Drug shortages mean a growing number of Americans aren't getting the medications they need. That's causing drug companies and doctors to ration available medications in some cases.
"We're now at 213 shortages for this year," says Erin Fox of the University of Utah, who tracks national drug shortages. "That surpasses last year's total of 211. And it doesn't seem like there's an end in sight."
The shortages involve a wide range of medications: cancer chemotherapy agents, anesthetics, antibiotics, electrolytes needed for nutrient solutions, and dozens more. One drug currently in short supply is used in critically ill patients to bring down soaring blood pressure.
"We know this is a dire public health situation," Assistant Secretary of Health and Human Services Howard Koh told NPR, "and there have been delays in care."
According to those who are tracking drug shortages, there have been more than delays. Some patients have died.
That's what the American Society of Health-System Pharmacists found when they did an anonymous survey of members. Last week the Associated Press reported that at least 15 people have died as a result of drug shortages.
And last spring, nine Alabama patients died and 10 others got seriously ill after getting bacteria-contaminated intravenous feeding solutions made by local pharmacies. In a report on that episode, the Institute for Safe Medication Practices notes that hospitals are relying more on such "batch" suppliers "due to an unprecedented escalation in shortages" of IV nutrient fluids from pharmaceutical companies.
'Robbing Peter To Pay Paul' With Calcium
Fifteen-year-old Kevin Zakhar of Bethel, Conn., is one among thousands of patients affected by a months-long shortage of electrolytes — minerals such as calcium, phosphorus and magnesium necessary for normal metabolism.
Zakhar can't eat at all. A year ago, his small intestine suddenly kinked, cutting off its blood supply. Surgeons had to remove the entire small bowel, which is where nutrients in food get absorbed. So he must depend on daily intravenous feeding.
"The solution has all of his calories, all of his minerals, all the vitamins that he needs," says his mother, Laura, who hooks him up to an IV pump every afternoon. "It's everything that you and I would get by eating."
But in August, a pharmacist phoned Laura Zakhar to say a necessary nutrient called calcium gluconate wouldn't be in that week's supply due to a national shortage.
"My first words to the pharmacist were, 'Who do I call? Who do I write? What can I do?'" Zakhar said. "And he said, 'Hopefully, it will just be a short period of time, and I don't really know what you can do.'"
Checking around, Zakhar found the shortage of IV calcium had been brewing since April, when one of the nation's two suppliers shut down due to contamination on their manufacturing lines. She hadn't known about it because pharmacists had been trying to protect Kevin's supply as long as they could.
"My son was one of the last patients they took it from because of his circumstance — he can't take anything by mouth," Zakhar says.
One reason that Kevin Zakhar hasn't been able to get the calcium solution he needs is that hospitals have been reserving it for patients who need it even more desperately than he does.
Kathy Gura, a pharmacist at Children's Hospital in Boston, points to one of those patients, a tiny infant born only 23 weeks past conception, as premature as a baby can be and still survive. And he wouldn't have survived without the same kind of IV feeding that Kevin Zahkar gets.
Gura and caregivers at other hospitals say they have had to divert scarce electrolytes from other children and adults to save the lives of fragile preemies. Gura calls it "robbing Peter to pay Paul."
More Shortages At A Hospital
Across town at the Massachusetts General Hospital, New England's largest, pharmacist Paul Arpino says drug shortages were once rare. Now they're routine.
Arpino often gets calls in the middle of the night from desperate doctors and nurses. "We try to react as quickly as possible to these shortages," he says. "Sometimes there's not a lot of notice. But when we're informed of the shortage, we really get all hands on deck."
He says drug shortages plague every corner of Mass General, from the emergency department to operating rooms to intensive care.
Currently, for example, intensive care doctors are coping with a shortage of a drug called labetalol that's used to treat patients whose blood pressure is going through the roof. Labetalol is so scarce that the hospital recently decided to reserve it only for patients having a brain hemorrhage.
Dr. Taylor Thompson, medical director of the Mass General's medical ICU, calls it rationing – something most people think happens only in socialized medical systems or developing nations, not in America. But experts say the problem has been building over the past decade, and has accelerated since 2006.
"It's really no way to run an integrated health care delivery system, to take cornerstone drugs and have to do without and find alternatives monthly," Thompson says.
Doctors and nurses do find work-arounds. They try different drugs or combinations. But that increases the risk of a dangerous medical error.
"It would be a bit like a pilot coming to Logan Airport in the morning and (being told), 'We're out of Airbuses, you're going to have to fly a 727. And oh, by the way, you're taking off in 10 minutes.' "
Are Generics To Blame?
