Products Affected - Description

• • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 1 mL ampule, 10 count, NDC 00409-3380-31
  • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 2 mL ampule, 10 count, NDC 00409-3380-32
  • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 5 mL ampule, 10 count, NDC 00409-3380-35
  • Sufentanil solution for injection, West-Ward, 50 mcg/mL, 1 mL ampule, 10 count, NDC 00641-6110-10
  • Sufentanil solution for injection, West-Ward, 50 mcg/mL, 2 mL ampule, 10 count, NDC 00641-6111-10

Reason for the Shortage

• • West-Ward is no longer actively marketing sufentanil 1 mL and 2 mL ampules. The 5 mL ampules are available.[1]
  • Pfizer had sufentanil on shortage due to material shortage. Pfizer discontinued sufentanil ampules in October 2016. The vials continue to be marketed.[2]
  • Akorn has Sufenta available.[3]

Available Products

• • Sufenta solution for injection, Akorn, 50 mcg/mL, 1 mL ampule, 10 count, NDC 17478-0050-01
  • Sufenta solution for injection, Akorn, 50 mcg/mL, 2 mL ampule, 10 count, NDC 17478-0050-02
  • Sufenta solution for injection, Akorn, 50 mcg/mL, 5 mL ampule, 10 count, NDC 17478-0050-05
  • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 1 mL vial, 10 count, NDC 00409-3382-21
  • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 2 mL vial, 10 count, NDC 00409-3382-22
  • Sufentanil solution for injection, Pfizer, 50 mcg/mL, 5 mL vial, 10 count, NDC 00409-3382-25
  • Sufentanil solution for injection, West-Ward, 50 mcg/mL, 5 mL ampule, 10 count, NDC 00641-6112-10

• • All marketed presentations are available.

• • 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 opiate agonists vary in onset time, duration of action, and how supplied, see Tables 1, 2 and 3 below. [10-14,4-9]
  • 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 4 provides some alternatives to sufentanil for specific clinical situations.
  • Some presentations of alternative agents including fentanyl and butorphanol are in short supply.[15]

  Table 1. Comparison of Selected Short Acting Opiate Agonist Used for Adjunct Anesthesia4-7

  Opioid Agonists	How Supplied
  Alfentanil (Alfenta, generic)	500 mcg/mL Ampules: 2 mL, 5 mL, 10 mL, 20 mL
  Fentanyl (generic)	50 mcg/mL Ampules: 2 mL, 5 mL, 10 mL, 20 mL
  Remifentanil	Vials: 1 mg, 2mg, 5 mg
  Sufentanil (Sufenta, generic)	50 mcg/mL Ampules: 1 mL, 2 mL, 5 mL

  
  

  Table 2. Onset of Action and Half-Life of Selected Short Acting Opiate Agonists Used for Adjunct Anesthesia 10-14,4-9

  Opioid Agonists	Onset of action, intravenous (minutes)	Initial Half-life (minutes)	Re-distribution half-life (minutes)	Terminal half-life (minutes)	Context Sensitive (minutes)
  Alfentanil (Alfenta, generic)	<2	1	14	90-111	58.5
  Fentanyl (generic)	<5	1.7	13	219	262.5
  Remifentanil	1 to 3	1	6	10-20	3.7
  Sufentanil (Sufenta, generic)	1 to 3	1.4	17	164	33.9

  
  

  Table 3. Duration of Action of Selected Short Acting Opiate Agonists Used for Adjunct Anesthesia10-14,4-9

  Opioid Agonists	Intravenous duration of action (minutes)	Dose and duration dependent (duration of action)
  Alfentanil (Alfenta, generic)	30-60 min Single dose: 10 min	Yes
  Fentanyl (generic)	30-60 min	Yes
  Remifentanil	3-10 min	No
  Sufentanil (Sufenta, generic)	Single dose: 36 min	Yes

  
  

  Table 4. Selected Alternatives to Sufentanil for Specific Clinical Situations

  Use	Alternative Regimen	Comments
  Analgesia in Labor and Delivery	Epidural Fentanyl: 25 to 100 mcg16 Fentanyl: 50 to 100 mcg plus 10 mL bupivacaine; may repeat dose when pain returns or initiate patient controlled epidural analgesia.17-20 Intravenous Butorphanol: 1 to 2 mg every 3 to 4 hours as needed11,17,21 Nalbuphine: 5 to 10 mg every 3 to 6 hours as needed11,17,22 Fentanyl: 50 mcg once, then 25 mcg every 20 to 30 minutes as needed20 Patient controlled intravenous analgesia Remifentanil: 0.2 to 0.93 mcg/kg bolus dosing with 1 to 3 minute lockout intervals.17,23	Remifentanil is not given intraspinally because it contains glycine.12 Optimal dosing has not been established for remifentanil in labor analgesia.23

  
  

• 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, June 25, July 16, August 21, October 7 and 23, November 26, 2014; January 7, March 11, April 29, July 1, September 15, November 2 and 23, 2015; January 6, February 18, March 29, April 29, May 9, June 9, July 27, November 2, 2016; January 31, and February 8, 2017.
  2. Pfizer (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, June 30, July 21, August 22, October 8 and 23, November 26, 2014; January 8, March 19, May 4, July 9, September 22, November 2 and 24, 2015; January 27, February 29, April 8, May 2, June 9, August 15, October 9, 2016; January 31, and February 7, 2017.
  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, June 30, July 21, August 18, October 7, November 3 and 26, 2014; January 5, March 17, May 4, July 9, August 28, November 2 and 20, 2015; January 20, February 25, April 8 and 29, June 8, August 15, October 11, 2016; January 18, and February 8, 2017.
  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 at: http://www.ashp.org/shortages. 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.