Module 6

04/10/2024

User Testing of Leaflet - Process

Review results • 90% pass rate (find and understand information) • Quantitative and qualitative feedback

Prepare report • Review feedback for further updates to leaflet

Report reviewed • Reviewed in MAA procedure • Detailed assessment report template

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Electronic Patient Information Leaflet (ePIL)

“less than 50 per cent of people always or often read the PIL and only 10 per cent of people read the PIL when they receive their repeat prescription” (KSS AHSN et al, 2023)

TOPRA Regulatory Rapporteur July/August 2024 – Marie Woe, Erika Aparicio, Kathryn Sharpe (UK ePI Task Force evidence review: ePILs)

• An electronic patient information leaflet (ePIL) is the digital form of a regulator-authorised PIL for a medicine, adapted for handling and dissemination via the internet, e-platforms and in print

• ePILs are a subset of electronic product information (ePI)

• can help to address many existing issues surrounding the accessibility of medicinal product information in its current paper leaflet format

• ePILs have the potential to be personalised and to be interoperable with other existing systems or services

• PIL updates could be made more quickly

The Organisation for Professionals in Regulatory Affairs

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