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Shortage of injectable morphine products

by
Optum Workers' Comp
| Jan 03, 2018

According to the U.S. Food and Drug Administration (FDA), morphine injection products have recently been in short supply. Morphine sulfate injection is an opioid analgesic made by several pharmaceutical manufacturers, including Fresenius Kabi USA, LLC, Pfizer (Hospira, Inc.), and West-Ward Pharmaceuticals, in a number of different strengths and formulations. As reported by the FDA and American Society of Health-System Pharmacists (ASHP), there have been a number of reasons for these shortages, including but not limited to, increased demand for the medication and manufacturing delays.

  • Fresenius Kabi: Shortage is due to increased demand. Fresenius Kabi has morphine 2 mg/mL 1 mL syringes and 4 mg/mL 1 mL syringes on intermittent backorder and the company is releasing product as it becomes available. Morphine 5 mg/mL 1 mL syringes are on backorder and the company estimates a release date of 1st quarter 2018. Morphine 8 mg/mL and 10 mg/mL 1 mL syringes are on backorder and the company cannot estimate a release date. In addition, Astramorph injection has been unavailable since 2012; Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.
  • Pfizer: Shortage is due to manufacturing delays. Pfizer anticipated 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. Pfizer expects the shortage of prefilled syringe products to recover by late-first quarter 2018. However, morphine 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL Carpuject syringes, 8 mg/mL 1 mL iSecure syringes, 10 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL Carpuject syringes are on backorder and the company estimates a release date of June 2019. In addition, Pfizer discontinued morphine ADD-Vantage vials in January 2017.
  • West-Ward: Shortage is due to increased demand. West-Ward launched several new morphine sulfate products in late-September 2015. They are not actively marketing 15 mg/mL 1 mL vials or 8 mg/mL 1 mL vials but are still marketing the 8 mg/mL 1 mL vials. West-Ward has Duramorph 0.5 mg/mL 10 mL ampules and 1 mg/mL 10 mL ampules on a weekly allocation. Morphine 4 mg/mL 1 mL vials, 10 mg/mL 1 mL vials, and 8 mg/mL 1 mL vials are on backorder and the company estimates a release date of 1st quarter 2018. 

 

Since morphine injections are administered by healthcare professionals, such as in hospitals and outpatient facilities, these medications are not dispensed at retail pharmacies or distributed directly to claimants. Therefore, injectable morphine products are not allowed on our standard formularies. For more up-to-date information on morphine sulfate injection shortages and anticipated resupply dates, visit the FDA’s website here.

Sources:
  1. U.S. Food and Drug Administration. FDA Drug Shortages. Current and Resolved Drug Shortages and Discontinuations Reported to FDA. Available at https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Morphine%20Sulfate%20Injection,%20USP&st=c&tab=tabs-1. Accessed January 2, 2018.
  2. American Society of Health-System Pharmacists (ASHP). Drug Shortages. Current Drug Shortages. Morphine Injections. Available at https://www.ashp.org/drug-shortages/current-shortages/Drug-Shortage-Detail.aspx?id=664. Accessed January 2, 2018.




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