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.

These parenteral amino acids products shortage considerations were approved by the ASPEN Clinical Practice Committee and the Board of Directors on April 20, 2016.

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:

  1. Assess and regularly reassess each patient as to the indication for PN and provide  nutrition via the oral or enteral route when possible.
  2. Purchase only as much amino acids products supply as needed. In the interest of fair  allocation to all patients nationally, please do not stockpile.
  3. ONLY use Neonatal/Pediatric-specific amino acids or disease-specific amino acids for the  indicated patient populations.
  4. Reserve high concentration amino acids products (e.g., greater than 10%) for fluid-restricted patients requiring PN.
  5. 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. Hospira, Inc. Customer Service: 1-877-946-7747
  6. 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.
  7. Assess your PN patient population to determine if standardized, commercially-available  parenteral nutrition products1 may be appropriate for a portion of your patient  population.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Report severe drug product shortage information to the FDA Drug Shortage Program  (DSP).
  13. Report any patient adverse events or medication hazard related to shortages  to ISMP Medication Errors Reporting Program (MERP).
Reference:
  1. 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.
Suggested Readings:
  • Ayers P, Adams S, Boullata JI, et al. A.S.P.E.N. Parenteral nutrition safety consensus recommendations. JPEN J Parenter Enteral Nutr. 2014;38;296-333.
  • Boullata JI, Gilbert K, Sacks G, et al. A.S.P.E.N. Clinical guidelines: Parenteral nutrition ordering, order review, compounding, labelling, and dispensing. JPEN J Parenter Enteral Nutr. 2014;38:334-371.
  • Chan LN. Iatrogenic malnutrition: a serious public health issue caused by drug shortages. JPEN J Parenter Enteral Nutr. 2013; 37:702-704.
  • Cohen MR, Smetzer JL. Weathering the storm: managing the drug shortage crisis. Hosp Pharm. 2011:46:7-11.
  • Corkins MR, Griggs KC, Groh-Wargo S, Han-Markey TL, Helms RA, Muir LV, Szeszyski EE, Task Force on Standards for Specialized Nutrition Support for Hospitalized Pediatric Patients and the American Society for Parenteral and Enteral Nutrition Board of Directors. Standards for Specialized Nutrition Support: Hospitalized Pediatric Patients. Nutr Clin Pract. 2013;28:263-276.
  • Hanson C, Thoene M, Wagner J, Collier D, Lecci K, Anderson-Berry A. Parenteral nutrition additive shortages: the short-term, long-term and potential epigenetic implications in premature and hospitalized infants. Nutrients. 2012;4:1977-1988.
  • Hassig TB, McKinzie BP, Fortier CR, Taber D. Clinical management strategies and implications for parenteral nutrition drug shortages in adult patients. Pharmacotherapy. 2014;34:72-84.
  • Holcombe, B. Parenteral nutrition product shortages: Impact on safety. JPEN J Parenter Enteral Nutr. 2012;36:44S-47S.
  • Institute for Safe Medication Practices. Survey links PN shortages to adverse patient outcomes. Medication Safety Alert! February 13, 2014;34(2).
  • Kaur K, O'Connor AH, Illig SM, Kopcza KB. Drug shortages as an impetus to improve parenteral nutrition practices. Am J Health Syst Pharm. 2013;70:1533-7. Mirtallo JM. The drug shortage crisis. JPEN J Parenter Enteral Nutr. 2011;35:433.
  • Mirtallo JM, Holcombe B, Kochevar M, Guenter P. Parenteral nutrition product shortages: The ASPEN strategy. Nutr Clin Pract. 2012;27:385-391.
  • Storey MA, Weber RJ, Besco K, Beatty S, Aizawa K, Mirtallo J. An evaluation of parenteral nutrition errors in an era of drug shortages. Nutr Clin Pract. 2016;31:211-217.
  • Task Force for the Revision of Safe Practices for Parenteral Nutrition: Mirtallo J, Canada T, Johnson D, Kumpf V, Petersen C, Sacks G, Seres D, Guenter P. Safe practices for parenteral nutrition. J Parenter Enteral Nutr. 2004;28:S39-S70. Errata: J Parenter Enteral Nutr. 2006;30: 177.
  • The Joint Commission. Medication Management Standard MM. 02.01.01: The hospital selects and procures medications. Elements of performance 1-16, 2016.
  • Ukleja A, Freeman KL, Gilbert K, Kochevar M, Kraft MD, Russell MK, Shuster MH: Task Force on Standards for Nutrition Support: Adult Hospitalized Patients, and the American Society for Parenteral and Enteral Nutrition Board of Directors. Standards for nutrition support: Adult hospitalized patients. Nutr Clin Pract. 2010;25:403-414.
Important Note: These recommendations do not constitute medical or professional advice, and should not be taken as such. To the extent the information published herein may be used to assist in the care of patients, this is the result of the sole professional judgment of the attending health professional whose judgment is the primary component of quality medical care. The information presented herein is not a substitute for the exercise of such judgment by the health professional.

Revised by the ASPEN Clinical Practice Committee’s Nutrition Product Shortage Subcommittee:
Steve Plogsted, PharmD, BCNSP, CNSC (Chair); Stephen C. Adams, MS, RPh, BCNSP; Karen Allen, MD; M. Petrea Cober, PharmD, BCNSP; June Greaves, RD, CNSC, CD-N, LD, LDN; Kris M. Mogensen, MS, RD, LDN, CNSC; Amy Ralph, MS, RD, CNSC, CSO, CDN; Ceressa Ward, PharmD, BCPS, BCNSP; and Joe Ybarra, PharmD, BCNSP.

Approved by the ASPEN Clinical Practice Committee and the Board of Directors on April 20, 2016.
Questions regarding these recommendations should be directed to Beverly Holcombe,
PharmD, BCNSP, FASHP, FASPEN; Clinical Practice Specialist, A.S.P.E.N.
at [email protected]