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Information to Use in the Event of an Intravenous Multivitamin Shortage - May 2012

Information to Use in the Event of Adult IV Multivitamin Shortage

 

The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is a community of professionals representing all disciplines and areas of interest in nutrition support therapy.  A.S.P.E.N. has developed parenteral nutrition (PN) shortage considerations in order to assist its members and other clinicians in coping with PN shortages for their patients.

 

For the most up-to-date supply information, please see these websites:
American Society of Health-System Pharmacists (ASHP), Drug Shortages Resource Center 

FDA Drug Shortage Program, Current Drug Shortages 

 

Adult Intravenous Multivitamin Shortage 

During the shortage period, consider one or more of the following measures:

 

  1. The use of pediatric intravenous multivitamins for adults is not recommended.  Using pediatric intravenous multivitamins for adults may contribute to a shortage of pediatric products.  A shortage of pediatric intravenous multivitamins could create a potential risk of vitamin deficiencies in neonatal and pediatric patients that may have an even greater need for vitamins.  Furthermore, pediatric intravenous multivitamins contain vitamins in doses or ratios that may be unsuitable for adults. 
  2. If unable to obtain a 13-vitamin product, may use a 12-vitamin product (without vitamin K) and supplement vitamin K.  The dose of vitamin K in the 13-vitamin products is 150 mcg.  Alternative intravenous vitamin K dosing is 0.5-1 mg/day or 5-10 mg per week. See Table below for ingredients in each product.
  3. If unable to obtain a 12-vitamin product (without vitamin K), may use a 13-vitamin product (with vitamin K).  However, the coagulation activity of the patient must be closely monitored and for those patients receiving warfarin therapy, adjusted accordingly.  The amount of vitamin K in the 13-vitamin product (150 mcg) may or may not affect the warfarin coagulation activity.
  4. Assess each patient as to the indication for PN and provide nutrition via the oral or enteral route when possible.  Consider switching to oral or enterally administered multivitamins when oral/enteral intake is initiated (excluding patients with malabsorption syndromes).  Oral liquid multivitamins may not provide a complete vitamin profile.  The vitamin profile should be reviewed and missing components supplemented, if available.
  5. Reserve intravenous multivitamins for those patients receiving PN or those with a therapeutic medical need for intravenous multivitamins.
  6. When all options to obtain intravenous multivitamins have been exhausted, ration intravenous multivitamins in PN, such as reducing the daily dose by 50% or giving one multivitamin infusion dose three times a week.
  7. If intravenous multivitamins are no longer available, administer individual parenteral vitamin entities.  Thiamine, ascorbic acid, pyridoxine, and folic acid should be given daily. Thiamine is critical as several deaths have resulted from cardiac failure due to thiamine deficiency when long-term PN patients did not receive vitamins for three to four weeks.  Patients receiving a carbohydrate load are particularly susceptible to thiamine deficiency.  It should also be noted that megaloblastic anemia secondary to folate deficiency has been reported in PN patients who did not receive folate for 4-5 weeks.  Suggested daily intravenous doses are thiamine 6 mg, folate 0.6 mg, ascorbic acid 200 mg, and pyridoxine 6 mg unless otherwise clinically indicated.  Intravenous vitamin K dosing is 0.5-1 mg/day or 5-10 mg per week.  Administer cyanocobalamin (B12) at least once per month.
  8. Purchase only as much supply as needed.  In the interest of patient safety and fair allocation to all patients nationally, please do not stockpile.
  9. Compound PN in a single, central location (either in a centralized pharmacy or as outsourced preparation) in order to decrease inventory waste.  Consider a supply outreach to other facilities in your geographic location.
  10. Facilities and practitioners must 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 rules and regulations.
  11. Report severe drug product shortage information to the FDA Drug Shortage Program (DSP).  
  12. Report any patient problems related to shortages to ISMP Medication Errors Reporting Program (MERP).  
  13.  

ADULT INTRAVENOUS MULTIVITAMIN PRODUCTS 

Vitamin 

M.V.I. Adult™
(Hospira)
 

(per 10 mL) 

M.V.I.-12®
(Hospira)
 

(per 10 mL) 

Infuvite® Adult
(Baxter)
 

(per 10 mL) 

A * (retinol)

1 mg *

1 mg *

3300 units

D*

5 mcg* (ergocalciferol)

5 mcg* (ergocalciferol)

200 units (cholecalciferol)

E* (dl-alpha tocopheryl acetate)

10 mg*

10 mg*

10 units

K (phytonadione)

150 mcg

None

150 mcg

C (ascorbic acid)

200 mg

200 mg

200 mg

B-1 (thiamine)

6 mg

6 mg

6 mg

B-2 (riboflavin)

3.6 mg

3.6 mg

3.6 mg

Niacinamide

40 mg

40 mg

40 mg

Dexpanthenol

15 mg

15 mg

15 mg

B-6 (pyridoxine)

