National Pain Management Strategy Coordinating Committee

Pharmacy Workgroup

**Fentanyl Transdermal Patch Dosing and Safety Information Paper**

**Fentanyl transdermal patches have recently been associated with a
number of serious adverse events and deaths nationwide. Clinicians
should use the fentanyl patch only if they are familiar with the
prescribing information. This letter provides clinicians with important
information to promote the safe use of the fentanyl transdermal patch.**

**Who Should Receive Fentanyl transdermal patch**

-   Fentanyl tranasdermal patch is indicated in patients who have
    persistent, moderate to severe chronic pain that

> ○ requires continuous, around-the-clock opioid administration for an
> extended period of time, and
>
> ○ cannot be managed by other means such as non-steroidal analgesics,
> opioid combination products, or immediate-release opioids.

-   Fentanyl transdermal patch should NOT be used for management of
    mild, acute, short-lasting, or intermittent pain. It should not be
    used on an as-needed basis.

-   Fentanyl transdermal patch should ONLY be used in patients who are
    already receiving opioid therapy, who have demonstrated opioid
    tolerance, and who require a total daily dose at least equivalent to
    fentanyl 25 mcg/h.

-   Patients who are considered opioid tolerant are those who have been
    taking, for a week or longer, at least 60 mg of oral morphine daily,
    or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral
    hydromorphone daily, or an equianalgesic dose of another opioid.

**[Dosing and Administration]{.underline}**

***Converting from Other Opioids to the Fentanyl Transdermal Patch***

-   As a general rule, when converting to fentanyl from another opioid,
    use about 25mcg/h of fentanyl transdermally for every 90 mg of oral
    morphine equivalent.

-   Appropriate dosage increments should be based on the daily use of
    supplemental opioids with the equivalency of morphine 45
    milligrams/day orally to a 12.5 micrograms/hour increase in the
    transdermal **fentanyl** dose. Duragesic-12 delivers 12.5mcg/h of
    fentanyl.

**INITIAL FENTANYL**

**TRANSDERMAL DOSAGE**

**Only for converting another**

**opioid to fentanyl**

Adapted from the Duragesic PI, 2007

\* The VA/DOD Medications Pocket Guide and equianalgesic opioid
conversión ratios may be found at
<http://www.oqp.med.va.gov/cpg/cot/G/OT_Med.pdf> .

-   Alternatively, the dose of fentanyl can be calculated using the
    following table. **This table should only be used when converting to
    fentanyl; it should NOT be used when converting from fentanyl to
    another opioid.** The conversion ratios are conservative and may
    result in overdosage if used to convert fentanyl to other opioids.

-   Prescribe a short-acting opioid analgesic, to be taken by the
    patient as needed, when fentanyl is first started, since the onset
    of the analgesic effects of fentanyl may be delayed about 20 hours.

-   Titrate patients upwards no more frequently than every 72 hours
    after the initial dose or no more frequently than every 6 days
    thereafter. Serum fentanyl concentrations increase gradually
    following initial application of the patch, generally leveling off
    between 12 and 24 hours and remaining relatively constant, with some
    fluctuation, for the remainder of the 72-hour application period.
    Dosage increases made more frequently than the recommended intervals
    may result in too rapid systemic accumulation of drug and
    potentially serious toxicity.

-   **Do not cut or damage the patch.** If the transdermal system is cut
    or damaged, controlled drug delivery will not be possible, which can
    lead to the rapid release and absorption of a potentially fatal dose
    of fentanyl.

*Converting from Fentanyl to Other Opioids*

-   There are no FDA-approved dosing instructions on how to convert
    patients from fentanyl to other opioids. After discontinuing the
    fentanyl patch, titrate the new opioid according to the patient's
    level of pain relief and tolerability.

-   Take into consideration the fact that, after removal of the fentanyl
    patch, serum fentanyl concentrations decline gradually, falling
    about 50% in approximately 17 (range 13-22) hours.

#### [Patient Education]{.underline}

#### Clinicians should educate patients on the proper use, storage, and disposal of fentanyl transdermal patch.

-   Advise patients to wear the patch continuously for 72 hours, and
    that each patch should be applied to a different skin site **after
    removal of the previous transdermal patch**.

-   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.

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

-   The patch should not be used if the seal is broken, or if it is
    altered, cut, or damaged in any way prior to application. This could
    lead to the rapid release of the contents of the patch and
    absorption of a potentially fatal dose of fentanyl.

-   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.

-   Patients should avoid exposing the application site to direct
    external heat sources, such as:

    -   heating pads,

    -   electric blankets,

    -   heat lamps,

    -   saunas,

    -   hot tubs, and

    -   heated water beds, etc.

-   If patients develop a high fever while wearing the patch they should
    contact their physician.

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

-   Patients should be made aware of the potential for severe
    constipation and other opioid side effects.

-   Patients should be informed that, if the patch dislodges and
    accidentally sticks to 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.

-   Fentanyl TDS should be kept out of the reach of children and pets,
    preferably in a locked cabinet.

-   Patients should be advised to fold (so that the adhesive side
    adheres to itself) and immediately flush down the toilet any used
    fentanyl patches after removal from the skin. Accidental exposure or
    misuse may lead to death or other serious medical problems.

**[References]{.underline}**:

Duragesic Patch . Full US Prescribing Information.
<http://www.duragesic.com/active/janus/en_US/assets/common/company/pi/duragesic.pdf#zoom=100>.

VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy
for Chronic Pain. Medications Pocket Guide.
<http://www.oqp.med.va.gov/cpg/cot/G/OT_Med.pdf>.

Opioid Therapy for Chronic Pain. VA/DoD Clinical Practice Guideline for
the Management of Opioid Therapy for Chronic Pain.
<http://www.oqp.med.va.gov/cpg/cpg.htm>.

Fudin J. Chemical classes of opioids.
([http://www.paindr.com/Opioid%20Chemistry%2004-2006.rtf](http://www.paindr.com/Opioid Chemistry 04-2006.rtf))

PDR® entry for Duragesic Transdermal System (Ortho-McNeil). From
MICROMEDEX.
[http://vaww.visn8.med.va.gov/mdxcgi/htmldisp.exe?CTL=D:\\mdx\\mdxcgi\\MEGAT.SYS&SET=1C6F2BEA9730B810&SYS=3&T=0960&D=1&Q=18](http://vaww.visn8.med.va.gov/mdxcgi/htmldisp.exe?CTL=D:\mdx\mdxcgi\MEGAT.SYS&SET=1C6F2BEA9730B810&SYS=3&T=0960&D=1&Q=18).