Fentanyl is a highly potent opioid with a narrow therapeutic index – a small margin between therapeutic and toxic blood concentrations.1
Infants and children are at higher risk of accidental exposure to fentanyl as they explore their world by touching and tasting things within their reach. Fentanyl patches are particularly dangerous if put in the mouth, or if they accidentally attach to a child's skin. This can lead to serious adverse events, including fatalities in some cases.2, 3
Since the 2006 expansion of the PBS indication to include non-cancer pain4 there has been an increase in fentanyl prescribing in Australia. It is crucial to educate and remind people about appropriate use of fentanyl patches, including careful application, storage and disposal.
Advise your patients to:
- Keep patches out of reach of children before, during and after use.3
- A locked cupboard at least 1.5 metres off the ground is a good place to store medicines.5
- Consider covering the patch with an adhesive film to keep it on your body.6
- The skin should be completely dry before the patch is applied – it may also be poorly adherent if the skin is hairy, oily or sweaty.7, 8 If there is hair at the application site, clip it before application (do not shave).7
- Regularly check the patch is still in place, either by touch or visual examination.6
- There have been cases of patches being transferred from person to person while sharing a bed.3
- Fold the patch when disposing so that the adhesive sides stick together.7
- Wrap in paper or plastic and ensure this is disposed of carefully.
- Seek medical attention immediately if you suspect a child may have been inadvertently exposed to, or has ingested, a patch.3, 5
Exposure in children has resulted in tragic outcomes
A recent Therapeutic Goods Administration Medicine Safety Update has reported two cases of children who were hospitalised after being accidentally exposed to fentanyl patches.3 One child experienced somnolence and the other lost consciousness.3
Reports of accidental exposure to fentanyl patches in children aged < 5 years have also been made to the NSW Poisons Information Centre.3
Over the last 2 decades the US Food and Drug Administration reported 26 cases of accidental exposures to fentanyl patches in children, including 12 hospitalisations and 10 deaths. More than half of these cases occurred in children aged 2 years or less.9
Infants and toddlers are at higher risk of accidental exposure
The risk of a partially detached patch being transferred from an adult to an infant is high, as infants are often held by adults.6
Toddlers explore their world by touching and tasting things within their reach. Thus they are at increased risk of finding a poorly stored or improperly disposed of patch and ingesting it or adhering it to themselves.6
Greater risk in children of death and serious adverse effects
Fentanyl is a high-potency opioid – death and serious adverse effects have occurred in children who are exposed to, or who ingest, patches, whether they have been used or are unused.6
The risk of the following adverse effects increases with dose:3
- extreme somnolence progressing to coma
- respiratory depression with the potential for respiratory arrest
- cardiac arrhythmias, circulatory collapse and cardiac arrest.
Identifying early signs of fentanyl exposure is challenging
Early signs of fentanyl exposure are non-specific and difficult to identify in young children. One of the early signs is lethargy, which may be confused with fatigue.6
Advise patients using fentanyl patches to contact the doctor or Poisons Information Centre immediately for advice, or go to the nearest hospital emergency department if there is reason to suspect a child has been exposed to a patch.3, 5
Emphasise that medical assistance is required even if the child does not display drowsiness, discomfort or other signs of poisoning.5
Properties that improve effectiveness increase the hazard risk
Fentanyl patches deliver a high opiate dose, with the lowest available dose being 12 micrograms per hour, considered approximately equivalent to 45 mg/day of oral morphine.7
- A high concentration of fentanyl ensures effective transdermal delivery.14
- Drug movement occurs through diffusion across a concentration gradient between the high concentration in the patch and the low concentration in the skin.14
- Used patches can retain high residual levels of the active ingredient (around 35% to 52% for higher doses and 90% for the 25 microgram-per-hour patch).15
- If the patch is not disposed of carefully children are at risk of being accidentally exposed to its contents.3
The patch is a long-acting formulation with an initial delayed onset followed by a prolonged duration of action. After 3 days' application plasma concentrations are halved about 20–27 hours after removal.7
- The patch will work effectively for 3 days before it needs to be replaced.7
- It is important to monitor serious adverse effects carefully for at least 24 hours after removing the patch, as there is potential for adverse effects to continue after therapy has been discontinued.7
- Fentanyl will remain in the blood for some time after the patch has been removed due to the formation of a fentanyl depot under the skin.14
Easy to apply and remove
- Ease of application and removal of the patch means there is increased flexibility in stopping and starting therapy.