6 mg

6 mg

6 mg

B-12 (cyanocobalamin)

5 mcg

5 mcg

5 mcg

Biotin

60 mcg

60 mcg

60 mcg

Folic Acid

600 mcg

600 mcg

600 mcg

 

 

 

 

Other: 

 

 

 

Aluminum

43-183 mcg/L **

43-78 mcg/L **

70 mcg/L** ‡

Polysorbate 80

160 mg

160 mg

140 mg

Polysorbate 20

2.8 mg

2.8 mg

None

Propylene Glycol

3 g

3 g

3 g

* 1 mg Vitamin A = 3,300 USP units

5 mcg Vitamin D = 200 USP units

10 mg Vitamin E = 10 USP units

** Maximum, labeled concentration at product expiration date; Hospira products vary depending if it is unit vial, single-dose or multi-dose packaging.

‡ Product label revised, 9/2007

 

Suggested Readings:

  1. Task Force for the Revision of Safe Practices for Parenteral Nutrition: Mirtallo J, Canada T, Johnson D, Kumpf V, Petersen C, Sacks G, Seres D, Guenter P. Safe practices for parenteral nutrition. J Parenter Enteral Nutr. 2004;28:S39- S70. Errata: J Parenter Enteral Nutr. 2006;30: 177.
  2. Centers for Disease Control and Prevention. Deaths associated with thiamine-deficient total parenteral nutrition. MMWR Morb Mortal Wkly Rep. 1989;38:43.
  3. Centers for Disease Control and Prevention. Lactic acidosis traced to thiamine deficiency related to nationwide shortage of multivitamins for total parenteral nutrition -- United States, 1997. MMWR Morb Mortal Wkly Rep. 1997 Jun 13;46:523-528.
  4. Romanski SA, McMahon MM. Metabolic acidosis and thiamine deficiency. Mayo Clin Proc. 1999;74:259-263.
  5. Alloju M, Ehrinpreis NM. Shortage of intravenous multivitamin solution in the United States. N Engl J Med. 1997;337:54.
  6. Kudsk KA, Holcombe BJ, Bernstein E. Response to shortage of intravenous multivitamin solution in the United States. N Engl J Med. 1997;337:54.
  7. Rulewski N. Response to shortage of intravenous multivitamin solution in the United States. N Engl J Med. 1997;337:54.
  8. Temeck J, Sobel S. Response to shortage of intravenous multivitamin solution in the United States. N Engl J Med. 1997;337:55.
  9. Francini-Pesenti F, Brocadello F, Famengo S, et al. Wernicke’s encephalopathy during parenteral nutrition. J Parenter Enteral Nutr. 2007;31:69-71.
  10. Velez RJ, Myers B, Guber MS. Severe acute metabolic acidosis (acute beriberi): an avoidable complication of total parenteral nutrition, JPEN J Parenter Enteral Nutr. 1985:9:216-9.
  11. Hahn JS, Berquist W, Alcorn DM, Chamberlain L, Bass D. Wernicke encephalopathy and beriberi during total parenteral nutrition attributable to multivitamin infusion shortage. Pediatrics. 1998;10: E1

 

Pediatric Intravenous Multivitamin Shortage 

During the shortage period, consider one or more of the following measures:

 

  1. Reserve pediatric intravenous multivitamins for children less than 2.5 kg or less than 36 weeks gestational age. 
  2. Consider switching to oral or enterally administered multivitamins when oral/enteral intake is greater than 50% of needs (excluding patients with malabsorption syndromes).  Oral liquid multivitamins may not provide a complete vitamin profile.  The vitamin profile should be reviewed and missing components supplemented, if available.
  3. Consider use of adult intravenous multivitamins for children during the shortage; use 5 mL of adult vitamins in all children >2.5 kg or 36 wks gestation while saving the pediatric product for smaller neonates in order to conserve the supply.  Supplement intravenous vitamin K daily (total daily dose = 200 mcg). The vitamin K content of the adult multivitamin product should be noted when supplementing with additional vitamin K.
  4. In the event that NO pediatric intravenous multivitamins are available, infants less than 2.5 kg or less than 36 weeks gestation should receive an adult intravenous multivitamin at a daily dose of 1 mL/kg up to a maximum of 2.5 mL/day. Note: Adult intravenous multivitamin products contain propylene glycol and polysorbate which may be toxic to neonates.
  5. Use the full adult dose (10 mL) of adult intravenous multivitamins for children greater than 11 years of age. [Please refer to the adult multivitamin recommendations above in the event of a concurrent shortage.]
  6. While it is important to limit intravenous aluminum intake, clinical judgment must prevail by weighing potential vitamin deficiencies against potential aluminum toxicity. Clinicians should routinely monitor for any signs and symptoms of vitamin deficiencies and aluminum toxicity.
  7. Assess each patient as to the indication for PN and provide nutrition via the oral or enteral route when possible.
  8. Purchase only as much supply as needed. In the interest of patient safety and fair allocation, do not stockpile.
  9. Compound PN in a single, central location (either in a centralized pharmacy or as outsourced preparation) in order to decrease inventory waste.  Consider a supply outreach to other facilities in your geographic location.
  10. Facilities and practitioners must 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 rules and regulations.
  11. Report severe drug product shortage information to the FDA Drug Shortage Program (DSP) 
  12. Report any patient problems related to shortages to ISMP Medication Errors Reporting Program (MERP).    

