Amid COVID-19, the Challenge Of DIY 503B Continues I n 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.”
‘In these critical [pandemic] situations, I cannot underscore enough the importance of having these [outsourcing] relationships, and even multiple relationships for redundancy.’ —Deidra Dickerson, PharmD 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,”
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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
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