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Sufentanil Injection

[02 July 2014]

Products Affected - Description

Sufentanil 50 mcg/mL, Hospira
1 mL ampule (NDC 00074-3380-31)
1 mL vial (NDC 00074-3382-21)
2 mL ampule (NDC 00074-3380-32)
2 mL vial (NDC 00074-3382-22)
5 mL ampule (NDC 00074-3380-35)
5 mL vial (NDC 00074-3382-25)

Sufentanil 50 mcg/mL, West-Ward
2 mL ampule (NDC 00641-6111-10)

Sufenta 50 mcg/mL, Akorn
1 mL ampule (NDC 17478-0050-01)
2 mL ampule (NDC 17478-0050-02)
5 mL ampule (NDC 17478-0050-05)

Reason for the Shortage

  • West-Ward has sufentanil on shortage due to manufacturing delays.1
  • Hospira has sufentanil on shortage due to manufacturing delays.2

Available Products

Sufentanil 50 mcg/mL, West-Ward1
1 mL ampule (NDC 00641-6110-10)
5 mL ampule (NDC 00641-6112-10)

Estimated Resupply Dates

  • Hospira has all sufentanil 50 mcg/mL presentations on back order and the company cannot estimate a release date.2
  • West-Ward has sufentanil 50 mcg/mL 2 mL ampules on back order and the company estimates a release date of mid-July 2014.1
  • Akorn has Sufenta 50 mcg/mL 1 mL, 2 mL and 5 mL ampules available in limited supply through wholesalers.3


Implications for Patient Care

Sufentanil is labeled for use as an adjunct for general anesthesia maintenance.4 Sufentanil is also labeled for use with oxygen as an anesthetic agent in high risk patients, including those undergoing complicated neurosurgical procedures or cardiovascular surgery.4 Sufentanil, given by the epidural route and in combination with bupivacaine, is also labeled for analgesia during labor and delivery.4

Safety

Sufentanil, alfentanil, fentanyl, and remifentanil may sound alike/look alike. However, dosage recommendations vary significantly between the agents.4-7 Patient harm can occur if these agents are used erroneously. Use extra caution not to confuse these agents.

Alternative Agents & Management

  • Alternative opiate agonists vary in onset time and duration of action, see Table 1.4-14
  • No single agent can be substituted for sufentanil. The choice of an alternative agent must be patient-specific and based on the clinical situation, venous access, renal and hepatic function, and other comorbid conditions. Utilize stakeholder clinicians to help make specific plans for individual patient populations. Table 2 provides some alternatives to sufentanil for specific clinical situations.
  • Some presentations of alternative agents including fentanyl and butorphanol are in short supply.15

Related Shortages

References

  1. West-Ward (personal communications). January 11, February 14, April 5, May 10, June 17 and 28, August 10, September 30, November 2, December 7 and 28, 2011; January 20, February 9 and 28, March 23, April 9, May 2 and 24, June 21, July 3, August 6, September 4 and 14, October 12, December 17, 2012; January 21, February 25, April 22, May 24, June 4, July 3 and 29, August 9, October 3 and 18, December 6, 2013; January 11, March 3 and 28, April 18, May 2 and 30, and June 25, 2014.
  2. Hospira (personal communications and website). January 11, February 15, April 5, May 10, June 17 and 28, August 8 and 22, September 27, October 11 and 31, December 7 and 27, 2011; January 26, February 10 and 27, March 27, April 12, May 2 and 24, June 4 and 18, July 3, August 13, September 5 and 17, October 31, December 19, 2012; January 23, February 25, April 17, May 24, July 29, August 12, October 3 and 23, November 11, 2013; January 14, March 4 and 31, April 23, May 9 and 30, and June 30, 2014.
  3. Akorn (personal communications).February 14, June 21, August 10, September 29, October 31, December 7 and 28, 2011; January 26, February 10 and 29, March 30, April 12, May 2 and 22, June 6 and 20, July 3, August 16, September 5 and 18, October 30, December 19, 2012; January 23, February 26, April 19, May 24, July 29, August 12, October 3 and 23, December 10, 2013; January 13, March 4 and 31, April 23, May 8, and June 30, 2014. 
  4. Sufentanil Injection [product information]. Lake Forest, IL: Hospira; 2004.
  5. Fentanyl Injection [product information]. Lake Forest, IL: Hospira; 2008.
  6. Alfentanil Injection [product information]. Lake Forest, IL: Hospira; 2004.
  7. Ultiva (remifentanil) Injection [product information]. Lake Forest, IL: Mylan Institutional; 2009 March.
  8. Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2011. Updated periodically.
  9. Lacy CF, Armstrong LL, Goldman MP, Lance LL, eds. Drug Information Handbook. 17th ed. Hudson, OH: Lexi-Comp; 2010.
  10. Opiate Agonists. In: McEvoy GK, Snow EK, Miller J, Kester L, Welsh OH, eds. AHFS 2011 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2011: 2188-2231.
  11. Nonvolatile Anesthetic Agents. In: Morgan GE, Mikhail, MS, Murray, MJ. Clinical Anesthesiology. 4th ed. New York, NY: McGraw-Hill; 2006:179-204.
  12. Opioids, Analgesia, and Pain Management. In: Brunton LL, Chabner BA, Knollman BC, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, NY: McGraw-Hill; 2011: 481-525.
  13. Scott LJ, Perry CM. Remifentanil: a review of its use during the induction and maintenance of general anaesthesia. Drugs. 2005;65(13):1793-1823.
  14. Scholz J, Steinfath M, Schulz M. Clinical pharmacokinetics of alfentanil, fentanyl and sufentanil. An update. Clin Pharmacokinet. Oct 1996;31(4):275-292.
  15. American Society of Health-System Pharmacists. Drug Shortage Resource Center. Available online. Accessed on November 2, 2011.
  16. Baughman VL, Golembiewski J, Gonzales JP, Alvarez, W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 2010.
  17. Gibbs RS, Karlan BY, Haney AF, Nygaard I, eds. Danforth’s Obstetrics and Gynecology. 10th ed. Philadelphia, PA: Wolters Kluwer Health / Lippincott Williams & Wilkins; 2008.
  18. Morgan GE, Mikhail MS, Murray MJ. Clinical Anesthesiology. 4th ed. New York, NY: Lange Medical Books; 2006.
  19. Bankowski BJ, Hearne AE, Lambrou NC, Fox HE, Wallach EE. The John Hopkins Manual of Gynecology and Obstetrics. 2nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2002.
  20. Weiner C, Buhimschi C. Drugs for Pregnant and Lactating Women. 2nd ed. Philadelphia, PA: Saunders Elsevier; 2009.
  21. Butorphanol Injection [product information]. Lake Forest, IL: Hospira; 2004.
  22. Nalbuphine Injection [product information]. Lake Forest, IL: Hospira; 2007.
  23. Hinova A, Fernando R. Systemic remifentanil for labor analgesia. Anesth Analg. 2009;109(6):1925-1929.

Updated

Updated July 2, 2014 by Jane Chandramouli, PharmD, Drug Information Specialist. Created November 9, 2011 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation 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. Novation, 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 Novation, 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 Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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