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Parenteral Nutrition Intravenous Fat Emulsions Product Shortage Considerations 

 

May 2013


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 Intravenous Fat Emulsion (IVFE) shortage period, consider one or more of the following measures:

  1. Assess each patient as to the indication for PN and provide nutrition via the oral or enteral route when possible.
  2. Purchase only as much IVFE supply as needed.  In the interest of fair allocation to all patients nationally, please do not stockpile.
  3. 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.
  4. Prioritize supply of IVFE as follows:
    • 10% - use for adults and older pediatric patients without fluid restriction;  can use dextrose/amino acids or total nutrient
      admixture formulations
    • 20% - prioritize for neonates and smaller pediatric patients; older pediatric patients and adults requiring fluid restriction
    • 30% - use for compounding total nutrient admixtures
  5. Neonatal/Pediatric hospitalized patients should continue the same IVFE as before the shortage as the provision of IVFE is critical to these patients.
  6. Adult, mild-to-moderately malnourished hospitalized patients on PN less than 2 weeks may have IVFE withheld during a shortage unless it is considered essential in the judgment of the healthcare professional.
  7. Adult, hospitalized patients on PN greater than 2 weeks should receive a total of 100 g fat weekly, which may be given by whatever method is safe and efficient (minimizing IVFE waste) to prevent essential fatty acid deficiency (EFAD) with the remainder of non-protein energy provided by
    dextrose. Patients should be monitored for EFAD. Signs and symptoms of EFAD include diffuse dry, scaly rash, alopecia, thrombocytopenia, anemia, and impaired wound healing. Biochemical evidence of EFAD is confirmed by a triene-to-tetraene ratio of >0.4.1,2  For some specific adult hospitalized patients (e.g., patients with glucose intolerance, severely malnourished patients, patients at risk for re-feeding syndrome, and during pregnancy), IVFE should be provided as a component of daily energy based on current practice prior to the shortage. 
  8. Adult, hospitalized, critically-ill patients receiving propofol should not need additional IVFE to prevent EFAD since the soybean oil in the medication will supply needed essential fatty acids.
  9. Home or long-term care patients should continue to receive the same IVFE therapy as before the shortage.  However, minimize use of IVFE when clinically feasible. At a minimum, patients should receive a total of 100 g fat weekly which may be given by whatever method is safe and efficient (minimizing IVFE waste) to prevent EFAD with the remainder of non-protein energy provided by dextrose.   Patients should be monitored for EFAD. For some specific adult home or long-term care patients, (e.g., patients with glucose intolerance, severely malnourished patients, patients at risk for re-feeding syndrome, and during pregnancy), IVFE should be provided as a component of daily energy based on current practice prior to the shortage.
  10. 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.
  11. Report severe drug product shortage information to the FDA Drug ShortageProgram (DSP). See: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm142398.htm 
  12. Report any patient problems related to shortages to ISMP Medication Errors Reporting Program (MERP).  To access that reporting mechanism, click here.
     

Suggested Readings:

  1. Sardesai VM, The essential fatty acids. Nutr Clin Pract. 1992;7:179-186.
  2. Hamilton D, Austin T, Seidner DL. Essential fatty acid deficiency in human adults during parenteral nutition. Nutr Clin Pract. 2006;21:387-394. 
     

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 Fat Emulsion National Shortage Task Force: Vincent W. Vanek, MD, FACS, CNSP Chair; Penny Allen, RD, LD, CNSC; Lillian P. Harvey Banchik, MD, CNSP, FACS; Bruce Bistrian, MD, PhD; Sharon Collier, RD, LDN, M Ed; David F. Driscoll, Ph.D.; Kathleen Gura, PharmD, BCNSP; Deborah R Houston PharmD, BCNSP; John Miles, MD; Jay Mirtallo, MS, RPh, BCNSP, FASHP; Kris M. Mogensen, MS, RD, LDN, CNSD; and Doug Seidner, MD, CNSP. (2010)
 

Revised by the A.S.P.E.N. Clinical Practice Committee 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. (2013)
 

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: peggig@aspen.nutr.org 

 

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