Baxter, FDA scramble to overcome shortage of nitroglycerin

A shortage of saline solution has already been hampering hospitals. Now emergency rooms are finding it difficult to get nitroglycerin, a drug they often turn to first when heart attack patients arrive.

According to The New York Times, Baxter International ($BAX) became the sole supplier of the drug last year when manufacturing problems sidelined supplies from Hospira ($HSP) and American Regent. Then in November, Baxter had to recall a lot of nitroglycerin in 5% dextrose when particulate was found in a vial. Unable to keep up with demand, Baxter has been rationing the drug to healthcare providers, the newspaper reported. It limited hospitals to 40% of their usual orders in January, then cut that to 20% this month, leaving doctors to figure out how to cope.

"It's one of those drugs that in certain circumstances, there really is no substitute for," Dr. Frederick Blum, an emergency room physician at Ruby Memorial Hospital in West Virginia, told the NYT. Supplies at his hospital are depleted to the point that if a couple of patients needed extended use, they would run out, he said.

A bulletin from the American Society of Health-System Pharmacists said American Regent has upgraded a plant and will be staging supplies as its production expands. Baxter spokeswoman Deborah Spak told the newspaper that it is ramping up production by the end of the week, allowing it to return to shipping at the same levels it had been in January. She noted that Baxter has been the one continuous supplier of nitroglycerin and was "hopeful that overall demand and supply will resume to a more predictable state within the next few months."

Meanwhile, the FDA has found an overseas supplier that can provide some product "in coming weeks," Capt. Valerie Jensen, associate director of the FDA's drug shortage program, told the NYT. "This is a critical drug. We will have something in place," she said.

The FDA is pursuing a similar solution for getting additional supplies of saline, another hospital staple that has been affected by supply constraints from the same three manufacturers. These tight spots in the supply chain illustrate one of the points in a recent Government Accountability Office report on drug shortages. Only a few manufacturers produce a majority of the low-margin sterile injectable drugs, and if they have issues, the supply chain suffers and frustration grows with the drug industry.

Dr. Ann Toran, chief of cardiac surgery at North Shore Medical Center in Salem, MA, told the NYT, "You want to feel that we're living in a land where if you come into the hospital with a heart attack, that you can get the best of care." She said her hospital's supply of nitroglycerin was running short. "To have that hanging over you as a doctor--a critical shortage of this essential medication--I just don't know what to say."

http://www.fiercepharmamanufacturing.com/story/baxter-fda-scramble-overcome-shortage-nitroglycerin/2014-03-26