A tornado that touched down on a Pfizer facility could send the fragile pipeline of sterile injectable medicines into disarray, which may force hospitals and other drug manufacturers to employ workaround strategies to ensure access.
The tornado that struck Pfizer’s Rocky Mount, North Carolina, plant on Wednesday wrecked its warehouse and slightly damaged its medicine production areas, the company said in a news release Friday.
Pfizer is still working to assess the full extent of the damage to the complex, which produces nearly 8% of sterile injectables used in U.S. hospitals. In the meantime, the company is moving intact medicines to nearby storage sites, identifying sources to replace supplies and “exploring alternative manufacturing locations."
In the event that the manufacturing plant is no longer usable, it would be a “worst-case scenario" that would require other pharmaceutical companies to ramp up production of sterile injectables including anesthesia, analgesics, therapeutics, anti-infectives and neuromuscular blockers, said Soumi Saha, senior vice president of government affairs at Premier, a group purchasing and consulting organization.
“Historically, we've seen that even two weeks of downtime for a production line associated with a critical medication can lead to months of shortage,” Saha said.
Even if other manufacturers have the capacity to produce certain medications, they may still have to apply for approval from the Food and Drug Administration or the Drug Enforcement Administration, Saha said. And it is not always economically feasible for companies to enter the marketplace with drugs that produce low profit margins, such as sterile injectables.
Hospitals have grown accustomed to short supplies of sterile injectables, which have grown pervasive and severe, said Tom Kraus, vice president of government relations at the American Society of Health-System Pharmacists. In the meantime, hospitals will consider alternatives.
Prior to the catastrophe at the Pfizer plant, the American Society of Health-System Pharmacists already identified shortages of several sterile injectable products. Among them is sterile water, which drugmaker American Regent stopped manufacturing in 2021, and other companies have struggled to keep up with the increased demand since then. Other products, including certain sodium chloride bags and injections, have been in shortage since 2017, according to the ASHP.
Natural disasters, drug recalls and quality issues pose threats to the sterile injectable drug pipeline. For instance, when Hurricane Maria wiped out the drugmaker Baxter’s Puerto Rico manufacturing facilities in in 2017, it caused ripple effects that constrained supplies worldwide.
“The sterile injectable marketplace, especially for generic drugs, is one that has been fragile for many years,” Saha said.
Policymakers could devise ways to mitigate future shortages, Kraus said. That may include diversifying manufacturing so that isn’t concentrated in just a few facilities and providing funds for health systems to maintain buffer supplies, he said.
Federal agencies also should more effectively coordinate their responses to shortages, Saha said. “We still don't have clarity on when something like this happens: Who is leading the response?” she said. “That creates a lot of confusion as to who you should be speaking to and where you should be going for your information."
Alex Kacik contributed to this story.
