Drug Shortages Update

February 2012

Background 

Latest_Shortages_and_How_to_Report_Shortages 

A.S.P.E.N._Recommendations 

Report_Adverse_Events 

Public_Policy_and_Current_Legislation 

 

Background

Drug shortages in PN: 

A.S.P.E.N. is continually addressing the ongoing shortage of vitamins, electrolytes, and other IV nutrition ingredients that has critically impacted hospitals nationwide. There are now 19 parenteral nutrition components on the American Society of Health System Pharmacists (ASHP) drug shortages list. A recent study by the American Hospital Association found that 89 percent of hospitals have experienced nutrition product shortages.¹ The FDA reports that in 2010, 74% were IV medications including PN products. All PN products except dextrose and water have been in short supply at some point since spring of 2010.

 

Contributing factors to PN drug shortages: 

• Raw material quality
• Enforcement of FDA standards and regulations
• Manufacturer business decisions
• Just in time inventory levels
• Grey market distributors
• Stockpiling by end end-users
• Changes in clinical practice

 

Impact on Safety

Nutrition Product Shortages:  Impact on Safety by Dr. Beverly Holcombe – presented at the 2011 A.S.P.E.N. Parenteral Nutrition Safety Summit

 

ISMP: 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

 

(Cohen, Smetzer. Hosp Pharm 2011:46(1):7-11)

 

Latest Shortages and How to Report Shortages

Latest Shortage News

 

To Review Product Supply Information and to Report PN Product Shortages:

Food and Drug Administration Drug Shortage Program 

 

American Society of Health-System Pharmacists (ASHP) Drug Shortages Resource Center 

 

A.S.P.E.N. Recommendations for PN Product Shortages 

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. 

 

1. 2011 Parenteral Nutrition Cysteine Shortage Consideration (HTML) (.PDF)
2. 2011 Parenteral Nutrition Trace Element Product Shortage Considerations (HTML) (PDF)
3. 2011 Parenteral Nutrition Electrolyte/Mineral Product Shortage Considerations (HTML)
4. 2010 Information to Use in the Event of an Intravenous Amino Acid Shortage (HTML)
5. 2010 Information to Use in the Event of an Intravenous Fat Emulsion Shortage (HTML) (.PDF)
6. 2010 IV Multivitamin Shortage Information (HTML) (.PDF)

 

A.S.P.E.N. is continuing to address the drug shortages issue by:

• 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
• 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.
• Releasing information for conservation and alternate therapy measures through a new document, Parenteral Nutrition Electrolyte/Mineral Product Shortage Considerations. 
• Releasing new recommendations on the L-cysteine shortage
• Supporting current congressional legislation by asking A.S.P.E.N. members to contact their federal legislators and ask for their cosponsorship of S. 296 and H.R.2245. 
• Gathering stories on how people have been impacted by the drug shortages

 

To Report Adverse Events Related to PN Product Shortages:

Institute for Safe Medication Practices Medication Error Reporting Program (MERP)  

 

Public Policy and Current Legislation

Current Legislation and Call to Action

 

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@aspen.nutr.org