Thompson isn't quite sure why drug shortages are happening so often. "My understanding is it appears that the major problem is business decisions around generic drugs," he says.
Most drugs in short supply have been older generic drugs, which are generally less profitable. Hospitals are most affected, because many scarce drugs are intravenous forms, not pills dispensed in bottles.
But actually, officials at the Food and Drug Administration say only 11 percent of shortages happen because a company decides to stop making an unprofitable drug. Most shortages, they say, occur because something goes wrong in the manufacturing process that halts production.
The problem today is there are fewer companies making essential drugs. So when one manufacturer stops producing, there may be only one other supplier – and it can't keep up with demand. This is what happened with calcium gluconate, the missing ingredient in Kevin Zakhar's IV nutrient mix. (Last Friday, one of the two manufacturers told NPR that it was resuming shipments and Zakhar should have a steady supply beginning this week.)
Whatever the tangled causes, all those involved believe drug shortages are the new normal in U.S. medical care.
That's why the Mass General recently formed a task force on drug shortages. Its chairman, surgical oncologist Annekathryn Goodman, says next month the group will begin to confront the agonizing questions of how to decide who gets the available drug when there's not enough to go around.
"If it ever gets to a place where you have to choose one patient over another," Goodman says, "that is a very tough, ethical, existential, emotional issue — for us, for the people receiving the care."
Goodman is currently grappling with a problem that foreshadows such difficult choices. A drug called Doxil, which is highly effective in treatment some advanced ovarian cancers, is being rationed by its manufacturer right now.
Betsy Neisner, the consumer representative on the new drug shortage task force, is a patient of Goodman's who had been getting Doxil.
"I was getting it monthly, responding superbly, until July of this year, when I went into the hospital to have my infusion and the cupboard was bare," Neisner says. "They didn't have it. There was a nationwide shortage."
She had to switch to an older drug that caused months of terrible nausea and fatigue, and damaged the nerves in her feet. Last Friday she started getting Doxil again after her turn came on the manufacturer's waiting list.
"It's really astonishing and terrifying," Neisner says, "because you assume that if there's something that we've invented, that we've made available, it will stay available. And that's not true anymore."
More wrenching decisions may be just around the corner for patients with ovarian and breast cancer. A critical drug called Taxol is now on the FDA's shortage list.
And Mass General's pharmacists say they have less than a month's supply of Taxol on hand.
DAVID GREENE, Host:
It's MORNING EDITION, from NPR News. Good morning. I'm David Greene.
LYNN NEARY, Host:
Today in Your Health, we consider a fast-growing problem. Many patients can't get their prescription drugs because of drug shortages. It can be a drug to treat cancer, an antibiotic or an IV medication doctors need to bring down soaring blood pressure. This past week, Dr. Howard Koh of the U.S. Department of Health and Human Services told NPR that the federal government is alarmed.
HOWARD KOH: We know this is a dire public health situation, and there have been delays in care.
NEARY: Koh says the government doesn't know of any deaths related to drug shortages. But last week, the Associated Press reported that at least 15 people have died as a result. NPR's Richard Knox says U.S. doctors and hospitals struggle every day to get what their patients need.
RICHARD KNOX: Meet Kevin Zakhar, and you'd think, pretty typical 15-year-old boy.
KEVIN ZAKHAR: I play video games, watch TV, surf the Web, chat with my friends on Facebook. I just tend to live my life as if nothing had happened.
KNOX: What happened was that a year ago, his mother found him on the bathroom floor in the middle of the night. His small intestine had twisted back on itself. Surgeons had to remove Kevin's entire small intestine, where nutrients get absorbed. Now he can't eat at all. So he gets all his nutrition from an IV solution. It comes every week in a big cooler, delivered by a home care pharmacy to his mom, Laura Zakhar.
LAURA ZAKHAR: The solution has all of his calories, all of his minerals, all of the vitamins that he needs, all the electrolytes that you need. It's everything that you and I would get by eating.
KNOX: Until Kevin gets a rare intestinal transplant, his life depends on this precious liquid. Every afternoon at four, his mother hooks him up to the IV to let nourishment drip into Kevin's vein overnight.
ZAKHAR: I have become my son's nurse.
KNOX: One week this summer, when she was mixing the solution, she noticed it was missing a trace mineral called selenium.
ZAKHAR: It just wasn't there.
KNOX: Then in August, the pharmacy called to say there's a national shortage of calcium for IV solutions.
