For organizations with multiple drug compounding locations, implementing a centralized media fill program can streamline processes, improve operational flexibility and lower costs, suggested Jamie Tharp, PharmD, BSCSP, an assistant director of pharmacy compounding compliance at Michigan Medicine, in Ann Arbor.
“In large health systems, many staff cross-cover to multiple work locations, often across multiple licensed locations, and qualifying sterile compounders in every location can become onerous, depending on how idealistically an organization or state interprets the standards,” Dr. Tharp said at the ASHP Midyear 2024 Clinical Meeting & Exhibition, in New Orleans.
“If you are in a state where you have leeway to develop your program and to follow the standards as they’re written in USP, you are not explicitly required to do a media fill in every location,” Dr. Tharp said. “That has an enormous impact on your organization from a cost and labor perspective.”
When Dr. Tharp queried the ASHP meeting attendees, many indicated they conduct media fill training and qualification at every location. She advocated for a more “realistic” centralized media fill program, which qualifies sterile compounders at one location, under the most challenging conditions defined by their organization. They are then allowed to compound at all other equivalent or less complex locations. This strategy reduces the need for duplicate training and assessments across multiple sites, significantly decreasing the labor hours required for training and competency evaluations, she noted.
Dr. Tharp presented estimated labor and cost savings for two sample centralized media fill programs: one at a small community hospital with one inpatient pharmacy and one infusion pharmacy, employing one pharmacy lead, five pharmacists and six pharmacy technicians; and the other at a four-hospital system, which included a central pharmacy, two satellites, six infusion centers, one home infusion and one research pharmacy group. That multisite model employed 18 pharmacy leaders, 159 pharmacists and 230 pharmacy technicians.
She used the University of Michigan’s July 2024 average salaries ($73 per hour for a clinical pharmacist and $23 per hour for a pharmacy technician) to calculate full-time equivalent (FTE) costs.
The small hospital example Dr. Tharp cited was based on “an idealistic program” model, in which all pharmacists and technicians are trained, qualified and doing ongoing competency in both locations where they work. Under that model, central fill would require approximately 466 hours per year in total, or 0.22 FTE, “which doesn’t seem like an enormous effort,” she said. “But with a realistic approach, training at only the most complex of the two locations represents 236 hours per year, or 0.11 FTE,” she said. “In a small rural hospital, if I can save you 230 hours or six weeks of somebody’s effort, that’s meaningful.”
The dollars invested on labor came to $10,259 in the idealist program versus $7,851 in the realistic program. “In a small community hospital’s budget, saving over $2,000 might be impactful,” she said.
At a large multisite institution, the labor and cost savings from a centralized media fill program can be even more significant, Dr. Tharp noted. In this example, an idealist program requires 39,329 hours or 18.92 FTE per year, compared with 7,032 hours and 3.38 FTE per year for the realistic program. Total program labor cost would be more than $1.2 million versus $227,733.
These market realities could lead to some troublesome unintended consequences, Dr. Tharp warned. “I worry that if we are required by our inspectors and states to conduct media fills at every location where staff work, we’re actually going to make business decisions to restrict the number of locations where people are cross-trained and allowed to work, which I think could ultimately hurt our ability to provide patient care,” Dr. Tharp explained. “Many of us survived working through the COVID-19 pandemic, where we had large staff outages or had to ramp up services, and we know how critical it is to have the right number of compounders and be able to provide services in a flexible, meaningful way for your organization.”
A Surge in Need
The need for centralized media fill programs at many institutions has increased dramatically in the aftermath of COVID-19 staffing shortages, said Kevin Hansen, PharmD, MS, BSCSP, the senior director of pharmacy compounding services at Premier Inc.
Previously, even in multi-hospital health systems, there wasn’t much of a need for a centralized program because every person showed up to one cleanroom suite that was their home base, Dr. Hansen told Pharmacy Practice News in an interview after the ASHP session. “One change that many organizations made when they began facing staffing challenges with pharmacy technicians, especially compounding technicians, was having staff rotate and cross-train between multiple locations,” he said. “Today, many institutions have rotations where technicians or pharmacists compound in two or three or four cleanrooms. That’s where the value equation for centralization really increases. But if you’re required to do a media fill in every location that you staff, that becomes burdensome.”
Dr. Hansen clarified that USP <797> does not require that resource-intensive approach. “We have seen regulators apply their own interpretation of the standard, suggesting that someone working in five different locations within an organization has to do a media fill for each,” he said. “But <797> doesn’t say that; it says compounding personnel must do one media fill as part of the aseptic manipulation competency requirements.”
But Dr. Hansen added this caveat: the one media fill “must simulate the most difficult and challenging procedures encountered, and at the minimum frequency based on which types of CSPs [compounded sterile preparations] are prepared [e.g., Category 1, 2 or 3].” The regulation also specifies only a single fill is required to meet the competency requirements, he stressed.
It’s also important “to differentiate between minimum requirements and best practices,” Dr. Hansen said. “Organizations may choose to perform additional media fills on certain types of compounding equipment or automation, but this would be above and beyond the minimum standard requirements.”
An Early Adopter’s Approach
Baptist Health South Florida, which has more than 20 compounding pharmacy locations, was an early adopter of a centralized media fill approach. When Patti Kujas, RPh, BSCSP, joined the system as the manager of compounding and compliance in 2020, the process was already in place. She supervises a team of three quality assurance technicians, and the four of them travel on a regular schedule to conduct media fill testing at the different locations.
Ms. Kujas’ previous institution, the Lehigh Valley Health Network, had a more decentralized approach to media fill. “I was at the largest hospital, and my team and I did the media fill there and for a couple of our satellites, but there were others doing it for other hospitals; there was nothing centralized,” she said. “What I love about having a central quality and compliance team is that it delivers a consistent approach to every person at every site. Sometimes when you have a lot of people involved in sterile compounding, you get ‘whisper down the lane’ training. One person does it one way; another person does it another way. I really am not a fan of that.”
Ms. Kujas said she prefers an alternative strategy. “I like the unbiased quality team approach, which delivers the same message across the entire network,” she explained. “You’re also getting eyes on the technicians in their work environment every six months, seeing exactly how they’re maintaining compliance and good aseptic technique, material transfer process, and cleaning.”
The sources reported no relevant financial disclosures beyond their stated employment.
This article is from the April 2025 print issue.