With its multiple, large-scale health facilities, Indiana University Health (IU Health) required assistance a few years back managing their demand for intrathecal pain pump–compounded medications. The need for more 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.
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:
Accurate billing was another hurdle. “Trying to actually bill effectively and get reimbursed appropriately is a challenge, and since AIS does a direct bill for us, those solutions have been solved,” said Tate Trujillo.
A Smooth Transition to Outsourced Compounding
The transition, which took place more than 6 years ago, was designed for minimal disruption. AIS facilitated staff training and pharmacy onboarding. They also implemented a streamlined ordering process. This groundwork has allowed IU Health to integrate outsourced compounding services with remarkable efficiency to this day.
The Future: Driving Better Outcomes for Patients and Providers
“Our top priority is ensuring patient safety while maintaining compliance with evolving regulations,” said Tate Trujillo. “AIS Healthcare’s robust processes, including double-gloving, redundant checks, and terminal sterilization, gave us confidence that they could deliver the quality and compliance we require.” Josie Klink, PharmD, Pharmacy Manager of Business Operations & Procurement, reaffirms that, “AIS has been an outstanding partner for us regarding the intrathecal pain pumps and this critical patient population.”
IU Health’s experience with AIS serves as a model for other health systems facing similar challenges. By prioritizing compliance, patient safety, and financial sustainability, IU Health has successfully navigated the complexities of Category 3 compounding and created a framework for continued excellence in patient care.
Watch the Full Video Case Study
See the case study video on AIS Healthcare’s partnership with IU Health at: aiscaregroup.com/videos/#case-studies
To learn more about how AIS Healthcare can help health systems navigate Category 3 compounding challenges, visit aiscaregroup.com or contact Chad Jeske, PharmD, Vice President, Hospital and Health Systems TDD Sales at cjeske@aiscaregroup.com.
The University of Wisconsin Health System (UW Health) was required to meet the complex needs of their patients with intrathecal pain pump compounded medications. The health system looked for a partner who could quickly integrate outsourced compounding services. An established regulatory-compliant program would enhance patient outcomes while increasing pharmacy, provider, and patient satisfaction.
Regulatory challenges are evolving and complex
Regulations for outsourced pharmacy needs are critical for safe patient care but pose significant challenges to health systems that utilize 503A pharmacies for outsourced compounded medications.
The Joint Commission requires that outsourced pharmacies meet or exceed United States Pharmacopeia (USP) Chapter 797 standards. USP 797 presents unique challenges for Category 3 compounding of sterile preparations, including increased sterility testing, staff training and competencies, and significant facility investments. Health systems must ensure that standard operating procedures (SOPs) reflect these standards, which require intensive, time-consuming administrative and operational challenges.
In search of a compounding partner
UW Health looked to find a state-of-the-art 503A compounding pharmacy to provide its patients with exceptional quality and service, as well as make it easy for patients and providers. Utilizing a 503A outsourced pharmacy presents implications from a regulatory, financial, and operational perspective. The health system needed a partner who could help minimize operational changes and streamline the necessary in-depth regulatory review. A key area in the transition would be to address the training and administrative changes related to patient-specific electronic ordering. A successful transition would mean robust customer service for key stakeholders.
AIS Healthcare (AIS): a winning solution for patients and providers
Pharmacy leaders at UW Health had a vision for quality patient care and a keen understanding of 503A outsourcing pharmacy requirements. They quickly identified AIS as a partner worthy of the regulatory and timetable challenge. As a dedicated 503A pharmacy for intrathecal medications, AIS offers an unparalleled approach to health system challenges. While maintaining the highest commitment to quality and patient safety, AIS provides flexibility to meet each system’s unique needs.
AIS provided all FDA-required regulatory documentation, as well as a robust quality report that outlined all quality control and assurance measures and outcomes. The report also included testing of Active Pharmaceutical Ingredients, stock solutions, environmental testing, and staff competency training assessments.
AIS provided a streamlined onboarding process for the medical center, incorporating staff training and a dedicated customer engagement team. The process included pharmacy and provider training on the proprietary provider ordering portal, which allowed convenient e-prescribing for the medical center.
Exceeding expectations
Working together, AIS and the UW Health team reached their goal of fully integrating the regulatory-compliant, highly customer-centric compounding services within just 4 weeks.
Timeline for decision-making and implementation:
“Our organization was in a place where we were looking for a new vendor to quickly support our need for third-party compounded pain pumps,” said Kristin Harney, PharmD, MS, of UW Health. “The AIS team was an incredible partner in helping us set up robust systems in a short amount of time. We appreciate their partnership, expertise, and engagement across our interprofessional team members.”
Transitioning to an outsourced 503A pharmacy can be challenging, especially when accounting for the health system’s regulatory, financial, and operational considerations. Many transitions are delayed due to assessment, stakeholder involvement, training needs, and complex regulatory requirements. By partnering with AIS, UW Health overcame these challenges and became regulatory-ready and compliant, maintaining current workflows with minimal changes.
The result: In just 4 weeks, UW Health partnered with AIS Healthcare for fully compliant, state-of-the-art compounding services that improve patient care, patient satisfaction, provider satisfaction, operational efficiency, and financial results.
AIS Healthcare provides exceptional and compliant 503A outsourcing for the highest quality and customer satisfaction. We can help your system overcome your most significant challenges with Category 3 intrathecal compounded medications. Visit aiscaregroup.com or email cjeske@aiscaregroup.com to learn more.