Products Affected - Description

• • 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, 5 mL preservative-free vial, 10 count, NDC 63323-0851-15
  • 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, NexJect syringe, 10 count, NDC 00409-4264-01
  • 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, 1 mL vial, 10 count, NDC 00409-2634-01
  • 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 vial, 10 count, NDC 00409-3365-10
  • Hydromorphone Hydrochloride solution for injection, Pfizer, 4 mg/mL, 1 mL Carpuject syringe, 10 count, NDC 00409-1304-31

Reason for the Shortage

• • Akorn ceased operations in February 2023.[1]
  • Fresenius Kabi has hydromorphone on shortage due to shipping delays.[2]
  • Hikma did not provide a reason for the shortage.[3]
  • Pfizer has hydromorphone on shortage due to manufacturing delays. All hydromorphone iSecure syringes have been discontinued.[4]
  • Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.[5]
  • Teva has hydromorphone injection available.[6]

Available Products

• • Dilaudid injection, Fresenius Kabi, 0.2 mg/0.2 mL, 0.2 mL preservative-free prefilled syringe, 10 count, NDC 76045-0121-11
  • Dilaudid injection, Fresenius Kabi, 0.5 mg/0.5 mL, 0.5 mL preservative-free prefilled syringe, 10 count, NDC 76045-0009-06
  • Dilaudid injection, Fresenius Kabi, 1 mg/1 mL, 1 mL preservative-free prefilled syringe, 10 count, NDC 76045-0009-11
  • Dilaudid injection, Fresenius Kabi, 2 mg/1 mL, 1 mL preservative-free prefilled syringe, 10 count, NDC 76045-0010-11
  • 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, 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 solution for injection, Pfizer, 0.25 mg/0.25 mL, NexJect syringe, 10 count, NDC 00409-1805-01
  • Hydromorphone Hydrochloride solution for injection, Pfizer, 1 mg/mL, 1 mL NexJect syringe, 10 count, NDC 00409-1283-37
  • 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 NexJect syringe, 10 count, NDC 00409-1312-36
  • 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

• • Fresenius Kabi has hydromorphone 1 mg/mL 1 mL vials and 4 mg/mL 1 mL vials on back order and the company estimates a release date of early-April 2024. There are short-dated hydromorphone 10 mg/mL 5 mL vials available with an expiration date of < 1 month.[2]
  • Hikma has hydromorphone 2 mg/mL 20 mL vials on allocation. The 2 mL vials are on back order and the company estimates a release date of early-April 2024.[3]
  • Pfizer has hydromorphone 2 mg/mL 1 mL vials are on back order and the company estimates a release date of November 2024. The 10 mg/mL 1 mL, 5 mL, and 50 mL vials are on back order and the company estimates a release date of November 2024 for the 1 mL vials, October 2024 for the 5 mL vials, and December 2024 for the 50 ml vials. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of April 2024. The 0.5 mg/0.5 mL NexJect syringes and 1 mg/mL 1 mL Carpuject syringes are available in limited supply.[4]

• • 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

• • 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]

• • 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.

• 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, November 7, 2019; January 20, March 6, June 23, August 11, November 20, December 14, 2020; April 12, July 21, September 15, November 8, 2021; March 14, 24, and 31, May 4, July 27, November 4, December 14, 2022; and February 14 and 22, 2023.
  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, November 1 and 22, 2019; January 3 and 17, February 11 and 28, March 6, April 3 and 24, May 22 and 29, June 19, July 17, August 7, December 4 and 18, 2020; February 5, April 9, May 21, June 25, July 30, August 13, September 17, December 3 and 10, 2021; and March 11 and 18, April 8, June 10, August 5, November 18, December 16 and 29, 2022; January 27, February 17, March 3 and 24, April 21, June 9, July 13, August 10 and 31, September 14, October 5 and 19, November 2 and 16, December 14, 2023; January 25, February 1 and 29, and March 14 and 21, 2024.
  3. 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, November 6 and 20, December 18, 2019; January 2, 22, and 29, February 6 and 26, April 8, May 20, June 3 and 24, July 15, August 5, December 9, 2020; February 10, April 7, May 19, June 23, July 28, August 11, September 15, December 1 and 10, 2021; March 9 and 23, April 13, June 8, August 10, November 22, December 14 and 28, 2022; February 1 and 15, March 2 and 23, April 20, June 8, July 12, August 9 and 30, October 4 and 18, November 1 and 21, December 13, 2023; January 24, February 28, and March 13, 20, and 27, 2024.
  4. 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, November 8 and 25, 2019; January 3, 23, and 30, February 12, March 4, April 10, May 1 and 22, June 3 and 23, July 20, August 7, December 4 and 18, 2020; February 5, April 11, May 21, June 25, July 30, August 13, September 17, December 3 and 12, 2021; March 11 and 18, April 12, June 10, August 10, November 20, December 20, 2022; January 2 and 6, February 1 and 20, March 6 and 24, April 25, June 9, July 14, August 13, September 1, October 6 and 24, November 3 and 21, December 3 and 15, 2023; January 26 and 29, and March 1, 19, and 27, 2024.
  5. Purdue Pharma (personal communication). May 30, 2017.
  6. 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, November 8, 2019; January 17, April 6 and 30, May 22 and 29, June 19, July 10 and 31, December 4 and 18, 2020; February 5, April 9, May 21, June 25, July 30, August 13, September 17, December 3 and 10, 2021; March 11, April 8, June 10, August 5, November 18, December 16, 2022; January 2 and 27, February 10, March 24, April 21, September 1, November 8, 2023' January 12, and February 26, 2024.
  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.