1. A program of the IAIM Peer to Peer Exchange Tennessee to Tirana (Albania): Vaccine Storage, Handling and Vaccine Vial Monitors Kelly L. Moore, MD, MPH Director, Tennessee Immunization Program Assistant Clinical Professor, Vanderbilt School of Medicine Tennessee Department of Health IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 1

2. Objective Not to teach you everything I learned, rather… Inspire your vision of how the IAIM Peer to Peer Exchange could enhance your work and ideas “Experience, travel – these are as education in themselves.” – Euripides (Greek poet, c. 480 – 406 BCE) IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 2

3. U.S. Vaccines for Children (VFC) Program (est. 1994) All routine vaccines through 18 years Eligible children State insurance for the poor (Medicaid) Uninsured Native Americans (American Indian, Alaskan Native) Underinsured (private insurance excludes vaccines) ~50% of US children qualify Administered by state immunization programs funded by the US Centers for Disease Control and Prevention (CDC) IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 3

4. VFC Program: Tennessee 700+ public health and private sector clinics Volunteer clinics handle federally-purchased vaccines delivered directly by national VFC vaccine distributor No charge to clinic or patient for vaccine Small administration fee charged to patient VFC vaccine must be separate from private inventory (for insured patients) Damaged/wasted/expired vaccine must be replaced – VFC inventory in one clinic often $20,000 or more Program requirements for quality of storage units, temperature monitoring, accountability IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 4

5. VFC Vaccine Storage Quality Clinics purchase own equipment Separate refrigerators/freezers strongly recommended (freezer for varicella vaccines) Continuous digital temperature monitoring strongly recommended Document temperatures checked twice each clinic day Probe in glycol or other buffer in center of unit Specific brands or products not endorsed by CDC Describe the qualities of a good choice Clinics or state programs must shop for options IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 5

6. Temperature Excursion (TE) TE of any length of time above or below 2°-8C° or above -15°C for frozen vaccines Call state program or manufacturer for guidance (usable?) Vaccine Vial Monitors (VVMs) not used Freeze indicators not used Most liquid vaccines considered wasted if data logger indicates any time below 0°C Shake test not approved for use to evaluate freezing TEs common, vaccine waste common Is this necessary? Is there a better way? Are there more objective ways to decide vaccine wasted? IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 6

7. Peer to Peer Proposal Chair of AIM Vaccine Storage and Handling Committee since 2006 Aware of WHO guidelines, VVMs, manufacturer explanations, differences in management of TEs Proposal: Learn about cold chain management in a country that follows WHO guidance at the level of the clinic user Pros and cons of VVMs where used I cannot implement changes (US regulations) Learn new perspectives, be a better advocate for improvement in the US IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 7

8. Albania: Hosted by Dr. Silvia Bino and team at Institute for Public Health IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 8

9. Albanian Immunization Program Follows WHO guidelines Visit itinerary: National Vaccine Depot Regional clinic, transport Neighborhood clinics (Tirana, Shkoder) Vaccine storage Outstanding Immunization Registry Discussion of influenza clinics for HCW We use same continuous temperature monitors! IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 9 TNAlbania

10. Notable differences to me Data logger settings for alarms different US: >8°C for 15 minutes or <2°C for 15 min. Albania: >8°C for 10 hours, <0°C for 1 hour VVM status logged upon receipt at each stage of distribution, if turning, use first Too warm? Review VVM for usability Simple 4 color scale Freezing? Trained staff use WHO- standard shake test No calls to manufacturers All participating clinics are government All equipment is WHO-prequalified Immunization rates exceed 95% IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 10

11. IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 11

12. Connections Bear Fruit, More Questions Their protocols prevented calling manufacturers, save time, expense, waste One TN Imm nurse spends 75% of her time making these calls VVMs appeared easy, helpful safety net Ease of interpretation, objective, better for a PM than no indication at all (US) I was interested in shake test Clear differences in CDC and WHO CDC approach relies totally on temperature monitor (data logger), wastes much more vaccine How much basis for difference in science vs. regulatory/legal concerns? Interest in simple equipment choices thanks to “prequalified” equipment IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 12 Albania Immunization Registry: new (above) and old (below)

13. Impact Cannot bring VVMs, other changes to the US alone Complex and costly regulatory standards for authorization by Federal Food and Drug Administration Could help make it easier for programs and clinics to identify good equipment options? Encourage some type of “prequalification” or “seal of approval” in US Proposal in development: AIM-hosted manufacturer webinars with program managers to raise awareness of product options available IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 13

14. New Friends, New Perspectives One week (personal leave from work) Narrow, focused question Relationships, time  learning far beyond proposal Generous hosts make experience rich Common mission, vision Different ways to address the same problem Unique chance for US manager to learn overseas IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 14

15. Thank you Albania Imm. Program Dr. Silvia Bino Erida Nelaj Iria Preza IAIM Inaugural Conference, March 3 - 4, 2015, Istanbul, Turkey 15 “Travel and change of place impart new vigor to the mind.” Seneca the Younger (Roman statesman, 4 BCE- 65 CE)