Readability testing and preparation of Bridging Reports for the package leaflet

In accordance with Directive 2001/83/EC (adopted with Legislative Decree no. 219 of 24 April 2006), as amended, the package leaflet of medicinal products should be the result of specific surveys carried out on homogeneous groups of possible patients, in order to check that the information reported are understandable and easy to be interpreted. 

This can be ensured by performing a readability test, a focus test or a bridging report.

The performance of a Full Readability Test consists in the following activities:

• Examination of the authorised package leaflet and alignment to the latest QRD version
• Text simplification (carried out by a specialised doctor)
• Preparation of a questionnaire including 18-20 questions to be asked to the interviewees, to evaluate whether the selected target has understood the text
• Enrolment of 23 people of different age, education and profession, based on the intended use of the drug, so that they can represent a significant example of the future users of the drug. The first 3 people undergoing the pilot test will be chosen among professionals of this sector that are familiar with the guidelines, and with the information included in the package leaflet.
• Performance of phase 1 and 2 of the interviews (10 people for each phase); if necessary, the PIL is amended and interviews are repeated.
• Collection and processing of the answers, preparation and statistic interpretation of the results, final draft of the English report

The preparation of a Bridging Report can replace a Full Readability Test if this has already been performed for a similar medicine or for package leaflets of medicinal products authorised by centralised procedure.

In particular, a Bridging Report includes a critical discussion and a detailed analysis of the differences between a package leaflet of a certain drug (Daughter) and that of another medicine that has already undergone a readability test and has obtained a positive outcome (Parent). The focus test also involves interviewees that shall answer specific questions only regarding those parts of the package leaflet differing from the Parent’s.

Di Renzo Regulatory Affairs has a unit dedicated to the preparation of readability testing of package leaflets, focus tests and bridging reports of human medicinal products.

We can carry out the following activities:

• Identification of the products to be subjected to either the readability testing, focus test or bridging report
• Preliminary evaluation of the Summary of Product Characteristics (SmPC) and Package Information Leaflet (PIL)
• Alignment of the Package Information Leaflet to the QRD format and simplification of the text to make it readable
• Performance of the readability test for all the provided phases, including the enrolment of the interviewees
• Preparation of all required documents and layout of the final package leaflet
• Performance of focus tests
• Preparation of bridging reports