What guidance should be taken during a sodium and potassium shortage? Should these agents be left out of TPN or restricted for specific patients?

Comment by InpharmD Researcher

The American Society for Parenteral and Enteral Nutrition (ASPEN) has recommendations on managing specific electrolyte shortages which include using alternative salt forms, using oral supplementation, and modifying intravenous fluids. In general, the limited supplies should be reserved for patients with therapeutic needs for intravenous electrolytes or they should be switched to oral or enteral electrolytes if possible. Specific details on electrolyte shortages and expected availability are located in Table 2 according to ASPEN, ASHP, and FDA shortage information.

Background

The American Society for Parenteral and Enteral Nutrition (ASPEN) made recommendations on managing electrolyte shortages in 2015. Specific recommendations include using alternative salt forms, using oral supplementation, and modifying intravenous fluids. A comprehensive list of recommendations can be found in Table 1. [1]

References:

[1] American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Electrolyte and Mineral Product Shortage Considerations 2015. https://www.nutritioncare.org/News/General_News/Parenteral_Nutrition_Electrolyte_and_Mineral_Product_Shortage_Considerations/. Accessed on September 20, 2021.
Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

What guidance is there for the current sodium and potassium shortage? Should sodium or potassium be left out of TPN or restricted for specific patients?

Please see Tables 1-2 for your response.

 

American Society for Parenteral and Enteral Nutrition (ASPEN) Parenteral Nutrition Electrolyte and Mineral Product Shortage Considerations
Shortage

Measures for managing each electrolyte and mineral shortage

 Signs and symptoms of deficiencies 
General guidance
  1. Assess each patient as to the indication for parenteral nutrition (PN) and provide nutrition via the oral or enteral route when possible.
  2. Consider switching to oral or enterally administered electrolyte or mineral supplement products when oral/enteral intake is initiated (excluding patients with malabsorption syndromes or nonfunctioning gastrointestinal tract). Consult a pharmacist for product information.
  3. Purchase only as much electrolyte and mineral injections supply as needed. In the interest of fair allocation to all patients nationally, please do not stockpile.
  4. Reserve intravenous electrolyte and mineral products for those patients receiving PN or those with a therapeutic medical need for intravenous electrolytes and minerals.
  5. Eliminate the use of parenteral electrolyte/mineral injections as a supplemental additive in enteral nutrition products.
  6. Limit the use of electrolyte/mineral additives in IV fluids to patients with disease states and clinical conditions for which they are appropriate.
  7. Reconsider the use of serum electrolyte algorithms/protocols as "automatic" (intravenous) IV electrolyte replacement therapies in otherwise asymptomatic patients.
  8. Use commercially available IV multi-electrolyte/mineral products as much as possible for replacement therapy.
  9. Review the entire portfolio of parenteral nutrition electrolyte and mineral products available nationally. There may be a shortage in one concentration or salt form but availability in another form.
  10. Assess your PN patient population to determine if a standardized, commercially available parenteral nutrition product with standard electrolytes might be appropriate for a portion of your patient population. Generally, additional components can be added to these products.
  11. Assess your PN patient population to determine if a standardized, commercially available multi-electrolyte product might be appropriate for a portion of those patients.
  12. During prolonged shortages of intravenous electrolytes and mineral products, the FDA  may approve the temporary importation of alternative products. These products may have different salts, concentrations, packaging, and labeling than the United States-approved products. The Dear Healthcare Professional Letter accompanying imported products should be read carefully.
  13. Consider decreasing or eliminating the daily amount of electrolyte added to the PN.
  14. Monitor serum electrolyte concentrations closely.
  15. Observe for an increase in deficiencies with the ongoing shortages. Increase your awareness and assessment for signs and symptoms of electrolyte and mineral deficiencies.
  16. Consider compounding PN in a single, central location (either in a centralized pharmacy or as outsourced preparation) to decrease inventory waste.
  17. Facilities and practitioners need to continue to observe and be compliant with the product labeling (e.g., package insert), USP General Chapter <797> Pharmaceutical  Compounding-Sterile Preparations, and state Boards of Pharmacy and federal rules and regulations.
  18. Include PN component shortages and outages in the health care organization’s strategies and procedures for managing medication shortages and outages.
  19. Report severe drug product shortage information to the U.S. FDA Drug Shortage  Program (DSP).
  20. Report any patient problems related to shortages to ISMP Medication Errors Reporting  Program (MERP).
 N/A

