de Vries Sieta T, van der Sar Maartje J M, Cupelli Amelia, Baldelli Ilaria, Coleman Anna Marie, Montero Dolores, Šipić Ivana, Andrić Adriana, Wennberg Annika, Ahlqvist-Rastad Jane, Denig Petra, Mol Peter G M
Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Dutch Medicines Evaluation Board, Utrecht, The Netherlands.
Drug Saf. 2017 Aug;40(8):729-742. doi: 10.1007/s40264-017-0535-0.
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).
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.
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.
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).
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.
欧洲药品国家主管当局（NCAs）负责协调与药品安全相关的沟通事宜。当前沟通方式的有效性受到了质疑，尤其是在与全科医生（GPs）沟通方面。
本研究旨在评估欧洲国家主管当局当前的药品安全沟通方式，并调查欧洲全科医生对药品安全沟通的认知及偏好。
通过网络调查向欧洲国家主管当局和医疗保健专业人员（HCPs）发放问卷。向参与欧洲加强药物警戒协作行动（SCOPE）联合行动的27个欧洲国家的每位代表发送电子邮件，对监管机构进行调查。通过网站链接、时事通讯和/或直接电子邮件，询问来自九个欧洲国家（丹麦、西班牙、克罗地亚、爱尔兰、意大利、荷兰、挪威、瑞典和英国）的医疗保健专业人员的偏好。从这项调查中，使用了全科医生的数据并进行了描述性分析。
报告了26个国家当前的国家主管当局做法。在23个国家（88%），国家主管当局除了向个别医疗保健专业人员分发外，还在其网站上发布直接面向医疗保健专业人员的沟通文件（DHPCs，即针对严重安全问题的紧急沟通信件）。10个国家（40%）的国家主管当局网站上提供了教育材料，21个国家主管当局（81%）表示有自己的公告/时事通讯，且通常在国家主管当局网站上发布（15个国家；60%）。完成调查的1766名全科医生中，超过90%知晓直接面向医疗保健专业人员的沟通文件。最受青睐的安全信息发送者是国家主管当局和专业机构，而了解安全信息的首选渠道是药品参考书和临床指南。全科医生认为重复安全问题很有用（英国为80%，意大利为97%）。对电子版而非纸质版的偏好因国家而异（瑞典为36%，西班牙为72%）。
国家主管当局在药品安全沟通方面采用类似方法。大多数全科医生知晓紧急沟通，且偏好类似的安全沟通发送者；然而，他们对形式的偏好因国家而异。
