Medical Malpractice Due to Fentanyl Overdose
 

Fentanyl is a synthetic opioid analgesic drug one hundred times more powerful than morphine. Its chemical structure makes it a very fast acting, and short acting pain medication. For that reason, fentanyl used intravenously (by injection) is quickly replacing morphine as a post-operative pain management tool.

Information for Patients

Patients and their caregivers should be provided with a Medication Guide each time DURAGESIC® (fentanyl transdermal) is dispensed because new information may be available. Patients receiving DURAGESIC® (fentanyl transdermal) patches should be given the following instructions by the physician:

Patients should be advised that DURAGESIC® patches contain fentanyl, an opioid pain medicine similar to morphine, hydromorphone, methadone, oxycodone, and oxymorphone.

Patients should be advised that each DURAGESIC® (fentanyl transdermal) patch may be worn continuously for 72 hours, and that each patch should be applied to a different skin site after removal of the previous transdermal patch.

Patients should be advised that DURAGESIC® (fentanyl transdermal) patches should be applied to intact, non-irritated, and non-irradiated skin on a flat surface such as the chest, back, flank, or upper arm.

Additionally, patients should be advised of the following:

In young children or persons with cognitive impairment, the patch should be put on the upper back to lower the chances that the patch will be removed and placed in the mouth.

Hair at the application site should be clipped (not shaved) prior to patch application.

If the site of DURAGESIC® (fentanyl transdermal) application must be cleansed prior to application of the patch, do so with clear water. Do not use soaps, oils, lotions, alcohol, or any other agents that might irritate the skin or alter its characteristics. Allow the skin to dry completely prior to patch application.

Patients should be advised that DURAGESIC® (fentanyl transdermal) should be applied immediately upon removal from the sealed pouch and after removal of the protective liner.

The DURAGESIC® (fentanyl transdermal) patch should not be used if the pouch seal is broken, or if the patch is cut, damaged, or changed in any way.

The transdermal patch should be pressed firmly in place with the palm of the hand for 30 seconds, making sure the contact is complete, especially around the edges.

The patch should not be folded so that only part of the patch is exposed.

Patients should be advised that the dose of DURAGESIC® (fentanyl transdermal) or the number of patches applied to the skin should NEVER be adjusted without the prescribing healthcare professional's instruction.

Patients should be advised that while wearing the patch, they should avoid exposing the DURAGESIC® (fentanyl transdermal) application site and surrounding area to direct external heat sources, such as:

• heating pads,
• electric blankets,
• sunbathing,
• heat or tanning lamps,
• saunas,
• hot tubs or hot baths, and
• heated water beds, etc.

Patients should also be advised of a potential for temperature-dependent increases in fentanyl release from the patch that could result in an overdose of fentanyl; therefore, patients who develop a high fever or increased body temperature due to strenuous exertion while wearing the patch should contact their physician.

Patients should be advised that if they experience problems with adhesion of the DURAGESIC® (fentanyl transdermal) patch, they may tape the edges of the patch with first aid tape. If problems with adhesion persist, patients may overlay the patch with a transparent adhesive film dressing (e.g., Bioclusive™ or Tegaderm™).

Patients should be advised that if the patch falls off before 72 hours a new patch may be applied to a different skin site.

Patients should be advised to fold (so that the adhesive side adheres to itself) and immediately flush down the toilet used DURAGESIC® (fentanyl transdermal) patches after removal from the skin.

Patients should be advised that DURAGESIC® (fentanyl transdermal) may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating machinery).

Patients should be advised to refrain from any potentially dangerous activity when starting on DURAGESIC® (fentanyl transdermal) or when their dose is being adjusted, until it is established that they have not been adversely affected.

Patients should be advised that DURAGESIC® (fentanyl transdermal) should not be combined with alcohol or other CNS depressants (e.g. sleep medications, tranquilizers) because dangerous additive effects may occur, resulting in serious injury or death.

Patients should be advised to consult their physician or pharmacist if other medications are being or will be used with DURAGESIC® (fentanyl transdermal).

Patients should be advised of the potential for severe constipation.

Patients should be advised that if they have been receiving treatment with DURAGESIC® (fentanyl transdermal) and cessation of therapy is indicated, it may be appropriate to taper the DURAGESIC® (fentanyl transdermal) dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms.

Patients should be advised that DURAGESIC® contains fentanyl, a drug with high potential for abuse.

