Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children
Provide clear information to patients and caregivers about how to minimise the risk of accidental exposure and the importance of appropriate disposal of patches. We continue to receive reports of unintentional opioid toxicity and overdose of fentanyl due to accidental exposure to patches.
Advice for healthcare professionals:
- always fully inform patients and their caregivers about directions for safe use for fentanyl patches, including the importance of:
- not exceeding the prescribed dose
- following the correct frequency of patch application, avoiding touching the adhesive side of patches, and washing hands after application
- not cutting patches and avoiding exposure of patches to heat including via hot water (bath, shower)
- ensuring that old patches are removed before applying a new one
- following instructions for safe storage and properly disposing of used patches or those which are not needed (see instructions below)
- ensure that patients and caregivers are aware of the signs and symptoms of fentanyl overdose (see below) and advise them to seek medical attention immediately (by dialing 999 and requesting an ambulance) if overdose is suspected
- in patients who experience serious adverse events, remove patches immediately and monitor for up to 24 hours after patch removal
- report any cases of accidental exposure where harm has occurred or suspected side effects via the Yellow Card Scheme
Background
Accidental exposure to transdermal fentanyl can occur if a patch is swallowed or transferred to another individual (see Drug Safety Update, September 2008, and Drug Safety Update, July 2014). In 2014, following an EU review, advice on minimising risk of accidental transfer added to Summary of Product Characteristics and the Patient Information Leaflet for transdermal fentanyl products.
Reports of accidental exposure to transdermal fentanyl
We continue to receive reports of preventable accidental transfer of fentanyl patches. Since July 2014 and up to October 2018, we have received 5 reports of fatal incidents specifying accidental exposure, accidental overdose, or product adhesion issue. Causes of death was not included in all reports but were understood to be related to opioid toxicity.
Provide clear information to patients and caregivers
All healthcare professionals, particularly those involved in the prescribing and dispensing of fentanyl patches, should provide clear information to patients and caregivers regarding risk of accidental transfer and ingestion of patches, and need for appropriate disposal of patches.
Advise patients and caregivers to follow closely the instructions on the patch packaging, the carton, and in the accompanying Patient Information Leaflet. To help you discuss this with patients, we have produced an updated ()
Urgent medical attention should be sought for anyone accidentally exposed to a fentanyl patches. Administration of naloxone may help to reverse an opioid overdose.
Storage and disposal of fentanyl patches
Fentanyl patches should be stored out of sight and reach of children. After use, patches should be folded so that the adhesive side of the patch adheres to itself and then placed back into the original sachet. Used patches should be kept out of sight and reach of children – even used patches contain some medicine that may harm children and may even be fatal.
Patients are advised to talk to their pharmacist about safe disposal of patches, both used and unused.
Signs and symptoms of fentanyl overdose
Warn patients and caregivers of possible symptoms of fentanyl overdose, which include respiratory depression (difficulty in breathing or shallow breathing); tiredness; extreme sleepiness or sedation; inability to think, walk, or talk normally; and feeling faint, dizzy, or confused. Opioid overdose can be fatal and requires urgent medical treatment.
About fentanyl
Fentanyl is a potent opioid analgesic—a 25 µg per hour fentanyl patch equates to daily doses of oral morphine of up to 90 mg. Fentanyl patches should be used only in patients who have previously tolerated opioids because of a risk of significant respiratory depression in opioid-naive patients.
The initial dose of fentanyl should be based on a patient’s opioid history. Please consult the summaries of product characteristics (SPC) for information on starting doses and dose conversion.
Report harm from accidental exposure to the Yellow Card Scheme
Please report medication errors resulting in harm, including accidental exposure to a medicine, or suspected side effects on a Yellow Card.
Your report helps to improve the safety of medicines in the UK. Never assume someone else will report an adverse drug reaction – if in doubt, report via the Yellow Card website or Yellow Card App (download via iTunes Yellow Card for iOS devices or via PlayStore Yellow Card for Android devices).
Article citation: Drug Safety Update volume 12, issue 3: October 2018: 4.