Feature Story

Advancing Nutrition for Patients, Advocating for Safety and Access

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Nutrition is an essential part of life, and this need is often amplified by acute or chronic illness. Yet, several studies indicate that an estimated 30 to 50 percent of U.S. hospitalized patients show signs of malnutrition,1,2,3  which can occur as a result of an imbalanced diet, impaired digestion or absorption of nutrients, or other medical conditions when metabolic requirements exceed intake. 

Malnutrition is a global problem studies have shown as many as 40 percent of hospitalized elderly patients in Canada and nearly 40 percent of hospitalized patients in Europe suffer from malnutrition.4,5 Left unmanaged, it can increase morbidity and mortality and lead to serious health complications, including extended hospitalization.6  

"Malnutrition is a huge problem for hospitalized patients around the world," said Mark DeLegge, MD, global medical director at Baxter. "More and more, we're realizing that nutrition should be one of the first things we pay attention to in the hospital setting."

Some patients are unable to consume nutrients orally because of their condition or because they do not have a functioning gastrointestinal tract. These patients must be fed via an alternate method such as parenteral nutrition. Parenteral nutrition is intravenous (IV) administration of nutrition, which may include protein, carbohydrates, lipids (fats), vitamins and other trace elements for patients who cannot ingest food orally or enterally (tube-fed). 

More than Counting Calories
Often, when people read consumer food nutrition labels, they tend to focus on the number of calories versus the nutritional ingredients. But similar to everyday life, achieving proper nutrition in the hospital is not just a matter of counting calories.  While patients may begin their hospitalization well-nourished, if they don't receive the right amount and combination of nutrients throughout their hospitalization, their health may suffer. Striking the correct balance of nutritional content in a timely manner can help combat complications and be an important part of a patient's recovery.

For example, patients who have undergone trauma (such as surgery) experience a breakdown in muscle mass to support healing, so they need protein to help replace the lost muscle mass.7    Hospitalized patients also need energy supplied by carbohydrates, but supplying too much can lead to hyperglycemia (excessive sugar in the blood), and can impact clinical outcomes.8  Parenteral nutrition therapy requires constant monitoring and maintenance to ensure a patients' needs are being met.

"There is no one-size-fits-all approach to nutrition," says Paul Wischmeyer, MD, professor of Anesthesiology and director of Nutrition Support, University of Colorado at Denver School of Medicine.  "As healthcare practitioners, we need to be flexible in our approach to nutrition therapy to meet individual patient needs, and having a wide range of formulas gives us this enhanced flexibility."

Recent Challenges Facing Parenteral Nutrition
Many patients depend on parenteral nutrition as a life-sustaining therapy. However, in the past year, troubling circumstances have impacted the safe prescription, formulation and delivery of nutrition support.  These challenges, further complicated by severe drug shortages nationwide that diminished the availability of certain parenteral nutrition components, prompted Baxter to sponsor the first-ever Parenteral Nutrition Safety Summit with the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) this past September to work towards solutions.

With input from attending representatives from the U.S. Food and Drug Administration (FDA), the Institute of Safe Medication Practices (ISMP), the American Society of Health-System Pharmacists (ASHP), the Board of Pharmacy Specialties, the National Home Infusion Association (NHIA), Oley Foundation, and industry representatives, the Summit put forth a list of recommendations for the industry in order to overcome these obstacles.  Participants determined that going forward, efforts needed to be made in the, "standardization of prescribing processes including electronic ordering and education of prescribers; standardization of order review and verification processes; education, competency testing and thorough use of USP <797> processes in parenteral nutrition compounding; and standardization of parenteral nutrition processes and formulations, which may include use of commercially-available, ready-to-use products."9     

The ambitious recommendations made during the Summit have already started to take shape. In time for A.S.P.E.N.'s 2012 Clinical Nutrition Week held in late January, A.S.P.E.N. reconvened its PN Safety Task Force to review, prioritize and develop an operational plan for the summit's recommendations.

Baxter's IV Nutrition Leadership
Besides the company's more recent work in addressing these current issues, Baxter has been assisting clinicians in treating patients' diverse nutrient demands since the 1940s, when the company first introduced liquid proteins in the form of amino acids. Since then, Baxter has continued to advance IV nutrition for healthcare professionals and patients through ongoing improvements in both nutritional contents and technology, and now offers one of the broadest portfolios of IV nutrition therapy. 

Baxter pioneered the world's first "triple-chamber system" for IV nutrition, which provides many of the essential ingredients of balanced nutritionprotein, carbohydrates, lipids and electrolytes in a single containersimplifying the preparation of parenteral nutrition for hospitalized patients.  Multi-chamber systems are a practical option for hospitals to provide standardized IV nutrition for patients in a convenient and easy-to-activate system. The ingredients are provided in separate compartments to be mixed and administered when needed, simplifying the prescription and delivery of parenteral nutrition. Maintenance vitamins, additional electrolytes and trace elements may not be included and should be administered as required. 

