Product Shortages

Latest News 

A.S.P.E.N. continues to strive to provide up-to-date information on the supply of parenteral nutrition components.  However, the supply is constantly changing.  Clinicians are encouraged to directly contact the suppliers and the manufacturers for the status of supply availability.

Parenteral Nutrition Component Shortages Update - October 15, 2014

B.Braun Receives FDA Approval for Nutrilipid 20% - August 15, 2014 

 Hospira Reintroduces Aquasol A - August 12, 2014

Baxter Announces Availability of INFUVITE Multivitamins - June 24, 2014

Fresenius Kabi Provides Information on Peditrace in Newborns - June 10, 2014

A.S.P.E.N. Releases Trace Element Shortage Report - June 10, 2014

FDA Announces Temporary Importation of Normal Saline - March 31, 2014

ASHP Publishes Strategies to Manage IV Fluids Shortage - March 25, 2014

Baxter Informs A.S.P.E.N. that Intralipid Removed from Allocation - March 13, 2014

FDA Extends Temporary Importation of Peditrace and Addamel N - February 13, 2014

GAO Releases Drug Shortage Report – February 12, 2014

CLINIMIX and CLINIMIX E Injection/Baxter: Recall - January 7, 2014 

Background 

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. There are many parenteral nutrition (PN) components on the American Society of Health System Pharmacists (ASHP) and FDA drug shortages list.  A recent study by the American Hospital Association found that 89 percent of hospitals have experienced nutrition product shortages. (American Hospital Association Survey on Drug Shortages. June 2011).

In 2010 there were 178 drug shortages reported to the FDA of which 132 were sterile injectable drugs.  The number of reported shortages increased to 251 in 2011, 183 of which involved sterile injectable drugs.  As of February 28, 2013 there were 324 medications in short supply and of these 228 (70%) were sterile injectables.  (Erin Fox, University of Utah Drug Information Service)  All PN products except dextrose and water have been in short supply at some point since spring of 2010.

Why do drug shortages occur?

A major reason for these shortages has been quality/manufacturing issues. However there have been other reasons such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers. Discontinuations are another factor contributing to shortages. FDA can't require a firm to keep making a drug it wants to discontinue. Sometimes these older drugs are discontinued by companies in favor of newer, more profitable drugs.

With fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. The raw material suppliers the firms use are also limited in the amount they can make due to capacity issues at their facilities. This small number of manufacturers and limited production capacity for older sterile injectables, combined with the long lead times and complexity of the manufacturing process for injectable drugs, results in these drugs being vulnerable to shortage. When one company has a problem or discontinues, it is difficult for the remaining firms to increase production quickly and a shortage occurs.

The FDA provides additional information on drug shortages

Where can I obtain information about a drug shortage?    

Where/how do I report a shortage of a parenteral nutrition component? 

Product Shortage Management

A.S.P.E.N.'s Clinical Practice Committee Shortage Subcommittee has developed product shortage recommendations. These recommendations, approved by the Board of Directors, help clinicians manage PN therapy during a time of product shortages:

View product shortage management

A.S.P.E.N. News about Parenteral Nutrition Product Shortages 

Fresenius Kabi Provides Information on Peditrace in Newborns - June 20, 2014 

A.S.P.E.N. Releases New PN Trace ElementProduct Shortage Considerations – December 30, 2013  

Fresenius Kabi (APP) Manufacturing PotassiumPhosphate Injection - November 12, 2013

FDA Announces Temporary Importation of ZincInjection – November 4, 2013

Update on IV Multivitamin Supply – November 4, 2013 

FDA Describes Oversight for ImportingParenteral Nutrition Components- October 25, 2013

 

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