[10 December 2013]
Products Affected - Description
Sufentanil 50 mcg/mL, West-Ward1
2 mL ampule (NDC 00641-6111-10)
Sufentanil 50 mcg/mL, Hospira3
1 mL ampule (NDC 00074-3380-31)
1 mL NOVAPLUS ampule (NDC 00074-3380-49)
1 mL vial (NDC 00074-3382-21)
2 mL ampule (NDC 00074-3380-32)
2 mL Novaplus ampule (NDC 00074-3380-50)
2 mL vial (NDC 00074-3382-22)
5 mL ampule (NDC 00074-3380-35)
5 mL NOVAPLUS ampule (NDC 00074-3380-51)
5 mL vial (NDC 00074-3382-25)
Reason for the Shortage
- West-Ward had sufentanil on shortage due to manufacturing delays.1
- Hospira has sufentanil on shortage due to manufacturing delays.2,3
Sufenta 50 mcg/mL, Akorn2
1 mL ampule (NDC 17478-0050-01)
2 mL ampule (NDC 17478-0050-02)
5 mL ampule (NDC 17478-0050-05)
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 estimates a release date of December 2013 for the 2 mL ampules. Sufentanil 5 mL ampules and Novaplus 2 mL and 5 mL ampules are on back order with an estimated release date of March 2014. All other presentations are on back order and the company cannot estimate a release date.3
- West-Ward has sufentanil 50 mcg/mL 2 mL ampules available but product has a short expiration date (April 2014).1
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
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
- 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, and December 6, 2013.
- 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, and December 10, 2013.
- 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, and November 11, 2013.
- Sufentanil Injection [product information]. Lake Forest, IL: Hospira; 2004.
- Fentanyl Injection [product information]. Lake Forest, IL: Hospira; 2008.
- Alfentanil Injection [product information]. Lake Forest, IL: Hospira; 2004.
- Ultiva (remifentanil) Injection [product information]. Lake Forest, IL: Mylan Institutional; 2009 March.
- Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2011. Updated periodically.
- Lacy CF, Armstrong LL, Goldman MP, Lance LL, eds. Drug Information Handbook. 17th ed. Hudson, OH: Lexi-Comp; 2010.
- 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.
- Nonvolatile Anesthetic Agents. In: Morgan GE, Mikhail, MS, Murray, MJ. Clinical Anesthesiology. 4th ed. New York, NY: McGraw-Hill; 2006:179-204.
- 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.
- Scott LJ, Perry CM. Remifentanil: a review of its use during the induction and maintenance of general anaesthesia. Drugs. 2005;65(13):1793-1823.
- Scholz J, Steinfath M, Schulz M. Clinical pharmacokinetics of alfentanil, fentanyl and sufentanil. An update. Clin Pharmacokinet. Oct 1996;31(4):275-292.
- American Society of Health-System Pharmacists. Drug Shortage Resource Center. Available online. Accessed on November 2, 2011.
- Baughman VL, Golembiewski J, Gonzales JP, Alvarez, W, eds. Anesthesiology and Critical Care Drug Handbook. 9th ed. Hudson, OH: Lexi-Comp; 2010.
- 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.
- Morgan GE, Mikhail MS, Murray MJ. Clinical Anesthesiology. 4th ed. New York, NY: Lange Medical Books; 2006.
- 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.
- Weiner C, Buhimschi C. Drugs for Pregnant and Lactating Women. 2nd ed. Philadelphia, PA: Saunders Elsevier; 2009.
- Butorphanol Injection [product information]. Lake Forest, IL: Hospira; 2004.
- Nalbuphine Injection [product information]. Lake Forest, IL: Hospira; 2007.
- Hinova A, Fernando R. Systemic remifentanil for labor analgesia. Anesth Analg. 2009;109(6):1925-1929.
Updated December 10, 2013, by Ginny Jones, RPh, Drug Information Specialist. Created November 9, 2011 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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