PIL, a clear and readable source for information to patients
After doctors and pharmacists, the patient information leaflet is the main source of information on medicinal products available to consumers. However, in the past, the PIL was a summary, sometimes even a copy, of the technical sheet of the medicine consulted by doctors. Patients, disoriented by excessively scientific information, tended to rely on doctors and pharmacists – two health professionals perceived as more involved in health protection – rather than on pharmaceutical companies, sees as more interested in selling their products.
But these were different times, before rigorous clinical investigations and pharmacovigilance controls, that is before patients were put at the core of pharmaceutical and health management. The protection of patient health led to the creation, at European level, of a document that is much less technical and more within public reach. Though recalling the technical and scientific information provided to doctors, this is organised in a fixed, defined structure, within which it can be easily traced. Moreover, information is user-friendly, trying to “translate” medical and pharmaceutical jargon into a common use terminology.
Thus was born the QRD template
This is how the QRD template was born, a standard model for the drafting of information, found by a special working group of the European Commission dealing with the review of documents quality (Quality Review of Documents – QRD). The tasks of this working group include to ensure clarity, consistency and accuracy of the information on the product and to promote the readability of the information concerning it.
To this aim, regulations provide for the carrying out of a readability test (Readability User Testing, RUT), involving users to assess the level of understanding of the information contained in the PIL. The test – mandatory for more than 10 years for drugs authorised by European procedure and since 2015 for those registered with national procedure – is carried out in line with an updated version of the QRD template.
Simplification of the package leaflet
The PIL is also assessed by a doctor, who consider the possibility to simplify some technical terms: one of the factor discouraging reading and making understanding more difficult. Actually, although the QRD working group guideline provides for the use of expressions as closer as possible to common language, leaving technical terms in brackets, not all PILS are drafted in this way.
Subsequently, based on the text obtained, a questionnaire is prepared – twenty questions covering all sections of the PIL. In addition to these, there are also 5 questions on the graphics of the PIL and on how easy the reading is: another critical aspect is in fact the small size of the fonts, especially for elderly people, and unappealing layouts that do not highlight significant information.
Then volunteers are enrolled, a phase that should consider the variety of the public using drugs, presenting extremely different levels of education and schooling, as well as the wide range in the age of its potential users.
The readability test involves the selection of 3 groups: 3 volunteers for the “pilot test”, for the preliminary check of its content and to make final revisions; 10 for phase 1, and 10 for phase 2. The enrolment of these subjects, to be performed in full compliance with the privacy law, shall also consider the intended use of the drug, thus selecting the types of users or administrators the more similar to what can potentially happen in real life.
Even in these times of coronavirus, it is possible to perform interviews for readability testing of PILs, complying with the norms already applied in other environments: social distance, individual protection equipment (gloves, masks, etc.) and limited access, in order to protect the safety of the interviewer and interviewees as much as possible.
The answers from the interviewees and the opinion expressed on the graphic quality of the PIL will then be used to assess its usability by patients, considering all changes required, ensuring clear and readable information to users, based on which they can adjust their behaviour, and ask doctors and pharmacists for clarifications, when needed.
Written By: Maria Pia Felici
Foto di Mizianitka da Pixabay
