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0.9% Sodium Chloride Large Volume Bags

Last Updated: November 19, 2018
Status: Current

Products Affected - Description
    • 0.9% Sodium Chloride injection, BBraun, 1000 mL PVC/DEHP-free bag, NDC 00264-7800-00
    • 0.9% Sodium Chloride injection, BBraun, 250 mL PVC/DEHP-free bag, 24 count, NDC 00264-7800-20
    • 0.9% Sodium Chloride injection, BBraun, 500 mL PVC/DEHP-free bag, 24 count, NDC 00264-7800-10
Reason for the Shortage
    • Baxter discontinued 0.9% sodium chloride 250 mL and 500 mL AVIVA bags. The Viaflex bags and Viaflo bags are available.[1]
    • BBraun did not provide a reason for the shortage.[2]
    • ICU Medical cited increased demand as the reason for the shortage.[3]
    • Fresenius Kabi is no longer importing product.[8]
    • Baxter has received FDA approval for 0.9% sodium chloride in Viaflo containers manufactured in an FDA-approved facility in Spain. Additional information about this product is available at: http://www.baxter.com/information/saline_supply.html.
Available Products
    • 0.9% Sodium Chloride injection, Baxter, 1000 mL bag, 14 count, NDC 00338-0049-04
    • 0.9% Sodium Chloride injection, Baxter, 1000 mL PVC/DEHP-free bag, NDC 00338-9542-06
    • 0.9% Sodium Chloride injection, Baxter, 250 mL PVC/DEHP-free bag, NDC 00338-9542-01
    • 0.9% Sodium Chloride injection, Baxter, 250 mg bag, 36 count, NDC 00338-0049-02
    • 0.9% Sodium Chloride injection, Baxter, 500 mL bag, 24 count, NDC 00338-0049-03
    • 0.9% Sodium Chloride injection, Baxter, 500 mL PVC/DEHP-free bag, NDC 00338-9542-02
    • 0.9% Sodium Chloride injection, ICU Medical, 1000 mL bag, 12 count, NDC 00409-7983-09
    • 0.9% Sodium Chloride injection, ICU Medical, 150 mL bag, 32 count, NDC 00409-7983-61
    • 0.9% Sodium Chloride injection, ICU Medical, 250 mL bag, 24 count, NDC 00409-7983-02
    • 0.9% Sodium Chloride injection, ICU Medical, 250 mL PVC/DEHP-free bag, 24 count, NDC 00409-7983-25
    • 0.9% Sodium Chloride injection, ICU Medical, 250 mL (2 ports) bag, 24 count, NDC 00409-7983-53
    • 0.9% Sodium Chloride injection, ICU Medical, 500 mL (2 ports) bag, 18 count, NDC 00409-7983-55
    • 0.9% Sodium Chloride injection, ICU Medical, 500 mL bag, 24 count, NDC 00409-7983-03

Estimated Resupply Dates

    • BBraun has 0.9% sodium chloride 250 mL, 500 mL, and 1,000 mL PVC/DEHP-free bags on allocation to current customers.[2]
    • ICU Medical has all 0.9% sodium chloride bags readily available except the 0.9% sodium chloride 250 mL and 500 mL bags are available to current customers only. [3]

Implications for Patient Care

    • Sodium chloride injection is widely used for a variety of indications.[9] As this shortage worsens, other solutions such as lactated ringers may be affected.

Safety

    • Clinicians may need to utilize different product sizes if large bags are not available. More frequent bag changes may be needed.
    • Compounding sodium chloride solutions from sterile water for injection and concentrated sodium chloride injection could lead to medication errors and inadvertent administration of plain sterile water, and contribute to current shortages of concentrated sodium chloride injection (23.4% or 14.6%).
    • Multiple brands of products may be available in the system.
    • Avoid use of irrigation solution for intravenous use. Sterility requirements and limits on particulate matter differ between these two products.[1-2,4,10-12]

Alternative Agents & Management

    • Consider using oral hydration whenever possible.
    • Make policies to allow substitution of products based on product availability at the site. For example, an organization could choose to allow Lactated Ringers Solution to be substituted for 0.9% sodium chloride solution or 5% dextrose with 0.45% sodium chloride to be substituted for 5% dextrose. Table 1 provides a comparison of fluid components.
    • Evaluate total fluid requirements for surgeries. The American College of Surgeons 2014 Principles and Practice notes total volume replacement needs for elective surgeries are much less (500 mL to 3000 mL total) than traditionally thought (4500 mL to 6000 mL total).[13]
    • Evaluate the clinical need for intravenous fluid replacement and "keep vein open" orders at every shift change. Consider catheter locks and flushes for eligible patients. Discontinue infusions when appropriate.
    • Use smaller bag sizes for low rate infusions when possible. See Table 2 for suggestions. Use smaller bags and low flow rates as 0.9% sodium chloride is often used to keep an intravenous line open.
    • Consider reserving some products for specific clinical situations as outlined in Table 3.
    • Consider using commercial dialysis solutions whenever possible instead of compounding with normal saline.
    Table 1. Comparison of Selected Intravenous Fluids14-17
    Product mOsm/L Na (mEq/L) Cl (mEq/L) Dextrose (g/L) K (mEq/L) Ca (mEq/L) Lactate (mEq/L)
    0.9% Sodium Chloride 308 154 154
    0.45% Sodium Chloride 154 77 77
    5% Dextrose plus 0.225% Sodium Chloride 329 38.5 38.5 50
    5% Dextrose plus 0.45% Sodium Chloride 406 77 77 50
    5% Dextrose plus 0.9% Sodium Chloride 560 154 154 50
    5% Dextrose 252 50
    Lactated Ringers Solution 273 130 109 4 2.7 28
    Lactated Ringers and 5% Dextrose Solution 525 130 109 50 4 2.7 28

