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Epinephrine Injection

Last Updated: July 2, 2018
Status: Current

Products Affected - Description
    • Epinephrine injection, Amphastar, 0.1 mg/mL, 10 mL syringe, 10 count, NDC 76329-3316-01
    • Epinephrine injection, Amphastar, 1 mg/mL, 30 mL vial, 1 count, NDC 76329-9061-00
    • Epinephrine injection, Pfizer, 0.1 mg/mL, 10 mL 20 gauge LifeShield syringe, 10 count, NDC 00409-4921-34
    • Epinephrine injection, Pfizer, 1 mg/mL, 1 mL ampule, 25 count, NDC 00409-7241-01
Reason for the Shortage
    • Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.[1]
    • Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017.[2]
    • BPI has epinephrine 1 mg/mL 2 mL ampules available.[3]
    • Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.[4]
Available Products
    • Adrenalin injection, Par Sterile Products, 1 mg/mL, 1 mL vial, 25 count, NDC 42023-0159-25
    • Adrenalin injection, Par Sterile Products, 1 mg/mL, 30 mL multiple dose vial, 1 count, NDC 42023-0168-01
    • Epinephrine Snap-V Kit injection, Snap Medical Industries, 1 mg/mL, 1 mL 1 count, NDC 24357-0811-20
    • Epinephrine injection, BPI Labs, 1 mg/mL, 2 mL containing 1 mL sulfite-free and preservative-free ampule, 10 count, NDC 54288-0103-10

Estimated Resupply Dates

    • Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation.[1]
    • Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates a release date of July 2018.[2]
    • Snap Medical Industries has the Epinephrine Snap-V Kit available. Each kit contains an epinephrine 1 mg/mL 1 mL vial, (3) 1 mL luer lock syringes, and (3) 23-gauge 1-inch needles.

Implications for Patient Care

    • Epinephrine 0.1 mg/mL emergency syringes are unapproved products. Epinephrine emergency syringes are commonly used for treatment of ventricular fibrillation or pulseless ventricular tachycardia unresponsive to initial defibrillatory shocks, pulseless electrical activity, and asystole.[5-6]
    • Until the launch of the BPI 1 mg/mL 1 mL ampules, there had been no epinephrine products that were FDA-approved for intravenous use. Epinephrine 1 mg/mL 1 mL ampules from Hospira were unapproved products. These and all other epinephrine product were used off-label if given intravenously.

Safety

    • Epinephrine is a high alert medication and may cause significant patient harm when used in error.[6]
    • Create a dose conversion chart reflecting available epinephrine concentrations to keep in code boxes and post in areas where epinephrine is frequently used.[7]
    • Do not stock the 30 mL multi-dose vials in code boxes.[7]
    • If the 1 mg/mL 1 mL ampules or vials need to be used in place of the 0.1 mg/mL emergency syringes, include the diluent and syringe along with instructions for dilution of the 1 mg/mL epinephrine vial or ampule.[7]
    • Routine bulk compounding is not an option due to epinephrine having a short stability time and sensitivity to pH, light, and air.[7]
    • FDA has extended the expiration dating for certain lots of epinephrine 0.1 mg/mL 10 mL Abboject syringes. https://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm563360.htm
    • Medical providers must prepare and administer injections from the Epinephrine Snap-V Kits.8 This is not an auto-injectable product.8

Alternative Agents & Management

    • Consider conserving current supplies of epinephrine emergency syringes for code boxes or code situations.
    • Consider limiting the number of emergency syringes that are stocked in the code boxes.[7]

References

    1. Amphastar (personal communications). May 3 and 30, 2017.
    2. Pfizer (personal communications and website). May 3 and 26, June 2 and 14, July 6, August 4 and 28, September 29, November 7 and 15, December 1 and 8, 2017; January 6, February 9 and 20, March 9, May 11, and June 29, 2018.
    3. BPI Labs. May 3 2017.
    4. Par Pharmaceuticals. May 3, and June 12, 2017; and January 24, 2018.
    5. Epinephrine Injection product information. Lake Forest, IL: Hospira; 2016 March.
    6. Epinephrine. Lexi-Comp Online. Hudson, OH: Lexi-Comp Inc.; 2017.
    7. Institute for Safe Medication Practices. EPINEPHrine pre-filled syringe shortage. https://www.ismp.org/NAN/files/NAN-201006.pdf . Accessed May 31, 2017.
    8. Snap Medical Industries (personal communications). June 7, 2018.

Updated

Updated July 2, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 4, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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