Advertisement

Sodium Chloride 0.9% Injection Bags

[19 June 2014]

Products Affected - Description

0.9 % Sodium Chloride, Baxter
150 mL bag (NDC 00338-0049-01)
250 mL bag (NDC 00338-0049-02)
500 mL bag (NDC 00338-0049-03)
500 mL bag, PVC/DEHP-free (NDC 00338-6304-03)
250 mL bag, PVC/DEHP-free (NDC 00338-6304-02)
1000 mL bag (NDC 00338-0049-04)
 
0.9 % Sodium Chloride, BBraun
250 mL bag, PVC/DEHP-free (NDC 00264-7800-20)
500 mL bag, PVC/DEHP-free (NDC 00264-7800-10)
1000 mL bag, PVC/DEHP-free (NDC 00264-7800-00)

0.9 % Sodium Chloride, Hospira
500 mL bag (NDC 00409-7983-03)
1000 mL bag (NDC 00409-7983-09)
500 mL bag, PVC/DEHP-free (NDC 00409-7983-30) - discontinued
1000 mL bag, PVC/DEHP-free (NDC 00409-7983-48) - discontinued
 
Imported Product
0.9% Sodium Chloride, Baxter
500 mL bag, PVC/DEHP-free (NDC 00338-9542-02) (Product code FE 1323)
1000 mL bag, PVC/DEHP-free (NDC 00338-9542-06) (Product code FE 1324D)


0.9% Sodium Chloride, Fresenius Kabi – Australian/English Label
50 mL bag, PVC/DEHP-free (NDC 63323-0623-50)
100 mL bag, PVC/DEHP-free (NDC 63323-0623-00) - discontinued
500 mL bag, PVC/DEHP-free (NDC 63323-0623-59)
1000 mL bag, PVC/DEHP-free (NDC 63323-0623-10)

Reason for the Shortage

  • Baxter has 0.9% sodium chloride on shortage due to increased demand.1
  • BBraun had 0.9% sodium chloride on allocation due to increased demand.2
  • Hospira cites increased demand as the reason for the shortage.3
  • In cooperation with the FDA, Fresenius Kabi is providing 0.9% sodium chloride to the US market to help alleviate the national shortage. This 0.9% sodium chloride is manufactured in an FDA-approved facility in Norway by Fresenius Kabi AG. There will be presentations available with Australian/English label and the package insert is the same for all imported presentations.4,5
  • In cooperation with the FDA, Baxter is providing imported 0.9% sodium chloride to the US market to help alleviate the national shortage. This 0.9% sodium chloride in Viaflo containers is manufactured in Spain by Baxter.

Available Products

0.9 % Sodium Chloride, Hospira (allocated for current customers)
150 mL bag (NDC 00409-7983-61)
250 mL bag (NDC 00409-7983-02)
250 mL bag, PVC/DEHP-free (NDC 00409-7983-25)
250 mL bag (2 ports) (NDC 00409-7983-53)
500 mL bag (2 ports) (NDC 00409-7983-55)

Estimated Resupply Dates

  • Baxter has all 0.9% sodium chloride injection presentations on allocation. The 0.9% sodium chloride 250 mL PVC/DEHP-free bags are on back order and the company cannot estimate a release date. Baxter has additional information regarding their allocation process in a Dear Customer letter.1
  • Baxter has imported 0.9% sodium chloride in 500 mL and 1000 mL sizes available for direct order. Orders will be filled as product becomes available. Contact Baxter’s Center for Service at 888-229-0001 to place an order.1
  • BBraun is allocating all 0.9% sodium chloride PVC/DEHP-free bags.2
  • Hospira has 0.9% sodium chloride 500 mL and 1000 mL bags on allocation and the company is releasing product as it becomes available.3
  • Fresenius Kabi has Australian-English labeled 0.9% sodium chloride in 50 mL, 500 mL, and 1000 mL sizes available for direct order. Contact Fresenius Kabi customer service at 888-386-1300 to place an order.4,7

Implications for Patient Care

Sodium chloride injection is widely used for a variety of indications.8 While many products are in short supply, the product most affected is the 1,000 mL bags of sodium chloride.1-3 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.1-3,9-11

Alternative Agents & Management

  • Consider using oral hydration whenever possible.
  • Imported 0.9% sodium chloride is supplied in non-DEHP/PVC and latex-free bags. The US and both imported European products contain equivalent amounts of sodium and chloride, and the osmolality is the same. The active ingredients are listed as millimoles in the European products and as milliequivalents in the US products. The barcodes on the imported European products will not be recognized by US scanning systems and should not be used.4,5
  • A summary of the different products is available in a Fresenius Kabi “Dear Healthcare Professional letter” for the Scandinavian products as well as the Australian/English products.4,5
  • There are some important key differences between the current 0.9% sodium chloride products available in the US from Baxter (Viaflex and AVIVA containers) and the imported product (Viaflo Containers). A summary of the different products, including pictures, is available from Baxter in a “Dear Healthcare Professional letter” for the Spanish product. Additionally, Viaflo Instructions for Use are available from Baxter.6
  • 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).12
  • 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).11
  • 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 Fluids13-16
 

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 Situations17-19 

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). 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; and January 13, 15, and 16, March 24, April 29, May 22, and June 19, 2014.
  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, and June 19, 2014.
  3. Hospira (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, and June 2 and 19, 2014. 
  4. Fresenius Kabi USA. Dear Healthcare Professional Letters (customer letters). Accessed March 28, 2014.
  5. Fresenius Kabi. Sodium chloride 0.9% [product information]. Pymble New South Wales, Australia: Fresenius Kabi Australia Pty Limited, 2010.
  6. Baxter. Dear Healthcare Professional Letter. Accessed April 29, 2014. 
  7. Fresenius Kabi USA (personal communications). March 27, April 14 and 30, and May 19, 2014.
  8. 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.
  9. <1> Injections. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 33-37.
  10. <71> Sterility tests. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 69-74.
  11. <788> Particulate matter in injections. In: The United States Pharmacopeia, 35th revision. Rockville, MD: The United States Pharmacopeial Convention; 2012: 339-342.
  12. 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.
  13. Hospira. Lactated Ringer’s Injection USP, Lactated Ringer’s and 5% Dextrose Injection, USP [product information]. Lake Forest, IL: Hospira; 2009.
  14. Hospira. Dextrose and Sodium Chloride Injection, USP [product information]. Lake Forest, IL: Hospira; 2009.
  15. Hospira. Sodium Chloride Injection, USP [product information]. Lake Forest, IL: Hospira; 2010.
  16. Hospira. Dextrose Injection, USP [product information]. Lake Forest, IL: Hospira; 2010.
  17. 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.
  18. Peng ZY, Kellum JA. Perioperative fluids: a clear road ahead? Curr Opin Crit Care. 2013 Aug;19(4):353-8
  19. 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 June 19, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created January 16, 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.

« Back to Drug Shortage Product Bulletins

Advocacy Activity
Get the latest updates on ASHP's advocacy activity on drug shortages.
Advertisement