Sunday, February 9, 2014

Wis. hospitals conserve saline in face of national shortage but say patient care not affected

MILWAUKEE — Wisconsin's hospitals and first responders are conserving intravenous saline solution after federal officials warned of a national shortage possibly linked to an influenza outbreak.
Medical officials say they're cautious but not worried yet and patient care shouldn't be affected. Suppliers of the salt solution, which is used to rehydrate trauma patients and assist in the delivery of drugs, say they're ramping up production but can't guarantee when the supply will be fully replenished.
The U.S. Food and Drug Administration began receiving reports in December of supply problems, production delays due to maintenance and other issues at three major saline-solution makers. The FDA began monitoring the situation and seeking alternate sources, said Valerie Jensen, the associate director of the agency's drug-shortages program.
She said the problem was exacerbated by high demand, potentially due to an increase in influenza patients who needed fluids.
FDA officials haven't heard of situations where patient care has been affected, but doctors are reassessing how they use saline solution.
"Hospitals are having to make decisions to treat more critical patients," Jensen said.
First responders also are being cautious, conserving their supplies and using smaller dosages.
Dr. Charles Cady, the medical director for the Kenosha Fire Department, said his staffers routinely administer sterile salt solution to patients with trauma, blood loss or low blood pressure. Also, if a patient needs an intravenous injection, a saline flow helps push the drug into the vein, he said.
Now, instead of administering saline routinely, first responders are saving it for patients who absolutely need it, he said. They're also dispensing it with 10-milliliter syringes instead of the standard 1-liter bags. Cady said he would prefer not to do that because it's less efficient and leaves more packaging to be discarded, but the change will help the fire department make its current three-month supply last about six months.
"It's kind of ironic, though, that we have to change the way we take care of patients because of a shortage of a product that costs pennies," Cady said.
Saline solution is essentially a 0.9 percent solution of table salt in sterile water, but manufacturers said it's not as easy to produce as one might think. For example, the components in the plastic bags must come from specific, approved suppliers, and changes to the process require a full-scale review, along with documentation to the FDA.
"More than 30 steps are involved in the manufacturing process, including production of the sterile water used to make the solutions," said John O'Malley, a spokesman for manufacturer Baxter Healthcare Corp.
Baxter and the FDA declined to speculate on how long the shortage will persist, citing uncertainty in demand and market supply.
The Wisconsin Department of Health Services said it was keeping tabs on the situation but wasn't offering specific guidance to hospitals
"The important thing is to have the medical staff aware and ready to implement changes if needed," DHS spokeswoman Jennifer Miller said.
No hospitals have reported being critically low on the saline solution, according to the Wisconsin Hospital Association.
Cady, the Kenosha Fire Department medical director, said he was confident the cautious measures his staff was taking would be sufficient.
"Seeing how saline can be lifesaving in some patients I am very concerned, but grateful we haven't felt it (the shortage) yet," he said. "We're very careful about what we've got. I think we'll be OK."

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