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9/12/2019

Morphine Injection

Products Affected - Description

    • Morphine injection, Fresenius Kabi, 5 mg/mL, 1 mL preservative-free prefilled syringe, 24 count, NDC 76045-0006-10
    • Morphine injection, Fresenius Kabi, 5 mg/mL, 1 mL vial, 25 count, NDC 63323-0455-01
    • Morphine injection, Fresenius Kabi, 8 mg/mL, 1 mL vial, 25 count, NDC 63323-0458-01
    • Morphine injection, Pfizer, 1 mg/mL, 10 mL preservative-free vial, 25 count, NDC 00409-3815-12
    • Morphine injection, Pfizer, 10 mg/mL, 1 mL preservative-free Carpuject syringe, 10 count, NDC 00409-1893-01
    • Morphine injection, Pfizer, 10 mg/mL, 1 mL preservative-free iSecure syringe, 10 count, NDC 00409-1893-11
    • Morphine injection, Pfizer, 2 mg/mL, 1 mL preservative-free iSecure syringe, 10 count, NDC 00409-1890-11
    • Morphine injection, Pfizer, 25 mg/mL, 1 mL preservative-free vial, 50 count, NDC 00409-1135-02
    • Morphine injection, Pfizer, 4 mg/mL, 1 mL preservative-free iSecure syringe, 10 count, NDC 00409-1891-11
    • Morphine injection, Pfizer, 50 mg/mL, 50 mL vial, 50 count, NDC 00409-1134-05
    • Morphine injection, Pfizer, 8 mg/mL, 1 mL preservative-free Carpuject syringe, 10 count, NDC 00409-1892-01
    • Morphine injection, Pfizer, 8 mg/mL, 1 mL preservative-free iSecure syringe, 10 count, NDC 00409-1892-11

Reason for the Shortage

    • Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.[1-2]
    • Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.[2]
    • Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is prioritizing production of certain morphine Carpuject syringes.[3]
    • Hikma did not provide a reason for the shortage.[4]
    • Piramal Critical Care has Mitigo 10 mg/mL 20 mL and 25 mg/mL 20 mL vials available.[5]

Available Products

    • Duramorph (preservative-free) injection, Hikma, 0.5 mg/mL, 10 mL ampule, 10 count, NDC 00641-6020-10
    • Duramorph (preservative-free) injection, Hikma, 1 mg/mL, 10 mL ampule, 10 count, NDC 00641-6019-10
    • Infumorph (preservative-free) injection, Hikma, 10 mg/mL, 20 mL ampule, 1 count, NDC 00641-6039-01
    • Infumorph (preservative-free) injection, Hikma, 25 mg/mL, 20 mL ampule, 1 count, NDC 00641-6040-01
    • Mitigo injection, Piramal Critical Care, 10 mg/mL, 20 mL preservative-free vial, 1 count, NDC 66794-0160-02
    • Mitigo injection, Piramal Critical Care, 25 mg/mL, 20 mL preservative-free vial, 1 count, NDC 66794-0162-02
    • Morphine injection, Fresenius Kabi, 10 mg/mL, 1 mL vial, 25 count, NDC 63323-0451-01
    • Morphine injection, Fresenius Kabi, 2 mg/mL, 1 mL preservative-free prefilled syringe, 24 count, NDC 76045-0004-10
    • Morphine injection, Fresenius Kabi, 2 mg/mL, 1 mL vial, 25 count, NDC 63323-0452-01
    • Morphine injection, Fresenius Kabi, 4 mg/mL, 1 mL preservative-free prefilled syringe, 24 count, NDC 76045-0005-10
    • Morphine injection, Fresenius Kabi, 4 mg/mL, 1 mL vial, 25 count, NDC 63323-0454-01
    • Morphine injection, Hikma, 10 mg/mL, 1 mL vial, 25 count, NDC 00641-6127-25
    • Morphine injection, Hikma, 4 mg/mL, 1 mL vial, 25 count, NDC 00641-6125-25
    • Morphine injection, Hikma, 8 mg/mL, 1 mL vial, 25 count, NDC 00641-6126-25
    • Morphine injection, Pfizer, 0.5 mg/mL, 10 mL preservative-free vial, 25 count, NDC 00409-3814-12
    • Morphine injection, Pfizer, 2 mg/mL, 1 mL preservative-free Carpuject syringe, 10 count, NDC 00409-1890-01
    • Morphine injection, Pfizer, 4 mg/mL, 1 mL preservative-free Carpuject syringe, 10 count, NDC 00409-1891-01
    • Morphine injection, Pfizer, 50 mg/mL, 20 mL vial, 50 count, NDC 00409-1134-03

Estimated Resupply Dates

    • Fresenius Kabi has morphine 5 mg/mL 1 mL syringes on back order and the company estimates a release date of early- to mid-October 2019. The 5 mg/mL 1 mL vials and 8 mg/mL 1 mL vials are on back order and the company estimates a release date of mid-September 2019. Check wholesalers for inventory.[2]
    • Pfizer has morphine 1 mg/mL 10 mL preservative-free vials on back order and the company estimates a release date of September 2019. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of August 2020. The 8 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of December 2019. The 10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of December 2019. The 25 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of March 2020. The 50 mg/mL 50 mL vials are available in limited supply.[3]

Implications for Patient Care

    • ASHP has an FAQ on the injectable opioid shortage at https://www.ashp.org/Drug-Shortages/Shortage-Resources/Injectable-Opioid-Shortages-FAQ. This discusses multiple issues including inventory and pharmacy operational strategies.

