Pharmacy directors wary of heparin shortages

April 14, 2008

Until problems with Baxter heparin are resolved, APP Pharmaceuticals has been working hard to ensure that there are no gaps in supply to hospial and dialysis units.

The deaths of four patients who received high doses of heparin produced by Baxter Healthcare still have federal health officials scratching their heads-and many hospital pharmacy directors biting their fingernails.

"We buy our heparin through an intermediary that has been able to provide enough for us so far, but we're anticipating supply issues in the next month or so," said Peter Cerone, director of pharmacy services at Brookhaven Memorial Hospital Medical Center in East Patchogue, N.Y. Brookhaven reported several adverse reactions to the Baxter product before discontinuing it in early January, before the company made the problems public. None of the reactions were life threatening and the patients should suffer no long-term effects, said Linda Watson, the hospital's director of hemodialysis.

"They've been pretty good about it," Cerone said. "But as supply dwindles, other companies may try to take advantage. Prices will probably go up."

The source of the Baxter problem may be a Chinese manufacturer that the FDA failed to inspect, due to an admitted oversight. Its inspectors have since visited the plant in question and discovered "a heparin-like contaminant," said the FDA's chief medical officer, Janet Woodcock, M.D. She added, however, that no direct causal link has been found between the contaminant and the adverse events.

Like Baxter, APP uses a combination of domestic and foreign suppliers, including manufacturers based in China. Do hospital pharmacy managers fear a repeat of the problem that happened with the Baxter-produced heparin?

"Yes, I'm concerned, but right now until they say it's causing harm to people, it (the APP heparin product) is the only major option we have," said Dwaine Keller, director of pharmacy for Rush University Medical Center in Chicago. Keller reported that Rush, which had been a Baxter customer, is living hand to mouth in terms of supply and that it has tightened up its medical necessity processes to make sure that the hospital's heparin is used judiciously. "We're jumping through hoops to make sure we're using it safely, especially with neonates," Keller said. "Every patient is being evaluated on a case-by-case basis."

In the meantime, hospital pharmacy directors hope the heparin time bomb can be defused before disaster strikes. "APP has upped production, but I don't think the situation is as rosy as the FDA makes it out to be," Keller said. "We're getting exactly what we need and not any more."

THE AUTHOR is a writer based in Vernon, N.J.