Concentrated phosphate
  1. Consider using the alternate salt IV phosphate as available and balance the sodium and potassium accordingly.
  2. Consider oral or enteral phosphate products/supplements to replete or maintain serum phosphorus concentrations.
  3. Consider commercially available standardized, commercial PN products that contain phosphate.
  4. Decrease the daily amount/dose of phosphate added to PN formulations.
  5. Reserve phosphates for pediatric and neonatal patients requiring PN.
  6. Reserve phosphates for those patients with a therapeutic medical need for phosphorus.
  7. Consider using IV organic phosphate injections, if available.
  8. Consider the provision of daily IV fat emulsion to all PN patients as clinically appropriate. Note: IV fat emulsions contain 15 mmol/L of phosphate as egg phospholipids.
 Impaired diaphragmatic contractility,  tachycardia, hypocapnia, respiratory failure, tissue hypoxia, decreased myocardial contractility, paralysis, weakness, paresthesias, neurologic dysfunction, seizures, death.

Concentrated sodium 
  1. Consider using alternate IV sodium salts and concentrations as available and balance the chloride, acetate, and phosphate accordingly.
  2. Consider administering IV medications in 0.9% sodium chloride (normal saline [NS]) instead of 5% dextrose in water (D5W) when compatible.
  3. Consider changing/increasing the sodium concentration of IV fluids (0.45% to 0.9%  sodium chloride).
  4. Consider using NS for irrigation with enteral nutrition when patients are on both enteral and parenteral therapy. 
 Headache, lethargy, disorientation, restlessness, nausea, vomiting, muscle cramps or weakness, depressed reflexes, seizures, coma, and death

Concentrated potassium 
  1. Consider using alternate IV potassium salts as available and balance the chloride, acetate, and phosphate accordingly.
  2. Consider oral or enteral potassium products/supplements to replete or maintain serum potassium levels.
  3. Use premixed, intravenous potassium products as much as possible for IV maintenance/ replacement therapy. Minimize the use of IV potassium additives in IV fluids.
 Nausea, vomiting, weakness, constipation, EKG changes, cardiac arrhythmias, sudden death, paralysis, respiratory compromise, and rhabdomyolysis

 

References:

American Society for Parenteral and Enteral Nutrition. Parenteral Nutrition Electrolyte and Mineral Product Shortage Considerations 2015. https://www.nutritioncare.org/News/General_News/Parenteral_Nutrition_Electrolyte_and_Mineral_Product_Shortage_Considerations/. Accessed on September 20, 2021.

 

Product Shortage

Manufacturer and Product

 Estimated Shortage Duration Alternative Products Available
Sodium acetate injection

Fresenius Kabi USA, LLC

32.8% 400 mEq 100mL PBP (NDC 63323-0032-00)

Hospira, Inc.

100 mEq/50 mL (2 mEq/mL); Pharmacy Bulk Package Glass Fliptop Vial (NDC 00409-3299-05)

200 mEq/100 mL (2 mEq/mL); Pharmacy Bulk Package Glass Fliptop Vial (NDC 00409-3299-06)

40 mEq/20 mL (2 mEq/mL); Single Dose Plastic Fliptop Vial (NDC 00409-7299-73)

Pfizer

200 mEq/100 mL vial, 25 count (NDC 00409-3299-06)

40 mEq/20 mL vial, 25 count (NDC 00409-7299-73)

100 mEq/50 mL vial, 25 count (NDC 00409-3299-05)


October 2021

 


February 2022


February 2022


February 2022

 

November 2021

-

-

Milla Pharmaceuticals

100 mEq/50 mL (2 mEq/mL) (NDC 69784-230-20)

200 mEq/100 mL (2 mEq/mL) (NDC 69784-231-20)
Sodium bicarbonate injection

Amphastar Pharmaceuticals, Inc.

