The United Kingdom: Press release: Fentanyl skin patches - use and dispose of...

People using fentanyl skin ('transdermal') patches and their carers should check that the patches are stuck on securely and are disposed of safely. This follows reports to the Medicines and Healthcare products Regulatory Agency (MHRA) of these patches accidentally sticking to other people's skin on contact.

Fentanyl skin patches are effective for relieving severe chronic pain when used according to instructions. The MHRA has received three reports of accidental contact with or transfer of fentanyl patches to date. Two of the three reports concerned children. People using fentanyl patches are reminded that the used patch should be folded in half so that the adhesive side sticks firmly to itself. It should then be safely thrown away in a secure bin so that it is not picked up by young children. If a patch is transferred to another person, remove it and get medical help immediately. If a patch is swallowed, get medical help immediately.

A European review assessed the risks of accidental exposure (including accidental transfer and improper disposal) associated with these patches. As a result, the product information for people who use these patches and healthcare professionals will be updated to strengthen these warnings and stress the importance of keeping the patches out of reach and sight of children.

Please refer to the following website in MHRA for details: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON437720

In Hong Kong, there are six registered pharmaceutical products which are fentanyl transdermal patches, namely Durogesic Transdermal Patch 50mcg/h (HK-53753), Durogesic Transdermal Patch 100mcg/h (HK-53754), Durogesic Transdermal Patch 25mcg/h (HK53755), Durogesic Transdermal Patch 12mcg/h (HK-53883), Fentanyl HPO Transdermal Patch 50mcg/h (HK-59083), and Fentanyl HPO Transdermal Patch 25mcg/h (HK-59084). All the products are prescription-only medicines. Related news has been released by the US FDA, Health Canada and Singapore Health Sciences Authority, and was posted on the Drug Office website on 20 April 2012, 24 September 2013, 12 October 2013 and 4 July 2014. Letter to healthcare professionals to draw their attention to similar safety concerns as mentioned in the announcement had also been issued on 20 April 2012. So far, the Department of Health (DH) has not received any local adverse drug reaction report related to these products. In view of the above MHRA's announcement, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The DH will keep vigilant on any further safety update related to fentanyl transdermal patches by other drug regulatory authorities.

Ends/ Tuesday, July 22, 2014
Issued at HKT 14:00

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