Washington – Army Master Sgt. Harold Kinamon entered a military hospital in Ohio for routine respiratory surgery to help him sleep better. The operation, in October 2005, progressed smoothly. He went home with nothing more than a raw throat and a painkiller contained in an adhesive patch on his skin.
That night, Kinamon, 41, died in his sleep. He was killed by an overdose of the drug delivered through the patch.
What made his death even more tragic was that the dangers of using skin patches to administer the particular painkiller he received, an opiumlike drug called fentanyl, were clearly understood at the time.
Only three months earlier, the Food and Drug Administration – responding to a rash of similar deaths – had issued a strong warning: Although beneficial under appropriate conditions, fentanyl patches should be used with great caution, and not for postoperative pain relief.
But Kinamon’s death reflects more than an individual misfortune. Health- care providers nationwide are still not getting the message as fentanyl patches continue to be implicated in scores of deaths.
Failure to solve the problem is all the more serious because the use of medicinal patches is spreading to other drugs – painkillers, birth-control drugs and medications for children with attention-deficit disorder. Moreover, a new generation of high-tech patches is expected to make many more drugs available in patch form.
The benefits of patches have been accompanied by problems, replicating a common pattern with many medical advances: Breakthroughs often come with risks and downsides that may not be fully recognized until later.
Drug-safety experts are urging the FDA to re-examine the whole issue of medicinal patches. One primary problem seems to be how to get the right dose of a drug through a patch for different patients under differing conditions.
Patches are “a neat way of delivering drugs,” said Dr. Curt D. Furberg of the Wake Forest University medical school, but they are not an unalloyed blessing.
Patches’ higher total exposure
Once swallowed, pills create a peak of the drug, which drops as the time for the next dose approaches. Patches maintain a steadier level of the drug, but, over time, this can lead to higher total exposure to the drug.
“What is the corresponding patch level that would be equivalent to oral drugs?” Furberg said. “People use different formulas, and there is disagreement.”
Recently, the Daytrana patch for attention-deficit disorder ran into problems. Opening the patch and getting it to stick was difficult, although the maker says the adhesion problem has been fixed. Also, the medication can irritate the skin, causing welts. The FDA is investigating.
For patches in general, their effect can vary considerably from patient to patient.
“Some people may not get enough of the drug, which defeats the purpose of taking it. And some may get too much … which is going to hurt some people,” Furberg said.
Fully informed about safety
In the case of fentanyl, the FDA said in July 2005, patches should be prescribed at the lowest practicable dose, should not be used to treat short-term pain or pain after an operation, and should only be used by patients already established on opioid drugs.
Patients and caregivers must be fully informed about safety, the FDA said.
According to Kinamon’s sister Deana, that did not happen in his case. The patch he got provided the second-highest available dose of fentanyl. And she said she did not recall receiving special instructions about the patch when she picked her older brother up at the hospital.
He went in on his day off for surgery to correct his sleep apnea and was killed by a pain medication, said his sister. “There’s honor in dying for your country on the battlefield, but there is really no kind of honor associated with that.”
The hospital, Wright-Patterson Medical Center, declined to comment on the case, citing privacy laws, but said it had since put safeguards in place for fentanyl patches.
