Patient Information Leaflet ‘Shortcomings’ Report Published

European Union guidance on patient information leaflets (PILs) should include more principles of good information design, and allow for more flexibility in the template for such leaflets. In addition, there should be more input from patients through making ‘user testing’ more iterative, and more care is needed when translating tested leaflets, so that the lay language introduced as a result of testing in one language is not lost during translation.

These are some of the findings from a report produced by the Dutch Health Research Institute (NIVEL) at Utrecht University for the European Commission. Prof Theo Raynor, Luto’s founder and academic advisor, acted as expert consultant and co-author to this study, which has recently been published.

PILs come inside every pack of medicines in the EU, and are the mainstay of information to help people use medicines safely and effectively – it is the only comprehensive and objective information source that patients are guaranteed to receive. Their quality is generally seen as being improved since the requirement for leaflets to be ‘user tested’ – by lay people – but further improvement is necessary. This is why the European Commission asked for this study, relating to the ‘shortcomings’ of PILs.  The work included an extensive literature search, a European-wide stakeholder survey and an online discussion forum for stakeholders and the report is now available.

Study on the Package Leaflets and the Summaries of Product Characteristics of Medicinal Products for Human use.

In an accompanying commentary the committee notes that they will now draft an assessment to the European Parliament on current shortcomings in PILs and how these could be improved in order to better meet the needs of patients.

Summary of comments to the study report on the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC).

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