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 Supply issues related to Baxter's small-volume saline bags - which
are produced in the U.S. market in Puerto Rico - have begun to ease
as production there improves, Scott Luce, general manager of
Baxter's U.S. Hospital products division, wrote in a letter
addressed to customers and seen by Reuters.
Drugmakers including Baxter have been scrambling to meet demand for
essential hospital products including IV saline and smaller IV bags,
which have been disrupted by prolonged power outages in Puerto Rico
after Hurricane Maria pummeled the Caribbean island on Sept. 20.
"Overall, we are making progress on product supply," Luce wrote.
All three of Baxter's plants in Puerto Rico that make small IV bags
- used to mix and deliver a host of medicines to hospital patients -
are now connected to the commercial electric grid, Luce said.
The company has maintained diesel generators to handle intermittent
power outages and has installed backup satellite communications to
support plant operations.
Baxter only makes the smaller volume IV products in Puerto Rico; it
manufactures larger IV bags elsewhere in the United States.
Shortages of the smaller bags in the wake of the hurricane caused
many hospital pharmacists to turn to larger IV bags to deliver
medications. Now, with the United States in the throes of one of the
worst flu seasons in several years, demand for the larger volume
bags - used to hydrate flu patients - has increased dramatically.
"We've been producing as much as we can, but we're not the only one
in the market," said Baxter spokesman William Rader.
The market for the larger bags had been constrained even before the
hurricane. In August, B. Braun Medical warned customers that
production interruptions had caused decreases in supply of the
company's small- and large-volume products.
In a statement issued earlier this month, U.S. Food and Drug
Administration Commissioner Scott Gottlieb said the agency had given
B. Braun and Baxter temporary approval to import products from some
of their overseas operations, including allowing Baxter to import
product from Brazil. At that time, Gottlieb said he believed the IV
fluid shortage would improve shortly.
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The FDA has also been working with companies to extend expiration
dates on products, when it can be done safely. It recently approved
two additional companies - Fresenius Kabi, a unit of Germany's
Fresenius, and Spain's Laboratorios Grifols - to supply saline to
the U.S. market.
In its letter to customers, Baxter said the FDA has now granted it
permanent approval to bring larger IV bags manufactured in Mexico
into the U.S. market.
"The news is very good," said Christi Guess, senior director of
contract services for Vizient, which negotiates with medical
companies on behalf of its member hospitals.
She said with the addition of the products from the Mexico plant,
Baxter is now up to 100 percent allocation for most saline products,
which means clients can order 100 percent of what they have
historically ordered in the past, but no more.
Erin Fox, who tracks nationwide drug shortages and heads the
University of Utah health system’s drug information and support
services, said saline supply issues remain.
"We're not even close to getting what we used to," she said.
Hospital pharmacists have turned to a number of workarounds to
address the shortages. For example, hospitals have used syringes to
deliver some medications but that has resulted in shortages of
syringes, Fox said.
"It's a house of cards," Fox said. "Each solution you come up with
has resulted in some kind of a roadblock."
(Reporting by Julie Steenhuysen; Editing by Cynthia Osterman and
Leslie Adler)
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