ASPEN is continually addressing the ongoing shortage of 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 Shortage News
As of October 19, 2020 the FDA considers the following PN components in shortage:
American Regent Update on Multitrace® Products
Coronavirus Aid, Relief, and Economic Security (CARES) Act Includes Provisions for Drug Shortages
The CARES Act includes provisions that address drug shortages by providing the FDA with expanded authorities.
- Priority review for drugs in shortage including review of applications and expedited inspections.
- Manufacturers reporting a shortage must provide more details about the shortage including the cause, extent and expected duration of the shortage. Interruptions or disruptions of the supply of the drug’s active pharmaceutical ingredient must also be reported.
- Manufacturers must develop risk management and redundancy plans for their supply chains, identifying factors that could impact production of finished products or active pharmaceutical ingredients.
Shortage ManagementASPEN 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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