Update: The Food and Drug Administration has given Baxter International permission to import saline and other intravenous solutions from its manufacturing facilities in Australia and Ireland to ease shortages in the United States, according to letters that the company sent its customers on Monday.
The products affected are smaller-volume bags of sodium chloride, known as saline, and dextrose. These normally ubiquitous solutions are used to rehydrate patients and to dilute medications from antibiotics to painkillers to cancer drugs. Their manufacturer, Baxter International, has said that “multiple production days” were lost in the wake of Hurricane Maria, and it has set up an allocation system for hospitals based on past purchases.
The situation could be a harbinger of further shortages resulting from the extensive damage to Puerto Rico's sprawling pharmaceutical-manufacturing sector. FDA Commissioner Scott Gottlieb said in a statement Friday that the agency is working to help the island “recover its medical product manufacturing base…a key component of the island's economic vigor.”
However, he warned, even facilities with only minor damage are working at just partial capacity. “New shortages could result from these disruptions, and shortages that existed before the storms could potentially be extended,” he said.
More than four dozen FDA-approved drugmaking facilities are in Puerto Rico, including ones owned by Pfizer Inc., Merck, Eli Lilly, Johnson & Johnson, Bristol-Myers Squibb and Amgen. The plants produce treatments for cancer and HIV, as well as immunosuppressants for patients with organ transplants. Among the top-selling medications manufactured there are the blood thinner Xarelto and the cholesterol drug Lipitor, according to a report by Healthcare & Life Sciences Review.
Several manufacturers said recently that they didn't anticipate product shortages resulting from the hurricane, saying their facilities weren't heavily affected. But people on the island say it has been a challenge for many to get to work and to get products in and out.
A Baxter spokesman said Friday that “limited production” of IV fluids is occurring at its Puerto Rico facilities. He said the company is “working to leverage our global manufacturing footprint to support alternative production of these products as we work to restore operations.”
Some hospitals on the U.S. mainland said late last week that they haven't been impacted by Baxter's problems, while others said they are having trouble getting the popular “mini-bags” that they use to deliver drugs to patients. While two other manufacturers make IV solutions, supplies are tight. Some medical centers are switching to other brands or to larger-volume IV bags that Baxter makes elsewhere.
But those and other changes can require a change in procedures on how drugs are administered — and new orders and training for the nursing staff — to ensure efficiency and patient safety, according to hospital officials.
Chicago's Rush University Medical Center, like many other systems, uses a Baxter product called the “mini-bag plus” to administer IV solutions to patients. The bags allow a nurse to add a prescribed medication, mix it up and give it to the patient quickly.
Thomas Wheeler, corporate director of pharmacy at the medical center, said he no longer can get the Baxter bags and so has shifted to a product that works somewhat differently. Usually, he said, he would have made such a change slowly after extensive planning. But in this case, he added, he had to put it into place in 48 hours.
Kuldip Patel, associate chief pharmacy officer of Duke University Hospital in Durham, N.C., said he ran out of the mini-bags after getting only 25 percent of his normal order. Like other large hospitals, Duke has its own compounding service that can prepare IV solutions from raw ingredients if necessary, but the process is time-consuming, Patel said.
Jeff Thiel, assistant vice president for pharmacy services at NorthShore University HealthSystem, which is headquartered in Evanston, Ill., said he's getting half his normal supply from Baxter. Switching to a different product “is not terrible,” he said, “but it does cause some disruption in the work flow.” And Erin Fox, director of the Drug Information Center at the University of Utah Health system, said it hasn't been able to get the Baxter mini-bag plus since before the hurricane. “We are thinking, how do we conserve the small bags that we have?” she said.
All the hospital officials said that patient care has not been impaired.
For years, hospital pharmacists have had to grapple with shortages of dozens of drugs. Experts blame several factors, including manufacturing glitches, quality-control problems and business mergers. The IV-solutions market has seen significant upheaval since last year. Pfizer bought Hospira, a pharmaceutical and device company, and spun off its IV products to the infusion company ICU Medical Inc. Another company, B. Braun Medical Inc., has a smaller share of the IV market. Baxter remains the dominant player.
“This year has been challenging for multiple manufacturers,” said Chris Snyder, drug information pharmacist for shortages and recalls at the Cleveland Clinic. “And the hurricane has definitely compounded it.”
Several doctors and pharmacists remain on edge about the possibility of additional problems. Peter Adamson, who is chairman of the Children's Oncology Group, said that the clinical trials it conducts nationwide have not yet had participating hospitals hit by drug shortages related to Puerto Rico. But Adamson, a pediatric oncologist at Children's Hospital of Philadelphia, said “there remains great concern that treatment for children with cancer may soon be affected.”
Several hospital officials are calling on the FDA and drugmakers operating in Puerto Rico to release more information about what other products might soon be in short supply, as well as to allow hospitals to purchase some supplies from overseas, if necessary.
An agency spokeswoman said it is working with some companies to speed up import of supplies from other manufacturing sites. It also is working to expedite approval of other dosage forms and generic versions, she said. In his statement, Gottlieb said he plans to provide more details on specific products as he learns more about the situation there.