Nutritional Drug Shortages Take Toll on The Smallest Patients

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Daniel Rosenberg of Hospira, a drug manufacturer the FDA cited as helping to provide supplemental drugs after the American Regent/Luitpold shutdown, wrote in a statement that the current shortage was related to the shutdown, "and the difficulty of ramping up production to cover for the unanticipated loss of production from that manufacturer."

Rosenberg did not address any other reasons for continued TPN component shortages.

FDA spokesman Christopher Kelly said that while the FDA can work with companies like American Regent/Luitpold to minimize the effects of the shortage, they do not have the power to demand manufacturers produce certain drugs or the ability to ensure the resulting product is safe for use.

"The reasons for drug shortages are complex and often outside of FDA's control. For example, the majority of drug shortages are caused by a breakdown in quality and manufacturing processes," said Kelly, citing problems with sterility or particulates in drugs as being common problems. "In fact, about 75 percent of drug shortages are caused by manufacturing issues."

As frustrating as the shortages for TPN have been for Finley and his parents, Finley's gastronomy tube, or g-tube, provides his parents with a secondary means of giving him nutrients. For other patients, such as premature infants lacking fully developed digestive systems, there is no back-up plan.

In neonatal and pediatric wards, pharmacists and doctors have had to make difficult decisions about who gets the TPN components and who goes without.

Plogsted said neonatal patients virtually always have the highest priority since they have no additional nutritional stores, but, in theory, this can mean not giving nutrients like zinc, key for growth, to a full-term infant with a heart problem.

Petra Cober, a neonatal pharmacist for the Akron's Children's Hospital, said that, with a lot of planning and extra work, she and her team have been able to stay "a couple of inches ahead of the shortages."

"We're limping by on the skin of our teeth," said Cober. "We have to dedicate a ton of time and resources to maintain that ability when it could be better spent working on other kids."

Cober said she and her team often meet with doctors to decide ahead of time which patients absolutely must have the nutrients and how other nutritional options, such as oral dosages of certain elements, could be used to keep all patients healthy. When a patient is on a lower dosage of a certain nutrient, it often means they have to undergo additional tests to ensure their health isn't compromised.

Additionally, the TPN shortages have been so severe in her region that pharmacists from nearby pediatric hospitals meet periodically to swap shortage stories and, if the shortages are really dire, they swap vials of different nutritional drugs to ensure no hospital is completely lacking an essential nutrient.

At one point after hearing about an impending lipid shortage, Cober purchased special oils, "as the emergency back-up of the emergency back-up," that could be used on some premature infants to provide them with lipids. It's a medical technique that became outdated when TPN was invented and that most of the doctors in the neonatal unit were unfamiliar with. Cober said she has never used the oils and is unlikely to do so, but they're still in her office in case there is an emergency.

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