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Drug Shortages Update

Latest News 

Background 

Why do drug shortages occur? 

Where can I obtain information about a drug shortage? 

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

Does A.S.P.E.N. have recommendations for managing shortages? 

Do parenteral nutrition product shortages affect patient safety? 

What should I report and how do I report an adverse event related to a parenteral nutrition product shortage? 

How is A.S.P.E.N. addressing the continued shortages of parenteral nutrition components? 

A.S.P.E.N. news about parenteral nutrition product shortages 

 

Latest News*   

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 

 

*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. 

 

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 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%) are 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 at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm#q1 

 

Where can I obtain information about a drug shortage?    

 

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

 

Does A.S.P.E.N. have recommendations for managing shortages of parenteral nutrition components? 

These product shortage recommendations, developed by the Clinical Practice Committee Shortage Subcommittee and approved by the Board of Directors, help clinicians manage parenteral nutrition therapy during this time of product shortages.

  • Parenteral Nutrition Trace Element Product Shortage Considerations, 2013 (HTML) 
  • Parenteral Nutrition Intravenous Fat Emulsion Shortage Considerations, 2013 (HTML)
  • Information to Use in the Event of an Intravenous Amino Acid Shortage, 2013 (HTML)
  • IV Multivitamin Shortage Information, 2012 (HTML) (.PDF)
  • Parenteral Nutrition Cysteine Shortage Consideration, 2011 (HTML) (.PDF)
  •  Parenteral Nutrition Electrolyte/Mineral Product Shortage Considerations, 2011 (HTML)

 

Do parenteral nutrition product shortages affect patient safety?  

Shortages pose safety risks throughout the entire parenteral nutrition process, from procurement to patient outcomes.

The following are leading clinical concerns as identified in an Institute for Safe Medication Practices (ISMP) survey.

  • Increasing volume of critically important medications in shortage
  • Use of less desirable, unfamiliar alternatives
  • Errors and poor patient outcomes due to absence or delay in treatment
  • Preventable adverse events by use of alternative drugs
  • Lack of advanced warning when drugs are nearly in shortage
  • Precious clinical hours lost to time time-consuming activities required to manage shortage  

Holcombe, B. Parenteral nutrition product shortages: Impact on safety. JPEN J Parenter Enteral Nutr. 2012;36,:44S-47S.   

http://pen.sagepub.com/content/36/2_suppl/44S.full.pdf+html  

Cohen MR, Smetzer JL. Weathering the storm: managing the drug shortage crisis. Hosp Pharm. 2011:46:7-11. 

http://www.metapress.com.libproxy.lib.unc.edu/content/c03646k108617r12/fulltext.pdf 

 

What should I report and how do I report an adverse event related to a parenteral nutrition product shortage? 

Any adverse event or suboptimal patient outcome related to PN product shortage is considered a medication error andshould be reported to Institute for Safe Medication Practices Medication Error Reporting Program (MERP.  Some examples of patient scenarios that should be reported are weight loss due to underfeeding, deficiencies of vitamins and/or trace elements, acid-base balance disturbances due to lack of chloride or acetate salts, inability to advance PN to goals due to lack of phosphate, and increased catheter-associated blood stream infections due to lack of ethanol for ethanol locks.  The reporting system is accessed via Institute for Safe Medication Practices Medication Error Reporting Program (MERP) 

 

How is A.S.P.E.N. addressing the continued shortages of parenteral nutrition components? 

  • Asking the FDA to provide safe alternatives and monitoring parameters since most alternatives are not as effective or safe.
  • Recommending that the FDA approve importation from global markets including Europe and Canada and other drug manufacturers/suppliers that meet their requirements
  • Supporting legislation to prevent and resolve drug shortages.
  • Facilitating communication between leaders and A.S.P.E.N. members concerning patient care-related issues.
  • Distinguishing between local supply issues and a true national shortage.
  • Developing recommendations on how to manage product shortages and quickly get them approved and disseminated.
  • Working with ISMP regarding safety issues due to shortages and/or patient harm due to shortages.
  • Encouraging A.S.P.E.N. members to report shortages.
  • Conducting webinars to discuss parenteral nutrition product shortages.
  • Surveying clinicians on the extent and severity of the parenteral nutrition product shortages
  • Gathering stories on how people have been impacted by the drug shortages.
  • Publishing papers on the parenteral nutrition product shortages.

