Medical, Dietetic And Pharmacy Staff Work Together To Handle Shortages Of Key Intravenous Nutrition Components In The NICU

October 18, 2011

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I was recently interviewed about a subject that is receiving increasing attention: a widespread shortage of many medications in the United States. This shortage has a range of causes that are well-described elsewhere but fundamentally relate to inherent and worsening problems in the production, distribution and identification of key medications.

For those of us at the front lines of patient care, our questions are: 1) How do we ensure good patient care when we have medication shortages? and 2) What can we do to advocate for short- and long-term solutions to this serious problem?

As a neonatologist, the shortage of key components for intravenous nutrition in neonates hits close to home. At any given time, Texas Children’s Hospital has about 20 infants in the hospital’s neonatal intensive care unit (NICU) and a similar number who

are home but rely on intravenous nutrition to obtain the basic nutrition needed for growth and development; such babies have a small size and lack the ability to take a full diet or have one of a wide range of illnesses that makes them unable to tolerate a full diet.

The good news is that the long-term outcome for most of these babies is excellent. They will ultimately be able to tolerate a full diet and not need intravenous nutrition at all. However, for a period of time, which can range from a few days to a few years, they are very dependent on intravenous nutrition.

Beginning about 6 months ago, we faced a severe shortage of some key components of this intravenous nutrition, called parenteral nutrition (PN). This was a national shortage caused by a loss of manufacturing capacity at the very few companies that produce some key components of PN. We immediately mobilized a team of physicians, dietitians and pharmacists to determine how to make sure that babies received the needed PN despite the national shortages.

One of the key shortages has been of minerals, especially calcium and phosphorus, needed for bone growth, and an amino acid, cysteine, that makes it possible to include more calcium and phosphorus in PN.

We looked very carefully at the science related to these minerals in the medical literature, including studies done at Texas Children’s Hospital at the Children’s Nutrition Research Center, to learn how we could decrease our use of these products and still meet the needs of our most vulnerable patients.

We have made the best of a difficult situation by identifying which babies were in greatest need and stretching each dose of PN to make the greatest impact. By necessity, ever since April, we have decreased the amount of mineral many babies receive as allowed by their size and medical condition. We evaluate each baby every day to determine how best to proceed. Our careful, individualized approach has successfully avoided any severe consequences for any baby.

We are constantly monitoring both the supply of minerals and the response of our babies. We believe our proactive strategy has prevented any harm to these infants. However, any approach to stretching a limited supply of needed minerals will be less than ideal, as we don’t want to have limits on providing for our patients. It has taken a tremendous effort to make sure we are meeting patient needs. Stretching inadequate medication supplies is not a long-term solution at this hospital or anywhere. Our children should not be caught up in manufacturing and supply chain problems!

Many members of the Texas Children’s Hospital staff are working with professional organizations such as the American Academy of Pediatrics and the American Society for Parenteral and Enteral Nutrition (ASPEN) to raise awareness and work for improved communication about shortages between hospitals, drug producers and the Food and Drug Administration. We are reaching out to our colleagues nationwide to share ideas and advocate for a solution.

I, my fellow neonatologists and other pediatric faculty are grateful to our dedicated group of dietitians and pharmacists tirelessly working in the interest of our babies.

We will do our best to keep the community informed of this situation, but ask your help in supporting efforts to have a comprehensive solution to medication shortages developed on a national level. Dr. DeWayne M. Pursley, chair of the American Academy of Pediatrics’ Section on Perinatal Pediatrics, testified before congress to this end. There are Senate and House versions of a bill to improve communication from drug companies regarding upcoming shortages. You can show your support for the bill by going to http://www.opencongress.org/bill/112-h2245/show.

Readers are welcome to address specific questions to me or post them on the blog.

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