Medical Writing Writing for Lay Audiences Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?

Volume 24, Issue 4 - Writing for Lay Audiences

Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?


Package leaflets (PLs) have been legally required to accompany medicines in the EU since 1999. Despite the best intentions and efforts, however, they are generally not well-received by the public for whom they are intended. This paper picks up on the challenges that medical regulatory writers face in producing quality PLs using the official PL template when research indicates that patients would prefer a more personalised genre that incorporated their experiences and knowledge. This paper advocates greater inclusion of patients’ perspectives, as this is currently achievable given the current legislation. The paper also notes the tantalising prospect of replacing the template with a set of recommendations that draws on knowledge of what works best for patients.

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Writing for lay audiences
President's Message
Writing for lay audiences: A challenge for scientists
Patient education accessibility
Legislation and the lay audience: Challenges of communicating benefit and risk in the light of new regulations
Medical writing for two audiences – The RMP public summary
Layperson summaries of clinical trial results: Useful resources in the vacuum of regulatory guidance
Package leaflets for medication in the EU: The possibility of integrating patients’ perspectives in a regulated genre?
What do writers need to know about user testing?
Medical journalism: Another way to write about science
Elements of storytelling in medical journalism
A stroll through the medical blogosphere
Writing narrative style literature reviews
News from the EMA
Profile: An interview with Laura Carolina Collada Ali: On the peculiarities of working for independent research organisations
The Webscout
In the Bookstores
Regulatory Writing
Lingua Franca and Beyond
Gained in Translation
English Grammar and Style
Out On Our Own


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