ZAKHAR: My first words to the pharmacist was: Who do I call? Who do I write? What can I do? And he said hopefully it will just a short period of time, and I don't really know what you can do.
KNOX: Not having daily calcium is serious. The body needs it not only for healthy bones, but for muscles to contract and nerves to fire. If there's not enough calcium in the diet, the body steals it from the bones. Checking around, Zakhar found the shortage of IV calcium had been brewing for months. Behind the scenes, pharmacists had been trying to protect Kevin.
ZAKHAR: My son was one of the last patients that they took it from because of his circumstance that he can't take anything by mouth.
KNOX: One reason that Kevin hasn't been able to get the calcium solution he needs is that hospitals have been reserving it for patients who need it even more desperately than he does.
KATHY GURA: We're inside the neonatal intensive care unit by one of our patient's bedsides.
KNOX: That's Kathy Gura, a pharmacist at Children's Hospital in Boston. We're looking at a tiny little guy who was born four months ago when he was only 23 weeks past conception. That's as premature as a baby can be and still survive. And he wouldn't have survived without the same kind of IV feeding that Kevin Zakhar gets.
GURA: That's the parenteral nutrition solution we've been talking about that's hanging there in the brown bag.
KNOX: So if you have another patient in the hospital who's older and more resilient, you would take some that that patient would otherwise get and make sure this kid got it?
GURA: Exactly. We'd be robbing Peter to pay Paul.
KNOX: And it's not just one medication or one kind of patient. Across town at the Massachusetts General, New England's largest hospital, pharmacist Paul Arpino says drug shortages were once rare. Now they're routine.
PAUL ARPINO: Anti-seizure medications, neuromuscular blocking agents, electrolytes like calcium gluconate, sodium phosphorus.
KNOX: Often, Arpino gets a call in the middle of the night from a desperate doctor or nurse.
ARPINO: We try to react as quickly as possible to these shortages. Sometimes there's not a lot of notice. But when we're informed of the shortage, we really, you know, all hands on deck.
KNOX: There are shortages in every corner of this big institution, from the emergency department to operating rooms to intensive care.
ARPINO: We're going to the MICU, which is the medical ICU.
KNOX: Do you find yourself rationing, saying this patient needs it, that patient can do without?
TAYLOR THOMPSON: Absolutely.
KNOX: Rationing: Most people think it only happens in socialized medical systems or developing nations, not in America. But the problem's been building here over the past decade. Today, Thompson says drug rationing is a fact of life.
THOMPSON: It's really no way to run an integrated health care delivery system, to take cornerstone drugs and have to do without and find alternatives monthly.
KNOX: Doctors and nurses do find work-arounds. They try different drugs, or a combination of medications. But that increases the chance of a dangerous medication error.
THOMPSON: It would be a bit like a pilot coming to Logan Airport in the morning and saying, we're out of Airbuses. You're going to have to fly a 727. And, oh, by the way, you're taking off in 10 minutes.
KNOX: Do you have any sense why this is happening, why this is now no longer rare, but something you have to integrate into daily practice?
THOMPSON: Well, my understanding is it appears that the major problem are business decisions around generic drugs.
KNOX: That's why the Mass General recently formed a task force on drug shortages. It's chaired by a cancer specialist named Annekathryn Goodman.
ANNEKATHRYN GOODMAN: We have several ethicists on it. We have a palliative care doctor. We have a ER doc.
KNOX: Goodman says next month, the group will begin to confront the agonizing questions of who gets what when there's not enough of an important drug to go around.
GOODMAN: If it ever gets to a place where you have to choose one patient over another, that is a very tough, ethical, existential, emotional issue - for us, for the people receiving the care.
KNOX: Betsy Neisner is the consumer representative on the new taskforce. She's also an ovarian cancer patient who'd been getting Doxil.
BETSY NEISNER: I was getting it monthly, responding superbly until July of this year, when I went into the hospital to have my infusion and the cupboard was bare.
KNOX: They just didn't have it.
NEISNER: They didn't have it. There was a nationwide shortage.
KNOX: She had to switch to an older drug that caused months of terrible nausea and fatigue and damaged the nerves in her feet.
NEISNER: It's really astonishing and terrifying, because you assume that if there's something that we've invented, that we've made available, that it'll stay available. And that's not true anymore.
KNOX: And more wrenching decisions may be just around the corner for patients with ovarian and breast cancer. A critical drug called Taxol is now on the FDA shortage list. And Mass General has less than a month's supply on hand. Richard Knox, NPR News, Boston. Transcript provided by NPR, Copyright NPR.