The regulation of PIL and RUT testing

Following Croatia’s integration into the EU, it is the obligation of each marketing authorization holder for medicinal products in Croatia to conduct a User Testing of Patient Information Leaflets (PIL testing / Readability testing) and to deliver its results within the documentation updates about the medicinal product to the relevant Agency in accordance with the defined deadlines.

All medicinal products marketed in the European Economic Area (EEA) are required by European Union law to be accompanied by a Patient Information Leaflet (PIL) which provides a set of comprehensible information for the safe and appropriate use of the medicinal product.

Since 2005, European legislation requires that PILs must undergo testing to demonstrate that they are written in a clear and understandable language, and to ensure that patients are able to find relevant information and to act upon it appropriately. This is referred to as “readability testing” or “user testing” (RUT).

Ultimately, the test is a measure for the improvement of consumer safety: its intention is to make the application of a medicinal product as safe and efficacious as possible for the patient.

For more information visit the website of the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) here.

Appropriate respondents (potential users of the PIL) are selected. Participants are representative of the population this product is intended for.

The interview

Each participant is asked to read the concerned PIL prior to the interview.
During face-to-face interviews with trained qualitative researchers, respondents are asked to locate a number of key pieces of information in the leaflet and explain them in their own words. Interviews are performed in a private, relaxed and quiet environment.

Oral interviews last about 30 minutes, and respondents are asked 12 to 15 questions, followed by four further questions of a more general nature.

Questions focus on what the medicinal product is used for, how it is used and the adverse reactions associated with the medicinal product.

Interview rounds

Initially, a pilot study is carried out (consisting of five interviews) to test out the suitability of the questions for assessing the PIL.

Following this, at least two rounds of 10 interviews are completed. At each stage feedback is given to the PIL writer so that improvements to the PIL can be made if required.

Determining the test outcome

The European Commission’s Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use states that a satisfactory test outcome is when at least 16 out of 20 people are able to answer each question correctly. Satisfactory test outcome is when 90 % of literate adults are able to find the information requested within the PIL, of which 90 % can show that they understand it.

The final report includes a description of the test, analysis of the data and expert recommendations.