Skip to main content Back to Top
Advertisement

6/3/2019

Epinephrine Injection

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 - discontinued
    • 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 - discontinued

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 August 2019.[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; and April 26, 2019.
    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, June 29, August 10 and 30, September 28, November 1, December 7, 2018; January 31, March 1 and 29, April 26, and May 31, 2019.
    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 June 3, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 4, 2017 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Vizient, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

« Back to Drug Shortage Product Bulletins