As COVID-19 Continues to Surge, Turn to 503Bs for Help

In the era of COVID-19, health system pharmacy leaders are struggling to keep up with the scores of demands on their resources and time.

With coronavirus-related emergency department visits and hospitals admissions reminiscent of 2020, especially across the South and Southwest, pharmacy leaders are looking for effective and, in some cases, alternative solutions to help them just make it through a busy week.

503B outsourcing facilities are proving to be crucial partners to health-system and hospital pharmacies in helping to mitigate drug shortages and the impact on patients during the COVID-19 Delta variant surge this summer. The Drug Quality and Security Act, passed in 2013, has allowed 503B outsourcing facilities to compound certain nonsterile and sterile drug products in anticipation of need by providers¹ and based on meeting certain standards required by the FDA. With massive demand spikes for critical care medications because of the Delta variant, 503B facilities can supplement hospitals when commercial manufacturers cannot supply.

“Compounding sterile products is a complex business,” said Brian Swift, PharmD, MBA, chief pharmacy officer, enterprise vice president, and associate dean of professional affairs at Jefferson College of Pharmacy at Thomas Jefferson University Hospitals in Philadelphia, Pennsylvania. “503B compounding facilities serve an integral role in how we think about and execute our pharmacy strategy, especially during the pandemic.”

What follows are the 5 reasons to consider a 503B compounding partner:

1. Capacity and expertise
2. Critical staffing levels
3. High-risk or specialty compounding
4. Resiliency
5. Supply and demand of materials

Many 503B facilities have invested significantly in their operations, creating both expertise and operational capacity to support hundreds of hospitals and physician practice sites across the country. These 503B organizations are highly automated and have redundant systems to generate the high-quality, reproducible products we have come to rely upon as providers. Their product offerings have become standardized over time, which has resulted in more cost-effective production at scale, which brings substantial benefits to a hospital’s pharmacy.

As COVID-19–driven demand surges continue, these same 503B facilities can leverage their scale and relationships with active pharmaceutical ingredient and finished-goods suppliers to generate the much-needed doses of critical medications, such as fentanyl, midazolam, and certain neuromuscular blockers that providers urgently need in the intensive care unit.

This “just in time” inventory approach can help augment drug volumes to get through periods of supply shortages when traditional drug manufacturers and distributors are unable to keep up.

Compounding drugs such as concentrated intrathecal narcotic bags or manipulating nonsterile, raw materials into a final, sterilized product takes money and time. 503Bs can alleviate the burdensome task of compounding high-risk medications and at a lower cost point than many hospitals can achieve. Working with a 503B facility on high-risk medications also minimizes the downstream risk to patients who require them.

With the strain on virtually all hospital staff members during the Delta surge, including pharmacy employees assisting with COVID-19 vaccinations and booster requests, 503B partners can quickly assist by off-loading routine compounded sterile product volume at their offsite location. We are seeing a particular shortage of well-trained pharmacy technicians, so moving some work off the hospital campus may make sense for pharmacy leaders. Most 503B facilities work closely with hospital leadership to coordinate delivery to various facilities as needed. This removes some of the predictable hospital pharmacy clean-room workload, freeing up staff members to focus on the most pressing tasks.

As Premier noted in early 2020, having a multifactorial approach to combat drug shortages, in and out of a pandemic, is essential to providing high-quality patient care.² The entire US drug supply chain, and most notably hospitals, must become more resilient to weather this surge stage of the pandemic and drive health care transformation for the future.

503Bs can play an important role in enhancing pharmacy supply chain resiliency, but hospitals must choose their 503B facilities wisely. Leveraging multiple 503B partners, for instance, not only avoids putting all one’s eggs in one basket, but also helps competing vendors drive up quality while lowering costs. Diversity and strong 503B partner relationships ultimately benefit patients.

An important aspect when choosing to work with a 503B outsourcing facility is to have a robust vetting process to ensure the highest standards are achieved. For 503Bs failing to meet rigorous inspection or review, these facilities must either invest properly to comply with industry standards or exit the market; there is no third option. Health-system pharmacy leaders expect 503B partners to have the proper controls and procedures in place to produce the highest-quality end products.

Integrating a 503B facility into the pharmacy supply chain strategy has become a key component for hospitals during the global pandemic, and this trend will continue. A 503B’s ability to quickly provide vital medications can help address moment-in-time market imbalances, including spot, regional, and emergency-related shortages, and create added resiliency for the future.

Mike Wascovich, PharmD, MBA, RPh, is vice president of field pharmacy services at Premier, Inc, in Charlotte, North Carolina.

REFERENCES

1. Information for outsourcing facilities. FDA. Updated September 10, 2020. Accessed August 31, 2021. https://www.fda.gov/drugs/human-drug-compounding/information-outsourcing-facilities

2. Premier Inc. data shows drugs essential to providing care for COVID-19 patients quickly slipping into shortage. News release. Premier Inc. March 31, 2021. Accessed August 31, 2021. https://www.premierinc.com/newsroom/press-releases/premier-inc-data-shows-drugs-essentialto-providing-care-for-covid-19-patients-quickly-slipping-into-shortage