The drug nitroglycerin has long been an emergency room staple, a front-line drug that is often the first thing doctors try when a patient shows up with a heart attack.
So when Baxter International, the country’s only manufacturer of injectable nitroglycerin, recently told hospitals that it was sharply cutting shipments of the drug, the news sent pharmacists and emergency room doctors into a panic. Hospitals have been struggling for years with intermittent shortages of the drug, but with the latest news, doctors worried they could actually run out.
Assurances by Baxter and the Food and Drug Administration on Tuesday that they were taking steps to ease the shortage offered small comfort.
“It’s one of those drugs that in certain circumstances, there really is no substitute for,” said Dr. Frederick Blum, an emergency doctor who treats patients at Ruby Memorial Hospital in West Virginia, which operates a regional trauma center. Supplies of nitroglycerin are so low, he said, that “if we had one or two patients that were really sick that needed extended drips, it could exhaust our supply pretty quickly.”
The nitroglycerin shortage is the latest example of how patchy the supply of some of the nation’s most critical drugs has become in recent years. Hundreds of drugs and hospital products have become scarce, partly because manufacturing and quality problems at aging factories have led to shutdowns of production lines and entire facilities.
A report by a federal watchdog agency last month found that the number of annual drug shortages tripled from 2007 to 2012. Like the nitroglycerin shortage, many of the shortfalls involve generic injectable drugs, which are often made by just a handful of manufacturers. The report, by the Government Accountability Office, cited a study that found just three manufacturers produced 71 percent of the country’s sterile injectable cancer drugs in 2008.
Shortfalls have ranged from critical cancer drugs to run-of-the-mill staples like the pain drug morphine. Many of the drugs sell at very low prices, raising questions about the financial incentives for companies to continue making them. A bottle of nitroglycerin from Baxter, for example, sells at a wholesale price of about $6. “These are old drugs that we’ve been using for many, many years,” Dr. Blum said. “They’re like mom and apple pie.”
Baxter, based in Deerfield, Ill., has been rationing supplies of injectable nitroglycerin since January because it has not been able to keep up with demand after the two other manufacturers of the drug, Hospira and American Regent, stopped selling their products because of manufacturing problems and delays. The drug is so common, and in such demand, that nearly every emergency department in the country could be expected to keep it in stock, experts said.
Baxter has been the sole supplier since last year, and in January, it limited hospitals to 40 percent of their usual orders. This month, hospital pharmacists and doctors said they were told that their allotment would be reduced even further, to 20 percent.
The University of Virginia Medical Center, in Charlottesville, Va., typically uses 48 to 50 infusions of nitroglycerin a month. Since the restrictions were imposed in January, the hospital is limited to no more than 24 a month, said Dr. Robert E. O’Connor, the chairman of the emergency medicine department at the University of Virginia School of Medicine. He said the hospital’s stock was currently down to just four infusions, each of which would treat a patient for 18 to 20 hours. “It really limits how we can take care of patients,” he said.
Baxter said on Tuesday that it was increasing production of nitroglycerin and would go back to shipping the drug at the January levels by the end of this week. The F.D.A., which has taken the emergency step of hunting for overseas sources of the drug, also said that it expected the shortage to ease soon.
Capt. Valerie Jensen, associate director of the agency’s drug shortage program, said that it had identified another supplier outside the United States, and that she expected fresh supplies “in the coming weeks.”
“This is a critical drug,” she said in an interview. “We will have something in place.”
Captain Jensen added that a similar arrangement was underway with intravenous saline solution, which also has been in shortage — at times critically — for months. Baxter also manufactures intravenous saline.
But some expressed skepticism that Baxter would follow through with its promises.
“I sincerely hope that is true, but I don’t have a lot of faith that it will be because there is such a demand for this product,” said Erin Fox, a drug shortage expert at the University of Utah. She warned that Baxter and other drug manufacturers had frequently failed to meet their own deadlines, and she said that hospitals were struggling to make do, even at the previous supply levels. “We’ve seen from their estimated release dates for their saline products that those have been pushed off as well.”
Deborah Spak, a spokeswoman for Baxter, said the company had been forced to ration its shipments of nitroglycerin as it raced to order more raw materials and redirect operations to ramp up manufacturing of the drug. She said that fluctuations in allocations to hospitals were typical when a drug was in shortage.
“Baxter has been the one continuous supplier of nitroglycerin in the U.S. and the company is making every effort to meet the needs of customers,” she wrote in an email message, adding that the company was “hopeful that overall demand and supply will resume to a more predictable state within the next few months.”
Nitroglycerin, which helps open the blood vessels, has been used for more than a century to treat patients with heart disease. In some situations, doctors can treat patients with a paste that is applied to the skin, or with tablets that are dissolved under the tongue. But for people experiencing serious heart attacks or congestive heart failure, only the intravenous form will work.
Several doctors said they found the unpredictability of the shortages frustrating. “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,” said Dr. Ann Toran, chief of cardiac surgery at North Shore Medical Center, a hospital in Salem, Mass., whose pharmacy is down to a small supply of nitroglycerin. “To have that hanging over you as a doctor — a critical shortage of this essential medication — I just don’t know what to say.”
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