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Wed June 19, 2013
Drug shortages are affecting children in the NICU
Earlier this month, we came across this article in the Washingtonian entitled "Children Are Dying." It blew our minds. Could babies really be dying in neonatal intensive care units across the country because of drug shortages? We decided to check it out for ourselves to see if it was happening in Michigan.
The short answer: Yes, every NICU in Michigan* has experienced or is experiencing a wide variety of drug shortages; no babies have died because of the shortages, according to the various NICU officials.
To help us better understand what's going on with the shortages, I visited Dr. Bob Schumacher. He's the medical director of the NICU at the University of Michigan’s CS Mott Children Hospital. He's kind and soft-spoken; the kind of doctor who decorates his office with paintings and papier-mâché animals. So you can imagine how difficult it is for him to have to say this:
"It’s very disheartening when the medicine you’re looking at is known to have a significant impact on the well-being of a baby, and you can’t give it to them."
What Schumacher is talking about is a medicine shortage – everything from drugs used to resuscitate a newborn to drugs that provide nutrition. He scrolls down a virtual white board that U of M's pharmacists maintain, to help doctors and nurses know which drugs are on hold, which drugs they're rationing, and which drugs are back in rotation.
Yes, Schumacher says, there are workarounds. But the more workarounds they have to do, the more risk there is for human error. And sometimes there aren’t any workarounds. Take injectable Vitamin A, for example. Schumacher says Vitamin A is crucial to lung development, and "babies with premature lungs who are treated with extra vitamin A tend to do better in terms of their lung disease." But when there's a Vitamin A shortage, there's nothing pharmacists or doctors or nurses can do; there are no substitutes for injectable Vitamin A.
Erin Fox is the director of drug information at the University of Utah Hospitals and Clinics. Her group has been tracking national drug shortages since 2001 for the American Society of Health-System Pharmacists (ASHP). She says the reason for the shortage is pretty complicated.
"There’s no one person, no one company, no one reason we can point the finger at and blame," says Fox. Instead, she gives three reasons.
Reason #1: Supply chain. Only a few companies make these generic drugs. "If only two companies make a product and one has a problem, that’s almost always a shortage," explains Fox.
Reason #2: two: Generic drug companies run lean. Fox says because generic drug companies run very lean, they don’t have a backup plan if one of their manufacturing lines goes down. (The Generic Pharmaceutical Association refused to comment for our story.)
Reason #3: Quality. Some of the factories and plants are having quality issues, so the FDA shuts them down until they are in compliance, which leads to more drug shortages.
And for babies who start out life in the NICU, those drug shortages can follow them into childhood.
Bo Velarde-Chan is six-years old. He lives in Kalamazoo with his parents and baby sister. When he’s not working on his stand-up routine ("How do you get a tissue to dance? Put a boogie in it!"), you’ll find him playing with his Legos and dreaming up things to invent when he’s older ("Robotic bugs.")
To keep his little body going, Bo needs help. He was born with a rare disorder which doesn’t allow his body to absorb the nutrients he needs to eat and drink. So every day he gets his carbs, his proteins, his vitamins – everything he gets in liquid form intravenously. To put it bluntly, he needs these IV fluids to live.
His Mom, Kinn Chan de Velarde, says recently the shortages have been particularly bad. They’ve been short on everything from multivitamins to trace elements to phosphate, which helps Bo’s body produce energy and prevent osteoporosis. And each time, Bo’s doctors have had to develop workarounds:
"To think at this point that we could lose him or he could suffer a profound deformity or cognitive decline as a result of these trace elements being in shortage is so unimaginable," says Chan de Velarde. "You know all the adversity that he has overcome, and then to lose it all because the supply chain is unbroken, is unthinkable."
The FDA acknowledges the shortages and says it is monitoring the situation so that "treatment options will be available to patients." Patients like six-year old Bo Velarde-Chan.
Check out these links to read more about nationwide drug shortages:
The U.S. Food and Drug Administration's webpage on drug shortages
FDA takes action to ease neonatal drug shortage, a press release
The American Society of Health-System Professional's webpage on drug shortages
American Society for Parenteral and Enteral Nutrition's webpage on drug shortages
International Society for Pharmaceutical Engineering's 2013 survey on drug shortages
*We contacted every NICU in Michigan and all but one (Sparrow Hospital in Lansing) got back to us.
This piece was informed by the Public Insight Network.