- There is also potential for improved patient compliance, as patches may be more convenient to use than other formulations for some patients.14
Information for your patients
For detailed directions on how to apply and change a fentanyl patch advise patients to read the Consumer Medicines Information leaflet. This can be found in our Medicine Finder.
Advise patients that, if they suspect a child has been exposed to a fentanyl patch or there is a reason to suspect overdose, they should immediately telephone a doctor or the Poisons Information Centre for advice, or go to the emergency department at their nearest hospital, even if the child does not display drowsiness, discomfort or other signs of poisoning.5
The Poisons Information Centre 24-hour phone line is 13 11 26.
- Merck Manual. Drug bioavailability. May 2014. [Online] (accessed 16 January 2015).
- Victorian State Government Department of Health. Fentanyl patch misuse: serious injury, overdose and death. October 2012. [Online] (accessed 15 January 2014).
- Australian Government Department of Health. Medicines Safety Update, Volume 5 Number 4. Fentanyl patches and accidental exposure in children. August 2014. [Online] (accessed 15 January 2015).
- Roxburgh A, Burns L, Drummer OH, et al. Trends in fentanyl prescriptions and fentanyl-related mortality in Australia. Drug Alcohol Rev 2013;32:269–75. [PubMed].
- JANSSEN-CILAG Pty Ltd. Durogesic Transdermal System Consumer Medicine Information. 2014. [Online] (accessed 15 January 2014).
- US Food and Drug Administration. Fentanyl Patch Can Be Deadly to Children. 2014. [Online] (accessed 3 February 2015).
- JANSSEN-CILAG Pty Ltd. DUROGESIC Transdermal System Product Information. 15 January 2015. [Online] (accessed 15 January 2015).
- Margetts L, Sawyer R. Transdermal drug delivery: principles and opioid therapy. 2007. Cont Educ Anaesth Crit Care Pain 2007;7:171-6. [Online] (accessed 15 January 2015).
- US Food and Drug Administration. FDA Reminds the Public about the Potential for Life-Threatening Harm from Accidental Exposure to Fentanyl Transdermal Systems ("Patches"). April 2012. [Online] (accessed 3 February 2015).
- Carson HJ, Knight LD, Dudley MH, et al. A fatality involving an unusual route of fentanyl delivery: Chewing and aspirating the transdermal patch. Leg Med (Tokyo) 2010;12:157–9. [PubMed].
- Faust AC, Terpolilli R, Hughes DW. Management of an oral ingestion of transdermal fentanyl patches: a case report and literature review. Case Rep Med 2011;2011:495938. [PubMed].
- Roy SD, Flynn GL. Transdermal delivery of narcotic analgesics: pH, anatomical, and subject influences on cutaneous permeability of fentanyl and sufentanil. Pharm Res 1990;7:842–7. [PubMed].
- Nelson L, Schwaner R. Transdermal fentanyl: pharmacology and toxicology. J Med Toxicol 2009;5:230–41. [PubMed].
- Bajaj S. Transdermal drug delivery in pain management. Contin Educ Anaesth Crit Care Pain 2011;11:39–43. [Online].
- Van Nimmen NF, Veulemans HA. Validated GC-MS analysis for the determination of residual fentanyl in applied Durogesic reservoir and Durogesic D-Trans matrix transdermal fentanyl patches. J Chromatogr B Analyt Technol Biomed Life Sci 2007;846:264–72. [PubMed] .