The Duragesic patch: Fentanyl Can Kill More Than Pain...

Raritan, NJChronic pain sufferers will tell you that the Duragesic patch is so bad, it's good. Very, very good, in stemming the kind of chronic pain most closely associated with cancer patients, and others who suffer with ailments and agony the rest of us couldn't imagine having to live with.

But make no mistake, the Duragesic patch and the opioid that makes it so very good—fentanyl—is at the same time so very bad, especially in the wrong hands.

Just read the black box warning on the Duragesic web site. It goes on seemingly forever, as it should. The Duragesic fentanyl patch should only be used in a carefully controlled manner, and only prescribed to the people who can handle the stuff—in other words, individuals already conditioned against the rigors of opiates.

In the wrong hands, or misused—it can kill. It can, and it has.

The latest concern with the Duragesic surrounds a recall earlier this year, after some 25 mcg/hr patches were found to have a manufacturing defect relating to the patch reservoir, which contains the potent fentanyl gel. A few of the patches have turned up with a breach, or a small cut in the lining, which could defeat the time-release aspects of the patch and expose the patient, or a caregiver to potentially lethal amounts of fentanyl.

Pricara, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc. recalled the patches as a precaution, given the potent nature and characteristics of fentanyl.

One patch can provide up to 72 hours of relief by transferring controlled amounts of fentanyl through the derma, or skin. Under normal conditions it takes about 8-12 hours for the patch to start working, and often another opioid, such as morphine sulfate, is prescribed to the patient in an effort to stem what is known as breakthrough-pain.

However, this fentanyl can kill more than pain, if it falls into the wrong hands. And it has been falling into the wrong hands for decades as an illicit drug of choice. The problem is that most people don't understand it.

Most would be surprised to know that this fentanyl, which (thank goodness) is only available by prescription, is nonetheless a hundred times more potent than morphine and several times stronger than heroin. Illicit users have been known to acquire the patches through illicit means and double them up, or cut them up and either lick, swallow, snort, smoke or even inject the contents.

In an effort to stem this kind of illicit use, Janssen-Cilag Pharmaceuticals based in the U.K. came up with a different version of the Duragesic patch, known as the Durogesic. The big difference is while the Duragesic patch contains the fentanyl in a gel-filled sac or reservoir, the Durogesic patch stores the dreaded fentanyl in the plastic matrix of the patch. Thus, it cannot be cut open in the same fashion as a Duragesic patch can, and helps to mitigate the risk.

It should be noted that the Durogesic patch is used mostly in European countries, which carry more strict regulation for opioid drugs. It is not known of the Durogesic patch is available in North America.

Either way, the risk is substantial. Even the wearing of a single patch for pain by someone not properly conditioned to opiate drugs poses significant risk, as there would to a caregiver who might handle the patch incorrectly.

Wearing a Duragesic patch without paying attention to the prescribing conditions can also pose a hazard, such as lying on a heating pad. Heat can adversely alter the controlled migration of the fentanyl. Most important, is proper pre-conditioning to opioid drugs.

This stuff is powerful, and not for everyone. The involvement of both an educated doctor, and patient is integral to a positive outcome when using the Duragesic fentanyl patch. One doctor, it has been reported, prescribed a Duragesic patch for someone who was complaining of a simple headache. Such misdirected use is a recipe for disaster. A lethal dose of fentanyl can stop your heart, and stop you breathing.

But what of the prescribed disposal method, for used or unused patches? The Duragesic web site advocates that spent, or unused patches be folded into itself, towards the adhesive side, and then the patch is to be flushed down the toilet. There is no word of whether or not filled, but unused patches disposed in this manner would have any impact on municipal water supplies.

Perhaps that's a question that needs to be answered, given increased concern for all things environmental, together with the increasing number of legal professionals that specialize in environmental law.