Patient Information Leaflets: Evaluation of the European translation policy and the MHRA suggestion to increase user’s awareness of key safety issues.

Abstract

Patient Information Leaflets (PILs) are tightly regulated on a European level to guarantee a comprehensible document that contains usable information. A fixed structure with fixed wording and user testing are examples of attempts to improve the comprehensibility and usability of PILs. User testing is performed to identify factors that impede these objectives. When the PIL passes the user test, it is approved and can then be faithfully translated in another European language. Additional user testing is not required. The translation is checked by pharmaceutical professionals who primarily focus on the faithfulness of the translation to the original leaflet rather than on the comprehensibility of the translated version.

Despite the regulations, the UK Medicines and Healthcare products Regulatory Agency (MHRA) feels that the consumers need to be aware of the key safety issues of their medication. To achieve this, they suggest the inclusion of a headline section: an overview of the key safety information presented at the beginning of the PIL. So, the information in the headline section is also covered in the body of the leaflet.

The controversial policy of one user testing and the MHRA suggestion of a headline section are the focus of this research. The objectives of this research are to (1) evaluate the adequacy of faithful translation and (2) the effects of the inclusion of a headline section. Both the one user testing policy and the inclusion of a headline section has not been investigated before. Also, the linguistic point of view of this research is relatively new in the evaluation of PILs.