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 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 ShortagesResource Center
FDA Drug Shortages
ASPEN Product Shortage Latest News
During a Lipid Injectable Emulsion (ILE) (also
known as IV lipid emulsion/IV fat emulsion) products shortage period, consider
one or more of the following measures:
Assess and routinely reassess each patient as to the indication for PN and provide nutrition via the oral or enteral route
Purchase only as much ILE supply as needed. In the
interest of fair allocation to all patients nationally, please do not stockpile.
During prolonged shortages
of ILE products, the FDA may approve
the temporary importation of alternative products. These products may have different oil emulsion
components, fatty acid sources and amounts, and packaging and labeling compared
to products available in the United States. The Dear Healthcare Professional
Letter accompanying imported products should be carefully reviewed before
implementing clinical use. Members of the
healthcare team should be educated on any differences between imported ILE products
and ILE products approved for use in the U.S.
Compound PN in a single,
central location (either in a centralized pharmacy or as outsourced
preparation) 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 (eg, package insert), USP General Chapter
<797> Pharmaceutical Compounding-Sterile Preparations, and state Boards
of Pharmacy and federal rules and regulations.
Include PN component
shortages and outages in the healthcare organization’s strategies and
procedures for managing medication shortages and outages. These procedures should include a process:
- to identify and monitor patients who do not receive ILE,
- to notify providers when a shortage situation occurs, and
to notify patients receiving long-term (eg, more than
1 month) PN therapy and their caregivers when their PN formulation has been
adjusted for shortages and outages of PN components.
Prioritize supply of soybean
oil-based ILE as follows:
- Neonatal and pediatric hospitalized patients should continue the same ILE therapy as before the shortage to
minimize risk of adverse effects associated with essential fatty acid
deficiency (EFAD) in this high-risk patient population. Priority for ILE during critical shortages should be
given to neonates followed by pediatric patients and finally, adolescent patients.
- Adult, mild-to-moderately malnourished hospitalized patients receiving
PN less than 2 weeks may have ILE withheld during a shortage unless it is considered essential in the judgment of the healthcare
- Adult, hospitalized patients receiving PN greater than 2 weeks should
receive a total of 100 g of a soybean oil-based ILE weekly for EFAD prevention,2 which should be provided by the safest and most efficient method
that minimizes waste. The remainder of non-protein energy may be provided by
dextrose unless not indicated clinically, such as hyperglycemia,
hypertriglyceridemia, and obesity. ILE should be provided as a component of
daily energy based on current practice recommendations prior to the shortage
for some specific adult hospitalized patients (eg, patients with glucose
intolerance, severely malnourished patients, patients at risk for re-feeding
syndrome, during pregnancy). Patients should be monitored for EFAD. See #8 for more information on EFAD.
- Adult, hospitalized, critically-ill patients receiving propofol should
not require additional ILE for EFAD prevention since the soybean oil in the
medication will supply needed essential fatty acids (EFAs).
- Home or long-term care
patients receiving PN should continue to receive the same ILE therapy as before
the shortage. However, ILE should be minimized when clinically feasible. At a
minimum, patients should receive a total of 100 g of a soybean oil-based ILE
weekly for EFAD prevention which should be provided by the safest and most
efficient method that minimizes waste. The remainder of non-protein energy
should be provided by dextrose unless not indicated clinically, such as
hyperglycemia, hypertriglyceridemia, and obesity. ILE
should be provided as a component of daily energy based on current practice
recommendations prior to the shortage for some specific adult home or long-term PN patients (eg,
patients with glucose intolerance, severely malnourished patients, patients at
risk for refeeding syndrome, during pregnancy). Patients should be monitored
for EFAD. See # 8 for information on EFAD.
Monitor closely patients receiving PN for developing
EFAD when your institution is experiencing ongoing shortages. Increase awareness
and assessment for signs and symptoms of EFAD. Signs and symptoms of EFAD
include, but are not limited to, diffuse dry, scaly rash, alopecia,
thrombocytopenia, anemia, and impaired wound healing. Biochemical evidence of
EFAD is confirmed by a triene-to-tetraene ratio greater than 0.2.
Using topical oils for prevention
and treatment of EFAD has produced mixed results. Safflower and sunflower seed
oils had beneficial results whereas vegetable oil (corn oil) did not.
Consider using an
alternative ILE product such as a four-oil (soybean oil, medium chain
triglycerides, olive oil and fish oil) during a soybean oil-based ILE shortage. This product is only approved for use in adults in the
U.S. The doses
and frequency of administration to meet EFA needs for adults may be different
than soybean oil-based ILE. Consult the manufacturer for specific information
on meeting EFAs needs. The healthcare
team should be educated on the differences between alternative ILE products and
soybean oil-based ILE products.
In the event of a four-oil
(soybean oil, medium chain triglycerides, olive oil and fish oil) ILE shortage
use standard soybean oil-based ILE dosing and frequency to meet patients’ EFAs needs.
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 Institute for Safe
Medication Practices (ISMP) Medication Errors Reporting Program
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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; Stephen C. Adams, MS, RPh, BCNSP; Karen
Allen, MD; M. Petrea Cober, PharmD, BCNSP, BCPPS; June Greaves, RD, CNSC, CD-N, LD,
LDN; Amy Ralph, MS, RD, CNSC, CSO, CDN; Daniel T. Robinson,
MD; Kim Sabino, MS, RD, CNSC; Renee Walker, MS, RD, LD, CNSC, FAND; Ceressa T.
Ward, PharmD, BCPS, BCNSP, BCCCP; and Joe Ybarra, PharmD, BCNSP.
Approved by the
ASPEN Clinical Practice Committee and the Board of Directors on December 21,
regarding these recommendations should be directed to Beverly Holcombe, PharmD,
BCNSP, FASHP, FASPEN, Clinical Practice Specialist, ASPEN at [email protected]