Among its latest triple-chamber systems, Baxter offers OLIMEL (Amino Acids, Dextrose and Lipids, with/without Electrolytes Emulsion for Infusion) in Canada, Europe and most recently Asia-Pacific.  The uniquely designed range of OLIMEL formulations helps deliver the right amount of protein and energy to meet the needs of specific patient groups such as trauma, surgery and the chronically ill. 

In November 2011, Baxter introduced NUMETA (emulsion for infusion) in Europe, the first and only triple-chamber system for neonatal and pediatric patients (preterm newborns through age 18).  Unlike adults, children have a need for growth, which puts them at a particularly high risk of malnutrition because of higher nutritional demands.10  As a well-balanced, ready-to-use formulation, this triple-chamber system is specifically designed to meet the evolving nutritional needs of some of the youngest and most vulnerable patients.

Late last year, Baxter additionally broadened its robust portfolio of nutritional therapies with the acquisition of Baxa Corporation. The acquisition significantly expands the options Baxter offers to meet patients' nutritional requirements. Amongst the new offerings are automated compounding devices, including the EXACTAMIX compounders and ABACUS TPN Order Calculation Software.  These devices automate the total parenteral nutrition compounding process.

"Baxter has a long and proud history of bringing innovative IV nutrition products to market," said Phil Rackliffe, vice president of Baxter's Nutrition business.  "Through our recent acquisition and new product launches, we are looking to expand upon that legacy by addressing market needs and providing new innovations to better serve our global customers and enable Baxter to deliver sustainable long-term growth."

For more information, visit: http://www.baxter.com/healthcare_professionals/therapies/intravenous_administration/nutrition.html or the Baxter press room:

OLIMEL and NUMETA are not approved for sale in the United States.

OLIMEL (Amino Acids, Dextrose and Lipids, with/without Electrolytes Emulsion for Infusion)

Indication: OLIMEL is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated, and is approved by Health Canada and numerous European regulatory agencies. 

Important Risk Information

Contraindications: Patients who are hypersensitive to any ingredient in the formulation or component of the container.  Congenital abnormalities of amino acid metabolism, severe dyslipidemia, non-corrected metabolism disorders, severe sepsis, severe liver disease, blood coagulation disorders, thrombophlebitis, acute myocardial infarction, lipoid nephrosis, acute pancreatitis associated with hyperlipidemia, severe hyperglycemia. OLIMEL formulations with electrolytes must not be administered to patients with pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorus. 

Adverse Reactions: Treatment related adverse events reported during clinical trials include abdominal pain, diarrhea, nausea, tachycardia, hypertension, hypertriglyceridema and anorexia (3.57%).11

Full Prescribing Information for OLIMEL is available at www.olimel.ca.

NUMETA (Emulsion for Infusion)

Indication: NUMETA is indicated for parenteral nutrition in the pediatric population when oral or enteral nutrition is impossible, insufficient or contraindicated.

Important Risk Information

Contraindications: The general contraindications for administering NUMETA as an activated two-chamber container system (with the lipid chamber inactivated for intravenous infusion) are as follows: hypersensitivity to egg, soy or peanut proteins, or to any of the active substances, excipients or components of the container; congenital abnormality of the amino acid metabolism; pathogenically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous; and severe hyperglycemia. The addition of lipids (administering NUMETA as an activated three-chamber container system for intravenous emulsion) is contraindicated in the following additional clinical situations: severe hyperlipidemia, or severe disorders of lipid metabolism characterized by hypertriglyceridemia. 

Refer to the NUMETA product label for full prescribing information.12

Baxter, Abacus, Baxa, ExactaMix, Olimel and Numeta are trademarks of Baxter International Inc., or its subsidiaries.

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6Isabel M., Correia TD, Waitzberg D.The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr 2003;22 (3): 235-239.
7Rennie MJ. Muscle Protein Turnover and the Wasting Due to Injury and Disease. British Medical Bulletin (1985) Vol. 41, No. 3, pp. 257-264.
8McCowen KC et al. Hypocaloric total parenteral nutrition: Effectiveness in prevention of hyperglycemia and infectious complications-A randomized clinical trial. Crit Care Med 2000; 28: 3606.
9A.S.P.E.N. PN Safety Summit Report-out; Retrieved on January 31, 2012 from: http://www.baxter.com/press_room/press_releases/2011/09_30_11_parenteral_nutrition_safety.html
 10Koletzko B, Goulet O, Hunt J, et al. ESPGHAN / ESPEN Guidelines on Paediatric Parenteral Nutrition. JPGN. 2005. Link: http://espghan.med.up.pt/joomla/position_papers/con_22.pdf
11OLIMEL Product Monograph.