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By Michelle Meadows
Fentanyl skin patches provide convenient and effective relief for many people who experience chronic pain, and who have been taking pain medications for long periods of time. But health care providers and patients should be aware that deaths and other serious problems have resulted from accidental overdoses related to inappropriate use of the fentanyl patch, the Food and Drug Administration says.
The patch is applied to the skin and delivers fentanyl, a potent, strong opiate analgesic. The drug is slowly absorbed through the skin into the bloodstream and can relieve pain for up to three days from a single patch application.
"After applying the first patch, it can take 12 to 18 hours to reach the peak of pain relief, with some early pain relief occurring at four to six hours after the first administration," says Donald R. Stanski, M.D., a professor of anesthesia at Stanford University who was involved with the clinical drug development of the first fentanyl patch in the 1980s.
The most frequent use of the fentanyl patch has been to treat pain in people with cancer, and it is only appropriate for patients who have developed a degree of tolerance to the opiate analgesic effects because they have been previously using this type of drug, says Robert J. Meyer, M.D., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.
"Because the patch provides slow, continuous drug delivery, people with constant pain are less likely to experience waxing and waning of pain control," as occurs when the traditional oral medication or injections of the opiate wear off, Meyer says. Some people can experience breakthrough pain, which may require additional analgesic medication. "With the patch, patients don't have to take multiple doses of oral medications to control the underlying chronic pain," Meyer says. "But in some reports of overdose, we have seen misunderstandings about the recommended use of the product." Proper use of the patch that follows the drug's label is crucial.
The FDA is investigating deaths and overdoses that have occurred with both brand-name and generic fentanyl patches. The brand Duragesic (fentanyl transdermal system), manufactured by Janssen L.P. of Titusville, N.J., was approved by the FDA in 1990. A generic version, manufactured by Mylan Laboratories Inc. of Canonsburg, Pa., was approved in 2005.
In July 2005, the FDA issued a public health advisory on the fentanyl patch. Meyer says the advisory focuses on improving education about the signs of an overdose, proper patch application, drug interactions, proper storage and disposal of the patch, and safeguards for children.
The powerful pain-relieving properties of all opiates are countered by significant risks of depressed breathing that can cause unexpected death. Signs of an overdose include trouble breathing or shallow breathing, extreme sleepiness or sedation, an inability to walk or talk normally, and feeling faint, dizzy, and confused. People who experience these symptoms should seek emergency medical attention. Removing the patch won't reverse the problem; the drug is still absorbed into the body for more than 17 hours after the patch is removed.
The fentanyl patch should not be used for short-term, acute pain, pain that is not constant, or pain after an operation. "The patch is not for pain that occurs after surgery such as tonsillectomies or dental procedures," Meyer says.
The patch is only for people who experience moderate-to-severe chronic pain that is expected to last for weeks or longer and that cannot be managed by acetaminophen-opioid combinations, nonsteroidal analgesics, or as-needed dosing with short-acting opioids.
The patch also shouldn't be the first narcotic pain medicine that is prescribed. It should be used only in people who have been taking opiate analgesics for a period of time. It could be used if people have been taking at least 60 milligrams (mg) of oral morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer. Stanski says, "This prior opiate dosing results in a degree of tolerance, or resistance to the opiate that is relevant when the patch is subsequently used." Children who are younger than 2 years should not use the fentanyl patch. It also shouldn't be used in children 2 years of age or older who are not already using other opioid narcotic pain medicines. Patches should always be prescribed at the lowest dose needed for pain relief.
"Understanding and following directions is so important because of the potential for respiratory depression associated with all opiate analgesic medications, and especially with the fentanyl patch," says Stanski.
Some deaths have occurred because more than one patch was applied at the same time. Other problems associated with the patch include not removing one patch before applying another, and the failure of multiple caregivers to notice that someone else has applied a patch. The patches are clear, relatively transparent, and easily blend into the skin background.
The Institute for Safe Medication Practices (ISMP) received a report of a 77-year-old woman who died in March 2005 after using the fentanyl patch. Her primary care physician called in a prescription for the patch without examining her or educating her about the drug. She did not receive education from the pharmacy either, according to the ISMP's report.
The woman's friend helped her place the patch on her buttock, and the woman later used a heating pad in that area. Heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated water beds should not be used with the patch. "The heat will speed up the movement of fentanyl from the patch into the body much more rapidly than normal," Stanski says. "This creates a risk for an overdose situation."
Two days later, friends discovered that the woman had died. She had apparently used two of the five patches prescribed. According to the ISMP, in addition to using a heating pad with the patch, it is suspected that a second patch was applied without removing the first one.
Too much medication from a fentanyl patch also could be absorbed if a patch is damaged or broken. The effects may also be exaggerated if a person wearing a patch drinks alcohol, or takes other medicines that depress brain function. "As part of its pain-relieving effect, fentanyl also causes brain depression as seen by some sleepiness and sedation," Stanski says. "This can add to the effects of other drugs like sedatives and tranquilizers."
Fentanyl also should not be used with certain HIV drugs and antifungal medicines. "The HIV drugs slow the metabolism or breakdown of fentanyl in the body and can create an overdose situation," Stanski says. Patients should make sure their doctors know about all the medicines they are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Death and other serious problems have occurred because people were accidentally exposed to the fentanyl patch. According to Janssen, a patch was transferred from an adult to a child while hugging. In another case of unintended exposure, someone accidentally sat on a patch.
The ISMP says that a mother reported that her 4-year-old son died after applying the patch to his body. He either used a discarded fentanyl patch or a new one. She found him on the floor near an overturned trash can that contained discarded patches and wrappers.
Fentanyl patches should be stored in a secure place and kept out of reach of children. According to Duragesic's labeling, patches should be disposed of by folding the adhesive side of the patch together so that it sticks to itself. The patch should then be flushed down the toilet immediately upon removal.
Fentanyl is a Schedule II controlled substance, the highest level of control for drugs with a recognized medical use. It comes under the jurisdiction of the Drug Enforcement Administration.
There have been reports of people extracting fentanyl from the patches and abusing the drug. Uncontrolled delivery of this potent drug is very dangerous and raises the risk of overdose. The New York State Department of Health has investigated incidents in which fentanyl patches have been stolen from hospital ward stocks or have been removed from the skin of patients. Stanski says, "This risk of abuse, fraud, and crime is a fact for all opiates."
In June 2005, researchers from the University of Florida at Gainesville presented results of a study that found that the number of sudden deaths from fentanyl overdoses has been climbing nationwide. The study cited Florida Department of Law Enforcement records showing that abuse of the fentanyl patch resulted in the deaths of 115 people in Florida in 2004. Researchers said that many people who overdosed removed the full three-day dose from the patch and took it through injection, ingestion, or smoking.
As with other opiate drugs, there is a risk of becoming either addicted to the substance in the fentanyl patch or tolerant to the drug. The risk goes up for people who have a history of mental problems, or who have been addicted to other medicines, street drugs, or alcohol. According to Janssen, concerns about addiction and abuse shouldn't interfere with the management of chronic, long-term pain. The manufacturer encourages physicians to screen and monitor patients to reduce the risk of problems.
To report adverse events related to fentanyl patch products, contact the FDA's MedWatch program at https://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088. Fax reports to (800) FDA-0178.
The FDA's Center for Drug Evaluation and Research
www.fda.gov/cder/drug/InfoSheets/patient/fentanyIPIS.htm