Does ASPEN 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.
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
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 ASPEN 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 ASPEN 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 ASPEN 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
- Gumpper KF. Drug shortages and training. JPEN J Parenter Enteral Nutr. 2012; 36: 42S-43S.
- Mirtallo JM. The drug shortage crisis. JPEN J Parenter Enteral Nutr. 2011; 35: 433.
- 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.
- 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.
For more information and updates on this topic, contact Peggi Guenter, PhD, RN, Senior Director of Clinical Practice, Quality and Advocacy, at [email protected]