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Propofol Shortage Hits Nationwide

This information gives you an update on the nationwide propofol shortage.

Propofol Shortage Hits Nationwide

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Hospitals Hit with Propofol Shortage 

Adam Marcus

Medical centers nationwide are feeling the pinch on propofol in the wake of recalls by two manufacturers of generic forms of the sedative.  

The recalls involve propofol manufactured by Teva Pharmaceuticals and Hospira dating as far back as July. Although stemming from different reasons, the actions have led to a shortage of propofol that is forcing hospitals to ration their use of the drug and to use alternative medications for procedures ranging from surgery to sedation in the intensive care unit. 

One hospital in Rochester, N.Y., for example, said its supply of propofol will run out in less than 10 days. The facility is calling on its anesthesiologists to cut back on their use of the drug by switching to an alternative induction agent such as methohexital (Brevital, JHP), etomidate or sevoflurane; avoiding propofol for “marginal indications” like general anesthesia, reducing postoperative nausea and for patients undergoing prolonged intubations; and by substituting other drugs—fentanyl, midazolam, dexmedetomidine (Precedex, Hospira)—for monitored anesthesia care. 

The hospital also admonished its physicians to be parsimonious with the drug, which must be used or thrown out within six hours of the vial being opened: “Please do not draw it up until you are certain of use.” 

At Thomas Jefferson University Hospital in Philadelphia on Wednesday, propofol was not to be found in the ICU, said Eugene Viscusi, MD, director of regional anesthesia and acute pain management at the institution. “Propofol is our most widely used sedation agent in the ICU setting,” Dr. Viscusi said. “Today on rounds I saw no propofol there so it has already impacted practice. Not too much effect in the OR here, at least yet,” he added. 

Judith Jacobi, PharmD, a critical care pharmacist at Methodist Hospital/Clarian Health, in Indianapolis, and incoming president of the Society of Critical Care Medicine, said her facility is “soon to be in crisis on this. We have not made a definite plan, though,” Dr. Jacobi added. “We have alternatives and will need to use them.”

Double-Hit

The shortage is the result of a double-hit in the supply of propofol in the United States. Teva recalled approximately 57,000 vials of its propofol solution in mid-July, after at least 41 patients who received the drug fell ill with flu-like symptoms. The company announced that it had discovered high levels of endotoxin in vials of the sedative pulled from the affected lots. The company did not provide answers to questions about its recall by the time this article went to press. 

The Hospira action was more recent. The company notified its customers on Oct. 16 that it was recalling batches of propofol and Liposyn, an IV fat emulsion with which propofol is administered, after discovering metal particles in the products. 

Dan Rosenberg, a spokesman for the Lake Forest, Ill.-based company, said the recalled lots were manufactured between August and October. “We’ve identified the source as stainless steel equipment used in the manufacturing process,” added Mr. Rosenberg, who said the company has received no reports of harm to patients linked to the affected drugs. (Supplies of another Hospira anesthetic, thiopental [Pentothal], also are short because of manufacturing issues, according to the company, which expects to resume shipping the drug early next year. Mr. Rosenberg said the problems with the two agents are unrelated.) 

Mr. Rosenberg said the company has taken “corrective action” to address the manufacturing flaw. “What we’re telling our customers is, we expect to have replacement product soon.” 

That would be welcome news to Thomas Van Hassel, MS, RPh, director of pharmacy at Yuma Regional Medical Center, in Yuma, Ariz. 

“This is a critical problem for us all,” Mr. Van Hassel said. “A shortage of this nature requires immediate attention by every pharmacy director or clinical staff to address work-around and to obtain adequate supplies of alternative agents. It seems drug shortages of this type are cropping into our normal workflows on a rather regular basis,” Mr. Van Hassel added. “The agent involved changes, but the grief it causes doesn’t seem to get any easier.”

Hospira may benefit from its propofol recall. Several experts interviewed for this article said they have been or would consider using dexmedetomidine instead of propofol for sedation. Dexmedetomidine costs roughly four to five times as much as propofol, Mr. Van Hassel said. 

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