Smallest patients fall victim to national shortage of life-saving drugs

FDA holds public workshop to figure out solutions

All Children's Hospital_20100914170657_JPG

Copyright 2010 Scripps Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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Posted: 09/26/2011

ST. PETERSBURG, Fla. - Crystal Morena sits in the NICU of All Children's Hospital, holding one of her precious twins, Amir.  He came early at 32 weeks, and his lungs aren't fully developed yet.

He's also not able to eat. so he is being fed Total Parental Nutrition (TPN) intravenously.  Morena says, “If they can't seem to tolerate the feedings on their own, with formula or breast milk, the only other way to feed them is the TPN.  They say the TPN has all the nutrients that they need to grow and get their lungs better."

But Kevin Olson, the Director of Pharmacy at All Children's Hospital, says there is a national shortage on some of the key ingredients in that neonatal formula.  “The shortages we're experiencing are primarily the electrolytes and some of the trace elements, both of which are vital components to that parental nutrition we make."

Hospitals like All Children's buy these drugs from a wholesaler who gets it directly from the manufacturer. Those companies don't have to warn anyone a shortage is imminent nor do they have to keep making the drugs if they're needed. Olson says, “Some of it has to do with production of raw material.  A lot of our stuff is made out of the country."

A FDA spokesperson said since many of the drugs are generic, some stop making them when they are no longer profitable.

Right now the FDA is holding public workshops and webinars to both gather and disseminate information on this critical problem.

Olson says, “It's very critical. It's a daily battle for us. My buyer spends 75 percent of her day on the phone trying to locate products." Products that are keeping the smallest and most vulnerable of patients like little Amir alive.

Kevin Olson says All Children's Hospital has not and won't resort to the grey market. That's when a distributor buys needed drugs from a medical facility and sells it to another facility that is out but for a jacked-up price. He worries when drugs change hands that way there is less quality assurance.

Should the government step in and change the way drug manufacturers are regulated?  To weigh in, go to my face book fan page, 
www.facebook.com/lindahurtadoWFTS

Copyright 2011 Scripps Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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