[08 May 2013]
Products Affected - Description
Sublimaze Injection 50 mcg/mL, Akorn
2 mL ampules, 25 count (NDC 17478-0030-25)
Fentanyl Injection 50 mcg/mL, Hospira
10 mL ampules (NDC 00409-9093-36) - discontinued
2 mL ampule (NDC 00409-9093-32)
2 mL Carpuject syringe (NDC 00409-1276-32)
2 mL vial (NDC 00409-9094-22)
5 mL ampule (NDC 00409-9093-35)
5 mL vial (NDC 00409-9094-25)
20 mL vial (NDC 00409-9094-31)
50 mL vial (NDC 00409-9094-61)
20 mL ampule (NDC 00409-9093-38)
Fentanyl Injection 50 mcg/mL, West-Ward
2 mL vial (NDC 00641-6027-25)
2 mL ampule (NDC 00641-6024-10)
5 mL ampule (NDC 00641-6025-10)
5 mL vial (NDC 00641-6028-25)
20 mL ampule (NDC 00641-6026-05)
20 mL vial (NDC 00641-6029-25)
50 mL vial (NDC 00641-6030-01)
Reason for the Shortage
- West-Ward acquired Baxter’s fentanyl injection products in May, 2011. The company began changing NDC numbers in July, 2012.1,2
- West-Ward states the shortage is due to a manufacturing delay for the fentanyl 50 mcg/mL 20 mL ampules. The 20 mL vials are in short supply due to increased demand.
- Hospira states the shortage is due to increased demand and manufacturing delays including quality improvement activities. Hospira is increasing production of the ampules to help meet the demand. 3
- Akorn launched Sublimaze injection in late-March, 2012.4
Sublimaze Injection 50 mcg/mL, Akorn
2 mL ampules, 10 count (NDC 17478-0030-02)
5 mL ampules, 10 count (NDC 17478-0030-05)
5 mL ampules, 25count (NDC 17478-0030-55)
20 mL ampules (NDC 17478-0030-20)
Fentanyl Injection 50 mcg/mL, Hospira
10 mL vial (NDC 00409-9094-28)
Estimated Resupply Dates
- Akorn has Sublimaze 2 mL ampules, 25 count on back order with an estimated release date of mid-May, 2013.
- Hospira has fentanyl 50 mcg/mL 5 mL ampules and 50 mL vials on back order with an estimated release date of mid-May 2013. The 2 mL vials are on back order with an estimated release date of mid- to late-May 2013. The 2 mL amps and 20 mL vials are on back order with an estimated release date of late-May 2013. Fentanyl 50 mcg/mL 20 mL ampules are on back order with an estimated release date of mid- to late-May 2013. The 2 mL ampules and 20 mL vials are on back order with an estimated release date of late-May 2013. The 5 mL vial is on back order with an estimated release date of late-June 2013. Hospira has fentanyl 50 mcg/mL 2 mL Carpuject syringes on back order with an estimated release date of early-August, 2013.3
- West-Ward has fentanyl 50 mcg/mL 20 mL ampules on back order with an estimated release date of late-June 2013. The 2 mL and 5 mL ampules are on back order with an estimated release date of late-May 2013. West-Ward has fentanyl 50 mcg/mL 2 mL, 5 mL, 20 mL, and 50 mL vials on back order and the company cannot estimate a release date.1
Implications for Patient Care
Fentanyl is labeled for use in analgesia for short duration or as a narcotic supplement in general and regional analgesia.5 Fentanyl is also labeled for use with a neuroleptic for premedication of induction of anesthesia and as an adjunct for general anesthesia maintenance. Fentanyl is also labeled for use with oxygen as an anesthetic agent in high risk patients, including those undergoing complicated procedures.5
Remifentanil, alfentanil, fentanyl and sufentanil may sound alike/look alike. However, dosage recommendations vary significantly between the agents.5-8
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 1.5-15
- No single agent can be substituted for fentanyl. 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 fentanyl for specific clinical situations.
- Some presentations of alternative agents including sufentanil and butorphanol are in short supply.16
- Drawing up individual doses in syringes may help conserve product. Ensure USP 797 requirements are met.
- Consider reserving fentanyl for high risk populations such as newborn and obstetrics.
- West-Ward (personal communications). July 5, August 19, September 6 and 20, October 5, 20 and 27, November 1, 8 and 23, and December 6, 15, 19 and 28, 2011; January 4, 5 and 20, February 1 and 22, March 5, 12 and 20, April 9, May 9, June 14, July 30, August 6, September 24, October 12, November 16, and December 17, 2012; January 23 and 25, February 21, March 4, April 3, 17 and 22, May 8, 2013.
- Baxter (personal communications). June 7 and 14, July 21 and 27, September 8 and 30, October 20 and 25, November 3, December 7 and 21, 2010; January 4, 18, and 31, March 4 and 24, and May 9 and 18, and June 21, 2011.
- Hospira (personal communications). June 7 and 15, July 22 and 29, September 10, October 1, 11, 22, and 25, November 3, December 7 and 20, 2010; January 4, 18, and 31, March 4 and 23, May 10 and 23, June 20, July 5, August 15, September 6 and 20, October 3, 20, 24, and 31, November 8 and 22, and December 6, 13, 20 and 27, 2011; January 3, 9 and 30, February 20, March 5, April 12, May 9, June 11 and 18, July 30, August 13, October 1 and 24, November 12 and 27, December 19, 2012; January 23, February 6 and 21, March 4 and 8, April 3, 17, and 26, and May 8, 2013.
- Akorn (personal communications). March 14, April 12, May 9, June 7 and 20, August 2 and 16, October 1, November 16, and December 19, 2012; February 21, April 3 and 19, and May 6, 2013.
- Fentanyl Injection [product information]. Lake Forest, IL: Hospira; 2008.
- Sufentanil Injection [product information]. Lake Forest, IL: Hospira; 2004.
- 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. 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.
- 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.
- Diprivan (propofol) injection [product information]. Schaumburg, IL: APP, 2009.
- Trummel J. Sedation for gastrointestinal endoscopy: the changing landscape. Curr Opin Anaesthesiol. Aug 2007;20(4):359-364.
Updated: May 8, 2013 by Ginny Jones, RPh, Drug Information Specialist; April 26, 2013 by David M. Peterson, PharmD, Drug Information Specialist. Created November 2, 2011 by Michelle Wheeler, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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