THE CHALLENGE: NAVIGATING REGULATORY
AND OPERATIONAL CHALLENGES
IU Health’s pain clinic was tasked with delivering roughly 100
intrathecal pain pump refills per week. Between significant
compliance hurdles, and the escalating risk exposure
associated with in-house compounding, it became clear
that trying to do everything in-house was unsustainable.
Tate Trujillo, PharmD, BCPS, FCCM, FASHP, CPEL, Executive
Director of Pharmacy, Clinical Nutrition & Indiana Poison
Center at IU Health, explained, “We were trying to manage
this out of our satellite pharmacy and were not meeting
the need, particularly as the clinic was adding more and
more providers.” This led the pharmacy leadership team
to explore outsourcing solutions that could provide both
regulatory, compliance, and workflow improvements.
THE SOLUTION: AIS HEALTHCARE—THE RIGHT
COMPOUNDING PHARMACY PARTNER
IU Health needed to identify a pharmacy specializing
in Category 3 medications that could meet USP <797>
standards. Ideally, this pharmacy could integrate with IU
Health’s existing workflows and streamline administrative
burdens. After a thorough evaluation, IU Health chose
AIS Healthcare, an outsourcing partner with advanced
infrastructure, providing the highest standards in sterile
compounding.
AIS immediately began providing:
•
Quality control measures, from the industry-leading
cleaning, disinfection, and sanitization of its facilities
to the latest testing equipment
•
Terminal sterilization for enhanced safety and
compliance
Case Study: Challenges
and Solutions to Category 3
Compounded Medications
With its multiple, large-scale health facilities, Indiana
University Health (IU Health) needed assistance in
2019 managing their demand for intrathecal pain
pump–compounded medications. Increasing demand
for pain-pump refills, and the accompanying federal
compliance regulations posed significant operational
challenges. So they sought a trusted outsourcing
partner that could reduce overhead, streamline access,
and maintain the highest possible standards.
Indiana University Health
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