Fentanyl Patch: The Dangerous First Dose

by Jim Orr

Fentanyl transdermal is an opioid pain medicine (analgesic) that comes in a patch. The fentanyl patch is used to treat long-term pain and is only used in people who need continuous pain relief.

The fentanyl patch contains medicine in gel form inside it. The patch is placed on the skin and usually left there for 3 days. The drug is gradually absorbed through the layers of skin over that time. When a patient first starts the patch, it may take them 17 to 20 hours to feel its effects. When it is removed, a new patch is applied to a different area of skin.

Before starting fentanyl patches, the patient must have already gotten used to taking opioid pain medicines such as morphine, hydromorphone, or oxycodone, and have taken them every day for at least a week. According to fentanyl patch manufacturers, the fentanyl patch is “ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression.”

However, even when used as directed, the fentanyl patch can be fatal on the first use. Fentanyl is an extremely powerful drug and it is very important to not overestimate the first dose. According to the manufacturer of the brand name Duragesic fentanyl patch:

Overestimating the DURAGESIC® dose when converting patients from another opioid medication can result in fatal overdose with the first dose.

All generic fentanyl patches carry the same warning:

Overestimating the fentanyl transdermal system dose when converting patients from another opioid medication, can result in fatal overdose with the first dose.

Fentanyl patch doses must be carefully selected based on individual the status and circumstances of each patient and should be assessed at regular intervals after patch application. The manufacturers further warn that: “Reduced doses of DURAGESIC® [fentanyl patch] are suggested for the elderly and other groups discussed in PRECAUTIONS.”

In selecting an initial fentanyl patch dose, attention should be given to 1) the daily dose, potency, and characteristics of the opioid drugs the patient has been taking previously (e.g., whether it is a pure agonist or mixed agonist-antagonist), 2) the reliability of the relative potency estimates used to calculate the fentanyl patch dose needed (potency estimates may vary with the route of administration), 3) the degree of opioid tolerance and 4) the general condition and medical status of the patient. Each patient should be maintained at the lowest dose providing acceptable pain control.

Overestimating the fentanyl dose when converting patients from another opioid medication can result in fatal overdose with the first dose.

It can be a complicated matter to safely convert patients from other opioid painkilling drugs to the fentanly patch. Among other issues, the prescribing doctor or health care professional must take into consideration other medications the patient is taking. Indeed, the drug companies who make and sell the fentanyl patch specifically warn as follows:

The concomitant use of DURAGESIC® (fentanyl transdermal system) with other central nervous system depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g., benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants, and alcohol, may cause respiratory depression, hypotension, and profound sedation, or potentially result in coma or death. When such combined therapy is contemplated, the dose of one or both agents should be significantly reduced.

“[T]here are many misconceptions about the appropriate use of TDF [transdermal fentanyl patch] among health care providers, occasionally resulting in avoidable morbidity and mortality” according to Demystifying Opioid Conversion Calculations: A Guide for Effective Dosing by Mary Lynn M McPherson. (See also Welsh J et al. Physicians’ knowledge of transdermal fentanyl. Palliat Med. 2005;19:9–16). According to McPherson, research has found that “overall knowledge and confidence in using [the fentanly patch] was poor” among physicians and “[t]he bad news is that failure to completely understand these dosing principles may result in patient harm, including death.”

Heygood, Orr & Pearson has successfully prosecuted more cases involving deaths due to fentanyl products than all the other firms in the country combined. We have spent years studying fentanyl, its uses and its misuses. We have deposed hundreds of doctors, scientists and experts on the subject of fentanyl products.

If you or a loved one has experienced the tragedy of losing a family member as a result of Fentanyl pain patch usage, you and your family deserve answers to your questions. If the loss was as a result of a prescribing error, you have the right to demand that the responsible healthcare provider be held accountable. Contact us for a free consultation so we can help you determine the best way to protect your legal rights and interests.

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