PIL of the Month – a Study of Best Practice in Patient Information Leaflets

Abstract

Patient empowerment has become increasingly important within the health sector and an important patient information document like the Patient Information Leaflet (PIL) has been the subject of an ongoing discussion for more than a decade. The PIL has often been heavily criticized for its lack of userfriendliness in spite of legal (EU) requirements that the PIL be easy to read, understand, and act upon. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced a new best-practice initiative called the PIL of the month, the aim of which is to further the improvement of the userfriendliness of PILs. This initiative focuses on positive aspects of PILs, however, the published quality criteria on which the selection builds hardly mention linguistic features at all. We have analyzed a corpus consisting of 10 PILs of the month in order to find out whether the PILs of the month constitute best-practice examples of userfriendliness from a linguistic point of view and if so how? In general we found many positive features and improvements on more traditional solutions, though we also still found many features which have a negative impact on userfriendliness. Only one leaflet could be said to constitute a real best-practice example, six leaflets were a mixture of positive and negative features, whereas three leaflets were very far from constituting best practice from a linguistic point of view.