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Sodium Chloride 0.45% Injection Bags

[21 August 2014]

Products Affected - Description

0.45% Sodium Chloride, Baxter
500 mL bag (NDC 00338-0043-03)
1000 mL bag (NDC 00338-0043-04)

0.45% Sodium Chloride, BBraun
500 mL bag, PVC/DEHP-free (NDC 00264-7802-10)
1000 mL bag, PVC/DEHP-free (NDC 00264-7802-00)

0.45% Sodium Chloride, Hospira
500 mL bag (NDC 00409-7985-03)
1000 mL bag (NDC 00409-7985-09)

Reason for the Shortage

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

Available Products

0.45% Sodium Chloride, Hospira
250 mL bag, ADD-Vantage (NDC 00409-7132-02)
250 mL bag, PVC/DEHP-free (NDC 00409-7985-25)
250 mL bag (NDC 00409-7985-02)

Estimated Resupply Dates

  • Baxter has both 0.45% sodium chloride injection presentations on allocation. Baxter has additional information regarding their allocation process in a Dear Customer letter.
  • BBraun has both 0.45% sodium chloride PVC/DEHP-free bags on allocation.2
  • Hospira has 0.45% sodium chloride 1000 mL bags on back order with an estimated release date in mid-August 2014. Hospira has 0.45% sodium chloride 500 mL available in limited supply and additional product is expected mid-September 2014.3

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.1-3

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.1-3,5-7

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 Fluids9-12
 

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 Situations13-15
 

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.

Related Shortages

References

  1. Baxter (personal communications). February 20, March 24, June 12, July 10, and August 20, 2014.
  2. BBraun (personal communications). February 20 and April 23, June 12 and 23, and August 21, 2014.
  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, and August 20, 2014.
  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.
  9. Hospira. Lactated Ringer’s Injection USP, Lactated Ringer’s 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 August 21, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created February 20, 2014 by Erin R. Fox, PharmD, FASHP, Director of Drug Information and Michelle M Wheeler, PharmD, Drug Information Specialist, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation 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. Novation, 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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