Nutritional Drug Shortages Take Toll on The Smallest Patients

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A list of the TPN drugs that have waxed and waned over the last few years can sound like a periodic table pop quiz, with phosphorous, zinc, copper, selenium and chromium all making appearances.

Lose one essential element and you can't just replace it with a Flintstone vitamin. Unlike a meal, there are no extraneous components of TPN and the different components are carefully calibrated to provide people with the exact necessary nutrients to survive.

Phosphate helps muscles contract and is vital for patients on respirators, zinc helps people process specific enzymes, chromium joins up with carbohydrates so you can process sugars in the body. Lipids or fats are particularly critical for premature infants who have no additional nutrient reserves.

According to Gerndt, Finley's TPN has been missing calcium, selenium and phosphate at various times. As a result, Gerndt had to give him supplemental nutrition through his gastronomy tube, a tube in his abdomen that goes directly to his stomach. This means 9 times per day Gerndt has to wrangle Finley and inject a total of six ounces of medication into his stomach. Since Finley's digestive system isn't fully functioning, she worries that he isn't absorbing all the nutrients he receives through the g-tube.

In recent weeks, Gerndt said, Finley has become more lethargic and complains about his stomach becoming tight from the medication.

"We just try to focus on every day. I'm all choked up. It's just hard because it's not like [these drugs] don't exist," said Gerndt. "It is draining because life is challenging enough and this makes it more challenging."

In May the FDA announced it that they would import three additional TPN components from Norway for use in the U.S and expected to import others to alleviate the shortages.

Critical drug shortages have become a growing problem in the U.S. for the last few years. There are currently 238 drug shortages, according to the American Society of Health-System Pharmacists. A 2011 Associated Press review of industry reports found that there had been at least 15 deaths from drug shortages in the prior 15 months.

In June 2012, the FDA came under fire in in a report from the U.S. House of Representatives Committee on Oversight and Government Reform that cited the FDA's actions as a contributing factor in the large number of drug shortages. The report found that the FDA had sent a high number of warning letters to manufacturers, an increase from 474 letters in 2009 to 1,720 letters in 2011, which led to multiple major manufacturers going through remediation at the same time, which severely narrowed supply lines as they shut down manufacturing.

The report also found that the rise in regulation coincided with manufacturers having less financial incentive to make generic, injectable drugs. The report said that was partly caused by hospitals and TPN providers using group purchasing organizations, which could negotiate lower prices from manufacturers, and the implementation of the Medicare Modernization Act in 2003, which lowered the prices Medicare would pay for generic injectable medications.

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