1. Characterization of Vaccine Waste Resulting from Storage Failures Identified by Immunization Programs, July 13 through September 4, 2009 Kelly L. Moore, MD, MPH Tennessee Immunization Program Chair, AIM Vaccine Storage and Handling Working Group

2. Study Acknowledgments Co-Authors Katelyn WellsKatelyn Wells Helen Fox FieldsHelen Fox Fields AIM Vaccine Storage and Handling Working Group AIM Research Committee AIM Executive Committee All Participating Immunization Programs

3. Reason to Conduct Study 2008 AIM Survey of Program Managers (PM) –Improper vaccine storage is critical issue –Wide variations in resources used, policies –PM demand for consistent, data-driven guidance IOM, FDA, CDC, ACIP members –Need to produce evidence of scope, type and cost of storage failures resulting in vaccine waste No existing studies fit needs

4. Purposes of This Study 1.Characterize the common types of events that result in vaccine waste 2.Understand cost of improper storage (particularly public costs) 3.Use results to advocate for evidence-based guidelines useful for responding to the common types of events 4.Provide individualized report to each IP Not to define the criteria used for decision to waste vaccine

5. Study Design Collect event-specific information on storage failures that result in vaccine waste –Exclude failures where no vaccine wasted Quantify $ value of vaccine wasted during a defined period –Exclude vaccine wasted during shipping (responsibility of distributor)

6. Study Design Features evaluated –Was vaccine inside storage unit, or left out –Single out of range temperature or repeated –Estimated or actual time out of range –Greatest deviation from acceptable temperature –How many doses of each vaccine were wasted (list public and privately purchased separately) –Calculated value of vaccine using CDC’s published price lists (Retail and Federal Contract)

7. Study Design Events identified by immunization programs (IP) during an 8 work-week period July 13 through September 4, 2009 Questionnaire completed on Survey Monkey for each incident (waste of refrigerated, frozen vaccines separately) –Incomplete reports (those without doses wasted reported) were excluded from analysis (22 R, 16 F) Few privately purchased doses were reported, aggregate results reported are for publicly purchased vaccines only

8. Results 45 of 64 IP participated –39 of 50 states –4 of 6 cities –2 of 8 territories Total incidents reported = 318 (~40/wk) –10 incidents (4 freezer, 6 refrigerator) included privately purchased vaccine –237 (75%) refrigerated vaccine incidents 58 of 237 (24%) occurred before study period –81 (25%) frozen vaccine incidents 21 of 81 (26%) occurred before study period

11. Results: Waste outside unit and multiple exposures Vaccine left out: 61 of 318 (19%) –19 of 81 (23.5%) frozen vaccine incidents –42 of 237 (17.7%) refrigerated vaccine incidents 53 of 237 (22%) incidents involved >1 temperature excursion at identification 21 of 81 (26%) freezer incidents involved >1 excursion at identification IPs were asked to characterize most recent incident

12. Types of Freezer Units involved in Vaccine Waste Incidents (n=45)

13. Types of Combination Freezers involved in Vaccine Waste Incidents (n=39 of 45) Acceptable to VFC

14. Types of Stand Alone Freezers involved in Vaccine Waste Incidents (n=6 of 45)

15. 75% 72 hours or less

17. Types of Refrigerator Units involved in Vaccine Waste Incidents (n=139)

18. Types of Combination Refrigerators involved in Vaccine Waste Incidents (n=117 of 139) Acceptable to VFC

19. Types of Stand Alone Refrigerator Units Involved in Vaccine Waste Incidents (n=22 of 139)

20. 89% 72 hours or less

21. 79% at 72 or lower

23. Publicly Funded Vaccine Doses Wasted and Financial Impact

24. Publicly Funded Frozen Vaccine Wasted: Doses = 2,491 and Value = $135,283 DosesValue

27. Conclusions Most vaccine waste occurs in combination (R/F) units About 1 in 5 events, vaccine is left outside unit ≥75% of incidents: <72 hours; <72°F; single excursion 51% of $ wasted (23%of doses) on refrigerated vaccine from 3 vaccines = HPV, MCV, PCV Total value of publicly funded vaccines wasted in 8 weeks among 45 (of 64) IPs = $1,167,781 Extrapolated to 1 year = $7,590,580 Findings demonstrate scale of problem, support better vaccine storage practices and storage failure guidance

28. Thank you to every IP who participated Kelly Moore, MD, MPH (TN) –Kelly.moore@tn.govKelly.moore@tn.gov Katelyn Wells, MS (AIM) –Aim.research@hotmail.comAim.research@hotmail.com Helen Fox Fields, BA (AIM) –Aiminfo@comcast.netAiminfo@comcast.net

29. Extra Slides