Updated 10:15 a.m. ET:
The natural disaster in Puerto Rico knocked out the manufacturing capacity for small-volume presentations of sodium chloride and dextrose at one of two major suppliers, and that could send a ripple effect throughout the U.S. healthcare industry.
Baxter International is the biggest supplier of intravenous bags of dextrose and sodium chloride, also known as saline, that providers regularly give to patients to regulate heart rate and blood pressure during heart surgery, among other uses. Baxter said its Puerto Rico manufacturing facility, which produces smaller-volume bags of the IV fluids used primarily to mix with other medications, has lost "multiple production days" after Hurricane Maria tore through the island. The company said that it has resumed limited production in all of its facilities on Puerto Rico and that its larger-quantity saline products were not impacted.
Sodium chloride and dextrose are vital drugs used every day in hospitals around the country, said Chris Snyder, drug information pharmacist at Cleveland Clinic who manages shortages and recalls.
"We're talking about two manufacturers that support nearly the entire U.S. and one of them is out and the other manufacturer doesn't have enough supply to make up for it," he said.
While the Cleveland Clinic has the benefit of a drug compounding facility on-site that will partially insulate it from the shortage, Chief Pharmacy Officer Scott Knoer said he is waiting for the other shoe to drop as other suppliers are exhausted.
"The whole country will be scrambling," Knoer said. "I'm waiting for the cascade effect of this. This has major implications for hospitals everywhere."
The latest shortage is one of many in recent years resulting from manufacturing delays. Experts blame a lack of competition among drug manufacturers, which are increasingly consolidating to offset high production and compliance costs.
Baxter and ICU Medical—which acquired Hospira from Pfizer in February—provide the bulk of IV fluids, while B. Braun provides a much smaller share. Baxter, B. Braun and ICU Medical list saline shortages due to increased demand, according to the American Society of Health-System Pharmacists website. The companies said that they have small-volume bags on allocation.
Baxter said in a statement that the company had acted to ease some of the supply disruptions by transporting finished products off the island before the hurricane hit.
The company said in a Sept. 23 letter to customers that it would conserve the supply of many products made in Puerto Rico, including IV solution bags, by giving out fixed amounts to U.S. hospital customers based on their average demand.
In the meantime, the University of Utah Health system has had to change how it has made multiple products, said Erin Fox, who directs the university's Drug Information Center.
"It has caused some serious problems for our system," she said.
There are few viable alternatives to the drugs, one being an oral application, experts said. Baxter also produces larger-volume bags of the IV fluids in the U.S., which providers may try to repurpose, Snyder said. But giving patients too much would be problematic, he said.
Puerto Rico is home to dozens of drug and device manufacturing facilities, including cancer drugs, immunosuppressants used by transplant patients and devices for diabetic patients, Dr. Scott Gottlieb, the U.S. Food and Drug Administration commissioner, said in a statement on Sept. 25.
"In the face of a natural disaster of this proportion, it is an evolving landscape and so we will continue to stay on top of the situation," he said. "We are aware of several other instances where we may soon face critical shortages if we don't find a path for removal or ways to get production back up and running."
The agency is helping get the products to providers and formed a task force to mitigate drug shortages in disaster situations, Gottlieb said.
"I'm really worried about the chronic nature of these shortages," the Cleveland Clinic's Knoer said.
Editor's note: The story was updated to reflect that Baxter has resumed limited production activity in its Puerto Rico facilities.
