So sodium Bicarbonate is Baking Soda, so why is there a shortage of it in the medical field? Why are we waiting and getting this from Australia? Is it just to drive the cost up? I don't get it....
Sodium Bicarbonate Injection
[18 January 2013]
Products Affected - Description
Sodium Bicarbonate Injection 8.4%, Amphastar (IMS)
50 mL syringe, 10 count (NDC 00548-3352-00)
Sodium Bicarbonate Injection 4.2%, Hospira
10 mL syringe, 10 count (NDC 00409-5534-34)
Sodium Bicarbonate Injection 7.5%, Hospira
50 mL syringe, 10 count (NDC 00409-4916-34)
Sodium Bicarbonate Injection 8.4%, Hospira
10 mL syringe, 10 count (NDC 00409-4900-34)
50 mL Lifeshield syringe, 10 count (NDC 00409-6637-34)
50 mL vial, 25 count (NDC 00409-6625-02)
Sodium Bicarbonate Injection 8.4%, Phebra5,6
10 mL vial, package of 10 (Sagent item reference number #32982)
Reason for the Shortage
American Regent discontinued their sodium bicarbonate 8.4% and 7.5% 50 mL vials in late 2010.1
Hospira had sodium bicarbonate on back order due to manufacturing delays and increased demand for product. Hospira discontinued their sodium bicarbonate 8.4% 50 mL Ansyr syringes in August, 2009.2
APP has sodium bicarbonate on back order due to increased demand.3
Amphastar has sodium bicarbonate on back order due to increased demand.4
FDA is allowing temporary importation of sodium bicarbonate 8.4% injection, from Phebra in Australia. Product may be ordered through Sagent Pharmaceuticals. The solution is supplied as sodium bicarbonate 8.4% in 10 mL single use vials. The main difference between Phebra’s product and current US products is how the sodium bicarbonate solution is supplied. Additionally, Phebra’s product label does not contain an NDC number. More information on the product packaging and ordering procedures can be found online.5,6
Sagent is supplying Phebra’s sodium bicarbonate directly to hospitals and not through wholesalers. The ordering information can be found online.5,6
Sodium Bicarbonate Injection 4.2% Neutralizing Additive Solution, APP
5 mL vial (NDC 63323-0026-05)
Neut, 4% sodium bicarbonate neutralizing additive solution, Hospira
5 mL vial (NDC 00409-6609-02)
Estimated Resupply Dates
Amphastar has sodium bicarbonate 8.4% 50 mL syringes on intermittent back order and the company is releasing product regularly.4
Hospira has sodium bicarbonate 4.2% 10 mL syringes, 7.5% 50 mL syringes, 8.4% 10 mL syringes on back order with an estimated release date in January, 2013. The 8.4% 50 mL vials, and 8.4% 50 mL syringes are on intermittent back order and the company is releasing product as it becomes available.2
Sagent has Phebra’s sodium bicarbonate injection on back order and the company is expecting additional product in early-February, 2013.6
Implications for Patient Care
Sodium bicarbonate injection is commonly used in critical care settings during advanced cardiac life support (ACLS). The product is also used to manage metabolic acidosis and hyperkalemia and to increase urinary pH. Sodium bicarbonate injection may be used as an antidote for selected products such as methyl alcohol, phenobarbital, or salicylates.7,8 Some centers may also use the injectable product to prepare extemporaneous oral solutions of omeprazole or lansoprazole.9
Few alternatives are available. Clinicians should make every effort to reserve supplies for critical care uses.
Alternative Agents & Management
Prepare oral solutions of omeprazole or lansoprazole using a sodium bicarbonate solution prepared from baking soda (1 teaspoon baking soda dissolved in 240 mL water).10
Tromethamine (THAM) may be a potential alternative for selected patients.11 This product is in short supply (NDC 00409-1593-04) as well.2
Sodium Lactate Injection— Resolved
American Regent (personal communications). March 19, 2012.
Hospira (personal communications). February 22 and 23, March 30, May 11, June 1 and 23, July 23, August 2 , December 1 and 15, 2010; January 4 and 3, March 23, April 26, May 23, June 20, July 28, August 22, October 31, November 16 and 29, December 14, 2011; January 26, February 17, March 12, 16, 19, and 27, April 11 and 23, May 2, 14, 23, and 25, June 4, 7, and 18, July 3 and 25, August 8 and 22, September 17, October 4, 11, and 22, November 6 and 28, and December 10, 2012; January 2 and 16, 2013.
APP (personal communications). February 15, May 11, June 1 and 23, November 29, December 1 and 14, 2010; January 3, June 23, July 22, August 23, October 4, November 16 and 29, December 12, 2011; January 26, February 17, March 9 and 28, April 11 and 23, May 18 and 23, June 4, 8, and 18, July 3 and 25, August 8 and 20, September 18, October 4, 10 and 22, November 5 and 26, and December 7, 2012; January 2, 7, and 16, 2013.
Amphastar (personal communications). November 29, 2010; January 4, February 3, March 29, April 25, June 23, August 24, November 16 and 29, December 13, 2011; January 26, February 17, March 12, 16, 19, 23, and 28, April 11 and 23, May 10 and 22, June 4, 7, and 14, July 25, August 16, September 10, October 4, 8, and 24, November 2 and 26, December 10, 2012; January 18, 2013.
FDA (personal communication). January 4, 2013.
Sagent Pharmaceuticals (personal communication). January 7 and 16, 2013.
Sodium Bicarbonate. In: McEvoy GK, Snow EK, Miller J, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:2748 – 2752.
Sodium Bicarbonate. In: Baughman VL, Golembiewski J, Gonzales JP, Alvarez W, eds. Anesthesiology & Critical Care Drug Handbook, 9th ed. Hudson, OH: Lexi-Comp; 1301 – 1304.
DiGiacinto JL, Olsen KM, Bergman KL, Hoie EB. Stability of Suspension Formulations of Lansoprazole and Omeprazole Stored in Amber-Colored Plastic Oral Syringes. Annals of Pharmacotherapy. 2000;34:600-605.
Walters JK, Zimmermann AE, Souney PF, Katona BG. The Use of Omeprazole in the Pediatric Population. 1998;32:478-481.
Tromethamine. In: McEvoy GK, Snow EK, Miller J, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011:2753 – 2754.
Updated January 18, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created March 23, 2012 by Erin R. Fox, PharmD, Manager, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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