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12/5/2019

Hydromorphone Hydrochloride Injection

Products Affected - Description

    • Hydromorphone Hydrochloride solution for injection, Pfizer, 1 mg/mL, 1 mL ampule, 10 count, NDC 00409-2552-01
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 1 mg/mL, 1 mL iSecure syringe, 10 count, NDC 00409-1283-10
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 10 mg/mL, 1 mL vial, 10 count, NDC 00409-2634-01
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 2 mg/mL, 1 mL ampule, 10 count, NDC 00409-3356-01
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 2 mg/mL, 1 mL iSecure syringe, 10 count, NDC 00409-1312-10
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 4 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-1304-31
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 4 mg/mL, 1 mL ampule, 10 count, NDC 00409-2540-01

Reason for the Shortage

    • Akorn has hydromorphone injection on shortage due to increased demand.[1]
    • Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing their product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018.[2]
    • Pfizer did not provide a reason for the shortage.[3]
    • Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.[4]
    • Teva did not provide a reason for the shortage.[5]
    • Hikma did not provide a reason for the shortage.[6]

Available Products

    • Dilaudid injection, Fresenius Kabi, 0.5 mg/0.5 mL, 0.5 mL preservative-free prefilled syringe, 24 count, NDC 76045-0009-05
    • Dilaudid injection, Fresenius Kabi, 1 mg/1 mL, 1 mL preservative-free prefilled syringe, 24 count, NDC 76045-0009-10
    • Dilaudid injection, Fresenius Kabi, 2 mg/1 mL, 1 mL preservative-free prefilled syringe, 24 count, NDC 76045-0010-10
    • Hydromorphone Hydrochloride solution for injection, Akorn, 10 mg/mL, 1 mL ampule, 10 count, NDC 17478-0540-01
    • Hydromorphone Hydrochloride solution for injection, Akorn, 10 mg/mL, 5 mL ampule, 10 count, NDC 17478-0540-05
    • Hydromorphone Hydrochloride solution for injection, Akorn, 10 mg/mL, 50 mL vial, 10 count, NDC 17478-0540-50
    • Hydromorphone Hydrochloride injection, Fresenius Kabi, 1 mg/mL, 1 mL vial, 25 count, NDC 63323-0852-25
    • Hydromorphone Hydrochloride injection, Fresenius Kabi, 10 mg/mL, 1 mL preservative-free vial, 10 count, NDC 63323-0851-10
    • Hydromorphone Hydrochloride injection, Fresenius Kabi, 10 mg/mL, 5 mL preservative-free vial, 10 count, NDC 63323-0851-15
    • Hydromorphone Hydrochloride injection, Fresenius Kabi, 10 mg/mL, 50 mL preservative-free vial, 1 count, NDC 63323-0851-50
    • Hydromorphone Hydrochloride injection, Fresenius Kabi, 2 mg/mL, 1 mL vial, 25 count, NDC 63323-0853-25
    • Hydromorphone Hydrochloride injection, Fresenius Kabi, 4 mg/mL, 1 mL vial, 25 count, NDC 63323-0854-10
    • Hydromorphone Hydrochloride solution for injection, Hikma, 2 mg/mL, 1 mL vial, 25 count, NDC 00641-6151-25
    • Hydromorphone Hydrochloride solution for injection, Hikma, 2 mg/mL, 20 mL multiple dose vial, 1 count, NDC 00641-2341-41
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 0.5 mg/0.5 mL, 0.5 mL iSecure syringe, 10 count, NDC 00409-1283-05
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 1 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-1283-31
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 10 mg/mL, 5 mL vial, 10 count, NDC 00409-2634-05
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 10 mg/mL, 50 mL vial, 1 count, NDC 00409-2634-50
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 2 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-1312-30
    • Hydromorphone Hydrochloride solution for injection, Pfizer, 2 mg/mL, 1 mL vial, 10 count, NDC 00409-3365-01
    • Hydromorphone Hydrochloride solution for injection, Teva, 10 mg/mL, 1 mL vial, 10 count, NDC 00703-0110-03
    • Hydromorphone Hydrochloride solution for injection, Teva, 10 mg/mL, 5 mL vial, 10 count, NDC 00703-0113-03
    • Hydromorphone Hydrochloride solution for injection, Teva, 10 mg/mL, 50 mL vial, 1 count, NDC 00703-0018-01

