Medicines for treating ADHD will now include information written with youngsters and teens in mind, thanks to work by researchers at the University of Leeds and the MHRA.
This is the first time that a dedicated ‘youth friendly’ section has been added to the patient information leaflet provided with any medicine taken by under-18s.
The new section is designed to help children with attention deficit-hyperactivity disorder (ADHD) understand more about the medicines they take and how to take them safely. It is also helping young people feel included in discussions about their treatment.
More than half a million prescriptions for methylphenidate – a stimulant medicine to treat ADHD, sold under the brand names Ritalin, Concerta and Equasym – are dispensed each year in England. Up until now, however, the patient information leaflet included with every box has been written with only adults in mind.
Following agreement with drug companies, the Medicines and Healthcare products Regulatory Agency (MHRA) decided that a youth-friendly section should be included in all brands of methylphenidate prescribed and dispensed in the UK. This work was undertaken by University of Leeds researchers in collaboration with the Leeds-based company Luto Research.
The revised patient information leaflet now includes a section called ‘Information for children and young people.” 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. 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 section also offers advice to youngsters who may be sexually active.
“Children and young people are the main consumers of these medicines,” said University of Leeds' Professor of Pharmacy Theo Raynor. “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.”
Words and phrases in the youth friendly section were tested by adults and teenagers, as well as children as young as 10 who tested the leaflet along with a parent. Feedback from this testing helped ensure that the messages on safety and side effects were clear to a wide range of ages.
“We gave particular thought to the layout of the text, as well as the content,” Professor Raynor said. “Simple changes, such as making headings bolder, using bulleted lists and dividing long sentences into shorter ones can make a real difference when writing for all people, including children.”
“This is the first time that children and teens have had a chance to comment on the information that goes into medicine packs, and it has proven to be very successful,” he said. “We are now hoping that this approach can be taken for other medicines that are used widely by children, perhaps medicines for asthma or epilepsy.”
The work was co-ordinated by the MHRA as part of its drive to help people of all ages understand the medicines they are taking.
MHRA Head of Patient Information Quality, Jan MacDonald, said: “It’s vital that both children and adults understand the medication they are taking. The MHRA is committed to encouraging the pharmaceutical industry to develop new innovative ways to communicate information to patients and we believe that children and young adults with ADHD will be better informed about their healthcare from the new style of patient information.”
"The MHRA and the University of Leeds are jointly funding ongoing research that is looking at what improvements to patient information leaflets can be made to help patients understand their treatments better," she said.
The work was carried out by a team led by Professor Theo Raynor (University of Leeds, School of Healthcare) and David Wood and David Bryant (Luto Research).
For further information:
For interviews with Professor Theo Raynor, contact: Press Office, University of Leeds Communications & Press Office: Tel: 0113 343 4031, email pressoffice@leeds.ac.uk
For interviews with the MHRA and information on the regulation of patient information leaflets, contact the MHRA press office, Tel 0203 080 7651, email press.office@mhra.gsi.gov.uk
The project is described in more detail in the latest issue of the Pharmaceutical Journal: Nicola Gray, ‘Medicines information for children and young people – a forward step in the UK.’ http://goo.gl/E1xlI