands) –Terri Thornton (IA) –Laurel Wood (AK)

30. 30 Who completed the survey?