• Sodium Bicarbonate injection, Amphastar
  8.4%, 50 mL syringe, 10 count (NDC 76329-3352-01)
  
  Sodium Bicarbonate injection, Pfizer

• • Amphastar has sodium bicarbonate injection on shortage due to increased demand.
  • Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays related to obtaining glass syringe components.

• Neut, Pfizer
  Additive solution 4%, 5 mL vial, 1 count (NDC 00409-6609-02)
  
  
  

Estimated Resupply Dates

• • Amphastar has 8.4 % sodium bicarbonate 50 mL syringes on allocation.¹
  • Pfizer has 8.4 % sodium bicarbonate 50 mL syringes on back order and the company estimates a release date of late-July 2017. The 8.4 % sodium bicarbonate 50 mL vials are on back order and the company cannot estimate a release date. The 8.4% sodium bicarbonate 10 mL syringes are on back order and the company estimates a release date of mid-September 2017. The 4.2% sodium bicarbonate 10 mL syringes are on back order and the company estimates a release date of mid-July 2017. The 7.5% sodium bicarbonate 50 mL syringes are on back order and the company estimates a release date of late-September 2017.²
  • To help alleviate the shortage, FDA is granting Athenex Pharmaceutical Division (APD) the ability to import 10 mL vials of sodium bicarbonate from Phebra, an Australian company. Supplies are limited and only available via direct orders. Orders may be placed by contacting customer service at 855-273-0154 or apdorders@dlss.com.³

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 tricyclic antidepressants, methyl alcohol, phenobarbital, or salicylates.^4,5
  • Some centers have used the injectable product to prepare extemporaneous oral solutions of omeprazole or lansoprazole.⁶

Safety

• • Few alternatives are available. Clinicians should make every effort to reserve supplies for critical care uses.
  • If using sodium acetate as an alternative, infuse the product over 15 to 20 minutes rather than 1 to 2 minutes with sodium bicarbonate.⁸
  • When drawing up doses from vials, ensure appropriate sterility measures are taken following USP <797> recommendations for batching.
  • Pfizer has issued a recall on 42 lots of sodium bicarbonate 8.4% 50 mL vials and Neut 4% additive solution due to sterility concerns.

Alternative Agents & Management

• • Conserve sodium bicarbonate for critical uses. Avoid using product for non-essential purposes such as buffering lidocaine during this shortage. The Society of Critical Care Medicine (SCCM) has recommendations for conserving sodium bicarbonate..
  • Evaluate vial use and consider methods to conserve supplies such as drawing up doses from vials rather than wasting unused product. Review storage locations such as crash carts and reduce inventory where possible.
  • If purchasing premade Continuous Renal Replacement Therapy (CRRT) solutions, consider those with higher sodium bicarbonate concentrations.
  • Sodium acetate injection may be an appropriate substitute for toxicology emergencies. The initial dose for salicylate overdose, severe cardiac arrhythmias, and initial rapid treatment of QRS widening is 1 mEq per kg body weight infused over 15 to 20 minutes with a goal serum pH of 7.5 to 7.55. Maintenance infusions are sodium acetate 150 mEq in 1 L 5% dextrose.⁸
  • 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).⁷
  • Oral sodium bicarbonate 650-mg tablets (Rising Pharmaceuticals, NDC 64980-0294-10) may be an appropriate alternative for urine alkalinization in patients receiving high-dose methotrexate.⁹

References

• 1. Amphastar (personal communications). February 17 and May 4, 2017.
  2. Pfizer (personal communications). February 17, March 13 and 21, April, 14, May 3, 18, and 19, June 9, 15, and 22, and July 6, 2017.
  3. Athenex (personal communication). May 25, 2017.
  4. Sodium Bicarbonate. In: Baughman VL, Golembiewski J, Gonzales JP, Alvarez W, eds. Anesthesiology & Critical Care Drug Handbook, 10th ed. Hudson, OH: Lexi-Comp; 1444 - 1447.
  5. Sodium Bicarbonate. In: McEvoy GK, Snow EK, Miller J, eds. AHFS 2017 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2017:2852 - 2854.
  6. 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.
  7. Walters JK, Zimmermann AE, Souney PF, Katona BG. The Use of Omeprazole in the Pediatric Population. Annals of Pharmacotherapy.1998;32:478-481.
  8. Neavyn MJ, Boyer EW, Bird SB, Babu KM. Sodium Acetate as a Replacement for Sodium Bicarbonate in Medical Toxicology: a Review. J Med Toxicol. 2013;9:250-254.
  9. Rouch JA, Burton B, Dabb A, et al. Comparison of Enteral and Parenteral Methods of Urine Alkalinization in Patients Receiving High-Dose Methotrexate. J Oncol Pharm Practice. 2017;23:3-9.