Recall of transdermal fentanyl patch tests procedures at hospice agencies
Be able to ID, reach affected patients quickly with info
Although more than 30 million transdermal fentanyl patches are involved in a recent recall, well-planned processes enabled hospice agencies to contact and protect their patients affected by the recall.
In mid-February, 25 mcg/hr transdermal fentanyl patches manufactured under the brand name Duragesic (manufactured by PriCara; Raritan, NJ) and the generic patches manufactured by Sandoz (Princeton, NJ) were recalled voluntarily by the manufacturers due to a cut along the side of the patch that might result in the narcotic gel leaking.
"Only the 25 mcg patch was affected, not any of the other doses," says Michael Cinque, PharmD, chief pharmacy care officer for Hospice Phamacia in Philadelphia. "The chance of a patch leaking was one in 2 million, but it was important to contact all patients who received the patch."
"Our company received the recall notice on Feb. 12; and on Feb. 13, we contacted all of our hospice partners with the recall information along with educational information to share with staff members," Cinque says. Instructions on how to check for leaks included looking for oozing or wetness around the patch, he explains. Also, the cut in the patch is visible, so inspection of the patch was possible to determine if the patch was at risk for leaking, Cinque adds.
An additional recall of transdermal fentanyl patches manufactured by Actavis in Morristown, NJ, occurred shortly after the recall of the Duragesic patches due to a manufacturing error in which the packet was incorrectly folded in such as way that a leak might occur, says Cinque. "There were a limited number of lots of those patches affected, and none of our hospice agency partners received them," he says.
Janet Snapp, RN, MSN, vice president of clinical services at Hospice of the Bluegrass in Lexington, KY, says, "We chose to recommend disposal of all of the recalled patches that were in the patients' homes because we did not want to risk exposing nurses to a leaking narcotic as they inspected the stock of patches in the home." Snapp's in-house pharmacy was able to act quickly to identify patients who received the patches involved in the recall, she says. "This recall serves as a wake-up call for hospice agencies to make sure that their processes for identifying patients on specific medications are effective," Snapp adds.
While Hospice of the Bluegrass has an in-house pharmacy, hospice agencies that contract with outside organizations for pharmacy services should expect the same service during a recall, Snapp says. "Because hospice agencies provide the drugs to patients, we are ultimately responsible for the safety of the medications," she explains.
Nurses encouraged disposal
Only seven out of Snapp's 1,000 clients were using patches involved in the recall, she says.
"A nurse visited each home to talk with the patient and the family about the potential risk and to recommend that the patches be destroyed," she says. "Even though the hospice provides the medication, it is the patient's medication, so we can't destroy it."
Her nurses strongly recommended disposal of the unused patches by flushing them down the toilet, as directed by the Food and Drug Administration (FDA), and explained that fentanyl patches from another manufacturer would be delivered the next day, she adds. "Disposal of medication is difficult for many of our patients," she admits. Because older patients who lived through the Depression want to hoard supplies, nurses emphasized the potential safety risk and reassured them that they would not run out of pain medication, she adds.
"We also informed all of our nurses about the recall, not just those nurses visiting patients with the recalled patch," says Snapp. "Some family members saw news stories about the recall and had questions, especially if their family member was using a fentanyl patch."
Because the nurses had been alerted, they were able to answer questions and reassure patients who had patches that were not affected by the recall, she says. "We wanted to avoid situations in which patients refused to use their medications because they did not understand the recall," Snapp explains. "Our nurses' knowledge about the recall and the medications involved increased our patients' confidence in our services."
Some agencies had very few patients using transdermal patches because hospice medical directors don't always rely upon them for pain control. Ric Baxter, MD, hospice medical director and director of palliative care services at St. Luke's Hospice and Health Network in Bethlehem, PA, says, "I'm not a fan of transdermal fentanyl patches, and we usually work to transition patients to another pain medication when they are admitted to our hospice service, so the recall was not an issue for us."
Transdermal patches are most effective for patients with chronic, stable pain, Baxter says. He prefers medications that are more flexible when managing pain and allow for quicker changes of dosage, he says. Two of the pain medications he prefers are oxycodone and methadone, but both of these medications recently were affected by legal and regulatory decisions that affect price and dose, he says. The issues raised by recent recalls and decisions affecting narcotic pain medication point out the need for hospice agencies to have systems in place not only to identify patients on specific medications, but also to identify alternative medications for those patients, he adds.
Planning ahead means making sure that all pharmacies, including local pharmacies, that your agency uses have a process to notify you of recalls, identify patients using recalled medications, and provide direction on how your staff can identify and dispose of medications, says Cinque. "We included instructions on what to do if a patient, family member, or nurse got fentanyl gel on their skin," he says.
While soap and water usually is the recommended way to clean skin, water only is recommended for removing the narcotic gel, he says. "Soap changes the permeable barrier of the skin, making it easier for the drug to be absorbed, so water alone is better to remove the gel without increasing the risk of absorption," he explains.
When planning your response for a recall, don't forget to address how you will handle the recalled medications if, as in the recall of the fentanyl patches, the patient can continue using the medication once it is inspected for safety, says Cinque. "Disposal of medication can be costly, so you have to decide at what point risk outweighs cost," he says. For example, some agencies examined the patches by opening the packages to check for cuts that could cause leaks; other agencies simply recommended disposal of all patches without inspection, he says.
"This is a decision that needs to be made by each agency in each recall, taking into account the number of patients and the amount of medication involved, and the potential risk to patients and staff as they inspect the medications," Cinque says.
Need More Information?
For more information about fentanyl recall patch recalls, contact:
- Ric Baxter, MD, Hospice Medical Director and Director of Palliative Care Services, St. Luke's Hospital and Health Network, 2455 Black River Road, Bethlehem, PA 18015. Telephone: (610) 997-7120. E-mail: [email protected].
- Michael Cinque, PharmD, Chief Pharmaceutical Care Officer, Hospice Pharmacia, 1601 Cherry St., Suite 1700, Philadelphia, PA 19102. Telephone: (877) 882-7822 or (215) 282-1615. E-mail: [email protected].
- Janet Snapp, RN, MSN, Vice President of Clinical Services, Hospice of the Bluegrass, 2312 Alexandria Drive, Lexington, KY 40504. Telephone: (859) 276-5344. Fax: (859) 223-0490. E-mail: [email protected].
To sign up for notification of recalls, go to www.fda.gov/opacom/Enforce.html and click on "Sign up to receive FDA Enforcement Reports."
Although more than 30 million transdermal fentanyl patches are involved in a recent recall, well-planned processes enabled hospice agencies to contact and protect their patients affected by the recall.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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