Changes in Side Effect Risk Communication in Patient Information Leaflets over the Past Decade: Results of a Survey

Introduction: Patients’ perceptions of side effect risks are important influences on their medicine-taking behaviour. A previous survey of Patient Information Leaflets (PILs) showed considerable variation in the terms used to communicate risks. Objective: Our objective was to assess the methods used to describe risk of side effects in recent PILs and to compare them with PILs sampled in 2006. Method: We sampled PILs for the 50 most frequently dispensed medicines in England and Wales in 2012 and PILs for the 50 most recently licensed medicines. We assessed the use of risk frequency terms or numbers, and the use of the risk format recommended by the European Medicines Agency (EMA). Results: A majority (76 %) of PILs for the most frequently dispensed medicines included a risk frequency descriptor, with 66 % using the recommended format. No difference was seen between PILs for branded and generic medicines. All 50 PILs for the most recently licensed medicines used the EU recommended risk format. PILs from the 2012 sample were much more likely than those from the 2006 sample to include risk descriptors and to use a consistent approach. Conclusion: The increased use and consistency of risk descriptors in PILs should benefit patients, particularly those using multiple medicines produced by different market authorisation holders. A need remains for further research evaluating the risk format recommended by the EMA. There is also a need for research evaluating spoken information and other sources of printed risk information about medicines that is available to patients.