Nutrition experts participated in PN Safety Summit to discuss safety of PN therapy, patient care

Recent safety concerns in the preparation and delivery of parenteral nutrition (PN), commonly referred to as intravenous (IV) nutrition, prompted leaders from several major organizations to participate in a PN Safety Summit on September 23, 2011. The Summit participants agreed to several recommendations that will improve the safety of PN therapy and patient care, in the areas of PN order prescribing, order review and verification, and formulation compounding.

Hosted by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), the PN Safety Summit included representatives from the U.S. Food and Drug Administration, the Institute of Safe Medication Practices (ISMP), the American Society of Health-System Pharmacists, the National Home Infusion Association and industry representatives, among others. The Summit allowed experts in clinical nutrition to address the safety issues surrounding parenteral nutrition and to develop recommendations for improvement. When these therapies are not prepared with quality control measures in place, the sterility, stability and compatibility can be impacted, putting patients at risk. Preparing parenteral nutrition involves complex sterile preparations and should be handled in a carefully controlled environment with built-in quality assurance from prescribing, to formulating and delivery.

"During the past year, many circumstances and incidents have threatened the safety of parenteral nutrition as an important therapy," said Jay Mirtallo, A.S.P.E.N. president. "This is why A.S.P.E.N. convened the PN Safety Summit. We brought together key leaders to discuss the issues and to develop recommendations and action items that will help make this therapy safer. The outcomes will provide a blueprint for caregivers and will greatly benefit the patients receiving this life-sustaining therapy."

Recommendations from the PN Safety Summit will be published in a future issue of A.S.P.E.N.'s Journal of Parenteral and Enteral Nutrition. Summit participants agreed to focus on the following safety topics as part of the final recommendation:

• 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 PN compounding;
• Support the use of a standardized process such as standard PN formulations which may include use of commercially-available ready-to-use products.

One of the safety issues is the ongoing shortage of vitamins, electrolytes and other IV nutrition ingredients that has critically impacted hospitals nationwide. A recent study by the American Hospital Association found that 89 percent of hospitals have experienced nutrition product shortages. Further, drug shortages within a six-month period led to 58 percent of patients receiving a less effective drug and 32 percent experiencing an adverse outcome. Organizations such as A.S.P.E.N. and Baxter International Inc., have worked to address these shortages to ensure patients continue to receive the life-sustaining therapies they needed.

Baxter, a leading maker of parenteral nutritional therapies, sponsored the Summit and endorses the need for safe parenteral nutrition measures and preparation. "Patient safety is our number one priority, and as a market leader in parenteral nutrition, Baxter supports this initiative to gain consensus on parenteral nutrition practices and ways to improve patient safety," said Mark DeLegge, M.D., global medical director, Baxter International Inc. "An important part of patient safety is our commitment to ensuring consumers and suppliers have access to quality products in an efficient manner. It is our hope that these recommendations will improve patient safety overall."

Parenteral nutrition is intravenous administration of nutrition, which may include protein, carbohydrates, lipids (fats), minerals and electrolytes, vitamins and other trace elements for patients who cannot ingest food orally or enterally (tube-fed). Achieving the right balance of nutritional content in a timely manner can help combat complications and be an important part of a patient's recovery.

There are several treatment options for administering IV nutrition. Current guidance from ISMP recommends that pharmacy staff should start with sterile products when preparing compounded therapies or use commercially available ready-to-use products when available. In addition, A.S.P.E.N. supports the use of a standardized process which may include standardized PN formulations to help facilitate a consistent approach that reduces variation and promotes uniformity among clinicians and healthcare facilities.