SUCCESS STORY
ALTRU SPECIALTY
Altru Specialty Pharmacy
Keeping medication in proper temperature range –
winter, spring, summer, and fall
About Altru Specialty Pharmacy
Altru Specialty Pharmacy is a part of Altru Health System, which serves
people in North Dakota and parts of Minnesota. What began in 2014 as
a grassroots effort with one technician working in partnership with the
PharmD has grown to include three full-time technicians and three full-
time pharmacists. Still, the specialty pharmacy’s mission has remained
the same: to enhance care and improve the overall health and well-
being of its patients.
Background
According to Rosemary Kalenze, PharmD, Outpatient Pharmacy
Manager for Altru, the pharmacy initially thought it would be
best to test the performance of its medication packages using
Joint Commission accreditation requirements in addition to US
Pharmacopeia (USP) best practices for good storage and distribution
of drug products, which many accreditation agencies use as a
guideline. “We live and work in a climate that can be -40ºF in the
winter and 100ºF in the summer,” explains Kalenze. “To be sure we
are giving our patients the best possible care, it’s important to know
we are sending drug products in such a way that they remain both
effective and safe.”
Altru ultimately chose Zebra’s third-party Package Performance
Qualification (PPQ) testing to show that its packouts were configured
and performing correctly.
Package Performance Qualification
The specialty pharmacy did its first round of testing in 2019. “We
started with our refrigerated packouts, which need to be kept between
2°C and 8°C. We tested in cold weather to make sure packages were
staying in range for the amount of time we anticipated shipments to
take,” says Kalenze. In phase one, Altru included two different wireless
sensors. An M-300 measured temperatures inside the medication
packaging at regular intervals and an S-400 monitored the external
ambient temperature in the outer box. Test packages were sent to
Zebra, which analyzed the captured data.
“We learned a lot in that initial evaluation of our packaging,” Kalenze
says. Zebra gave Altru guidance on coolers and other packing
materials best for cold chain shipments to help improve its packout
design. “We made a few tweaks with the intent of giving patients even
greater confidence in the medications we deliver – and Zebra was
a great help through the entire process,” Kalenze says. Altru then
moved on to phase two for further testing of the passing phase one
package design.
SUMMARY
Customer
Altru Specialty Pharmacy
Altru Health System
Industry
Specialty Pharmacy
Challenge
After seven years of growth, the pharmacy
began to explore the performance of its
shipping packouts to make sure it could
maintain its mission: to enhance care and
improve the overall health and well-being of its
patients.
Solution
Altru ultimately chose Zebra* package
performance qualification (PPQ) testing to show
that packouts were configured and performing
correctly. Testing is conducted in two phases to
allow Zebra to capture and thoroughly analyze
all the information required to prepare the PPQ
report.
Results
Altru has instituted best practices throughout
the shipping process that deliver peace of
mind for the pharmacy, as well as its patients.
Another benefit is that the PPQ testing will help
the pharmacy achieve URAC accreditation.
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SUCCESS STORY
ALTRU SPECIALTY
In phase two, test packages were prepared in the same way, but
this time shipped to various geographies using different modes of
transportation such as courier and FedEx. Again, Zebra collected the
time-temperature data, this time using the information to prepare a
PPQ Report that shows the qualification of the packouts.
Aside from ensuring packages performed the way it needed them to,
Kalenze says one of the most significant benefits has been instituting
best practices throughout the shipping process. “Now every shipment
of refrigerated medication is packed the same way,” she says. “In the
past, there were no specific guidelines. So one person might include
one icepack in a shipment where another might put in three, which
could cause medication to freeze.”
Altru went on to complete its second round of PPQ testing with ease.
“We tested controlled room temperature (CRT) and refrigerated
shipments during the summer to ensure packouts keep medication
from getting too hot,” says Kalenze. “With all we learned in our
previous testing, the process the second time around was much
smoother and we successfully passed phase one on the first try.”
The Results
The specialty pharmacy was also pleasantly surprised to find that the
PPQ testing would help with its URAC accreditation, which it began
working toward in October 2019. “A lot of URAC’s requirements
are centered on providing documented proof that medication
temperatures are monitored and maintained,” says Kalenze.
“And everything we have done will apply.”
Looking Forward
Altru’s next step was to test CRT packages during the colder seasons
and retest refrigerated packouts. “Regular, seasonal PPQ testing is just
so important,” Kalenze says. “Our patients trust us – and we need to
continually earn that trust with every single shipment that goes out.”
More than that, she adds, most of the drugs the pharmacy delivers
– such as cancer medications – are critical to patients. “They have to
arrive on time and in good condition; it’s imperative.”
In the end, she says, “PPQ testing just delivers peace of mind – for the
pharmacy as well as for patients.”
“To be sure we are giving our
patients the best possible care, it’s
important to know we are sending
drug products in such a way that
they remain both effective and
safe.”
Rosemary Kalenze, PharmD,
Outpatient Pharmacy Manager
Altru Specialty Pharmacy
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