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5/26/2016

0.45% Sodium Chloride Injection Bags

Reason for the Shortage

    • Baxter had 0.45% sodium chloride on shortage due to increased demand.[1]
    • BBraun has 0.45% sodium chloride available to current customers.[2]
    • Hospira cited increased demand as the reason for the shortage.[3]

Available Products

    • 0.45% Sodium Chloride injection, BBraun, 1000 mL PVC/DEHP-free bag, 12 count, NDC 00264-7802-00
    • 0.45% Sodium Chloride injection, BBraun, 500 mL PVC/DEHP-free bag, 24 count, NDC 00264-7802-10
    • 0.45% Sodium Chloride injection, Baxter, 1000 mL bag, 14 count, NDC 00338-0043-04
    • 0.45% Sodium Chloride injection, Baxter, 500 mL bag, 24 count, NDC 00338-0043-03
    • 0.45% Sodium Chloride injection, Pfizer, 1000 mL bag, 12 count, NDC 00409-7985-09
    • 0.45% Sodium Chloride injection, Pfizer, 250 mL bag, 24 count, NDC 00409-7985-02
    • 0.45% Sodium Chloride injection, Pfizer, 250 mL PVC/DEHP-free bag, 24 count, NDC 00409-7985-25
    • 0.45% Sodium Chloride injection, Pfizer, 250 mL ADD-Vantage bag, 24 count, NDC 00409-7132-02
    • 0.45% Sodium Chloride injection, Pfizer, 500 mL bag, 24 count, NDC 00409-7985-03

Estimated Resupply Dates

    • All presentations are currently available.

Implications for Patient Care

    • Sodium chloride injection is widely used for a variety of indications.[4] Many large volume intravenous solutions are in short supply.[1,2,3]

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.[1,2,3,5,6,7]

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).[8]
    • 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.
    • 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 Fluids9,10,11,12
    ProductmOsm/LNa (mEq/L)Cl (mEq/L)Dextrose (g/L)K (mEq/L)Ca (mEq/L)Lactate (mEq/L)
    0.9% Sodium Chloride308154154--------
    0.45% Sodium Chloride1547777--------
    5% Dextrose plus 0.225% Sodium Chloride32938.538.550------
    5% Dextrose plus 0.45% Sodium Chloride406777750------
    5% Dextrose plus 0.9% Sodium Chloride56015415450------
    5% Dextrose252----50------
    Lactated Ringers Solution273130109--42.728
    Lactated Ringers and 5% Dextrose Solution5251301095042.728

    Table 2. Suggested Bag Sizes for Specific Rates of Infusion
    Infusion RateBag Size
    20 mL / hour or less 250 mL
    21 mL/hour to 40 mL/hour500 mL

    Table 3. Considerations for Reserving Products for Selected Clinical Situations13,14,15
    Clinical SituationProductComments
    Large volume replacement (surgery)Lactated Ringers SolutionLarge volumes of 0.9% sodium chloride may contribute to hyperchloremic acidosis.
    Patients requiring sodium restriction5% Dextrose Solution and Low Sodium Containing SolutionsConsider reserving a supply of solutions that are low in sodium.
    Patients susceptible to hypoglycemiaProducts containing 5% Dextrose SolutionWomen and children may be more susceptible to hypoglycemia following fasts > 24 hours.

References

    1. Baxter (personal communications). February 20, March 24, June 12, July 10, August 20, October 9, December 29, 2014; February 16, March 9, April 14, July 28, and October 28, 2015; and January 26, 2016.
    2. BBraun (personal communications). February 20 and April 23, June 12 and 23, August 21, 2014; February 18, May 5, July 28, September 3, and October 29, 2015; and January 26, 2016.
    3. Hospira (personal communications and website). February 20, March 4 and 25, April 25, May 9, June 10 and 23, July 2, 14, and 31, August 20, September 3, October 7, December 29, 2014; February 18, March 13, April 13 and 20, May 6, July 28, August 11, September 3, and October 30, 2015; and January 26, 2016.
    4. 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.
    5. <1> Injections. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 33-37.
    6. <71> Sterility tests. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 69-74.
    7. <788> Particulate matter in injections. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 339-342.
    8. 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.
    9. Hospira. Lactated Ringers Injection USP, Lactated Ringers and 5% Dextrose Injection, USP [product information]. Lake Forest, IL: Hospira; 2009.
    10. Hospira. Dextrose and Sodium Chloride Injection, USP [product information]. Lake Forest, IL: Hospira; 2009.
    11. Hospira. Sodium Chloride Injection, USP [product information]. Lake Forest, IL: Hospira; 2010.
    12. Hospira. Dextrose Injection, USP [product information]. Lake Forest, IL: Hospira; 2010.
    13. 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.
    14. Peng ZY, Kellum JA. Perioperative fluids: a clear road ahead? Curr Opin Crit Care. 2013 Aug;19(4):353-8.
    15. 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 May 26, 2016 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 6, 2015 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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