Communication on safety of medicines in Europe: Current practices and general practitioners’ awareness and preferences

Communication on safety of medicines in Europe: Current practices and general practitioners’ awareness and preferences PhD Sieta T. de Vries1, PhD Petra Denig1, PhD Peter G.M. Mol1,2 1Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, The Netherlands 2Dutch Medicines Evaluation Board, Utrecht, The Netherlands Background National competent authorities for medicines (NCAs) coordinate the communication on safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regards to reaching general practitioners (GPs). This study aimed to assess current European NCA safety communication practices, and to investigate European GPs’ awareness of and preferences for such communications. Methods Web-based surveys were distributed among European NCAs and healthcare professionals (HCPs). The survey among regulators was emailed to a representative of the 27 European countries participating in the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) joint action. HCPs from nine European countries (i.e. Denmark, Spain, Croatia, Ireland, Italy, the Netherlands, Norway, Sweden, and the UK) were asked about their preferences through a link to the survey on websites, in newsletters and/or in a direct email. Data from GPs were used for this study. Descriptive analyses were conducted. Results Current practices were reported for 26 countries. In 23 countries (88%), NCAs published direct healthcare professional communications (DHPCs) on their website in addition to distribution to HCPs. Educational materials were available on the NCA’s website in 10 countries (40%). Twenty-one NCAs (81%) indicated to have their own newsletter. More than 90% of the 1766 GPs who completed the survey, were aware of DHPCs. Preferred senders of safety information were mostly NCAs and professional bodies. Preferred channels for safety information were medicines reference books and clinical guidelines. GPs found repetition of safety issues useful (range 80% in the UK to 97% in Italy). Preference for an electronic rather than a hardcopy format varied per country (36% in Sweden to 72% in Spain). Conclusion NCAs use similar methods for medicines safety communications. Most GPs were aware of urgent communications and preferred similar senders of safety communications. However, their preferences towards the format differed per country