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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:

  • Glycophos is an organic phosphate, which is a different type of phosphate than the inorganic phosphate injection products currently marketed in the U.S. Organic phosphates tend to be more calcium compatible. This means at higher concentrations, solutions of calcium and phosphate may exist together without precipitating into an insoluble salt complex. In high pH solutions (admixture above pH 6.0), organic phosphate is less likely to precipitate.

  • Glycophos contains 1 mmol of phosphate per 1 mL of solution as compared to the phosphates currently marketed in the U.S., which contain 3 mmol of phosphate per 1 mL. When converting from inorganic phosphate products (i.e., sodium phosphate and potassium phosphate) to an organic phosphate product (i.e., sodium glycerophosphate), use the same amount of phosphate in millimoles.

  • Glycophos is intended for single use.

 

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.  
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This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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