Products Affected - Description

Reason for the Shortage

• American Regent has sodium phosphate injection on back order due to manufacturing delays.^1,2    
• American Regent has issued a statement that all lots of sodium phosphate may contain glass particles and filters must be used. Do not use if there are visible glass particles and filter all other product.^3,4
• Hospira has sodium phosphate injection on shortage due to manufacturing delays.⁵
• In cooperation with FDA, APP/Fresenius Kabi USA is providing Glycophos (sodium glycerophosphate) injection to the US market to help alleviate the shortage. Glycophos is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG, the parent company of APP.⁶    
  

Available Products

Estimated Resupply Dates

• American Regent has sodium phosphate 3 mmol/mL 5 mL, 15 mL, and 50 mL vials on back order and the company cannot estimate a release date.⁴
• Hospira has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a release date of July 2013.⁵
• APP/Fresenius Kabi AG have Glycophos on intermittent back order and the company is releasing product as it becomes available.⁷

Implications for Patient Care

Phosphate injection products are used to treat and prevent hypophosphatemia.⁸

Safety

• Dosing differs between the imported and FDA approved product. Use caution when switching between products.⁶
• Bar coding systems should not be used on Glycophos vials as incorrect information may be provided if the item is scanned.⁶
• Glycophos is preservative free and for single use only.⁶
• Compatibility data are limited for Glycophos.⁹
• Report any offers to sell Glycophos by an entity other than APP Pharmaceuticals to drugshortages@fda.hhs.gov. APP/Fresenius Kabi USA will only be releasing product to the following distributors: Amerisource Bergen, McKesson, Cardinal, Morris & Dickson, and HD Smith.

Alternative Agents & Management

• Glycophos contains sodium glycerophosphate, an organic phosphate that is different from any phosphate product available in the US. Glycophos is supplied in a 20 mL single dose vial and one milliliter of Glycophos contains 1 mmol of phosphate and 2 mEq of sodium. Glycophos does not contain a preservative and the product must be diluted before administration.⁹ APP/Fresenius Kabi USA has a Dear Healthcare professional letter that summarizes the key differences between products.
• Product labeling for Glycophos injection is available.
• A randomized crossover study compared pharmacokinetic parameters and adverse events of Glycophos and sodium phosphate when given to healthy adults. Both study medications were diluted in normal saline and given as a single infusion over 4 hours with a washout period of 7 days between doses. Pharmacokinetic parameters and adverse events were similar in both treatment groups.¹⁰
• A randomized crossover study compared pharmacokinetic parameters and adverse events of Glycophos and a total parenteral solution (TPN), Kabiven, containing sodium glycerophosphate and phospholipids when given to healthy adults. Glycophos was diluted in normal saline to the same concentration as the TPN formulation and given at the same rate and dose with a washout period between doses. Pharmacokinetic parameters and adverse events were similar in both treatment groups.¹¹
• Limited compatibility data are available for Glycophos (sodium glycerophosphate). However, the product labeling for Kabiven, a TPN product not available in the US, contains lipids, amino acids, electrolytes, and sodium glycerophosphate.   Information is available for Kabiven Labeling.  
• Fresenius Kabi has product labeling for various parenteral nutrition components, including compatibility information with Glycophos, on their website. Clinicians can access this information but must register first with Fresenius Kabi.   
• The American Society for Parenteral and Enteral Nutrition (ASPEN) has detailed recommendations for managing this shortage.¹² 

Key recommendations include:

• Reserve supplies for neonatal or pediatric patients or other vulnerable groups such as patients with short bowel or malabsorption syndromes.
• Use standardized premixed parenteral nutrition containing electrolytes and minerals whenever possible.
• Use premixed electrolyte and mineral products whenever possible.
• Avoid use of injectable electrolytes and minerals as supplements in patients receiving enteral nutrition.
• Monitor serum concentrations of electrolytes and increase vigilance of signs and symptoms of electrolyte and mineral deficiencies.
• Purchase only the supply needed, do not stockpile.
  

Related Shortages

• Bisacodyl Enema— Resolved

1. Luitpold Pharmaceuticals. Press Release. Accessed May 28, 2013.
2. Luitpold Pharmaceuticals. Press Release. Accessed May 28, 2013.
3. American Regent. Press Release.  Accessed April 16, 2013.
4. American Regent Laboratories (personal communications). December 12, 2012; January 16, February 4 and 20, March 18, April 9, 22, 25, and 29, May 23 and 28, and June 4 and 12, 2013.
5. Hospira (personal communications). December 12, 2012; January 16, February 4 and 20, March 18, April 9, 22, 25, and 29, May 23 and 28, and June 4 and 12, 2013.
6. APP/Fresenius Kabi USA. Dear Healthcare Professional Letters (customer letter).  Accessed May 29, 2013.
7. APP (personal communications). May 28 and June 4 and 13, 2013.
8. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2013.
9. Fresenius Kabi. Glycophos Concentrate for Solution for Infusion [product information]. Halden, Norway: Fresenius Kabi Norge AS, 2008.
10. Topp H, Hochfeld O, Bark S, Grossmann M, Joukhadar C, Westphal M, Straatsma H, Rothenburger M. Glycerophosphate is interchangeable with inorganic phosphate in terms of safety and serum pharmacokinetics. Pharmacology. 2011;88(3-4):193-200. doi: 10.1159/000331341. Epub 2011 Oct 4. PubMed PMID: 21986180.
11. Topp H, Hochfeld O, Bark S, Grossmann M, Joukhadar C, Westphal M, Straatsma H, Rothenburger M. Glycerophosphate does not interact with components of parenteral nutrition. Pharmacology. 2011;88(1-2):114-20. doi: 0.1159/000330066. Epub 2011 Aug 25. PubMed PMID: 21865768.
12. American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Electrolyte / Mineral Product Shortage Considerations.  Accessed May 28, 2013.
    

Updated