Communication on Safety of Medicines in Europe: Current Practices and General Practitioners’ Awareness and Preferences

Sieta T. Vries, Maartje J. M. Sar, Amelia Cupelli, Ilaria Baldelli, Anna Marie Coleman, Dolores Montero, Ivana Šipić, Adriana Andrić, Annika Wennberg, Jane Ahlqvist-Rastad, Petra Denig and Peter G. M. Mol ()
Additional contact information
Sieta T. Vries: University of Groningen, University Medical Center Groningen
Maartje J. M. Sar: University of Groningen, University Medical Center Groningen
Amelia Cupelli: Italian Medicines Agency (AIFA)
Ilaria Baldelli: Italian Medicines Agency (AIFA)
Anna Marie Coleman: Health Products Regulatory Authority (HPRA)
Dolores Montero: Spanish Agency for Medicines and Medical Devices (AEMPS)
Ivana Šipić: Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Adriana Andrić: Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Annika Wennberg: Medical Products Agency (MPA)
Jane Ahlqvist-Rastad: Medical Products Agency (MPA)
Petra Denig: University of Groningen, University Medical Center Groningen
Peter G. M. Mol: University of Groningen, University Medical Center Groningen

Drug Safety, 2017, vol. 40, issue 8, No 8, 729-742

Abstract: Abstract Introduction National competent authorities (NCAs) for medicines coordinate communication relating to the safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regard to reaching general practitioners (GPs). Objective The aim of this study was to assess current European NCA safety communication practices and to investigate European GPs’ awareness of and preferences for safety communications on medicines. Methods Web-based surveys were distributed among European NCAs and healthcare professionals (HCPs). The survey among regulators was emailed to a representative of each of the 27 European countries participating in the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. HCPs from nine European countries (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. From this survey, data from GPs were used and descriptive analyses were conducted. Results Current NCA practices were reported for 26 countries. In 23 countries (88%), NCAs published direct healthcare professional communications (DHPCs, i.e. urgent communication letters for serious safety issues) on their website in addition to distribution to individual HCPs. Educational materials were available on the NCA’s website in 10 countries (40%), and 21 NCAs (81%) indicated they had their own bulletin/newsletter, which is often presented on the NCA’s website (15 countries; 60%). More than 90% of the 1766 GPs who completed the survey were aware of DHPCs. The most preferred senders of safety information were NCAs and professional bodies, while the preferred channels for keeping up to date with safety information were medicines reference books and clinical guidelines. GPs found the repetition of safety issues useful (range of 80% in the UK to 97% in Italy). Preference for an electronic copy rather than a hardcopy varied per country (36% in Sweden to 72% in Spain). Conclusions NCAs use similar methods for safety communications on medicines. Most GPs were aware of urgent communications and preferred similar senders of safety communications; however, their preferences towards the format differed per country.

Date: 2017
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DOI: 10.1007/s40264-017-0535-0

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