[06 June 2013]
Products Affected - Description
Propofol injection, 10 mg/mL, APP
20 mL vial (NDC 63323-0270-25)
50 mL vial (NDC 63323-0270-50)
100 mL vial (NDC 63323-0270-65)
20 mL Novaplus vial (NDC 63323-0270-26)
50 mL Novaplus vial (NDC 63323-0270-57)
100 mL Novaplus vial (NDC 63323-0270-67)
Diprivan injection, 10 mg/mL, APP
20 mL vial, 25 count (NDC 63323-0269-20)
20 mL vial, 10 count (NDC 63323-0269-29)
50 mL vial (NDC 63323-0269-50)
100 mL vial (NDC 63323-0269-65)
Propofol injection 10 mg/mL, Hospira
20 mL vial (NDC 00409-4699-30)
50 mL vial (NDC 00409-4699-33)
100 mL vial (NDC 00409-4699-24)
Propofol injection 10 mg/mL, Teva
20 mL vial (NDC 00703-2856-04)
100 mL vial (NDC 00703-2859-03)
Reason for the Shortage
- Hospira has propofol on shortage due to manufacturing delays.1
- Teva has released limited amounts of propofol that can be ordered by calling 1-855-284-3896.2
- APP is releasing propofol to wholesalers as product gets released due to increased demand. APP started transitioning to 10 count packages on several products in March, 2013.3
- APP cannot keep up with increased demand for product.3 In cooperation with FDA, APP is providing Propoven 10 mg/mL injection to the US market again to help alleviate the shortage. Propoven is manufactured in FDA-approved facilities by Fresenius Kabi AG, the parent company of APP.5 Propoven is different from Diprivan in that it is preservative-free and contains medium-chain triglycerides as well as long-chain triglycerides. (Diprivan contains only long-chain triglycerides and also contains EDTA).4,5 APP has a Dear Healthcare professional letter online.4,5 Report any offers to sell Propoven by an entity other than APP Pharmaceuticals to email@example.com.
No presentations are readily available.
Estimated Resupply Dates
- Hospira has propofol 10 mg/mL 20 mL vials on intermittent back order and the company is releasing product regularly. Hospira has propofol 10 mg/mL 50 mL and 100 mL vials on back order and the company estimates a release date of June 2013. These will be allocated to contracted customers upon release.1
- Teva has propofol 20 mL and 100 mL vials available in limited supply.3
- APP has propofol, Diprivan, and imported Propoven on intermittent back order and the company is releasing product as it becomes available on a weekly basis. Check wholesalers for supply.3
Implications for Patient Care
- Propofol is a sedative hypnotic agent labeled for the induction of anesthesia in patients 3 years and older as part of an overall anesthesia regimen in patients undergoing surgery. Propofol is labeled for maintenance of anesthesia in patients 2 months of age and older, as part of an overall anesthesia regimen in patients undergoing surgery. Propofol is labeled for monitored anesthesia care in patients undergoing diagnostic or surgical procedures. Propofol is labeled for continuous sedation in adult patients who are mechanically ventilated in the intensive care unit.4,6
- Unlabeled uses of propofol include management of refractory status epilepticus or complex-partial seizures, treatment of postoperative nausea and vomiting or prevention of chemotherapy induced nausea and vomiting, conscious sedation, and treatment of itching secondary to cholestasis or opioid use.6
- Strict aseptic technique is recommended for all propofol products, but is essential for Propoven which is preservative-free. Propoven products are single-dose vials and each vial may only be used for a single patient. Propoven also differs from Diprivan in lipid composition. Clinicians must take this difference into account for patients receiving total parenteral nutrition (TPN), patients with fat metabolism disorders, or patients in which lipid emulsions must be used cautiously.4,5
- Propoven and US-labeled propofol products both contain soybean oil.4,5 The product labeling for Propoven includes a contraindication for use in patients with peanut or soy allergy due to a theoretical concern for cross-reactivity.5
Alternative Agents & Management
- Alternative intravenous hypnotic agents for the induction and maintenance of anesthesia vary in time of onset and duration of action, as shown in Table 1.
- Intravenous sedative medications used in the ICU include propofol, benzodiazepines (eg, midazolam, lorazepam), opioids, haloperidol, and dexmedetomidine.7,8 Table 2 compares select intravenous medications used for sedation in the intensive care unit.
- Intravenous medications used for procedural sedation include propofol, methohexital, dexmedetomidine, and benzodiazepines (eg, midazolam, lorazepam) in combination with opioids (eg, fentanyl, morphine). Table 3 summarizes alternatives for specific clinical situations.
- Minimize any potential drug waste. Propofol must be used within 12 hours.4
- Hospira (personal communications). April 2, May 22, June 4 and 18, July 30, September 12, October 15, November 18, December 10, 2012; February 5 and 15, and March 12, April 4, May 1, and June 4, 2013.
- Teva (personal communications). June 2, 2010; April 4, and May 2, 2013.
- APP (personal communications). March 29, April 5, 6, and 11, May 23, June 4 and 29, July 30, September 12, October 3, November 19, December 12, 2012; February 4, March 7, April 4, May 1, and June 4, 2013.
- Diprivan (propofol injection) product information. Schaumburg, IL: APP, 2009.
- APP. Dear Healthcare Professional Letters (customer letter). Accessed July 2, 2012.
- McEvoy GK, Snow EK, Kester L, Litvak K, Miller J, Welsh OH, eds. AHFS 2009 Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2009.
- Rhoney DH, Murry KR. National survey of the use of sedating drugs, neuromuscular blocking agents, and reversal agents in the intensive care unit. J Intensive Care Med 2003; 18: 139-45.
- Precedex (dexmedetomidine injection) product information. Lake Forest, IL: Hospira; 2008.
- Donnelly AJ, Baughman VL, Gonzales JP, Golembiewski J, Tomsik EA, eds. Anesthesiology and Critical Care Drug Handbook. 8th ed. Hudson, OH: Lexi-Comp; 2008.
- Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2009. Updated periodically.
- Bahn EL, Holt, KR. Procedural sedation and analgesia: a review and new concepts. Emerg Med Clin N Am 2005; 23:503-15.
- Miner JR, Burton JH. Clinical practice advisory: emergency department procedural sedation with propofol. Ann Emerg Med 2007; 50:182-7.
- Miner JR, Danahy M, Moch A, Biros M. Randomized clinical trial of etomidate versus propofol for procedural sedation in the emergency department. Ann Emerg Med 2007; 49:15-22.
- Falk J, Zed PJ. Etomidate for procedural sedation in the emergency department. Ann Pharmacother 2004; 38:1272-7.
Updated: June 6, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist; April 4, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist; March 12, 2013 by Michelle Wheeler, PharmD, Drug Information Specialist. Created October 28, 2009 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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