By John Roberts, ,
Published October 24, 2015
“How can they write me an IOU for medication?”
That’s Alex Aiello, and he's been battling leukemia since April 2009.
Aiello, 26, was on his last few courses of Atra, a drug known to raise cure rates to 80 percent from the usual 40 percent. But when he went to the pharmacy at Massachusetts General Hospital to get his medication at the beginning of September, he was told there wasn’t any.
“It’s just shocking to see how supplies are low of a major drug to help you fight leukemia,” he told me.
Aiello’s doctor, Eyal Attar, uses much stronger language. “It’s absolutely outrageous that we cannot have these drugs available in our country – with one of the most advanced medical systems available to treat our patients. It is very frustrating and it makes me, quite frankly, angry.”
Aiello’s is not an isolated case. According to a survey by the American Hospital Association, 99.5 percent of hospitals have experienced a drug shortage in the past six months. And 82 percent have had to delay treatment, while more than 50 percent report that they were not able to provide patients with the recommended treatment.
“We’re forced to go to a different regimen,” says Emory University Hospital medical oncologist Donald Harvey. “Sometimes that regimen may be inferior. Instead of changing from one therapy to another, we simply put it off in the cases of say, bone marrow transplants. And so we place that patient at potential risk because we’re having to delay that therapy.”
Hospitals complain that they get little – or no – warning of a shortage, nor are they told how long it will last. Amir Emamifar runs the pharmacy at Emory. Every day is a juggling act to make sure patients get some kind of medication.
“We’re dealing with 286 different shortages,” Emamifar told me. In addition to a staff of four that’s dedicated to sourcing medications on shortage, Emamifar spends a couple of hours each day dealing with the fallout.
The task is almost overwhelming.
For example, on Monday morning, Emory learned there was no intravenous valium to put on its crash carts. IV vitamins were in short supply. So were front-line chemotherapy drugs. And Emory only had a day’s supply of the anesthetic propofol at one of its four hospitals. The others had none. For many critical drugs, the cupboard is basically bare.
“You have to make sure that your most eligible and most needy patients get those medications," says Emamifar.
Emory isn’t yet rationing drugs, though it may soon have to. At Mass General, they’ve been rationing for weeks. Dr. Paul Biddinger runs emergency room operations. “We’ve not had to make a choice between patients, but between conditions,” he says. “Which condition most needs that particular drug, and which condition has the least acceptable substitutions.”
Dr. Attar says his oncology department is forced to make difficult choices in how to treat cancer.
“It really is gut wrenching,” he says, “especially when it gets to questions of treating adults versus kids. Treating patients with up-front disease versus patients that have relapse disease. These are some very difficult decisions that we don’t like to make.”
There is no single reason for the shortages. Some pharmaceutical companies have experienced manufacturing delays. Raw materials may be in short supply. And because most of these drugs have been off-patent for years, some drug companies don’t want to spend the money to upgrade lines to produce drugs with slim profit margins.
For example, Bristol-Myers Squibb had a shortage of the blood pressure medication Avalide because of a recall. It recently started shipping again. Teva Pharmaceuticals discontinued propofol because, according to a Teva spokesperson, “We believe that our existing, approved technology is not suitable to ensure that we can consistently produce the product to Teva's high quality standard.” Teva would have needed to make changes to its manufacturing process, and decided instead to discontinue the drug.
There is money to be made, though. The shortage has given rise to a burgeoning “gray” market for hospital drugs.
“For some reason they have the supplies,” says Emory’s Emamifar, “but they’re selling at exorbitant prices. The gray market can also be a dangerous place. There’s no way to insure that the drugs have been properly sourced, or stored.
Emamifar says he never buys off uses the gray market. But even approved wholesalers are trying to cash in. Emory often buys from the “secondary market” (known wholesalers who are not the hospital’s prime suppliers) and has to pay through the nose for drugs.
“Our cost has increased from 100-fold to 1,000-fold,” he says. “It’s basically like a stock market. The prices change on an hourly basis.”
When a drug is on shortage, hospitals are left to swap and substitute, which creates a fertile ground for mistakes. Even changing the size of a vial can lead to problems. “It’s an opportunity for error,” says Mass General’s Dr. Biddinger. “That is a bad thing in an ER, a bad thing in a life-threatening emergency.”
Erin Fox tracks national drug shortages at the University of Utah. “The total number of shortages is very difficult for hospitals to deal with,” she told me. “Patients are being put at risk for medication safety errors. Because there’s so many shortages, these safety errors are causing patient adverse effects, including death.”
In fact, an analysis by the Associated Press found at least 15 deaths that are directly attributable to the drug shortage.
And it’s getting worse – fast. The drug shortage problem has tripled since 2006. The FDA claims it has increased the number of shortages it has managed to avoid, but it’s a losing battle.
Legislation introduced in the House and Senate that would require manufacturers – under threat of penalty – to give more advance notice of a looming shortage is stuck in committee.
For the moment, patients are left to wonder if hospitals will have the drugs to treat them should they fall ill. Doctors will continue to fill the gaps with substitutes or delayed therapy. Patients will continue to be harmed.
And Alex Aiello can only hope that he received enough Atra before it became unavailable to rid him of his leukemia. There is no way to know.
“I am kind of nervous about it that it might come back,” Aiello says. “I always pray that it doesn’t come back.”
Reporter’s Note: The two hospitals that cooperated in the reporting of this story, Emory Healthcare in Atlanta and Massachusetts General Hospital, wanted to get the word out about the shortage to both better inform their patients and in hopes that publicizing the problem may lead to solutions. They acknowledge that many hospitals have kept a ‘buttoned lip’ about the problem for fear of upsetting their patients. Emory and Mass General -- among the most respected medical centers in the country -- thought that the public good was better-served by shining a bright light on this issue.