New organisation to advise on patients’ medicines leaflet
pharmafile | July 28, 2006 | News story | Medical Communications |Â Â Â
A new organisation has been set up to give the medicines regulatory agency independent advice on how to improve patient information leaflets for medicines.
The Commission on Human Medicines Expert Advisory Group on Patient Information (PIEAG) is investigating how the MHRA involves patients in issues surrounding medicines safety.
As well as looking at further ways to improve the patient information leaflets (PILs), which are included in the packaging of medicines, the new group will also offer advice on how the MHRA communicates to patients about the risk/benefit debate of the various medicines. In addition, it will explain how to encourage patients to use the 'yellow card' scheme to report suspected drug side-effects.
In July 2005, it became compulsory for pharmaceutical companies to seek views from target patient groups on the clarity of information in the PILs for all new medicines, and by the end of 2008, drug companies must seek opinions from established patient organisations on every existing medicines leaflet.
The MHRA published its report 'Always read the Leaflet' a year ago, giving guidance on how to prepare and test PILs to satisfy patients' needs.
Dr June Raine, vigilance and risk management of medicines director at the MHRA, said: "For many patients the leaflet is the only written information they will have about their medicine. High quality information can help patients use medicines safely and effectively."
She added: "Ensuring patients are involved means we now have more user-friendly PILs than ever before. We will continue to work with the PIEAG to ensure leaflets meet the needs of patients."
Joanne Rule, chairman of the PIEAG and chief executive of CancerBackup, said: "I am delighted to be able to chair this important group. It is vital that patients and the public receive quality information in order to make informed choices about medicines."
As part of its drive to improve PILs, the MHRA has published three examples of improved patient information leaflets on its website. They are GSK's Imigran, used to treat migraine, AstraZeneca's schizophrenia drug Seroquel and Pzifer's hypertensive, Amlopidine.
