January 18, 2018
The combination of a severe flu season and reduced supplies of intravenous (IV) fluid bags after Hurricane Maria devastated manufacturing plants in Puerto Rico has hospital teams strategizing on alternatives.
Tara Tehan, RN, nurse director of the neuroscience intensive care unit at Massachusetts General Hospital in Boston, told Medscape Medical News that she has been a nurse for 17 years, and in regard to the bag shortage, "I have never experienced anything like this before."
Hospital teams are looking for ways for patients to receive fluids and medications orally instead of intravenously, such as hydrating patients with Gatorade, she said.
Tehan said teams have also investigated whether they can use IV fluids for a longer period within manufacturer recommendations. They are evaluating which patients truly do need IV saline and are finding ways to use entire bags despite the fact that thresholds for changing bags may previously have been lower.
The strategies will be in place for weeks, if not months, she said. "We're certainly planning for late winter or early spring."
Hospitals across the nation are developing similar strategies. In findings reported January 11 from an informal survey by the American Society of Health-System Pharmacists, almost all respondents indicated that their hospital was affected by the shortage of bags, and more than 60% called the shortage severe.
FDA Broadening Supply Chains
Scott Gottlieb, MD, US Food and Drug Administration (FDA) commissioner, wrote in an update this week that he expects the crisis to ease "in the coming weeks and months."
"In addition to working with manufacturers to ensure that their Puerto Rico facilities can operate at full capacity, we've worked with manufacturers such as Baxter and B. Braun to import product into the US from their foreign facilities, including, most recently, from a Baxter facility in Brazil," Dr Gottlieb said.
The tight supply of saline products was further stretched by an increase in demand brought on by a particularly dangerous and widespread flu season, he noted.
The Centers for Disease Control and Prevention in its latest update said that in all states but Hawaii, the rate of influenza cases is high. As of January 6, the proportion of people seeing their healthcare provider for influenzalike illness was 5.8%, compared with the national baseline of 2.2%.
The FDA is also looking for additional ways to import saline products and is asking companies to submit data on extending expiration dates.
"If expiration dates can be [safely] extended, it would allow some near-expiry product that remains at the hospital level to be used," Dr Gottlieb writes.
That's an option that interests Kuldip Patel, PharmD, associate chief pharmacy officer at Duke University Hospital in Durham, North Carolina.
He said they have a large supply of large-volume bags that will expire in March, and they have systems in place to perform the testing necessary to extend the dating, but he said that they need the approval of the manufacturer or the FDA to extend use. He also hopes that by the time of expiry, the situation will be resolving.
Bag Supply Cut in Half
Since the September 16 hurricane, Dr Patel said, Duke has been working with about half the number of small-volume IV fluid bags that they ordinarily use to deliver medications that have to be administered over longer periods, such as antibiotics and antinausea medications.
He told Medscape Medical News that Duke has a well-honed shortage management process with an interdisciplinary team that tracks inventory and evaluates needs several times a week and that the health system is investing a great deal of time and resources to manage the supply and make changes.
Many medications are being given through IV push instead of with small-volume bags, for instance.
"But we haven't had to make critical choices in terms of rationing," he said.
He said saline products are now coming from new sources, such as Australia, Ireland, and Mexico, and he expects that that will continue for months, because it will be difficult for manufacturers in Puerto Rico to consistently and reliably meet demand in the near future.
Duke's supply has recently been inconsistent in volume and accuracy, he said, but in the past week, the allocation was increased.
"We're starting to see the light," Dr Patel said.
The FDA recognizes the need for a longer-term solution, he said, adding that for IV bags, as for generic drugs, the profit margins are low, and incentives may be low for manufacturers to produce them.
"Manufacturers certainly don't run out of the drugs that cost a lot of money," Dr Patel said.
"We should have redundancies in place for things that are critical to sustain life," he added.
Tara Tehan and Dr Patel have disclosed no relevant financial relationships.
Cold and Flu Resources
SOURCE: Medscape, January 18, 2018.