The Duragesic patch, which is up to 100 times more potent than morphine, was recalled on two separate occasions earlier this year after reports surfaced about a concern regarding a potential manufacturing defect. Lots of Duragesic 25 mcg/hr patches with expiry dates on, or before December 2009 were recalled in February, and again in March of this year.
A few of the patches were found to have a cut, or breach in the reservoir containing the extremely potent fentanyl gel, raising the possibility that the medication could be released too quickly, elevating the danger for the patient and creating a potential hazard for a caregiver. A cut in the reservoir is especially a concern because it may allow the fentanyl gel to come in direct contact with the skin.However, as it's been widely reported, a breach in the reservoir is just one risk associated with the potent fentanyl patches. There are others, and it often has to do with incorrect use and inappropriate patient profile.
The latter has to do with just what these pain patches were designed for; debilitating and / or chronic pain, for those who have built up a tolerance for both weaker pain medications, and who have been properly conditioned to withstand the rigors and potency of an opioid such as fentanyl. Without such prerequisites, a Duragesic prescription could be lethal in the wrong hands.
That's what happened to Adam Hendelson in 2003. The 28-year old Florida man was found dead at his computer, wearing a Duragesic pain patch on his arm, which he had been prescribed for easing chronic hip pain after a car accident. He was found to have three times the lethal limit of fentanyl in his system at the time he died.
Two years later, in 2005 Bud Kinamon went to a military hospital to seek treatment for his sleep apnea. After undergoing surgery to remove the uvula, the small fleshy growth at the back of his throat, Kinamon was sent home with a Duragesic patch for pain. After applying the patch, says his sister Deana, Kinamon went to sleep and never woke up. It was determined that he died from acute fentanyl intoxication.
Just three months earlier, according to a CNN report, the US Food and Drug Administration had issued a warning with regard to the incorrect use of the fentanyl patch, and the US Military duly forwarded the warning to all its facilities.However the warning, which included the caveat that fentanyl should not be used to treat short-term pain, pain that is not constant or pain after an operation, does not appear to have been heeded in the Kinamon case.
It has been reported that from 1998 to 2005 there were 3,545 deaths linked to fentanyl overdoses. A spokesperson for Safe Medication Practices said at the time that misprescribing represented the major issue, and that there was the potential for thousands of additional deaths going unreported.
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However, there are other aspects of the patch, even when prescribed to the right people for all the right reasons that further cloud the issue and increase the risk.
In 2005 a doctor conversant with the transdermal pain patches told a CNN reporter that the patch could not be allowed to heat up, or become too warm. A heating pad, for example, hot water or direct sunlight could increase the temperature on, or within the patch and cause the fentanyl to be released at a much higher rate.
For that to happen, with medication up to 100 times more potent than morphine, one can imagine the potential for disaster.