其 他 安 全 警 示
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| The United Kingdom:Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children (English Only) |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that accidental exposure to transdermal fentanyl can occur if a patch is swallowed or transferred to another individual.
In 2014, following an European Union (EU) review, advice on minimising risk of accidental transfer added to Summary of Product Characteristics and the Patient Information Leaflet for transdermal fentanyl products. MHRA continue to receive reports of preventable accidental transfer of fentanyl patches. Since Jul 2014 and up to Oct 2018, MHRA has 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.
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.
Healthcare professionals are advised:
- 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; and following instructions for safe storage and properly disposing of used patches or those which are not needed.
- Ensure that patients and caregivers are aware of the signs and symptoms of fentanyl overdose and advise them to seek medical attention immediately (by dialing 999 and requesting an ambulance) if overdose is suspected. 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.
- In patients who experience serious adverse events, remove patches immediately and monitor for up to 24 hours after patch removal.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/transdermal-fentanyl-patches-life-threatening-and-fatal-opioid-toxicity-from-accidental-exposure-particularly-in-children
In Hong Kong, there are 4 registered pharmaceutical products which are transdermal patch containing fentanyl, namely Durogesic Transdermal Patch 12mcg/h (HK-53883), Durogesic Transdermal Patch 25mcg/h (HK-53755), Durogesic Transdermal Patch 50mcg/h (HK-53753) and Durogesic Transdermal Patch 100mcg/h (HK-53754). All products are registered by Johnson & Johnson (Hong Kong) Ltd, and are prescription-only medicines.
So far, the Department of Health (DH) has not received any case of adverse drug reaction related to fentanyl. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 20 Apr 2012, with the latest update posted on 22 Jul 2014. Letters to inform local healthcare professionals of the risk of accidental exposure were issued by the DH on 20 Apr 2012. In Sep 2014, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the package insert of fentanyl patch products should include safety information related to accidental exposure. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Oct 12, 2018
Issued at HKT 17:00
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