Parenteral Nutrition Amino Acids Product Shortage Considerations

The American Society for Parenteral and Enteral Nutrition (ASPEN) is a professional society of physicians, nurses, dietitians, pharmacists, other allied health professionals, and researchers. ASPEN envisions an environment in which every patient receives safe, efficacious, and high quality patient care. ASPEN’s mission is to improve patient care by advancing the science and practice of clinical nutrition and metabolism. ASPEN has developed parenteral nutrition (PN) shortage considerations in order to assist its members and other clinicians in coping with PN shortages for their patients.

For the most up-to-date product shortage information, see these websites:
American Society of Health-System Pharmacists (ASHP), Drug Shortages Resource Center
U.S. FDA Drug Shortages
ASPEN Product Shortage Latest News

During the shortage period, consider one or more of the following measures:

Assess and regularly reassess each patient as to the indication for PN and provide nutrition via the oral or enteral route when possible.
Purchase only as much amino acids products supply as needed. In the interest of fair allocation to all patients nationally, please do not stockpile.
ONLY use Neonatal/Pediatric-specific amino acids or disease-specific amino acids for the indicated patient populations.
Reserve high concentration amino acids products (e.g., greater than 10%) for fluid-restricted patients requiring PN.
Consider reviewing the entire portfolio of amino acids products available nationally. There may be a shortage in one concentration but availability in another. Amino acids products along with their compositions and availability can be obtained from manufacturers.
1. Baxter Healthcare International, Inc. Customer Service: 1-800-262-3784
2. B. Braun Medical, Inc. Customer Service: 1-800-227-2862
3. ICU Medical, Inc. Customer Service: 1-800-824-7890
Different brands of amino acids products are not always directly substitutable, especially for total nutrient admixture (3-in-1) vs. dextrose/amino acids (2-in-1) PN formulations. They may have different pHs, different calcium-phosphorus solubilities, different amounts of phosphorus, as well as other characteristics that should be considered.
Assess your PN patient population to determine if standardized, commercially-available parenteral nutrition products¹ may be appropriate for a portion of your patient population.
During prolonged shortages of intravenous amino acids products, the FDA may approve the temporary importation of alternative products. These products may have different electrolytes, ratios (doses), packaging and labeling than United States products. The Dear Healthcare Professional Letter accompanying imported products should be read carefully.
Include PN component shortages and outages in the health care organization’s strategies and procedures for managing medication shortages and outages. These procedures should include:
1. a process to notify providers when PN formulations are adjusted due to shortages and outages of PN components, and
2. a process to notify patients receiving long-term PN therapy when their PN formulation has been adjusted for shortages and outages of PN components.
Compound PN in a single, central location (either in a centralized pharmacy or as outsourced preparation) in order to decrease inventory waste. Consider a supply outreach to other facilities in your geographic location.
Facilities and practitioners need to continue to observe and be compliant with the product labeling (e.g., package insert), USP General Chapter <797> Pharmaceutical Compounding-Sterile Preparations, and state Boards of Pharmacy and federal rules and regulations.
Report severe drug product shortage information to the FDA Drug Shortage Program (DSP).
Report any patient adverse events or medication hazard related to shortages to ISMP Medication Errors Reporting Program (MERP).

Reference:

ASPEN oard of Directors and Task Force on Parenteral Nutrition Standardization: Kochevar M, Guenter P, Holcombe B, Malone A, Mirtallo J. A.S.P.E.N. statement on parenteral nutrition standardization. JPEN J Parenter Enteral Nutr. 2007; 31(5):441–448.