FDA and hospitals are scrambling as the shortage of hydration products deepens

U.S. hospitals go through millions of bags of saline solution a week
January 30, 2014 | By Eric Palmer, FiercePharma

The FDA has worked to face down shortages of important, sometimes life-saving, drugs that have sprung up in recent years. But occasionally something as mundane as saline solution can set off a scramble, particularly when the flu season puts added pressure on supplies, leaving hospitals to look for ways to preserve scarce products.

“We have not heard of anyone running out of the IV solutions at this point, but we know the hospitals are not comfortable with the low supplies,” Valerie Jensen, FDA’s associate director for drug shortages told Reuters. Escalating hospital admissions for flu is adding pressure, she said. “The increase in demand pushed this into a shortage.”

Hospitals in the U.S. go through millions of bags of such products in a week, the FDA said. Bona Benjamin with the American Society of Health System Pharmacists, told the news service that the shortage is serious and hospitals are using oral rehydration fluids or smaller IV saline bags with slower drip rates when appropriate to cope.

The agency 10 days ago warned of a shortage of hydration products and said it was working with Baxter International ($BAX), Hospira ($HSP) and B. Braun Medical to boost production. Jensen told Reuters the FDA also is searching outside the U.S. for alternate supplies.

Baxter in December recalled four lots of saline, as well as one lot of 5% dextrose injection, in the U.S. and three other countries after particulate matter was discovered in the solutions. Hospira had recalled a lot last April. Baxter spokeswoman Deborah Spak told Reuters the company “has been manufacturing solutions at maximum capacity in amounts exceeding those of prior years and is making investments to further increase supply in 2014.” And Dan Rosenberg, a spokesman for Hospira said the company is doing everything it can to “meet the increase in demand.”

Cathy Denning with supply chain company Novation said from her perspective it looks like it could be another two months before supply and demand are back in line. Meanwhile, Benjamin says, healthcare providers are cobbling “together enough of a supply to get by day to day.”


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