Regulatory Focus™ > News Articles > MHRA Rolls Out First-ever Information Leaflet Specifically Aimed at Children

MHRA Rolls Out First-ever Information Leaflet Specifically Aimed at Children

Posted 07 June 2012 | By Alexander Gaffney, RAC 

Some medicines approved to treat attention deficit hyperactivity disorder (ADHD) in the UK will soon include information in the patient information leaflet specifically targeted towards those under the age of 18 thanks to a partnership between regulators, academia and industry.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced Thursday, 7 June it is moving to implement the new information layout-reportedly the first time it has been done in the UK-in order to help children "understand more about the medicines they take and how to take them safely."

The "youth-friendly" information section is the result of work by MHRA and researchers at the University of Leeds, who worked with drug companies who agreed to add the re-worked section to all brands of methylphenidate marketed in the UK.

"The new section provides clear and simple information about the consequences of possible side effects, using examples that may be relevant to children and teens," researchers explained. "For example, when advising users to avoid certain activities if they feel dizzy, it refers to horse riding, climbing trees and riding a bike."

The change was especially important because children are the main consumers of ADHD medications, said Professor Theo Raynor of the University of Leeds. "It is important that they have the opportunity to know why they have been given this drug treatment and how it can help them. The revised leaflet now gives them a chance to read about their medication in an easy and informative way."

The changes include bolder headlines, bulleted lists and simpler sentences, all of which was tested by both adults and children above the age of ten.

Read more:

MHRA - 'Youth friendly' messages on medicines for kids

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