News Column

Fentanyl Skin Patches - Use and Dispose of Safely Says Regulator

July 21, 2014

LONDON, July 21 -- The British Medicines and Healthcare Products Regulatory Agency issued the following news release:

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.

Deputy Director of Vigilance and Risk Management of Medicines, Dr Sarah Branch said:

"It is extremely important when applying a fentanyl skin patch that people check that they are stuck on securely. A patch may cause serious harm if it accidentally sticks to somebody else's skin or is swallowed.

"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.

"People who use fentanyl patches should be careful to keep them out of the reach and sight of children and dispose of them carefully.

"If you have suffered any side-effects which you suspect may have been a result of using these products, or know anyone who has, please report it to us via our Yellow Card Scheme"

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.

Notes to Editor

1. Link to information for people who use fentanyl patches and their carers

2. Link to Drug Safety Update

3. Link to Pharmacovigilance Risk Assessment Committee recommendations.

4. In 2013, approximately 12.5 million patches were dispensed in the UK (data derived from IMS Health IMS MIDAS, 01/2013 - 12/2013, by the MHRA)

5. The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health.

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Source: Targeted News Service

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