January 29, 2014
By Susan Kelly
The U.S. Food and Drug Administration said on Tuesday it is working with the three manufacturers of intravenous saline solutions commonly used to hydrate hospital patients to address a shortage caused by a spike in demand.
Healthcare providers are reserving supplies of the fluids for their most seriously ill patients, and the product manufacturers - Baxter International Inc, Hospira Inc and B. Braun Medical Inc - have stepped up production in response, said Valerie Jensen, FDA's associate director for drug shortages.
"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," Jensen said.
Manufacturers first notified FDA late last year that they expected delays in filling orders, but an increase in hospitalizations two weeks ago partly due to rising numbers of flu cases exacerbated the problem, she said.
"The increase in demand pushed this into a shortage," Jensen said.
To cope with the shortage, healthcare providers are using substitute products such as oral hydration fluids or smaller IV saline bags with slower drip rates when appropriate, said Bona Benjamin, director of medication use quality improvement for the American Society of Health System Pharmacists.
"We have heard from our members all over the country that the shortage is serious," Benjamin said. "People are able to cobble together enough of a supply to get by day to day."
Baxter spokeswoman Deborah Spak said the company has increased its production and is managing inventory to ensure supplies for customers with the most urgent needs.
"Baxter has been manufacturing solutions at maximum capacity in amounts exceeding those of prior years and is making investments to further increase supply in 2014," Spak said.
Hospira said it is expediting shipments to help mitigate local supply disruptions. "We are doing everything we can to meet the increase in demand," said company spokesman Dan Rosenberg.
Cathy Denning, a registered nurse with Novation, a supply chain company that works with hospitals and other healthcare providers, said it could be another two months before the shortage is resolved.
FDA's Jensen said the agency is also looking into alternative sources, including overseas suppliers, to help address the shortage.
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