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Information to Use in the Event of an Intravenous Amino Acids Shortage

October 2010

Introduction
 

There is currently an intravenous amino acids shortage in the U.S. due to a temporary decrease in market supply and it is not clear when the supply will return to normal levels.  The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) has assembled a group of experts to develop clinical recommendations for amino acids in parenteral nutrition (PN) during this shortage.  A.S.P.E.N. is also in constant communication with the U.S. amino acids suppliers and will continue to monitor the market and provide further information as this situation changes. It is anticipated that this shortage might continue until early 2011. Please inform A.S.P.E.N. if you are unable to obtain amino acid products once you have taken these steps below.

1. Purchase only as much supply as needed.  In the interest of fair allocation to all patients nationally, please do not stockpile.

2. Use Neonatal / Pediatric-specific amino acids (or specialty amino acids) ONLY for their indicated patient populations.

3. Consider reviewing the entire portfolio of amino acid solutions available nationally. There may be a shortage in one concentration but availability in another.  See attached Table (IV Amino Acid Products in the U.S.) for a detailed listing.

4. Use high concentration amino acid products (e.g., >10%) sparingly, for example, save high concentration amino acids for fluid-restricted PN patients.

5. Different brands of amino acid solutions are not always directly substitutable (especially for 3-in-1 vs. 2-in-1 PN formulations).  They may have different pHs, different calcium-phosphorus solubilities, different amounts of phosphorus, plus other characteristics that should be considered.

6. Consider the processes of temporarily changing your PN formulary and system. These may include the need to double check PN compounding processes (and PN automated compounder settings) when using a substituted amino acid product, educating prescribers, gaining Pharmacy & Therapeutics Committee approval as needed, and altering CPOE or order forms as needed.

7. During the period of shortage, wastage of amino acid products are a concern.  Any manipulation of amino acids from its original container may potentially increase risk of contamination and product instability.  Facilities and practitioners need to observe and be compliant with the amino acid product labeling (eg, package insert), USP General Chapter <797> Pharmaceutical Compounding-Sterile Preparations, and state Boards of Pharmacy rules and regulations.  Please consult the PN automated compounding device manufacturer and the manufacturer of the nutritional PN product regarding any issues with compatibility and use.  Practices outside of these sources should not be implemented.

8. Assess your PN patient population to determine if a standardized, commercial parenteral nutrition product1 (AKA, "premix" PN) might be appropriate for a portion of your patient population.

 

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.

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 

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. 

 

IV Amino Acid Product in the U.S.
October 12, 2010  (B.Braun updated October 2012)

 

Unless noted otherwise, product is available

Underlined products are specialty amino acids

 

Product  

Container Size 

Availability 

Hospira 

 

 

Aminosyn® 3.5% M with Electrolytes Sulfite-Free
0409-4196-05

1000 mL Plastic

 

Aminosyn® 8.5% Sulfite-Free
0409-4187-03

500 mL Plastic

 

Aminosyn® 8.5% with Electrolytes Sulfite-Free
0409-4203-03

500 mL Plastic

 

Aminosyn® 10% Sulfite-Free
0409-4191-03
0409-4191-05

500 mL Plastic

1000 mL Plastic

 

Aminosyn® II 8.5% Sulfite-Free

0409-4162-03

500 mL Plastic

 

Aminosyn® II 8.5% with Electrolytes Sulfite-Free

0409-4171-03

500 mL Plastic

 

Aminosyn® II 10% Sulfite-Free

0409-4164-03

0409-4164-05

500 mL Plastic

1000 mL Plastic

Estimated stock out mid-Nov.

Out of Stock

Aminosyn® II 10%

0409-7121-07

2000 mL Pharm Bulk Pkg — Plastic

Out of Stock

Aminosyn® II 15%

0409-7122-07

2000 mL Pharm Bulk Pkg — Plastic

Out of Stock

Aminosyn®-HBC 7% Sulfite-Free (High Branched Chain)

0409-4168-03

500 mL Plastic

 

Aminosyn®-PF 7% Sulfite-Free (Pediatric Formula)

0409-4178-03

500 mL Plastic

 

Aminosyn®-PF 10% Sulfite-Free (Pediatric Formula)

0409-4179-05

1000 mL Pharm Bulk Pkg — Plastic

 

Aminosyn®-RF 5.2% Sulfite-Free (Renal Formula)

0409-4166-03

500 mL Plastic

 

 

 

 

Baxter 

 

 

10% TRAVASOL (Amino Acid) Injection in VIAFLEX plastic container

0338-0644-03

0338-0644-04

0338-0644-06

500 mL Pharmacy Bulk Package

1000 mL Pharmacy Bulk Package

2000 mL Pharmacy Bulk Package

Product line on allocation from Baxter

15% CLINISOL-sulfite-free (Amino Acid) Injection in VIAFLEX plastic container
0338-0502-03

0338-0502-06

500 mL Pharmacy Bulk Package

2000 mL Pharmacy Bulk Package

Product line on allocation from Baxter

20% PROSOL - sulfite-free (Amino Acid) Injection in a VIAFLEX Plastic Container
0338-0499-06

