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 November 11, 2019 the FDA considers the following PN components in shortage:
FDA Publishes New Report Regarding Root Causes and Potential Solutions to Drug Shortages
Despite public and private sector efforts to prevent and mitigate drug shortages, they continue to occur. Last year, at the request of Congress, the FDA convened an interagency task force to study the problem, determine the root causes of drug shortages, and make recommendations for enduring solutions. This week, the FDA, on behalf of the Agency Drug Shortages Task Force, issued the report, “ Drug Shortages: Root Causes and Potential Solutions.” Based on insights gleaned from stakeholders in the public and private sectors, published research, and economic analyses, the report identifies the underlying factors causing drug shortages and recommends solutions to address them.
Drug Shortage Legislation Introduced
U.S. Senator Susan Collins (R-ME) and Senator Tina Smith (D-MN) introduced S.2723 Mitigating Emergency Drug Shortages (MEDS Act), legislation that would help increase the supplies of vital drugs needed to treat or prevent a wide variety of diseases, illnesses, and conditions.
House Energy & Commerce Committee Chair Frank Pallone (D-NJ) and Rep. Brett Guthrie (R-KY) introduced legislation H.R.4866 National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019, that aims to limit drug shortages and spur U.S. drug manufacturing by encouraging use of continuous manufacturing in the development and approval of drugs and biologics. The bill would give FDA $80 million to designate certain universities as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, which would study and recommend improvements to continuous manufacturing.
Appropriate Dosing for Parenteral Nutrition: ASPEN Recommendations
ASPEN recommendations for managing shortages of PN components.
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.
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.
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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