In a move to strengthen the role played by patients in the preparation of drug information, the EMEA is due to launch a scheme to involve patients in the review of both package leaflets and European Public Assessment Report summaries, within the next couple of weeks.
Whilst speaking at the 19th Drug Information Association conference held in Vienna, Dr Isabelle Moulon, Head of Sector, Medical Information at the EMEA said that from mid- April (after the Easter break), patients will review medical information documents for relevance and understanding. “After all, package leaflets are intended for use by the patient so why not check that the text is readable and easily understood. Unfortunately, patients think we try and hide information from them, but we actually want patients to have an active and productive dialogue with the sector,” said Dr Moulon.
As their name suggests, EPARs are designed to be accessible to the public, but previously, the copy was only ever reviewed by experts, effectively missing the target readership all together. With the new process, patients will review EPARs in parallel with CHMP rapporteurs, feeding back comments within 10 days. “Patient involvement will give us at the EMEA a better indication of whether patients appreciate and understand materials related to their medication. Usually we only ever hear from consumers if things go badly wrong. Until now we have had no other measure,” said Dr Moulton.
20 patient groups on hand
The EMEA has a list of 20 patient groups which are available to be called upon to review documents. The patients chosen will fulfil various set criteria for participating in EMEA activities. “We check their status regarding confidentiality and any conflicting interests, to ensure that we receive a trustworthy and unbiased response.”
David Hans-U Haerry is chair of the European Community Advisory Board for the European AIDS Treatment Group. He is concerned that quality of information may be sacrificed for readability and that translation and cultural diversity with respect to drug information has been overlooked. “Consumers have very diverse information requirements. In fact, on average, 20% of patients are foreigners and cannot read the package because they are functionally illiterate. Package leaflets need more illustrations, cartoons, and perhaps a simplified section followed by a separate more complex information section,” he explained.
The involvement of patients in reviewing medical information is part of an initiative started in 2002 to empower patients. Four issues were identified: pharmacocvigilance, transparency, interaction with the EMEA, and product information. “Now that we have developed patient interaction with the EMEA, we are focussing on pharmacovigilance or how to communicate the risk/benefit ratio and secondly, the dissemination of information,” adds Dr Moulon. By Becky McCall at the DIA conference in Vienna, Austria
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