 

 PEDIATRIC INTRAVENOUS MULTIVITAMIN PRODUCTS 

Vitamin 

M.V.I.® Pediatric
(Hospira)
 

(per 5 mL) 

Infuvite® Pediatric
(Baxter)
 

(per 5 mL) 

A *

0.7 mg * (retinol)

2300 units* (palmitate)

D*

10 mcg* (ergocalciferol)

400 units* (cholecalciferol)

E* (dl-alpha tocopheryl acetate)

7 mg*

7 units*

K (phytonadione)

200 mcg

200 mcg

C (ascorbic acid)

80 mg

80 mg

B-1 (thiamine)

1.2 mg

1.2 mg

B-2 (riboflavin)

1.4 mg

1.4 mg

Niacinamide

17 mg

17 mg

Dexpanthenol

5 mg

5 mg

B-6 (pyridoxine)

1 mg

1 mg

B-12 (cyanocobalamin)

1 mcg

1 mcg

Biotin

20 mcg

20 mcg

Folic Acid

140 mcg

140 mcg

 

 

 

Other:

 

 

Aluminum

42 mcg /L **

30 mcg/L** ‡

Polysorbate 80

50 mg

50 mg

Polysorbate 20

0.8 mg

None

Propylene Glycol

None

None

* 0.7 mg Vitamin A = 2,300 USP units

10 mcg Vitamin D = 400 USP units

7 mg Vitamin E = 7 USP units

** Maximum, labeled concentration at product expiration date

‡ Product label revised, 9/2007

 

Suggested Readings:

  1. American Society for Parenteral and Enteral Nutrition Board of Directors, and Task Force on Standards for Specialized Nutrition Support for Hospitalized Pediatric Patients: Jackie Wessel, Jane Balint, Catherine Crill, and Kimberly Klotz. Standards for Specialized Nutrition Support: Hospitalized Pediatric Patients Nutr Clin Pract, Feb 2005; 20: 103 - 116.
  2. The American Society for Parenteral and Enteral Nutrition Aluminum Task Force: Pamela J. Charney, MS, RD, LD, CNSD, Chair.   A.S.P.E.N. Statement on Aluminum in Parenteral Nutrition Solutions Nutr Clin Pract, Aug 2004; 19: 416 - 417.
  3. Poole RL, Schiff L, Hintz SR., et al. Aluminum Content of Parenteral Nutrition in Neonates: Measured Versus Calculated Levels. J Pediatr Gastroenterol Nutr, 2010: 50(2):208-211.
  4. American Academy of Pediatrics Committee on Drugs. “Inactive” ingredients in pharmaceutical products: Update (subject review). Pediatrics 1997; 99:268-278.
  5. Greene HL, Hambidge KM, Schanler R, et al. Guidelines for the use of vitamins, trace elements, calcium, magnesium, and phosphorus in infants and children receiving total parenteral nutrition: Report of the Subcommittee on Pediatric Parenteral Nutrient Requirements from the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition. Am J Clin Nutr 1988;48:1324-1342.
  6. Klein CJ. Nutrient Requirements for Preterm Infant Formulas. J Nutr 2002; 132:1395S-1577S

 

Important Note: These recommendations do not constitute medical or professional advice, and should not be taken as such.  To the extent the information published herein may be used to assist in the care of patients, this is the result of the sole professional judgment of the attending health professional whose judgment is the primary component of quality medical care.  The information presented herein is not a substitute for the exercise of such judgment by the health professional.

Developed by the A.S.P.E.N. CPC Shortage Subcommittee: Beverly Holcombe, PharmD, BCNSP, FASHP (Chair); Deborah A Andris, MSN, APNP; Gary Brooks, PharmD, BCPS, BCNSP; Deborah R Houston, RPh, CIC, BCNSP; and Steve Plogsted, PharmD, BCNSP, CNSC.  Approved by the Clinical Practice Committee, and the A.S.P.E.N. Board of Directors.

 

Questions regarding these recommendations should be directed to Peggi Guenter, PhD, RN, A.S.P.E.N. Senior Director of Clinical Practice, Advocacy, and Research Affairs at: peggig@aspen.nutr.org 

 

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