Patients, family members, and caregivers should be advised to protect DURAGESIC® (fentanyl transdermal) from theft or misuse in the work or home environment.

Patients should be instructed to keep DURAGESIC® (fentanyl transdermal) in a secure place out of the reach of children due to the high risk of fatal respiratory depression.

Patients should be advised that DURAGESIC® (fentanyl transdermal) should never be given to anyone other than the individual for whom it was prescribed because of the risk of death or other serious medical problems to that person for whom it was not intended.

Patients should be informed that, if the patch dislodges and accidentally sticks to the skin of another person, they should immediately take the patch off, wash the exposed area with water and seek medical attention for the accidentally exposed individual.

When DURAGESIC® (fentanyl transdermal) is no longer needed, the unused patches should be removed from their pouches, folded so that the adhesive side of the patch adheres to itself, and flushed down the toilet.

Women of childbearing potential who become, or are planning to become pregnant, should be advised to consult a physician prior to initiating or continuing therapy with DURAGESIC® (fentanyl transdermal).

Patients should be informed that accidental exposure or misuse may lead to death or other serious medical problems.

How Should I Use Fentanyl Transdermal Patch?

Because of the danger of overdose with the use of the fentanyl transdermal patch, there are strict guidelines which should be followed:

• You must always use DURAGESIC® (fentanyl transdermal) patches the right way:
• Do not use a DURAGESIC® (fentanyl transdermal) patch if the pouch seal is broken, or the patch is cut, damaged, or changed in any way.
• Do not use heat sources such as heating pads, electric blankets, heat lamps, tanning lamps, saunas, hot tubs, or heated waterbeds while wearing a DURAGESIC® (fentanyl transdermal) patch.
• Do not take hot baths or sunbathe while wearing a DURAGESIC® (fentanyl transdermal) patch.

If you have problems with the DURAGESIC® (fentanyl transdermal) patch not sticking:

• Apply first aid tape only to the edges of the patch.
• If problems with the patch not sticking persist, cover the patch with Bioclusive™ or Tegaderm™. These are special see-through adhesive dressings. Never cover a DURAGESIC® (fentanyl transdermal) patch with any other bandage or tape.

If your DURAGESIC® (fentanyl transdermal) patch falls off before 3 days or 72 hours, fold the sticky side together and flush down a toilet. Put a new one on at a different skin site.

Do not change your dose unless your doctor tells you to. Your doctor may change your dose after seeing how the medicine affects you. Do not use DURAGESIC® (fentanyl transdermal) more often than prescribed. Call your doctor if your pain is not well controlled while using DURAGESIC® (fentanyl transdermal).

Do not stop using DURAGESIC® (fentanyl transdermal) suddenly. Stopping DURAGESIC® (fentanyl transdermal) suddenly can make you sick with withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering). Your body can develop a physical dependence on DURAGESIC® (fentanyl transdermal) . If your doctor decides you no longer need DURAGESIC® (fentanyl transdermal) ask how to slowly reduce this medicine so you don't have withdrawal symptoms. Do not stop taking DURAGESIC® (fentanyl transdermal) without talking to your doctor.

Do not wear more than one DURAGESIC® (fentanyl transdermal) patch at a time, unless your doctor tells you to do so.

Call your doctor right away if you get a fever higher than 102°F or your body temperature increases from exercise. A fever or increase in body temperature may cause too much of the medicine in DURAGESIC® (fentanyl transdermal) to pass into your body.

If you use more DURAGESIC® (fentanyl transdermal) than your doctor has prescribed, get emergency medical help right away.

Do not drink any alcohol while using DURAGESIC® (fentanyl transdermal). Alcohol can increase your chances of having serious side effects.

Do not drive, operate heavy machinery, or do other possibly dangerous activities until you know how DURAGESIC® (fentanyl transdermal) affects you. DURAGESIC® (fentanyl transdermal) can make you sleepy. Ask your doctor to tell you when it is okay to do these activities.

When you remove your DURAGESIC® (fentanyl transdermal) patch, fold the sticky sides of a used DURAGESIC® (fentanyl transdermal) patch together and flush it down the toilet. Do not put used DURAGESIC® (fentanyl transdermal) patches in a trash can.

If you believe you or a loved one has been suffered a fentanyl overdose due to medical malpractice, learn more about your legal rights.