Medicines for treating attention deficit-hyperactivity disorder (ADHD) will now include information written specifically for young and teenage patients, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.
This is the first time that a dedicated "youth friendly" sector has been added to the patient information leaflet (PIL) provided with any medicine taken by under-18s, and is designed to help children with ADHD to understand more about the medicines they take and how to take them safely. It is also helping them to feel included in discussions about their treatment, says the MHRA, which undertook the work with University of Leeds researchers in collaboration with the Leeds-based company Luto Research.
More than 500,000 prescriptions for the ADHD treatment methylphenidate - which include Novartis' Ritalin, Johnson & Johnson's Concerta and Shire's Equasym - are dispensed in England every year, but until now, the PIL included with every box has been written with only adults in mind.
Following agreement with the drugs’ manufacturers, a youth-friendly section will now be included in all brands of methylphenidate prescribed and dispensed in the UK. The new section, called Information for Children and Young People, 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," says Theo Raynor, professor of pharmacy at 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," he adds.
Words and phrases in the youth-friendly sections were tested by adults and teenagers, as well as among children as young as 10 who tested the leaflet 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," says Prof Raynor. "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."
Prof Raynor added that this is the first time that children and teens have had a chance to comment on the information that goes into medicine packs, and that it has proven to be very successful. "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," he says.
The MHRA's head of patient information quality, Jan McDonald, 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 health care 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 PILs can be made to help patients understand their treatments better, she added.