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Amid COVID-19, the Challenge Of DIY 503B Continues
In retrospect, Vanderbilt University Medical Center hit “pause” on creating its own in-house 503B compounding facility at just the right time.
As 2019 drew to a close, the medical center’s Department of Pharmaceutical Services determined that, before moving forward, it would take the time to put key products through the enhanced stability testing required for meeting the extended beyond-use dating (BUD) standards that are part of the FDA’s current good manufacturing practice requirements for 503B compounding outsourcing facilities.
“We wanted to send all of our products through that level of testing just as a measure of preparedness for the future,” Deidra Dickerson, PharmD, the manager of sterile and nonsterile compounding at the Nashville, Tenn., institution, told Pharmacy Practice News. “So at the end of 2019, we made the decision to start using a 503B outsourcing facility while pulling back from our own internal program, planning to ramp back up later once the results started trickling in.”
After meeting with several outsourcing facilities, Vanderbilt settled on QuVa, which has compounding facilities in Sugar Land, Texas, and Bloomsbury, N.J., and serves more than 2,200 hospital customers with over 280 product SKUs. “We placed our first order with QuVa in January, right before the pandemic hit the United States,” Dr. Dickerson said. “By March and April, they were experiencing such demand that they were no longer able to bring on new customers because of the need to properly serve existing customers.”
Vanderbilt initially outsourced only a handful of products to QuVa, including ephedrine, epinephrine and phenylephrine syringes and phenylephrine and midazolam IV bags. But as the pandemic continued, more were added. “Fentanyl was an item that became challenging early on, and we were having difficulties procuring any of the vials for infusion we typically get from our standard wholesaler,” Dr. Dickerson said. “QuVa was able to step in then, which took a stressor off of us during that time frame.”
Funds Dry Up During Pandemic
Before the pandemic, many hospitals and health systems, such as Vanderbilt, were putting significant investments into pharmacy as one of their profit centers. However, with COVID-19 decimating the bottom line for many institutions, the availability of capital for major new investments, such as a 503B compounding facility, has dried up. “Of the CEOs and chief pharmacy officers I’ve spoken with, most of them say that prospectively trying to get into 503Bs probably isn’t in the works for at least another couple of years, financially speaking,” said Michael Souza, the CEO of New England Life Care (NELC), whose Advanced Compounding Solutions (ACS) 503B outsourcing facility is jointly owned by its 50-plus member hospitals (most in the Northeast).
Keith Thomasset, PharmD, ACS’s vice president of clinical solutions and chief pharmacy officer, said the company’s approach is catching on. “We are experiencing an uptick in interest based on our model, so much so that we’ve created a joint venture with another system-owned 503B facility in Minnesota, and we are combining our efforts both to market to a broader base and provide more capacity for the increased demand we’re seeing,” Dr. Thomasset said. “This is at least partially attributable to pressures from the pandemic, especially for those hospitals that were considering developing their own 503Bs. But even pre-pandemic, the capital investment and operating expenses associated with opening a 503B can get pretty scary if you’re going it alone.”
Fagron Sterile Services US, another leading 503B outsourcing company, found early in the pandemic that it had to modify its production planning. “We had a significant increase, approximately 20%, in demand from our customers, with hospitals requiring new and different products or much greater quantities of existing products for needs such as supporting high numbers of patients going on ventilators,” said Jason McGuire, who oversees the company’s operational and quality areas. “They needed
—Deidra Dickerson, PharmD
see DIY CHALLENGE, page 30
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large quantities of narcotics such as fentanyl and hydromorphone to sedate patients, and they just didn’t have the support within their facilities to provide the dosage forms and volumes they needed. Every day, there was something new that would pop up from health systems, and some of these products, quite frankly, we didn’t have immediately available,” Mr. McGuire said. “But we [were] still able to respond fairly quickly with something that would work and yet maintain a high level of quality.”
A Pioneer Partners Up
The midwestern hospital system SSM Health, which operates more than two dozen hospitals and health centers in Wisconsin, Illinois, Oklahoma and Missouri, was the first health system to register as a 503B sterile compounder in 2014, and remains one of only a handful of such systems in the country. SSM Health currently produces about nine products in-house. Because operating rooms closed to elective surgeries during the height of the pandemic, SSM Health pharmacy director Kristina Bryowsky, PharmD, said her facility shifted production toward bags for the ICU and away from OR syringes. “We saw a reduction in volume overall because of the ORs, so we shifted the days we would have produced other products to make sure we stocked up heavily on IV products for the ICUs, so we never had a shortage of those bags. That was a big relief for our ICU team,” Dr. Bryowsky said.
In December 2019, SSM Health had started its first round of testing to add fentanyl to its list of compounded products, but after the pandemic began, the system was unable to access active pharmaceutical ingredients (APIs) to complete the next two rounds of testing. Dr. Bryowsky said they will complete that testing before the end of the year, but in the meantime, to accommodate the high volume of fentanyl needed at the system’s larger hospitals, they use either an outsourcer or compound in-house under 503A’s internal <797> seven-day BUD limits.
“Some of our bigger centers had allocations with larger outsourcers, but if you didn’t have that already, you weren’t going to get it during COVID-19,” she said. “Because our ORs were closed and care had shifted to patients who were incredibly acute, the volume wasn’t as high. So we were able to spend the extra time to make internal batches of 300 bags with 2- or 5-mL vials, which is not something an outsourcer will do anyway.”
Because of the shutdown of elective surgeries in both hospital ORs and ambulatory surgery centers, compounders such as Fagron also were able to shift some of their capacity to meet hospitals’ ICU needs. “It was still a bit of a challenge, especially as it relates to narcotics—you have to go to the Drug Enforcement Administration [DEA] and request access for more than your original quote,” Mr. McGuire said. “Fortunately, the DEA was very responsive and helpful, as was the FDA. For example, if there was a product that we had never created before within our facility, we might not have performed the full stability testing or validation around it. So we were permitted to leverage our partner laboratories’ data available via R&D or the published literature, and then using FDA guidance, get something out there, even though it might have more limited dating. They were really trying to find ways for outsourcing facilities to be flexible during this extraordinary time, to meet patient needs while still maintaining our responsibility for the high quality of the products we produce.”
The February closure of PharMedium, AmerisourceBergen’s compounding business, was a double whammy for hospitals in the Northeast, noted Stuart Hinchen, the co-founder and CEO of QuVa. “The initial wave of COVID hit the Northeast particularly hard, and that was also an area where PharMedium had been very strong,” Mr. Hinchen said. “So a lot of hospitals were really cut short, and we were getting four times the regular demand for certain products, particularly in critical care. We had to give preferential treatment to COVID-related products wherever we could. We looked at other inventory we had on the shelves, and where we had adequate reserves, slots that would have gone to that inventory were reallocated to COVIDrelated products. Throughout March and April, every day was a major production effort and there really was no playbook.”
Keeping up With Shifting Demand
As changes in the pandemic have rippled throughout the country, along with reopenings of elective procedures, outsourcers have worked to keep up with shifting demand. “COVID-19 became less frantic in May [2020], but then elective surgeries started to open up in June, so we went through an oscillation as the health networks were extremely keen to get those going again,” Mr. Hinchen said. “Then in the summer, COVID-19 cases spiked in the Sun Belt, and we had dual pressures of both COVID-19 and elective surgeries.”
QuVa, NELC/ACS and Fagron all have increased capacity to meet the changing demand. QuVa has added more than 100 people to its labor force this year, with more staffing planned in the immediate future. “We put on a third shift in our Sugar Land site, which handles the bulk of our
—Eric Kastango, MBA, BSPharm
