Fentanyl Transdermal Patch

In July of 2005, the Food and Drug Administration (FDA) issued their first warning over the prescription and use of the Fentanyl Transdermal Patch. Fentanyl is a powerful opioid narcotic which is ten times more potent than morphine. Fentanyl works by stimulating receptor nerves in the brain to increase the pain threshold and reduce the patient’s perception of pain. Fentanyl is available in a few different forms; transdermal, transmucosal, and injectable.

When applied to the skin, the amount of Fentanyl gradually increases in the blood stream until it reaches a peak after 12 to 24 hours. Once the peak is reached, the concentration of Fentanyl remains the same in the blood stream for about a period of 72 hours. Once the patch is removed, the blood concentrations decrease slowly due to ongoing absorption of

In June of 2005, the “boxed warnings” and the “warning” section for Duragesic was updated to provide healthcare practitioners and patients with important safety information regarding their medication. The first major instruction and warning is that Fentanyl Transdermal patches are indicated for the management of persistent, moderate to severe chronic pain. It is only intended for those patients who are already receiving opioid therapy and who have demonstrated a tolerance to opioid therapy. The importance of it being only prescribed to those who have demonstrated opioid tolerance is because of their ability to be more resistant to the dangerous side effects of narcotic pain medications.

Despite the warnings that have been available for over two years, errors in prescription and usage still continues. In the summer of 2007, the Institute for Safe Medication Practices on two separate occasions (May and June) warned of the consequences of healthcare practitioners who prescribe this patch without paying attention to the proper prescribing guidelines or the potency of the patches. Examples noted by the Institute included an elderly patient who had several patches prescribed on her at one time. Another example noted was a post surgical patient who was not only sent home with three patches but also a prescription of oxycodone. That patient expired within 12 hours of discharge. Fentanyl patches should only be prescribed for chronic pain and not for post-surgical recovery.

The reports received by the FDA have also demonstrated that physicians are inappropriately prescribing Fentanyl Transdermal patches for headaches, occasional or mild pain, and surgery. The FDA report also notes that patients are incorrectly using the patch by replacing them too frequently, applying too many patches or applying a heat source to the patch. All of those uses can equate to dangerously high levels of Fentanyl in the blood.

Therefore the FDA warning includes the following safety information:

• The Fentanyl patch should only be used by patients who are opioid-tolerant and have chronic pain that is not well controlled with other pain medications.
• Healthcare professionals who prescribe and patients who use fentanyl should be aware of the signs of overdose including; trouble breathing, slow heartbeat, severe sleepiness, trouble walking or talking, feeling faint, dizzy or confusion.
• Patients who are prescribed the patch should tell their physicians about all of the medications that they are currently taking.
• Patients and their caregivers should be educated about how often to use the patch, what to do when the patch falls off, replacing a patch and disposal of the patch.
• Heat may increase the amount of Fentanyl that reaches the blood stream and the result can be life-threatening. (This includes heating pads, electric blankets, saunas, hot baths, or sun bathing).
• Those patients who have a fever higher than 102 degrees Fahrenheit should contact their physician right away.

If you have a case that involves the Fentanyl Transdermal Patch or are considering a case involving the patch, contact our office at Medical Jurisprudence, Inc. for case analysis and assistance.

References:
Food and Drug Administration, FDA Public Health Advisory: Important Information for the Safe Use of Fentanyl Transdermal System(Patch)(December 21, 2007) Retrieved from www.fda.gov/CDER/drug/advisory/fentanyl_2007.htm

Institute for Safe Medication Practices, Ongoing, Preventable Fatal Events with Fentanyl Transdermal Patches are Alarming!(June 28, 2007). Retrieved December 2007 from www.ismp.org/Newsletters/acutecare/articles/20070628.asp?ptr=y.

MedicineNet.com. Fentanyl Transdermal System(July 2005) Retrieved January 2008 from www.meidicinet.com/script/main/art.asp?articlekey=8109&pf=3page=1.