    Table 2. Suggested Bag Sizes for Specific Rates of Infusion
    Infusion Rate Bag Size
    20 mL/hour or less 250 mL
    21 mL/hour to 40 mL/hour 500 mL

    Table 3. Considerations for Reserving Products for Selected Clinical Situations
    Clinical Situation Product Comments
    Large volume replacement (surgery) Lactated Ringers Solution Large volumes of 0.9% sodium chloride may contribute to hyperchloremic acidosis.
    Patients requiring sodium restriction 5% Dextrose Solution and Low Sodium Containing Solutions Consider reserving a supply of solutions that are low in sodium.
    Patients susceptible to hypoglycemia Products containing 5% Dextrose Solution Women and children may be more susceptible to hypoglycemia following fasts > 24 hours.

References

    1. Baxter (personal communications). January 29, February 4, March 14, April 17, May 15, June 13, July 2, August 8, September 18, October 15, November 13, December 5, 2013; January 13, 15, and 16, March 24, April 29, May 22, June 19, July 31, September 10, November 3 and 11, 2014; January 28, April 15, May 18, June 3, July 6, September 9, October 29, 2015; January 7, March 24, May 31, July 20, October 17, and December 13, 2016; January 31, February 13, March 27, May 22, July 12, October 3, November 2, December 8, 2017; January 17, February 15, March 14, May 16, June 25, and August 29, 2018.
    2. BBraun (personal communications). January 29, February 4, March 14, April 17, May 15, June 13, July 2, September 9, October 15, November 18, December 5, 2013; January 16, February 27, April 14, May 19, June 19, September 10, 2014; January 28, April 20, July 6, September 9, 2015; January 26, March 21, May 23, October 11, and December 12, 2016; February 7, March 27, July 14, September 12, October 3, November 1, 2017; and January 17, 2018.
    3. ICU Medical (personal communications and website). March 27, April 4, May 22, July 11, October 3, 11, and 25, November 17, December 12, 2017; January 17, February 15, March 14, April 11, May 3 and 16, June 25, August 31, October 4, and November 13 and 16, 2018.
    4. Pfizer (personal communications and website). January 29, February 4, March 14 and 21, April 17, May 15, June 13, July 2 and 11, September 12 and 18, October 15, November 18, December 5 and 16, 2013; January 14, 16, and 28, February 27, March 4 and 28, April 14, May 21, June 2 and 19, July 31, September 3, November 3 and 14, 2014; January 28, February 16 and 24, April 20, May 4 and 18, June 2 and 17, July 6, September 15 and 28, October 30, 2015; January 26, March 24, May 31, August 5, October 19, and December 15, 2016; January 31, 2017.
    5. Fresenius Kabi USA (personal communications). March 27, April 14 and 30, May 19, June 19, July 31, September 11, November 3, 2014; April 20, 2015; and August 5, 2016.
    6. McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS DI (Lexi-Comp Online). Bethesda, MD: American Society of Health-System Pharmacists; 2014.
    7. <1> Injections. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 33-37.
    8. <71> Sterility tests. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 69-74.
    9. <788> Particulate matter in injections. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 339-342.
    10. Evolution of Intraoperative Fluid Therapy for Elective Surgeries: Historical and Current Fluid Requirements. In: Souba WW, Fink MP, Jurkovich GJ, Kaiser LR, Pearce WH, Pemberton JH, Soper NJ. ACS Surgery: Principles and Practice 2014. Accessed March 1, 2014 via STAT!Ref Online Electronic Medical Library. http://online.statref.com/Document.aspx?fxId=61&docId=158.
    11. Hospira. Lactated Ringer's Injection USP, Lactated Ringer's and 5% Dextrose Injection, USP [product information]. Lake Forest, IL: Hospira; 2009.
    12. Hospira. Dextrose and Sodium Chloride Injection, USP [product information]. Lake Forest, IL: Hospira; 2009.
    13. Hospira. Sodium Chloride Injection, USP [product information]. Lake Forest, IL: Hospira; 2010.
    14. Hospira. Dextrose Injection, USP [product information]. Lake Forest, IL: Hospira; 2010.
    15. Intravenous Fluids. In: Morgan GE, Michail MS, Jurray MJ, eds. Clinical Anesthesiology. 4th ed. New York, NY: Lange Medical Books / McGraw-Hill Medical; 2005: 692-696.
    16. Peng ZY, Kellum JA. Perioperative fluids: a clear road ahead? Curr Opin Crit Care. 2013 Aug;19(4):353-8.
    17. Raghunathan K, Shaw AD, Bagshaw SM. Fluids are drugs: type, dose and toxicity. Curr Opin Crit Care. 2013 Aug;19(4):290-8.

Updated

Updated November 19, 2018 by Michelle Wheeler, PharmD, Drug Information Specialist. Created September 16, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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