Safety

    • Exercise extreme caution when switching morphine concentrations or interchanging to other injectable opioid products (eg, hydromorphone). Equianalgesic dosing conversions are based on limited data and do not account for patient specific factors (eg, end organ function, pharmacogenomics) or incomplete cross-tolerance between opioids. No equianalgesic dosing conversion factors are universally accepted.[6-7]
    • Pfizer has sent a safety information letter about certain lots of morphine injection and other medications supplied in Carpuject syringes. There is a potential for particulates and cracked needle hubs.
    • Special instructions are described in this letter including doing visual inspection for cracks and particulate matter and using a 5 micron filter for administration. The details of the special handling instructions and affected lot numbers are available at https://www.pfizerinjectablessupply.com/sites/default/files/carpuject_specific_lot_handling_instructions.pdf.

Alternative Agents & Management

    • Use oral opioid dosage forms if the enteral route is available.[8]
    • Use patient controlled analgesia (PCA) presentations or prepare PCAs from multidose vials to conserve unit dose presentations. Patient controlled analgesia is the preferred method of parenteral opioid administration in postoperative patients.[8]
    • Work with prescribers to convert to an appropriate dose of another parenteral opioid if needed and available.

References

    1. BD (personal communications). October 2, 2015.
    2. Fresenius Kabi (personal communication). May 6 and 23, June 8, August 1 and 18, September 21, October 6, November 7, December 19, 2016; January 24, April 24, June 2, July 6 and 19, August 10, September 7, 21, and 28, October 27, November 10, 17, and 30, December 10, 15, and 17, 2017; January 12, February 5 and 15, March 2, 16, and 23, April 6 and 13, May 3, 10, and 19, June 4, 7, and 18, July 12 and 27, August 17 and 29, September 6, 14, 21, and 28, October 5, 12, 20, and 26, November 2, 9, 16, and 29, December 9, 20, and 27, 2018; January 11 and 18, February 1 and 21, March 1, 15, and 29, April 26, May 3, 11, and 24, June 27, July 5, 12, and 18, August 2, 16, 26, and 30, and September 6, 2019.
    3. Pfizer (personal communication and website). September 4 and 18, October 2 and 19, November 17 and 30, December 17 and 23, 2015; January 14, February 22, April 11, May 4, 10, 18, and 25, June 2, 17, and 23, August 1 and 25, September 6, October 8, November 10, December 19, 2016; January 24, February 22 and 24, May 4, June 2, 9, and 21, July 7, 25, and 31, August 11, September 6, 11, and 25, October 4, November 2, 15, and 28, December 5, 11, and 29, 2017; January 5 and 18, February 2 and 16, March 5, 16, and 23, April 9 and 20, May 4, 11, and 18, June 5 and 21, July 16 and 31, August 17 and 29, September 7, 14, 21, and 28, October 5, 16, 19, and 25, November 2, 9, 16, and 30, December 12 and 20, 2018; January 15 and 25, February 1 and 28, March 6 and 14, April 1, 24, 30, May 15 and 28, June 28, July 3, 12, and 26, August 2, 16, and 23, and September 10, 2019.
    4. Hikma (personal communication). August 12 and 26, September 15 and 30, October 1 and 15, November 30, December 14, 2015; January 6 and 28, February 18 and 28, March 29, April 11, May 3, 13, and 24, June 17, August 1 and 10, September 29, November 2, December 19, 2016; January 25, February 24, May 3, June 7, July 5 and 19, August 10, September 6, 22, and 29, October 27, November 9, 22, and 30, December 7, 14, and 20, 2017; January 5 and 18, February 1, 14, and 28, March 21, April 4 and 18, May 2, 10, and 16, June 6 and 20, July 11, August 1, 15, and 29, September 5, 12, 19, and 28, October 3, 10, 17, 24, and 31, November 7, 14, and 28, December 12 and 20, 2018; January 16, 23, and 30, February 27, March 6, 13, and 27, April 24, May 2, 8, and 29, June 27, July 3, 10, 24, and 31, August 14 and 21, and September 11, 2019.
    5. Piramal Critical Care (personal communications). April 27, 2019.
    6. Fishman SM, Ballantyne JC, Rathmell JP, eds. Bonica's Management of Pain. 4th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2010.
    7. McPherson ML, ed. Demystifying Opioid Conversion Calculations. Bethesda, MD: American Society of Health-System Pharmacists; 2010.
    8. Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17(2):131-157.

Updated

Updated September 12, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 16, 2009 by Jane Chandramouli, 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.

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