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
A program of the
IAIM Inaugural Conference, March 3 - 4, 2015,
Istanbul, Turkey
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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
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U.S. Vaccines for Children (VFC)
Program (est. 1994)
• All routine vaccines through 18 years
• Eligible children
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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
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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
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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
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Temperature Excursion (TE)
• TE of any length of time above or below 2°-8C° or
above -15°C for frozen vaccines
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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
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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
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Albania: Hosted by Dr. Silvia Bino and
team at Institute for Public Health
IAIM Inaugural Conference, March 3 - 4, 2015,
Istanbul, Turkey
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Albanian Immunization Program
• Follows WHO guidelines
• Visit itinerary:
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TN
Albania
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
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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 WHOstandard 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
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IAIM Inaugural Conference, March 3 - 4, 2015,
Istanbul, Turkey
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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
Albania Immunization Registry:
new (above) and old (below)
IAIM Inaugural Conference, March 3 - 4, 2015,
Istanbul, Turkey
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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
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New Friends,
New Perspectives
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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
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Thank you
Albania Imm. Program
• Dr. Silvia Bino
• Erida Nelaj
• Iria Preza
“Travel and change of place
impart new vigor to the mind.”
Seneca the Younger
(Roman statesman, 4 BCE- 65 CE)
IAIM Inaugural Conference, March 3 - 4, 2015,
Istanbul, Turkey
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