Testing the readability of the package leaflet shall be carried out in order to verify the extent to which patients are able to find, but also to understand the safety information listed in the accompanying instructions for the medicine. The test, therefore, has no effect on the content and quality of the information. However, it is conducted to identify any difficulties in legibility or intelligibility of the text written in the package information leaflet or booklet to use during their normal use. By testing the readability certain words or entire paragraphs will be set aside within the leaflet that are not clear to the patients and that can lead to errors in the use of a particular medicine, and thus would allow better adaptation of the instructions to the patient.
According to Directive 2001/83 / EC as amended by the Directive 2004/27 / EC, the readability of the instructions supplied with medicines and medical products for use by people is mandatory on the entire territory of the European Union and it is demanded that the application on the target population (potential customers) is tested in order to determine that the patients as potential users, are able to use medicines properly, or use them in accordance with the instructions set out in the Instructions.
For more information on the legal framework and other details on medicine readability tests click here.
The first experience in testing the readability go date back to the early 90s. It has shown that a well conducted interview is the best and most commonly used method of testing the readability instructions and as such this method is accepted by regulatory bodies. In this regard official guidelines "Guideline on the readability of the label and package leaflet of medicinal products for human use" have been issued (EC, Revision 1, January 2009), which provide details of performance testing of readability instructions, all in order to ensure representativeness of the results obtained.
BONIFARM has built a standardized method of carrying out the leaflet readability tests, paying attention to the quality standards, according to which we offer our clients a fast, professional and complete service.
- CHECK THE PACKAGE LEAFLET UNDERSTANDABILITY (Readability user testing)
- Analysis of existing product leaflet
- Suggestions and help with the necessary PIL amendments
- Pilot testing (3-6 respondents)
- 2/3 rounds of testing (total 20/30 patients)
- Preparation of final reports
- Potential additional clarification when requested by the Agency
- PREPARING AND MAKING REPORTS / TESTING FOR RESULTS BRIDGING
- TARGETED SCREENING OF THE PACKAGE LEAFLET UNDERSTANDABILITY (focus testing)