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Some same-day surgery programs are rescheduling elective surgeries, and programs might see their recovery times extended as they face a critical shortage of fentanyl and are forced to resort to alternate drugs that are less effective.
Fentanyl is a powerful, short-acting opioid used as the principal anesthetic agent in hospitals and ambulatory surgical centers across the country. The Food and Drug Administration (FDA) attributes the shortage to simply an increased demand in the market. There has been more than a 50% void in the marketplace as a whole, according to Tareta Lewis, spokeswoman for Abbott Laboratories’ hospital products division, a maker of fentanyl based in Abbott Park, IL.
According to a report published on-line in Anesthesiology News (www.mcmahonmed.com), unexpected demand coincided with one manufacturer’s decision to discontinue distribution of fentanyl 2-mL ampules. ESI Lederle, a Radnor, PA-based unit of American Home Products’ Wyeth-Ayerst Laboratories, still manufactures this size; however, it will be distributed by Baxter Pharmaceuticals as per a contractual agreement.
Anesthesiologists are reporting that these shortages are or will soon be impacting hospital surgery schedules, explains Philip Weintraub, spokesman for the Park Ridge, IL-based American Society of Anesthesiologists (ASA). Some facilities are reporting critical shortages of even alternate medications, he says. The shortage also is causing physicians to turn to less-effective alternative drugs, which affects patient discharge, Weintraub says. "When you start using morphine and Dilaudid, you increase time of patients in recovery room," he says.
Morphine’s effects can last for hours because it affects breathing and heart rate, Weintraub says. Until those functions return to normal, the facility won’t discharge the patient, he points out. "It could put a strain on the outpatient facility because the patient has to stay in there longer," Weintraub says.
The ASA performed an informal survey of representatives of the organization, covering a large geographic area, and the majority responded that they were experiencing a critical shortage of fentanyl. There also are widespread shortages of sufentanil and alfentanil, used to control pain during and after surgery, among other uses, as well as muscle relaxants, anti-nausea medications, and local anesthetics, according to the ASA. Both the ASA and sources interviewed for this story confirmed that facilities of all sizes and in all locations are experiencing shortages.
About six months ago, Harborview Medical Center in Seattle ran out of 2 ml and 5 ml packages of fentanyl, according to Bruce F. Cullen, MD, chief of anesthesiology and ASA vice president for scientific affairs. "The pharmacy had to go to all the other units in the hospital and remove their supply so that we could have it available for use in our ORs and ambulatory facility," Cullen says.
Patients on the ward had to receive alternate pain-relieving medications, he says. "I am not aware that patients were harmed as a result, but I did fear that physicians [nonanesthesiologists] and nurses who were not as familiar with these alternate medications might experience difficulty with their administration," Cullen says.
At press time, his facility still was in short supply of the 2 ml and 5 ml ampules. "We still have 20 ml ampules of the drug, but rarely is that large quantity necessary," Cullen says. "So, anesthesiologists will use a small amount of the 20 ml ampules of the drug when [20 ml] is unneeded, and patients are being charged for the larger amount because it is all that is available."
Other facilities had a bit of good luck in locating supplies of fentanyl. When Urological Ambulatory Surgery Center in Orlando, FL, was down to four vials of fentanyl, it obtained a supply of multidose vials through a pharmacy that has a dispensing license. "We’ve literally had to draw up fentanyl and hand them to the anesthesiologists for each case," says Elizabeth Acosta-Urban, RN, director of nursing at the facility.
"I told the pharmacist, I will take whatever you can get me,’" Acosta-Urban says. "If that meant I would have to far oversupply, that was fine, because we are outpatient surgery, and most cases are elective. If we’re not doing cases, we’re not getting paid, so we’re out of business."
For its part, Abbott Laboratories’ hospital products division has more than doubled its manufacturing of fentanyl, according to Lewis. ESI Lederle and Buffalo Grove, IL-based Akorn/ Taylor Pharmaceuticals, as well as Abbott, have experienced back orders of the drug. Abbott is reviewing each fentanyl order individually and giving priority to orders from health care facilities that conduct more surgeries and treat more high-acuity patients, Lewis says. ESI is fulfilling orders in the sequence they were received, according to a spokesperson. Akorn/Taylor Pharmaceuticals did not respond to questions about how the back orders are being handled.
At press time, the ASA was setting up meetings with hospital-based pharmacists, with invitations extended to government groups such as the FDA and Drug Enforcement Administration (DEA), to discuss the shortage and what action can be taken. The DEA sets production levels for the manufacture of certain narcotics, including fentanyl.
[Editor’s note: The FDA web page (go to www.fda.gov/cder/ and type in "drug shortage" on the search line) offers information on drug shortages, including a Drug Shortage Manual of Policies and Procedures and How to Report a Drug Shortage.]
For more information on coping with the fentanyl shortage, contact: Elizabeth Acosta-Urban, RN, Director of Nursing, Urological Ambulatory Surgery Center, 1812 N. Mills Ave., Orlando, FL 32803. Telephone: (407) 992-2656. Fax: (407) 896-9454. E-mail: email@example.com.