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|Newsletters: Drug Shortage Update|
Drug Shortage Update
Peggi Guenter, PhD, RN, and Beverly Holcombe, PharmD, BCNSP, FASHP, American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.)
LifelineLetter, July/August 2013
Due to severe shortages in IV phosphate and IV trace elements, the Food and Drug Administration (FDA) announced that new supplies of trace elements and phosphate injections, critical drugs used in parenteral nutrition, will be available to U.S. patients. On May 29, the FDA announced it has given permission for Fresenius Kabi to import Glycophos™, Peditrace™, and Addamel N™.
This is good news, but health care providers and consumers need to be aware that there are several differences between these products and those currently available in the U.S. Consumers should be aware of the differences between the products and know what products they are getting. Ask questions and consider sharing the information discussed below with your health care provider if you have concerns.
For background information as well as the most recent updates on drug shortages, visit the A.S.P.E.N. Web site (www.nutritioncare.org; select “Professional Resources,” “Drug Shortages Update”). More information, including details on how to sign the drug-shortage petition and suggestions for contacting your congressional representatives, is available on www.oley.org.
IV Phosphate (Glycophos™)
There are some key differences in the formulation and labeling between the current U.S.-marketed IV phosphate products and the imported product, Glycophos, which is sodium glycerophosphate. Fresenius Kabi’s “Dear Healthcare Professional” letter should be read carefully (online at www.fda.org [search for “Glycophos”] or from Oley, 800-776-6539).
Some of the notable differences are:
IV Trace Elements (Addamel N™, Peditrace™)
Also in May, the FDA announced importation of both adult and pediatric multi-trace element products. As with the IV phosphate, there are some key differences in the formulations, and Fresenius Kabi’s “Dear Healthcare Professional” letters should be read carefully (www.fda.gov; search for “adult multi-trace element” or “pediatric multi-trace element”; or from Oley, 800-776-6539).
The adult multi-trace element product contains a small amount of iron and caution should be taken when adding this product to parenteral nutrition formulations containing IV fat emulsions (total nutrient admixtures, 3-in-1 formulations) due to potential disturbance interaction of the fat emulsion. This product also contains other trace elements not routinely found in U.S. products, such as iodide and fluorine. For more information on trace elements, please see “2012 Recommendations for Changes in Commercially Available Parenteral Multivitamin and Multi-Trace Element Products” (Nutrition in Clinical Practice, August 2012) and the other references on the A.S.P.E.N. Web site.The tables compare these imported products and the traditional products now on shortage. For questions or to report an Adverse Drug Event, call (800) 551-7176, Monday to Friday, 8 a.m. to 5 p.m. (CST) or appmedicalinfo@APPpharma.com. Clinicians: To order these products, call the Fresenius Kabi Customer Service Department at (888) 386-1300.