8.4%, 50mL Luer-Jet Prefilled Syringe (NDC 76329-3352-1)

Fresenius Kabi USA, LLC

8.4% single dose vial, 50 mEq/50 mL (NDC 63323-089-50)

Hospira, Inc.

50 mEq/50 mL LifeShield® ABBOJECT® Glass Syringe (8.4% Concentration) (NDC 0409-6637-14)

2.5 mEq/5 mL Fliptop Vial (4.2% Concentration) (NDC 0409-5555-02)

Pfizer

4.2%, 5 mL vial, 25 count (NDC 00409-5555-02)


October 2021

 


August 2021

 

October 2021


October 2021

 


-

Amphastar

8.4%, 50 mL syringe, 10 count (NDC 76329-3352-01)

Exela Pharma Sciences

4.2%, 10 mL vial, 25 count (NDC 51754-5012-04)

8.4%, 10 mL vial, 25 count (NDC 51754-5011-04)

8.4%, 50 mL vial, 20 count (NDC 51754-5001-05)

Fresenius Kabi USA, LLC

4.2%, 5 mL vial, 25 count (NDC 63323-0083-05)

Pfizer

4.2%, 10 mL LifeShield syringe, 10 count (NDC 00409-5534-14)

7.5%, 50 mL LifeShield syringe, 10 count (NDC 00409-4916-14)

8.4%, 10 mL syringe, 10 count (NDC 00409-4900-14)

8.4%, 50 mL LifeShield syringe, 10 count (NDC 00409-6637-14)

8.4%, 50 mL vial, 25 count (NDC 00409-6625-14)

Hospira, Inc.

Infant 5 mEq/10 mL (0.5 mEq/mL) ABBOJECT® Glass Syringe (4.2% Concentration) (NDC 0409-5534-14) (old NDC 0409-5534-34)

2.5 mEq/5 mL (0.5 mEq/mL) Fliptop Vial Novaplus® (4.2% Concentration) (NDC 0409-5555-01)

44.6 mEq/50 mL (0.9 mEq/mL) LifeShield™ ABBOJECT™ Glass Syringe (7.5% concentration) (NDC 0409-4916-14)

50 mEq/50 mL (1 mEq/mL) Single Dose Glass Fliptop Vial (8.4% concentration) (NDC 0409-6625-14)

50 mEq/50 mL (1 mEq/mL) Single Dose Vial Novaplus® (8.4% concentration) (NDC 0409-6625-35)

Pediatric 10 mEq/10 mL (1 mEq/mL) LifeShield® ABBOJECT® Glass Syringe (8.4% Concentration) (NDC 0409-4900-14)
Sodium chloride 23.4% injection

Fresenius Kabi USA, LLC

30 mL vials (NDC 63323-0187-30)

200 mL vials (NDC 63323-0088-63)

 


-

August 2021

Fresenius Kabi USA, LLC

100 mL vials (NDC 63323-0088-61)

Hospira, Inc.

400 mEq/100 mL (4 mEq/mL); Pharmacy Bulk Package Glass Fliptop Vial (NDC 00409-1141-02)
Sodium chloride 0.9% injection

Fresenius Kabi USA, LLC

Single dose plastic vial, 0.9%, (18 mg/2 mL)(9 mg/mL)(NDC 63323-186-02)

Single dose plastic vial, 0.9%, (90 mg/10 mL)(9 mg/mL)(NDC 63323-186-10)

Single dose tear top vial, 0.9%, (900 mg/100 mL)(9 mg/mL)(NDC 63323-186-00)

Hikma Pharmaceuticals USA, Inc.

