January 23, 2025
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.