Pfizer has received grand jury subpoenas from the U.S. Justice Department as part of its antitrust investigation into the saline market, the company announced Wednesday.
The DOJ is seeking documents regarding the manufacturing, selling, pricing and shortages of intravenous solutions, including saline, as well as Pfizer's communication with competitors. The subpoenas came one day after ICU Medical, which acquired Pfizer's global infusion therapy business Hospira Infusion Systems in February, disclosed via Securities and Exchange Commission filings that it received a similar subpoena regarding IV solutions.
Pfizer said in a statement that it will evaluate the Justice Department's requests.
A national shortage of saline—one of the most common products used in hospitals—has beset the healthcare industry since 2013. Saline is used to help patients recover via intravenous infusions, diluting injectable medications and washing out wounds or organ tissue. There is currently a shortage of saline 0.9% injection bags, according to the American Society of Health-System Pharmacists.
Yet things aren't as bad as they were several years ago when health systems were counting bags of saline each day to make sure there were enough for the week's surgeries, said Erin Fox, director of drug information at the University of Utah Health Care's drug information service. Health systems can't always get the exact size or type of bag, but they can generally receive product, she said.
The shortage stems from a lack of resiliency in the supply chain combined with increased demand, ASHP said. Baxter International, one of the nation's leading saline producers along with Pfizer, discontinued some of its saline bag production. Fresenius Kabi no longer imports saline products, according to ASHP. The FDA has tried to bolster supply by importing saline from Spain and other European countries.
"Drug shortage has been the bane of healthcare's existence for a while," said Dr. Scott Knoer of Cleveland Clinic, adding that 2012 was one of the worst years. "This year, based on the first quarter, is on par with some of the worst years ever."
Baxter said in a securities filing Friday that one of its employees received a grand jury subpoena from the Justice Department seeking pricing of IV solutions, shortages and communication with competitors.
A saline shortage can lead to a myriad of administrative and safety concerns. When smaller bags are in short supply, more frequent bag changes are necessary, and compounding saline solution from sterile water for injection could lead to medication errors, ASHP said.
ASHP advises hospitals to avoid use of irrigation solution for intravenous use, substitute lactated ringers solution or dextrose when appropriate, use smaller bag sizes for low rate infusions when possible, and to reevaluate total fluid requirements for surgeries and "keep vein open" orders at every shift change.
