Readability test, Focus Test and Bridging Report

The European and Italian regulations on drugs provides for that medicinal products entering the Italian market are accompanied by a label and a package information leaflet including information, understandable by all users, to allow appropriate and safe use of the product.

The Package Information Leaflet (PIL) is a document containing all information required for a safe and appropriate use of a drug. The information reported in the package information leaflet is in line with the information reported in the “Summary pf Product Characteristics” (SmPC), a more technical and detailed document available to doctors.

This SmPC reports all information representing the set of characteristics of the drug as documented in the chemical-pharmaceutical, pre-clinical and clinical dossier submitted by pharmaceutical companies to the Competent Authorities in order to obtain the relevant Marketing Authorisation (MA) for a drug.

Package Leaflet source of Information

For users, the package information leaflet is the only source of information and instructions, especially for OTC drugs (on-the-counter, drugs that can be purchased without the need of a doctor’s prescription). For this reason, about 10 years ago, Italian legislators have imposed that all drugs should pass specific tests to evaluate the readability and easy understanding of PILs, also for drugs already present on the market. Europe had already been carrying out this project for some years, leaving a certain flexibility to Member States to comply as soon as possible. In parallel with this norm, Europe has also indicated a format to be followed for the drafting of PILs, defining a common structure ensuring uniformity of information.

This is show the QRD template was born. This is a standard model for the drafting of medicinal product information identified by a special working group of the European Commission, dealing with Quality Review of Documents (QRD).

The tasks of this working group is just to ensure clarity, consistency and accuracy in the product information and to promote its readability.

The Readability Test

To this purpose, the legal provisions provide for the performance of a readability test (Readability User Testing, RUT), involving the users, to assess the level of understanding of the information reported in the package information leaflet. The test is carried out starting from a first review by experts, who can make changes, also in line with the latest version of the QRD template.

The leaflet is often checked by a doctor, who evaluates the possibility of making technical terms more simple: one of the factors that mostly discourage the reading of the leaflet and make it more difficult to understand.

Then, some voluntaries are interviewed, their answers are elaborated and a report is drafted. The answers from the interviewees and the opinions expressed by them on the quality of the PIL graphics will be used to assess its fruition by patients, considering all necessary changes and ensuring clear and readable information for users, based on which they can adjust their behaviour and ask for any needed clarification to their doctor or pharmacist.

In special cases, legislators have allowed a simplification of this process by the mean of two tools: the focus test and the bridging report. The criteria for the exemption from the submission of the readability testing and the acceptance of the submission of a “Focus Test” or a “Bridging Report” are defined in the documents CMDh/100/2007/Rev 1 April 2009 and “FAQ on Product Information”.

They both require the essential data of having another full readability testing report available, performed on a similar product (called the “Parent”), as well as some considerations on the main differences with the product concerned by the evaluation (called the “Daughter”).

Parent and Daughter

If the two leaflets are similar, but the Daughter contains few but relevant information not included in the Parent (such as a pharmaceutical form with a very complicated method of administration), a focus test can be carried out, consisting in a “simplified” readability testing, both in the number of questions (that should only cover the different critical sections) and in the number of interviewees (that for a full readability testing is at least 20). Subsequently, as in full readability testing, results are assessed and a report is drafted.

If, on the other hand, the Daughter is like the Parent in every part, interviews can be completed skipped and a comparative and complete analysis of the PILs can be performed. The legislation provides for the use of two to a maximum of three Parent leaflets (for instance, it can be possible to refer to the design and layout of one leaflet and to the content of another).

In any case, a single report should be drafted where the differences of the two or more PILs are critically examined, with special reference to the safety information, message complexity, design, layout and language used. Along with the text, the layout should be also compared, including the text sixe and the font used, the arrangement of the sections and subsections, the structure of the leaflet (either vertical or horizontal), the selection of colour and contrast, the style of the writing and language, the location of key safety message in the text, the use of pictograms and the size of the PIL itself.

Written by: Michela Tonci

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