The number of new drug shortages, including shortages of sterile injectable drugs, has decreased. According to information on the FDA Drug Shortages
web site the shortage status of some parenteral nutrition (PN) components is now classified as “resolved”. However, for other products used to prepare PN admixtures shortages continue. The availability of PN components remains tenuous with supplies seeming adequate one day and unavailable the next.
The latest PN components to be in short supply are dextrose 70% and sterile water for injection. Baxter Healthcare recently informed A.S.P.E.N. that Clinimix and Clinimix E have been put on a “protective allocation.” This product allocation is the result of increasing demand for Clinimix in response to a temporary shortage of sterile water and 70% dextrose across the market. It is intended to help maintain equal access to supply by Baxter customers. The allocation is expected to last through the remainder of the year.
According to the
FDA Drug Shortage
web site the following PN components are considered in short supply.
Calcium gluconate injection
Cyanocobalamin (Vitamin B12) injection
Dextrose injection, 70%
Magnesium sulfate injection
Multi-vitamin infusion (adult and pediatric)
Phosphate (Glycophos) injection
Potassium chloride injection
Sodium chloride 23.4% injection
Sodium phosphate injection
Sterile water for injection solutions
Trace elements (adult, pediatric and neonate)
A.S.P.E.N. is continually addressing the ongoing shortage of vitamins, electrolytes, and other IV nutrition ingredients that has critically impacted hospitals and home infusion companies nationwide. A.S.P.E.N. has developed and published recommendations to assist clinicians in managing shortages of PN components. These strategies for rationing and conserving products are to be used only during shortages. Once a shortage of a PN component is resolved clinicians should provide patients with the full daily dose of that component.
Parenteral Nutrition Component Shortages: Suggested Readings and Reports
Davis, C, Javid PJ, Horslen S. Selenium deficiency in pediatric patients with intestinal failure as a consequence of drug shortage.
JPEN J Parenter Enteral Nutr. 2014;38:15-118.
Franck AJ. Zinc deficiency in a parenteral nutrition–dependent patient during a parenteral trace element product shortage.
JPEN J Parenter Enteral Nutr.
Published online before print January 28, 2014, doi: 10.1177/014860711ra4520995
Palm E, Dotson B. Copper and zinc deficiency in a patient receiving long-term parenteral nutrition during a shortage of parenteral trace element products.
JPEN J Parenter Enteral Nutr.
September 4, 2014, doi: 0148607114549255
Centers for Disease Control and Prevention. Notes from the field: zinc deficiency dermatitis in cholestatic extremely premature infants after a nationwide shortage of injectable zinc—Washington, DC, December 2012 [published correction appears inMMWR Morb Mortal Wkly Rep. 2013Mar; 1562(10):196]. MMWR Morb Mortal Wkly Rep. 2013 Feb 22;62(7):136-137.
Ruktanonchai D, Lowe, M, Norton SA, et al. Zinc deficiency-associated dermatitis in infants during a nationwide shortage of injectable zinc - Washington, DC, and Houston, Texas, 2012-2013. [published (correction appears in MMWR Morb Mortal Wkly Rep. 2014 Jan 31;63(4):82]. MMWR Morb Mortal Wkly Rep. 2014 Jan 17;63(2):35-7.
Pramyothin P, Kim DW, Young LS, Wichabnsawakun S, Apovian CM. Anemia and leukopenia in a long-term parenteral nutrition patient during a shortage of parenteral trace element products in the united states. JPEN J Parenter Enteral Nutr. 2013;37; 425-429.
Corrigan M, Kirby DF. Impact of a national shortage of sterile ethanol on a home parenteral nutrition practice: a case series. JPEN J Parenter Enteral Nutr. 2012;36:476-480.
Chan LN. Iatrogenic malnutrition: a serious public health issue caused by drug shortages. JPEN J Parenter Enteral Nutr. 2013; 37:702-704.
Mirtallo JM. The drug shortage crisis. JPEN J Parenter Enteral Nutr. 2011;35:433.
Holcombe B. Parenteral nutrition product shortages: impact on safety. JPEN J Parenter Enteral Nutr. 2012;36:2suppl,44S-47S.
Gumpper KF. Drug shortages and training. JPEN J Parenter Enteral Nutr. 2012;36; 2 suppl: 42S-43S.
Hassig TB, McKinzie BP, Fortier CR, Taber D. Clinical management strategies and implications for parenteral nutrition drug shortages in adult patients. Pharmacotherapy. 2014;34:72-84.
Guenter P, Holcombe B, Mirtallo JM, Plogsted SW, DiBaise JK; Clinical Practice and Public Policy Committees, American Society for Parenteral and Enteral Nutrition. Parenteral nutrition utilization: response to drug shortages. JPEN J Parenter Enteral Nutr. 2014;38:11-12.
Kaur K, O'Connor AH, Illig SM, Kopcza KB. Drug shortages as an impetus to improve parenteral nutrition practices. Am J Health Syst Pharm. 2013;70:1533-7.
Mirtallo JM, Holcombe B, Kochevar M, Guenter P. Parenteral nutrition product shortages: the A.S.P.E.N. strategy. Nutr Clin Pract. 2012;27:385-391.
Hanson C, Thoene M, Wagner J, Collier D, Lecci K, Anderson-Berry A. Parenteral nutrition additive shortages: the short-term, long-term and potential epigenetic implications in premature and hospitalized infants. Nutrients. 2012;4:1977-1988.
MacKay M, Anderson C. Physical compatibility of sodium glycerophosphate and calcium gluconate in pediatric parenteral nutrition solutions. JPEN J Parenter Enteral Nutr. 0148607114528982, first published on April 2, 2014.