CASE STUDY
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Study Design and Findings — An Overview
PARTNERING TO ENHANCE WORKFLOW EFFICIENCY TO HELP
CREATE BETTER PATIENT OUTCOMES
Infirmary Health is the largest non-governmental, non-profit healthcare system in
Alabama. Serving southern Alabama, the organization's network of award-winning
hospitals, physician practices, and affiliates makes it a top healthcare system on the
Gulf Coast. This includes Mobile Infirmary — Infirmary Health's flagship hospital, which
is among the leading hospitals in the state for surgical volume. The hospital houses
a comprehensive cardiovascular program with a hybrid OR/cath lab, the region’s only
Bariatric Center of Excellence, a CARF-accredited rehabilitation hospital, a renowned
cancer program, a thrombectomy-capable stroke center, and a freestanding emergency
department.
It's no surprise that Mobile Infirmary's doctors and nurses keep the I.V. room pharmacists
and technicians very busy. To help alleviate the stress and strain, Leiters, an FDA-
registered 503B outsourcing provider of compounded sterile preparations, reached out
to the hospital about participating in a workflow study for its new concentrated vials
— Vicky Vega, Pharm.D., says they were very interested. “We always want to be involved
in anything that promotes change and advancement,” says Vega. “Especially where that
means achieving better patient outcomes.”
READY-TO-DILUTE, CONCENTRATED, PRE-FILLED VIALS
Leiters' concentrated vials are ready-to-dilute, pre-filled vials of highly used compounded
sterile preparations that are not commercially available. Norepinephrine Bitartrate
(Norepi) was selected for this workflow study.
“We prepare a good many Norepi bags in all milligram strengths — 4 mg, 8 mg, and 16 mg,”
says Vega. “We could see how having something readily available in concentrated vials
could get medication to patients faster, so we wanted to take part."
MOBILE INFIRMARY PILOTS
INNOVATIVE CONCENTRATED
NOREPINEPHRINE VIALS
Nathan Browning,
Pharm.D.
I.V. Room Supervisor
~ Mobile Infirmary
Vicky Vega, Pharm.D.
Pharmacy Education
Coordinator
~ Mobile Infirmary
Roland Naseman, R.Ph.
Director of Pharmacy
~ Mobile Infirmary
CASE STUDY
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WORKFLOW STUDY: DESIGN
Nathan Browning, Pharm.D., was responsible for designing and tracking the workflow
study for Mobile Infirmary. “Vicky and I decided to break the study down into three
phases,” he explains.
• In Phase 1, Browning and his team gathered data on the I.V. room's traditional manual
compounding processes.
• In Phase 2, they switched to using Leiters' precise dosage Norepi vials for manual
compounding.
• In Phase 3, they used the concentrated vials of Norepi from Leiters that use the vial
docking technology so require no compounding.
“In each phase, we tracked the number of bags prepared, the staging time, the
compounding time, the pharmacist check time, and the time to administration,”
says Browning. “We then used that information to calculate the cost per bag in each
phase, which included product and supply costs as well as labor expenses.” The study
measured 8 mg and 16 mg vials across three and a half weeks.
Leiters was supportive through the entire process. “The team was very responsive and
answered my questions or helped me find a solution quickly no matter the challenge,”
says Browning. “At one point, we ran out of some of the study drug, and Leiters sent us
what we needed overnight so it was there by 7 a.m. the next morning.”
WORKFLOW STUDY: TOPLINE FINDINGS
8 mg Norepi
Phase 1
Phase 2
Phase 3
Number of Bags
23
24
N/A
Staging Time
56 seconds
85.3 seconds
N/A
Compounding Time
2.48 minutes
1.58 minutes
N/A
Pharmacist Check Time
26.6 seconds
15.3 seconds
9.6 seconds
Time to Administration
174.3 minutes
152 minutes
61.4 minutes
Cost Per Bag
$17.52
$16.49
$17.93
16 mg Norepi
Phase 1
Phase 2
Phase 3
Number of Bags
38
66
N/A
Staging Time
47.8 seconds
31.9 seconds
N/A
Compounding Time
3.8 minutes
1.34 minutes
N/A
Pharmacist Check Time
27.7 seconds
13.6 seconds
9.6 seconds
Time to Administration
246.4 minutes
161.4 minutes
59.2 minutes
Cost Per Bag
$31.05
$18.31
$19.89
Leiters
Concentrated Vials
Benefits at a Glance
• Compliant with all I.V. workflow
and I.V. compounding
software and all vial docking
technologies.
• The concentrated vial sterile
preparations are in solution,
making them easier to
dilute with no waiting
for reconstitution of a
lyophilized powder.
• Inventory space is reduced,
waste minimized, and inventory
turns increased.
• In the forward positions, vials
can be stored in automated
dispensing machines (ADMs)
for rapid retrieval, dose tracking,
and administration based on
the hospital's specific vial-to-
bag adapter and activation
processes.
• Pre-labeled vials and boxes
include TALLman lettering,
barcodes, and color-coding for
drug/strength differentiation to
help reduce medication errors.
