Hurricane Maria's damage to Puerto Rico led to saline solution shortage

SACRAMENTO, Calif. – Sacramento resident Charis Hill was caught off guard by the tiny bottle of saline solution hanging from the intravenous pole when she went for the latest infusion of medication that helps her avoid crippling pain. Accustomed to seeing a much larger bag of fluid, she immediately asked the staff about the change.

That's when she learned that since Hurricane Maria devastated Puerto Rico, key U.S. pharmaceutical plants on the island are experiencing manufacturing delays and distribution holdups that have caused unprecedented shortages of the widely used and critical fluid.

Intravenous infusions of saline solution are used to hydrate patients during treatment or to dilute drugs during infusions, and Hill said she's worried about whether there will be enough of the fluids when she arrives for her next treatment in six weeks.

Perhaps the best indicator of the dearth of saline solution is that patients such as Hill have begun to take notice.

Earlier this month, leaders of both the American Hospital Association and the California Hospital Association sent letters about the scarcity of supplies to the U.S. Food and Drug Administration, asking Commissioner Scott Gottlieb to take any and all steps to resolve the worsening shortages. The treatments, they said, are essential to patient care in hospitals.

"Baxter, one of the largest manufacturers of small-volume IV bags, has three plants located in Puerto Rico that continue to have issues with communications, transportation systems, and inadequate personnel during recovery efforts," wrote Alyssa Keefe, the vice president for federal regulatory affairs at the California Hospital Association. "These continued challenges threaten not only our present supply cache, but also future inventory needs — particularly with upcoming seasonal illnesses such as influenza."

Gottlieb said in a statement that the FDA is "taking steps to mitigate or avert product shortages, but we've still seen shortages of certain medically important products, some of which are sourced primarily or only in Puerto Rico."

Local health systems are taking various steps to ensure that patient care is not affected by the shortage. At UC Davis Health, for instance, the medical team is now giving drugs directly rather than diluting them with a minibag, said spokesman Charles Casey.

This takes more time for a nurse, Casey said, but it probably doesn't substantially increase costs.

"Since 2013," he said, "we have increased the amount [of saline minibags] that we purchase, but right now we cannot purchase any," said Casey, adding that the shortage of saline minibags deeply concerns the system's pharmacy leaders.

The medical team at Dignity Health is conserving as much of its saline solution supply as possible. Sutter Health said representatives from its pharmacy and clinical teams have worked together with inventory managers to find distributors that can supply what they need and to seek alternatives.

Hill, who suffers from a form of arthritis known as ankylosing spondylitis, snapped a picture of the little bottle of saline solution, just 50 cubic centimeters, at the top of the IV pole, and she posted it on Facebook, noting that a much larger bag typically hung there.

"I asked if they had saline in reserve and are using it up, but no, they ordered this," she said. "It's the second order since the hurricane, and this shipment had smaller bottles than the last."

Hill said she's worried that the shortage will affect the supply at her clinic. If she has to go to a hospital, she said, she's uncertain that her Medi-Cal plan will cover it.

"I won't have any choice but to go without it," she said. "The drug builds up in your system over six months. If I miss a dose I have to build it up again, and if I go too long without it, I'll be in severe pain and have to be bed-bound."

Thomas Nickels, who manages government relations for the American Hospital Association, said hospitals are switching patients to appropriate alternatives such as oral products, changing how they administer IV drugs and prioritizing patients based on clinical factors.

"We strongly urge FDA to do more by pushing current manufacturers to not only continue to produce these products at their maximum capacity but also to make investments to ensure an increasing supply for the future," Nickels wrote in his letter to the FDA. "We also encourage FDA to seek out and approve new domestic suppliers of these products in locations that are not prone to natural disasters."