Parenteral Nutrition Amino Acids Product Shortage Considerations
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is a community of professionals representing all disciplines and areas of interest in nutrition support therapy. A.S.P.E.N. 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 supply information, please see these websites:
American Society of Health-System Pharmacists (ASHP), Drug Shortages Resource Center
US FDA, Drug Shortage Program, Current Drug Shortages
A.S.P.E.N. News section (on homepage): http://www.nutritioncare.org/
During the amino acids shortage period, consider one or more of the following measures:
- Assess each patient as to the indication for PN and provide nutrition via the oral or enteral route when possible.
- Purchase only as much amino acid products supply as needed. In the interest of fair allocation to all patients nationally, please do not stockpile.
- Use Neonatal/Pediatric-specific amino acids (or specialty amino acids) ONLY for their indicated patient populations.
- Use high concentration amino acid products (e.g., >10%) sparingly. For example, save high concentration amino acids for fluid-restricted patients requiring PN.
- 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.
- Consider reviewing the entire portfolio of amino acid products available nationally. There may be a shortage in one concentration but availability in another. See attached Table (Intravenous Amino Acid Products in the U.S.) for a detailed listing.
- Different brands of amino acid 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 a standardized, commercial parenteral nutrition product1 (AKA, "premix" PN) may be appropriate for a portion of your patient population.
- Facilities and practitioners must 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 rules and regulations.
- Report severe drug product shortage information to the FDA Drug Shortage Program (DSP). See: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm
- Report any patient problems related to shortages to ISMP Medication Errors Reporting Program (MERP). To access that reporting mechanism, click here.
1A.S.P.E.N. Board 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.
- Mirtallo JM. The drug shortage crisis. JPEN J Parenter Enteral Nutr. 2011;35:433. http://pen.sagepub.com/content/35/4/433.full.pdf+html
- Mirtallo JM, Holcombe B, Kochevar M, Guenter P. Parenteral nutrition product shortages: The A.S.P.E.N. strategy. Nutr Clin Pract. 2012; 27:385-391. http://ncp.sagepub.com/content/27/3/385.full.pdf+html
- Holcombe, B. Parenteral nutrition product shortages: Impact on safety. JPEN J Parenter Enteral Nutr. 2012;36:44S-47S. http://pen.sagepub.com/content/36/2_suppl/44S.full.pdf+html
- Cohen MR, Smetzer JL. Weathering the storm: managing the drug shortage crisis. Hosp Pharm. 2011:46:7-11. http://www.metapress.com.libproxy.lib.unc.edu/content/c03646k108617r12/fulltext.pdf
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.
Developed by the A.S.P.E.N. Intravenous Amino Acids National Shortage Task Force: Vincent
W. Vanek, MD, FACS, CNSP, Chair; Jay Mirtallo, MS, RPh, BCNSP, FASHP; Larry Robinson, PharmD; Marty Kochevar, MS, RPh, BCNSP; and Peggi Guenter, PhD, RN, CNSN. (2010)
Revised by the A.S.P.E.N. CPC Shortage Subcommittee: Steve Plogsted, PharmD, BCNSP, CNSC, Chair; Gary Brooks, PharmD, BCPS, BCNSP; John DiBaise, MD; Antoinette Neal, RN, CRNI, CNSC, VA-BC; Joseph Ybarra, Pharm D, BCNSP. Approved by the Clinical Practice Committee and the A.S.P.E.N. Board of Directors.
Questions regarding these recommendations should be directed to Peggi Guenter, PhD, RN, CNSN, A.S.P.E.N. Director of Clinical Practice, Advocacy and Research Affairs at: firstname.lastname@example.org