Patient/User leaflet testing

Patient/User information leaflet testing – regulatory affairs  services

Many terms are used to describe the leaflet enclosed with a medicine and include ‘user leaflet’, ‘package leaflet’ and ‘patient leaflet’ or even simply ‘labelling’. Some of these terms may not be strictly appropriate and have specific implications. The following narrative however is intended to apply to a leaflet supplied with a medicine and for the benefit of the patient receiving it.

All medicines are required by European and UK law to be accompanied by a Patient Information Leaflet (PIL) setting out comprehensive information which is accessible to and understandable by those who receive it, so that they can use the medicine safely and appropriately.

The information required to be set out in the PIL is drawn from the Summary of Product Characteristics and intended to be presented in terms which the target patient population can easily understand.

European Law requires in addition that:

“The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible clear and easy to use…The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority.”

There is no prescribed methodology for such assessments (user tests) but experience has led to the development of suitable testing protocols generally found to be acceptable to competent authorities.

vector pharma has the expertise necessary to draw up PILs in accordance with the requirements and guidelines which apply in the UK and other EU member states and arrange where necessary for user testing and submission of the test methods and results to the competent authorities.

Note that the above summarises the requirements in outline but there are circumstances in which user testing may not be required or can be simplified.