Learning Objectives

After completing this continuing education activity you will be able to:

1. Discuss the role of soy-based lipid emulsion in the pathogenesis of intestinal failure-associated liver disease (IFALD).
2. Evaluate the strength of evidence supporting omega-3 fatty acid lipid emulsions for the treatment of IFALD.
3. Identify interventions other than omega-3 fatty acid lipid emulsions that may be effective for the treatment of IFALD.
4. Describe the difficulties patients and families may face when trying to obtain access to Omegaven under the compassionate use protocol.
5. Discuss reasons why maintaining compassionate use restrictions on Omegaven may be appropriate.
6. Explain the factors that contribute to the current drug shortage crisis.
7. Identify strategies for managing the care of patients who require drugs or nutrition products that are in short supply.
8. State mechanisms for reporting a drug or nutrient shortage or adverse patient outcomes resulting from such a shortage.
9. Explain that Omegaven's manufacturer Fresenius Kabi is preparing a new drug application for Omegaven, and that there are many possible scenarios through which the FDA may approve the product or request more data