CASE STUDY
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TIME SAVED GETS MEDICATION TO PATIENTS SOONER
“For us, the crux of the study was to see if we could reduce the time it took to hang a
bag on the patient,” says Browning. “Obviously, with the concentrated vials, there's no
compounding time since they're ready to use, but we found that even when we spiked
them under a hood, the relative prep time was something like 10 seconds compared to
two or three minutes or more for compounding.” That's because the concentrated vials
require a simple aseptic technique where the top is popped, swabbed, and spiked.
“The process saved a lot of time, which got medication to patients faster and freed up
our I.V. room to handle other urgent tasks.”
The nurses also liked the concentrated vials because they helped eliminate delays in
care for their patients. “Requesting a bag, waiting for it to get made, and then eventually
sent up all takes time,” says Browning. Based on Phase 1 data, that was an average of
264 minutes from request to administration for the 16 mg bags.
“With the concentrated vials, when nurses needed a bag — they could just go to the ADM,
pull out what they needed, dock it with vial docking technology and activate and hang it,”
Browning explains. In Phase 3 of the workflow study, Mobile Infirmary found that Norepi
infusion began significantly faster, in 59.2 minutes on average for 16 mg bags.
The result? 100% of nurses answering an internal survey said having the concentrated
vials in an ADM made it either a great deal or a lot faster to administer the first dose
compared to waiting for the I.V. room to compound the product.
Over 80% of nursing respondents stated that they would ‘very likely or likely’ support
the pharmacy’s continued use of the Norepi concentrated vial, as well as support other
critically needed drugs in the same format. According to Browning, the concentrated
vial was also supported by the I.V. room staff. Leiters provides compounded sterile
preparations in several different volumes and precise milligrams — Norepi comes in
4 mg, 8 mg, and 16 mg single-use vials. “With our previous product, the vials only came in
In your unit having the concentrated
vials in your automated dispensing
machine (ADM), was it quicker to
administer the first dose rather
than waiting on the pharmacy?
72.73%
27.27%
A Great Deal
A Lot
A Moderate
Amount
A Little
None at All
How likely would you support
the pharmacy to continue
to use the norepinephrine
bitartrate in this format?
63.64%
18.18%
18.18%
Very Likely
Likely
Neither Likely,
Nor Unlikely
Unlikely
Very Unlikely
How likely would you
request pharmacy to add
additional critically needed
drugs in this vial format?
63.64%
9.09%
18.18%
9.09%
Very Likely
Likely
Neither Likely,
Nor Unlikely
Unlikely
Very Unlikely
KEY NURSING SURVEY RESULTS
“
The process
saved a lot of
time, which got
medication to
patients faster
and freed up
our I.V. room
to handle other
urgent tasks.”
Nathan Browning, Pharm.D.
I.V. Room Supervisor
~ Mobile Infirmary
CASE STUDY
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4 mg, so if we needed a 16 mg bag, we'd have to pull four vials. With Leiters, it's just one,"
says Browning. This seamless process just adds an extra layer of confidence in the final
compounded product, he adds.
That's one of the reasons more than 90% of pharmacists and technicians surveyed internally
said the concentrated vials were easy to use, took less time to complete a dose compared to
a manual compounding processes, and would recommend the format to leadership.
WHY CONCENTRATED VIALS?
ASHP reports that health system pharmacies are faced with significant staffing
shortages – particularly among pharmacy technicians. Reasons cited in a recent survey
conducted by the organization include workload, work schedules and pay. Regardless of
why, the simple fact is that pharmacy managers are continually looking for ways to do
more with fewer resources by adding efficiency.1
Leiters concentrated vials add a lot of efficiency to pharmacy processes. Concentrated
vials reduce the time to compound medications by reducing manual steps. For example,
manually compounding a 16 mg/250 mL dose of Norepi diluent with commercially
available vials takes 34 steps from staging to pharmacist check. With the concentrated
vials, this is reduced to just nine steps.
ABOUT LEITERS
Leiters is an FDA-registered 503B outsourcing provider of compounded sterile
preparations and pharmacy services. Their team of experts in sterile pharmaceutical
manufacturing, compounding, and pharmacy provide a sophisticated understanding
of what it takes to elevate quality and consistency of supply in pharmaceutical
outsourcing. They combine a deeply experienced team, with robust processes, in a
state-of-the-art facility, to ensure delivery of the highest quality medicines.
1 "Hospitals and Health Systems Experiencing Severe Shortage of Pharmacy Technicians," ASHP, March 15, 2022:
https://www.ashp.org/news/20 22/03/15/hospitals-and-health-systems-experiencing-severe-shortage-of-pharmacy-technicians
Were the concentrated
vials easy to use?
53.85%
7.69%
38.46%
Very Likely
Likely
Neither Likely,
Nor Unlikely
Unlikely
Very Unlikely
Very Likely
Likely
Neither Likely,
Nor Unlikely
Unlikely
Very Unlikely
Did the concentrated vials
take less time to complete
a dose than the manual
compounding process?
92.31%
7.69%
Yes
No
58.33%
33.33%
8.33%
How likely would you recommend to
your leadership on continuing to use the
concentrated vials to save time, make
compounding easier and more accurate?
KEY PHARMACY SURVEY RESULTS
“
With our
previous product,
the vials only
came in 4 mg, so
if we needed a
16 mg bag,
we'd have to
pull four vials.
With Leiters,
it's just one.”
Nathan Browning, Pharm.D.
I.V. Room Supervisor
~ Mobile Infirmary