Earlier this Fall, Puerto Rico was pummeled by Hurricane Maria. In the wake of the storm’s devastation, hospitals and healthcare facilities on the mainland have shared in the aftermath. With manufacturing facilities located in Puerto Rico, Baxter Healthcare Corporation, a leading producer of amino acids and other parenteral infusions, was severely affected by the storm. As a result, there are now critical nationwide shortages of several premixed parenteral nutrition products. Read on to learn how you and your patients may be affected.
What Products are Affected by the Shortages?
Baxter has identified the following premixed amino acid solutions that are critically low:
- Clinimix E 2.75/5 (sulfite-free)
- Clinimix E 2.75/10 (sulfite-free)
- Clinimix E 4.25/5 (sulfite-free)
- Clinimix E 4.25/10 (sulfite-free)
- Clinimix E 4.25/20 (sulfite-free)
- Clinimix E 4.25/20
- Clinimix E 4.25/25 (sulfite-free)
- Clinimix E 5/15 (sulfite-free)
- Clinimix E 5/20 (sulfite-free)
- Clinimix E 5/25 (sulfite-free)
- Clinisol 15% (sulfite-free)
- Premasol 10% (sulfite-free)
- Travasol 10%
To review the National Drug Code (NDC) numbers for the Clinimix E products, click here. For all others, click here.
When ordering parenteral nutrition, order wisely. Baxter has placed all amino acid formulations on allocation, which means they are making extra efforts to ensure fair distribution of these very limited resources.
How to Manage these Critical Shortages
Stay informed. Check to see if your facility utilizes any of the products that are down to critically low levels. If so, stay in touch with your supplier. Find out if any other products are available to be substituted. The American Society for Parenteral and Enteral Nutrition (ASPEN) is sending weekly updates to its members. You can read their management tips here.
Use parenteral nutrition for only those patients who have no other option. As a dietitian, you are likely doing this already. But make extra efforts to delay the initiation of parenteral nutrition in those patients who are not malnourished and accelerate the weaning process for those who may be candidates for oral or enteral feeding.
Order wisely. Baxter has placed all amino acid formulations on allocation, which means they are making extra efforts to ensure fair distribution of these very limited resources. Thus, please do not order more than you need in an effort to “stockpile” supplies.
Use substituted products, if appropriate. Baxter does have adequate supplies of Clinisol, Premasol, and Prosol in different concentrations. In November, the FDA approved the temporary importation of a handful of amino acid preparations from the Baxter facility in the United Kingdom. These products are listed below.
ASPEN cautions healthcare providers to carefully read dosing instructions and review the contents of these products, particularly with regard to pH, calcium-phosphorus solubility, and aluminum content for neonates. Keep in mind there are other parenteral nutrition components manufactured in the United States by other companies including, B. Braun Medical, Inc., Hospira Inc., and Pfizer Injectables that may suit your patients’ needs.
- Synthamin 17 without electrolytes (10% amino acids product)
- Clinimix 2.75% amino acids in 7.5% glucose with electrolytes (1000 ml)
- Clinimix 2.75% amino acids in 10% glucose with electrolytes (1000 ml)
- Clinimix 4.25% amino acids in 15% dextrose with electrolytes (2000 ml)
As we navigate these shortages together as a network of clinicians, be patient. Unfortunately, these amino acid shortages are the latest addition to the list of parenteral nutrition component shortages. Dietitians On Demand supports the efforts of our dietitians who work hard every day to meet the needs of their patients.
Important note: This information does not constitute medical or professional advice and should not supersede facility-specific guidelines or recommendations. The formulations listed above may not be a comprehensive list of all products affected by nationwide shortages. Be sure to check with your local supply chain for the most up-to-date parenteral nutrition shortage information.
Sara Glanz, MS, RD, LD, CNSC is a travel dietitian for Dietitians On Demand. She is passionate about empowering dietitians to be more involved with the interdisciplinary healthcare team. Her favorite adventures while on assignment include: The 17-Mile Drive in Monterey, CA; Lake Placid, NY; Montreal, Canada; and of course, the Jelly Belly® Jelly Bean and Ben & Jerry’s® ice cream factories located in Fairfield, CA and Burlington, VT, respectively.
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