Estimated Resupply Dates

    • Pfizer has 10 mg/mL 1 mL vials are available in limited supply. The 1 mg/mL 1 mL ampules are available in limited supply. The 2 mg/mL 1 mL ampules and 4 mg/mL 1 mL ampules are on back order and the company estimates a release date of April 2020 for the 2 mL ampules and December 2019 for the 4 mL ampules. The 1 mg/mL 1 mL iSecure syringes and 2 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of January 2020. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of January 2020.[3]

Implications for Patient Care

    • FDA is allowing temporary importation through Pfizer of hydromorphone 2 mg/mL 1 mL ampules that are marketed in Canada. More information on the NDC number and ordering of the ampules is available at https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM617292.pdf.
    • 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 hydromorphone concentrations or interchanging to other injectable opioid products (eg, morphine). 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.[7-8]
    • Pfizer has sent a safety information letter about certain lots of hydromorphone 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.[9]
    • 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.[9]
    • Avoid using high concentration hydromorphone presentation (eg, 4 mg/mL, 10 mg/mL) for intermittent parenteral doses lower than 1 mg to prevent dosing errors.
    • Work with prescribers to convert to an appropriate dose of another parenteral opioid if needed and available.

References

    1. Akorn (personal communication). May 30, August 2, December 8, 2017; January 10, February 9, April 26, May 15, June 12, July 13, September 21, November 2, December 26, 2018; February 26, April 12, and November 7, 2019.
    2. Fresenius Kabi (personal communication). June 7, July 7 and 27, August 31, September 28, October 27, November 17 and 30, December 15 and 22, 2017; January 7 and 12, February 5, March 2 and 23, April 6 and 27, May 10, June 7, 18, and 22, July 5 and 27, August 3, 13, and 17, and September 6, 14, and 28, October 5, 12, 20, and 26, November 2, 9, 16, and 29, December 9 and 20, 2018; January 3 and 18, March 1, 8, 5, 21, and 29, April 19, May 3 and 30, June 27, July 5, 12, and 18, August 2, 12, and 30, September 6 and 27, and November 1 and 22, 2019.
    3. Pfizer (personal communication and website). June 1, 2, 9, and 22, July 7 and 14, August 2, September 6, 11, and 29, November 2 and 28, December 12 and 29, 2017; January 5 and 18, February 9, March 5 and 23, April 9 and 24, May 11, June 1, 8, and 22, July 12 and 31, August 7, 15, and 21, September 7 and 14, October 1, 5, 12, 19, and 25, November 2, 9, 16, and 30, December 12 and 21, 2018; January 8 and 22, March 6 and 21, April 3, 19, and 30, May 31, June 28, July 3, 12, and 23, August 2 and 13, September 6 and 27, and November 8 and 25, 2019.
    4. Purdue Pharma (personal communication). May 30, 2017.
    5. Teva (personal communication). May 30, 2017, July 28, September 6, October 17, November 27, December 4, 2017; January 8, February 5, March 5 and 19, April 9 and 30, May 14, June 11, July 9 and 30, August 13 and 20, September 10, and October 1, 15, and 28, November 9, 16, and 30, December 10 and 24, 2018; January 14, March 4 and 18, April 1 and 22, May 27, June 24, July 1, 12, and 29, September 6, and November 8, 2019.
    6. Hikma (personal communication). May 23, July 7 and 19, September 6 and 29, October 26, November 22 and 30, December 14 and 30, 2017; January 5 and 18, February 1 and 28, March 21, April 4 and 25, May 10, June 6 and 18, July 11, August 1, 9, 15, and 22, September 5, 14, and 26, October 3, 10, 17, 23, 24, and 31, November 16, December 12, 2018; January 9 and 23, March 6 and 20, April 3 and 17, May 2 and 29, June 27, July 3, 10, 24, and 31, August 7, September 4 and 25, and November 6 and 20, 2019.
    7. Fishman SM, Ballantyne JC, Rathmell JP, eds. Bonica's Management of Pain. 4th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2010.
    8. McPherson ML, ed. Demystifying Opioid Conversion Calculations. Bethesda, MD: American Society of Health-System Pharmacists; 2010.
    9. 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 December 5, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 5, 2017 by Leslie Jensen, 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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