ASPEN is continually addressing the ongoing shortage of parenteral nutrition (PN) components by working with and maintaining communications with the FDA, pharmaceutical manufacturers, other professional healthcare organizations and clinicians to stay up to date on the status of shortages, collaborate to resolve shortages and to provide resources for managing shortages.
LATEST Product & Shortage News
Baxter North Cove, NC Facility Disruption of Site Operations Baxter Update on CLINIMIX Product Code & Packaging Changes—September 13, 2024
Fresenius Kabi Update on Vitalipid/Vitlipid Injection 10mL Single Dose Glass Ampule—September 25, 2023
Fresenius Kabi Update on Temporary Importation of Vitalipid N ADULT and Vitalipid N INFANT —September 21, 2023
Pfizer Provides Update on Tornado Recovery in Rocky Mount—August 28, 2023
Fresenius Kabi Update on Omegaven® Supply—August 23, 2023
Baxter Update on Infuvite Supply—August 11, 2023
Baxter Provides Update on EVA Bags—July 20, 2023
Fresenius Kabi Provides Update on Omegaven ® Supply—July 14, 2023
Baxter Provides Update on Intralipid 20% Supply —June 8, 2023
Intralipid® Lipid Emulsion Update From Baxter and Fresenius Kabi—June 8, 2023
Baxter Update on U.S. INFUVITE Supply—March 14, 2023
Baxter Provides Update on INFUVITE Multivitamin for Infusion—November 8, 2022
Baxter Provides Update on ExactaMix Valve Set Components—October 25, 2022
Update on SMOF Supply—August 2, 2022
Baxter Provides Update on Allocation of Amino Acids, Clinolipid, select Exactamix compounding materials, Infuvite, and Intralipid—July 26, 2022
Fresenius Kabi Provides Update on SMOFlipid—June 6, 2022
Baxter Response to ExactaMix Valve Set Constraints—May 11, 2022
ASPEN, ASHP, ISMP, and NHIA Provide Guidance for Baxter ExactaMix Automated Compounding Device (ACD) Valve Set—May 5, 2022
Baxter Provides Update on Supply of Infuvite—May 3
Baxter Provides Update on Supply of Valve Set for ExactaMix Automated Compounder—April 20, 2022
Baxter Provides Update on the Supply of Infuvite—April 7, 2022
Fresenius Kabi Provides Update on Supply of SMOFlipid—March 15, 2022
Fresenius Kabi Provides Update on Supply of SMOFlipid—January 3, 2022
Baxter Provides Update on Supply of Infuvite—November 16 2021
ASPEN Provides Guidance for Meeting Essential Fatty Acids Requirements in Adult Patients During Limited Supply of Lipid Injectable Emulsions—October 25, 2021
Pfizer Discontinuing Multi-Vitamin Infusion Products—October 25, 2021
B.Braun Provides Update on Supply of Nutrilipid 20%—September 14, 2021
Webinar "Optimizing Patient Care During a Multivitamin Shortage"—March 10, 2021
A recording of this free informational webinar on managing current intravenous multivitamin shortages across the age continuum and the safe use of temporarily imported multivitamins is available in the
ASPEN eLearning Center.
Submit Comments Regarding PN Product Shortages: ASPEN is committed to continually addressing PN product shortages by working with the FDA, manufacturers, other professional healthcare organizations, and clinicians. This communication helps ASPEN stay up to date on the status of shortages, collaborate to resolve shortages and to develop and provide resources to aid in the management of shortages. Comments and input regarding information and experience related to shortages and outages by clinicians is valuable to ASPEN.
If your institution is experiencing a shortage of any PN products or components, please voluntarily provide your comments by clicking here.
Please note, ASPEN is not able to personally communicate regarding these submissions. Thank you in advance for your comments.
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As of August 17, 2023 the FDA considers the following PN components in shortage:
Shortage Management
ASPEN recommendations for managing shortages of PN components. ASPEN's Clinical Practice Committee Nutrition Product Shortage Subcommittee has developed product shortage recommendations to help clinicians manage PN therapy during times of product shortages. These recommendations, approved by the Board of Directors, are regularly reviewed and revised to provide up-to-date information on ways to optimize patient care during shortages.
Appropriate Dosing for Parenteral Nutrition: ASPEN Recommendations
Persistent shortages of PN components have led to a tendency of practitioners providing less than adequate dosing, which can lead to nutrient deficiencies and impair growth and healing. Clinicians who have entered practice within the last 10 years may have never cared for patients receiving PN therapy without a shortage of PN components. This document provides both the appropriate PN nutrient requirements and dosing recommendations for adult, neonatal, and pediatric patients. ASPEN has also developed a webinar addressing this patient care issue.
Why do PN Component Shortages Occur?
Medication shortages can result in delayed or compromised therapy, cause providers to prescribe an alternative therapy, result in medication errors, adversely affect patient outcomes, and consume healthcare resources.1,2 Clinicians caring for patients receiving PN have been dealing with shortages since the mid-1980’s when there was an intravenous multivitamin shortage. Since that time there have been shortages of PN components, but they were infrequent and short-lived. However, since 2010 almost every component used in preparing PN has been in shortage at least once. Shortages have become more frequent and longer in duration with some shortages continuing for almost 10 years.
Providing this therapy is particularly challenging for clinicians because PN is a complex medication and may contain 20 or more ingredients, of which multiple components may simultaneously be in limited supply. The availability of PN components must be considered during every step of the PN use process from ordering the PN prescription to administering this therapy to a patient. Unlike antibiotics, there are no therapeutic alternatives for missing PN components. Adults, neonates, and pediatric patients who need this life-sustaining therapy have no alternatives if there is a shortage of one or more of the critical components in the PN.
The reasons for drug shortages can result from many factors, including regulatory, natural disasters, voluntary recalls, issues with raw materials, increase in demand, discontinuation, loss of manufacturing site, and quality issues. Some firms made the business decision to discontinue an older medication to produce a newer, more profitable medication.
More than half of the drug shortages are sterile injectables, which includes PN components. Sterile injectables are produced by small number of manufacturers and they have a limited production capacity, especially for older products. Furthermore, the production of sterile injectables is a complex, complicated process long lead times. Any production problems or quality issues will likely result in a shortage.
1. American Society of Health-System Pharmacists. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009;66:1399-1406.
2. Report on Drug Shortages for Calendar Year 2016. https://www.fda. gov/downloads/Drugs/DrugSafety/DrugShortages/UCM561290.pdf.Accessed July 29, 2017.
Where can I find out if a drug is in shortage?
Where/how do I report a shortage of a PN component?
What should I report and how do I report an adverse event related to a PN product shortage? Any adverse event or suboptimal patient outcome related to PN product shortage is considered a medication error and should 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).
Where can I learn more about drug shortages and resources for managing shortages? MEDICATION AND PN COMPONENT SHORTAGES READINGS AND REPORTS
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