Pramyothin SP, Kim DW, Young LS, Wichansawakun S, Apovian CA. 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. 0148607112463942, first published on October 15, 2012 http://pen.sagepub.com/content/early/2012/10/15/0148607112463942.full.pdf+html   

Gumpper KF. Drug shortages and training. JPEN J Parenter Enteral Nutr. 2012; 36: 42S-43S. http://pen.sagepub.com/content/36/2_suppl/42S.full.pdf+html   

Mirtallo JM. The drug shortage crisis. JPEN J Parenter Enteral Nutr. 2011; 35: 433. http://pen.sagepub.com/content/35/4/433.full.pdf+html    

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.   

http://pen.sagepub.com/content/36/4/476.full.pdf+html    

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. http://ncp.sagepub.com/content/27/3/385.full.pdf+html  

 

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

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

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

FDA Announces Temporary Importation of Zinc Injection – November 4, 2013

Update on IV Multivitamin Supply – November 4, 2013  

FDA Describes Oversight for Importing Parenteral Nutrition Components- October 25, 2013

BBraun Announces Availability of Amino Acids Products- October 15, 2013

FDA Approves Clinolipid Intravenous Fat Emulsion– October 7, 2013

Update on IV Fat Emulsion Supply – October 7, 2013

B. Braun Announces Shortage of TrophAmine and NephrAmine - August 27, 2013

Fresensius Kabi Announces Extended Availability of Imported Products- August 13, 2013

B. Braun Announces Shortage of Amino Acids- August 6, 2013

Fresenius Kabi and Baxter Announce Importation of Intralipid 20%- August 22, 2013  

Hospira Announces Temporary Interruption of Sodium Phosphate Production– August 1, 2013  

Baxter Announces INFUVITE Adult is Available – July 31, 2013

Fresenius Kabi Provides Information on Imported Parenteral Nutrition Components-July 31, 2013-- Updated

A.S.P.E.N. Provides Resources for IV Phosphorous Dosing-July 16, 2013

FDA Announces Importation of Phosphate Injection Product- May 29, 2013

Cupric Chloride Available- May 22, 2013 

A.S.P.E.N. Releases New PN IV Fat Emulsion Shortage Considerations- May 16, 2013  

A.S.P.E.N. Releases New PN Amino Acids Product Shortage Considerations, May 3, 2013 

PN Drug Shortages: Update- April 25, 2013  

Baxter Increases IV Fat Emulsion Allocation - March 31, 2013  

Hospira returns to manufacturing Aminosyn® and Aminosyn II®. March 11, 2013 

Neonatal Zinc Deficiencies Associated with Shortage- February 2013 

Pediatric IV Multivitamin Supply- February 2013 

A.S.P.E.N. Continues to Work on PN Drug Shortages- February 2013 

Current Shortages- December 2012 

A.S.P.E.N. Receives Feedback from FDA Drug Shortage Program - September 2012  

Hospira Notifies A.S.P.E.N. About Aminosyn® Supply - September 2012  

Update on Parenteral Nutrition Product Shortages - September 2012  

Potassium Phosphate Supply Improving - May 2012  

Amino Acid Supply Improving- May 2012  

Multivitamin Shortage Survey Results- May 2012  

A.S.P.E.N. Signs onto Multi-Organizational Letter to Congress-May 2012 

Latest Shortage News: Multivitamins-February 2012 

Latest Shortage News: Amino Acids-January 2012 

 

For more information and updates on this topic, contact Peggi Guenter, PhD, RN, Senior Director of Clinical Practice, Advocacy, and Research, A.S.P.E.N. at peggig@nutritioncare.org 

 

Baxter