2000 mL Pharmacy Bulk Package

Product line on allocation from Baxter

6% PREMASOL - sulfite-free (Amino Acid) Injection in VIAFLEX Plastic Container
0338-1131-03

500 mL Pharmacy Bulk Package

Product line on allocation from Baxter as of 10-7-2010

10% PREMASOL - sulfite-free (Amino Acid) Injection in VIAFLEX Plastic Container
0338-1130-03

0338-1130-04

0338-1130-06

500 mL Pharmacy Bulk Package

1000 mL Pharmacy Bulk Package
2000 mL, Pharmacy Bulk Pharmacy

Product line on allocation from Baxter as of 10-7-2010

8% HEPATASOL - sulfite-free (Amino Acid) Injection in VIAFLEX Plastic Container
0338-0504-03

500 mL container

Product line on allocation from Baxter as of 10-7-2010

 

 

 

CLINIMIX 2.75/5 sulfite-free (2.75% Amino Acid in 5% Dextrose) Injection in CLARITY Dual Chamber Container

0338-1132-03

1000 mL

 

CLINIMIX 4.25/5 sulfite-free (4.25% Amino Acid in 5% Dextrose) Injection in CLARITY Dual Chamber Container

0338-1133-03

0338-1089-04

1000 mL

2000 mL

 

CLINIMIX 4.25/10 sulfite-free (4.25% Amino Acid in 10% Dextrose) Injection in CLARITY Dual Chamber Container

0338-1134-03

0338-1091-04

1000 mL

2000 mL

 

CLINIMIX 4.25/20 sulfite-free (4.25% Amino Acid in 20% Dextrose) Injection in CLARITY Dual Chamber Container

0338-1135-03

0338-1093-04

1000 mL

2000 mL

 

CLINIMIX 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection in CLARITY Dual Chamber Container

0338-1136-03

0338-1095-04

1000 mL

2000 mL

 

CLINIMIX 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection in CLARITY Dual Chamber Container

0338-1137-03

0338-1099-04

1000 mL

2000 mL

 

CLINIMIX 5/20 sulfite-free (5% Amino Acid in 20% Dextrose) Injection in CLARITY Dual Chamber Container

0338-1138-03

0338-1101-04

1000 mL

2000 mL

 

CLINIMIX 5/25 sulfite-free (5% Amino Acid in 25% Dextrose) Injection in CLARITY Dual Chamber Container

0338-1139-003

0338-1103-04

1000 mL

2000 mL

 

CLINIMIX E 2.75/5 sulfite-free (2.75% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection in CLARITY Dual Chamber Container

0338-1107-04

0338-1142-03

1000 mL

2000 mL

 

CLINIMIX E 2.75/10 sulfite-free (2.75% Amino Acid in 10% Dextrose with Calcium) Injection with Electrolytes in CLARITY Dual Chamber Container

0338-1143-03

0338-1109-04

1000 mL

2000 mL

 

CLINIMIX E 4.25/5 sulfite-free (4.25% Amino Acid with Electrolytes in 5% Dextrose with Calcium) Injection in CLARITY Dual Chamber Container

0338-1144-03

0338-1113-04

1000 mL

2000 mL

 

CLINIMIX E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection in CLARITY Dual Chamber Container

0338-1145-03

0338-1115-04

1000 mL

2000 mL

 

CLINIMIX E 4.25/25 sulfite-free (4.25% Amino Acid with Electrolytes in 25% Dextrose with Calcium) Injection in CLARITY Dual Chamber Container

0338-1146-03

0338-1119-04

1000 mL

2000 mL

 

CLINIMIX E 5/15 sulfite-free (5% Amino Acid in 15% Dextrose with Calcium) Injection with Electrolytes in CLARITY Dual Chamber Container

0338-1147-03

0338-1123-04

1000 mL

2000 mL

 

CLINIMIX E 5/20 sulfite-free (5% Amino Acid in 20% Dextrose with Calcium) Injection with Electrolytes in CLARITY Dual Chamber Container

0338-1148-03

0338-1125-04

1000 mL

2000 mL

 

CLINIMIX E 5/25 sulfite-free (5% Amino Acid in 25% Dextrose with Calcium) Injection with Electrolytes in CLARITY Dual Chamber Container

0338-1149-03

0338-1127-04

1000 mL

2000 mL

 

B Braun 




 

 

 

 

 

  15% amino acids

 0264 3200 55

1000 mL glass

 

10% FreAmine® III

0264-9011-55

1000 mL glass

B Braun increasing supply of 1L FreAmine III

6.9% FreAmine HBC®

0264-9350-55

750 mL fill in 1000 mL container-glass

 

ProcalAmine® (3% AA & 3% glycerin with Lytes)

0264-1915-07

1000 mL glass

 

5.4% Nephramine®

0264-1909-55

250 mL glass

 

8% Hepatamine®

0264-9371-55

500 mL glass

 

6% TrophAmine®

0264-9361-55

500 mL glass

 

10% TrophAmine®

0264-9341-55

500 mL glass

 

 

 

Baxter