Drug shortages are more common than most people know, because most people and patients are never told, according to The New York Times piece this week. Imagine being a doctor with two pediatric patients and only one dose of life saving medicine. How do you decide who to give it to? These are questions doctors face today in the United States because of a drug shortages going on behind the scenes.
“It was painful,” said Dr. Yoram Unguru, an oncologist at the Children’s Hospital at Sinai in Baltimore and a faculty member at the Berman Institute of Bioethics at Johns Hopkins University. “We kept coming back to wow, we’ve got that tragic choice: two kids in front of you, you only have enough for one. How do you choose?”
According to the reporting, hospitals face limited supplies when drug manufacturers decide a drug isn’t lucrative enough to continue production, manufacturing problems arise, federal crackdowns on safety, and so on.
In recent years, shortages of all sorts of drugs — anesthetics, painkillers, antibiotics, cancer treatments — have become the new normal in American medicine. The American Society of Health-System Pharmacists currently lists inadequate supplies of more than 150 drugs and therapeutics… But while such shortages have periodically drawn attention, the rationing that results from them has been largely hidden from patients and the public.
Patients’ weight can be taken into account. Obese patients, who researchers found needed up to three times the amount of an antibiotic before surgery than average-size patients, were given only the standard dose at the Cleveland hospital until a shortage subsided.
Some institutions prioritize based on age; others do not. Marc Earl, a Cleveland Clinic pharmacist, said children were not favored over adults during chemotherapy shortages. But at other hospitals, they have been, because of their potentially longer life span or because they sometimes require smaller doses of a drug.
“We do play the pediatric card for sure,” said Alix Dabb, a pharmacy specialist in pediatric oncology at Johns Hopkins Hospital. Dr. Kenneth Cohen, director of pediatric neuro-oncology there, and his colleagues were close to being forced into making “very, very hard decisions,” he said. “The discussions became, ‘Why are two kids more important than one adult?’”
In a survey of cancer doctors conducted in 2012 and 2013, 83 percent of respondents who regularly prescribed cancer drugs reported having been unable to provide the preferred chemotherapy agent at least once during the previous six months. More than a third of them said they had to delay treatment “and make difficult choices about which patients to exclude,” according to a letter published in The New England Journal of Medicine.
The threat of future shortages in children’s treatments is serious enough that Dr. Peter Adamson, who leads the Children’s Oncology Group, the largest international group of children’s cancer researchers, assigned his organization to set priorities. “We’ve been forced into what we think is a highly unethical corner,” he said in an interview.
The effort, led by Dr. Unguru, the Baltimore oncologist, recommended that the drugs be rationed based on the ability to save lives or years of life, including curability of a child’s cancer and the importance of the drug in improving the chances. It also recommended that children participating in clinical research should not get priority over those who are not, because of concerns about coercing families into trials. The group also advised that allocation decisions be public.
Merck, the manufacturer, said it filled requests from a waiting list in the order received, and left rationing decisions to doctors. Some cancer centers reduced the length of BCG treatment from three years to one, because the benefit may be smaller after the first year. Others restricted BCG to patients whose tumors were mostly likely to spread or recur. And still others decided to reduce the typical dose so that each vial could be used for three patients instead of one, which some experts say raises questions about efficacy. Some outpatient clinics just ran out.
In the operating room at the Cleveland Clinic, Dr. Brian Fitzsimons has long relied on a decades-old drug to prevent hemorrhages in patients undergoing open-heart surgery. The drug, aminocaproic acid, is widely used, cheap and safe. “It never hurt,” he said. “It only helps.”
Then manufacturing issues caused a national shortage. “We essentially did military-style triage,” said Dr. Fitzsimons, an anesthesiologist, restricting the limited supply to patients at the highest risk of bleeding complications. Those who do not get the once-standard treatment at the clinic, the nation’s largest cardiac center, are not told. “The patient is asleep,” he said. “The family never knows about it.”