Pittsburgh's neonatal intensive care units struggle with nutrient shortages
Hospitals seek options for fragile infants in nationwide shortfall
June 9, 2013 4:00 AM
The infant is fed through intravenous tubes with nutrients known as parenteral nutrition, or TPN.
Bathed in ultraviolet light, registered nurse Lindsey Evans cares for a 2-day-old infant at West Penn Hospital's neonatal intensive care unit. The IV bag of nutrients is covered with a brown plastic bag to prevent oxidation.
By Anya Sostek Pittsburgh Post-Gazette
Abram Binus was not happy. His tiny red fists balled up, his 2-pound body writhed, his immature lungs belted out cries barely audible outside his West Penn Hospital incubator.
Nurse Lindsey Evans swooped in to help, soothing him with her hands that spanned most of his body and adjusting his breathing mask. Abram calmed.
Temporary crisis averted.
But a much more complicated problem is facing babies like Abram, born prematurely and getting much of their sustenance from intravenous nutrition.
Because of factory shortages, hospitals nationwide are struggling to meet demand for nutrients like phosphorus, zinc and calcium essential for growth and development.
"It's an absolutely huge deal -- it's critical," said Amanda Geist, pharmacist for the West Penn neonatal intensive care unit. "You can juggle a little bit, but at the end of the day you need to feed these infants."
At West Penn, all infants born as early as Abram and his twin brother Micah -- who entered the world June 1 at 29 weeks gestation -- are started exclusively on intravenous nutrition, also known as total parenteral nutrition, or TPN.
Abram and Micah, of Butler, are gradually transitioning from TPN to breast milk. At any one time, about half of the roughly 30 preemies at the West Penn NICU will be on TPN -- either because their guts aren't ready for full milk or formula or if they develop stomach infections or other complications.
The reasons for the shortages -- which started a couple of years ago but have intensified in the last few months -- are complicated, said Jay Mirtallo, a professor of clinical pharmacy at Ohio State University.
These nutrients aren't rare in nature, but only a few factories nationwide manufacture nutrients to be used for TPN, said Mr. Mirtallo, past president of ASPEN or the American Society for Parenteral and Enteral Nutrition. Because the medications are injected directly into veins, they must be extremely pure and are therefore hard to manufacture, he said. Profit margins on these nutrients are low, he said, meaning it might be more lucrative for factories to manufacture something else.
"There might be three manufacturers that make the nation's supply," he said. "If one manufacturer has a problem, the others don't have the capacity to address the shortages in a timely manner. It's not a short-term thing to fix."
That scenario happened in December when the American Regent factory decided to shut down its manufacturing after inspections by the Food and Drug Administration uncovered contamination.
The government can't force manufacturers to make certain drugs and in part because of our free-market health care system, the nutrient shortage seems to be unique to the U.S.
"I've talked to our colleagues in Europe, South America, Asia and they were astounded," said Mr. Mirtallo. "How can the U.S. have a shortage like this? And not just how can this happen, but how can it go on for so long?"
Norway to the rescue
Late last month, the FDA announced that it would begin importing trace elements, potassium phosphate and sodium phosphate from a plant in Norway to try to ease the U.S. shortage.
TPN is also used for adult and child patients who have gastrointestinal blockages or other digestive problems. Its impact is felt most in premature babies, however, because their bodies do not have prior stores of the nutrients.
Staff at local hospitals are hopeful that international drugs might make a difference, but hadn't seen relief yet.
All three Pittsburgh NICUs -- West Penn, Children's Hospital of Pittsburgh of UPMC and Magee-Womens Hospital of UPMC -- have seen shortages of nutrients but all say that they've been able to manage without affecting patient health.
"We have not had any clinical problems related to this," said Nilima Karamchandani, medical director for the NICU at West Penn. "We've been able to handle it so far but I'm worried about the future."
Other places have not been so lucky. A bulletin from the Centers for Disease Control and Prevention documented problems at Children's National Medical Center with lesions on the skin of three premature babies after the hospital ran out of zinc. Dr. Karamchandani said she had heard of a similar case in a New York hospital.
A 2012 survey by ASPEN found that the NICU population in Pennsylvania was seeing more fractures, which they noted could be a result of nutritional shortages.
An article in Washingtonian Magazine referenced other cases of adverse effects on preemies and children in Texas and Tennessee, including the development of Wernicke encephalopathy, a serious neurological disorder, from a shortage of intravenous multivitamins.
It's 'bearable,' but ...
At West Penn, doctors have been managing the shortages by creative pharmacy practices. For the past few months, premature babies have been receiving a double dose of phosphorus every other day, rather than a single dose every day, to reduce waste (with a single dose, there's more extra in the vial that has to be discarded).
That strategy required extra blood draws from babies at first -- not an optimal choice for babies with low blood volume anyway -- but doctors needed to be sure that the babies were getting proper nutrition. Calcium levels have also had to be adjusted, said Dr. Karamchandani, because calcium and phosphorus have to be given in a certain ratio.
"It's bearable in the sense that it's not made a dramatic difference in the care so far but I am concerned about it," she said.
West Penn has also stopped allowing certain nutrients to be dispensed individually at the nurse's station, requiring instead that they come from the pharmacy to minimize waste from individual vials.
When there are nutrient shortages, buyers at West Penn also call around to hospitals in Pittsburgh and as far away as Maryland and West Virginia to see if they have any to spare, though all hospitals are struggling with the same problem.
Pharmacists at the UPMC hospitals say that have been able to move supplies around within the hospital network to make sure that no patients are denied proper care. It's a difficult problem, they say, because the shortages are so unpredictable.
"This latest trend in shortages sometimes has no rhyme or reason as to why a certain medication will not be available," said Jeff Goff, director of pharmacy at Children's. "You're just seeing one after another cascade in these shortages and you cannot predict why one class is short as opposed to another."
Mr. Goff declined to say what specific steps Children's was taking to address its shortages, saying generally, "we've had to alter things but nothing to the point where we believe that patients truly in need are affected by the outcome," he said.
At Magee-Womens Hospital, pharmacists have started ordering premade IV nutrition bags for adult patients to have more individual nutrients available for babies, said Rosella Hoffman, director of pharmacy. The hospital has also analyzed literature and determined that "many trace elements, such as selenium which has been on shortage, are not essential during the first week of life," she said.
For hospitals, it's also meant dramatic changes in personnel -- resources once used caring for patients are now spent tracking down supplies and formulating shortage solutions.
"I've been a director of pharmacy for 13 years and the last two years have been amazing -- amazing in a bad way," said Mr. Goff. "I've never seen anything like it."