0.9%, 2 mL vial (NDC 0641-0497-25)

Hospira, Inc.

10 mL (0.9%); Single Dose Plastic Fliptop Vial (NDC 00409-4888-10)

0.9%; Single Dose Plastic Fliptop Vial (NDC 00409-4888-20)

0.9%; Single Dose Plastic Fliptop Vial (NDC 00409-4888-50)


September 2021

 

August 2021


-



-

 

September 2021

December 2021

January 2022

Fresenius Kabi USA, LLC

Single dose plastic vial, 0.9%, (180 mg/20 mL)(9 mg/mL) (NDC 63323-186-20)

Medefil, Inc.

0.9%, in a plastic syringe (10 mL) (NDC 64253-202-30)
Sodium phosphate injection

Fresenius Kabi USA, LLC

Phosphorus 15 mmol/5 mL, Sodium 20 mEq/5 mL, vial (NDC 63323-170-05)

Phosphorus 45 mmol/15 mL, Sodium 60 mEq/15 mL, vial (NDC 63323-170-15)

Hospira, Inc.

Phosphorus 45 mmol/15 mL, Sodium 60 mEq/15 mL, vial (NDC 0409-7391-72)

Pfizer

45 mmol/15 mL vial, 25 count (NDC 00409-7391-72)


October 2021

 

October 2021




January 2022

 

November 2021

 None
Potassium acetate injection

Hospira, Inc.

100 mEq/50 mL (2 mEq/mL), Pharmacy Bulk Package Glass Fliptop Vial (NDC 00409-3294-51)

40 mEq/mL (2 mEq/mL), Single Dose Plastic Fliptop Vial (NDC 00409-8183-01)

Pfizer

40 mEq/20 mL vial, 25 count (NDC 00409-8183-01)

100 mEq/50 mL vial, 25 count (NDC 00409-3924-51)


February 2022


February 2022


-

November 2021

Exela Pharma Sciences, LLC

40mEq (2mEq/ml) 20mL (NDC 51754-2001-4)

Hospira, Inc.

100 mEq/50 mL (2 mEq/mL), Pharmacy Bulk Package Glass Fliptop Vial NovaPlus (NDC 00409-3294-25)

40 mEq/mL (2 mEq/mL), Single Dose Plastic Fliptop Vial NovaPlus (NDC 00409-8183-25)
Potassium chloride injection

Fresenius Kabi USA, LLC

20 mEq/10 mL vial, 25 count (NDC 63323-0965-10)

40 mEq/20 mL vial, 25 count (NDC 63323-0965-20)

60 mEq/30 mL vial, 25 count (NDC 63323-0967-30)

Pfizer

20 mEq/10 mL vial, 25 count (NDC 00409-6651-06)

40 mEq/20 mL vial, 25 count (NDC 00409-6653-05)



October 2021

September 2021

October 2021

 

September 2021

September 2021

Fresenius Kabi USA, LLC

10 mEq/5 mL vial, 25 count (NDC 63323-0965-05)

Pfizer

10 mEq/5 mL vial, 25 count (NDC 00409-6635-01)
Potassium phosphate injection

Fresenius Kabi USA, LLC

150 mmol/50 mL vial, 25 count (NDC 63323-0086-50)

Pfizer

45 mmol/15 mL vial, 25 count (NDC 00409-7295-01)


September 2021

 

-

Fresenius Kabi USA, LLC

45 mmol/15 mL vial, 25 count (NDC 63323-0086-15)

15 mmol/5 mL vial, 25 count (NDC 63323-0086-05)

 

References:

U.S. Food and Drug Administration (FDA). FDA Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm. Accessed September 20, 2021.

American Society of Health-System Pharmacists. Drug Shortages List. https://www.ashp.org/drug-shortages/current-shortages/drug-shortages-list?page=CurrentShortages. Accessed September 20, 2021.