A proposal to digitise the package leaflet for medicines

The Associazione Farmaceutici dell’Industria (Afi) presented the ‘My e-Leaflet’ project which was developed with key stakeholders from the Italian healthcare community, including patient associations, healthcare professionals and practitioners.

The project, in which I participated as an expert, produced a consensus document that was drafted by a large working group that, starting from the key principles published by Ema and the study of the regulatory perimeters, as well as the potential of the technologies available today, defines the content, form and purpose of the digital package leaflet (PIL).

The consensus document explores both the regulatory aspects of a possible digitization of the information contained in the IF and hypothesizes, what could be the possible applications and interactions that the digital management of this information could allow.

The project aimed to understand the orientation of citizens and their opinion on the paper FI through a survey promoted by AFI on national social media that saw the participation of about two thousand Italian citizens of different age groups.

The survey showed that the absolute majority of respondents are more likely to read the package leaflet as they get older, but 89% felt that the leaflets could or should be further improved in terms of both graphics (46%) and comprehensibility and usability (38%). In addition, 80% of respondents expressed interest in having a digital version of the package leaflet on a website or in an app to complement the currently available paper version.

The paper explains what will be possible with the digital IF where, by this definition, we mean a native and structured document designed for electronic use and dissemination via web, electronic platforms and print.

Formats such as PDF, Word or other free text files that do not meet the principles outlined by the EMA are not considered useful for the objectives of the initiative because they do not bring concrete benefits to stakeholders.To learn more, you can download the short version of the document here or the extended version here.

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