Sandberg Andreas, Ehlers Pauliina, Torvinen Saku, Sandberg Heli, Sivén Mia
Division of Pharmaceutical Chemistry and Technology, Faculty of Pharmacy, University of Helsinki, FI-00014 Helsinki, Finland.
MedEngine Oy, FI-00130 Helsinki, Finland.
Healthcare (Basel). 2021 Nov 11;9(11):1540. doi: 10.3390/healthcare9111540.
Challenges in post-marketing adverse event reporting are generally recognized. To enhance reporting, the concept of additional monitoring was introduced in 2012. Additional monitoring aims to enhance reporting of adverse events (AE) for medicines for which the clinical evidence base is less well developed.
The purpose was to get a deeper understanding of the underlying reasons why additional monitoring has not increased AE reporting as much as initially hoped. We examined how healthcare professionals (HCPs) in Finland perceive additional monitoring, why they do or do not report AEs more readily for these medicines and how they interact with patients treated with additionally monitored medicines.
An anonymous, open questionnaire was developed and made available online at the e-form portal of University of Helsinki. Physicians, nurses, and pharmacists were invited to complete the questionnaire via their respective trade or area unions. Content analysis of answers to open-ended questions was performed by two independent coders.
Pharmacists have the best understanding about additional monitoring but at the same time do not recognize their role in enhancing monitoring. Only 40% of HCPs working with patients knows always or often if a specific medicine is additionally monitored. Half (53%) of HCPs do not tell or tell only rarely patients about additional monitoring. 18% of HCPs reported having received additional monitoring training whereas 29% had received general AE reporting training. AE reporting was more common among HCPs who had received training.
Additional monitoring awareness among HCPs and patients should be increased by organizing regular educational events and making additional monitoring more visible. Educational events should emphasize the significance additional monitoring has on patient safety and promote a reporting culture among HCPs.
上市后不良事件报告面临的挑战已得到普遍认可。为加强报告工作，2012年引入了额外监测的概念。额外监测旨在加强对临床证据基础尚不充分的药品不良事件（AE）的报告。
目的是更深入地了解额外监测未如最初期望那样增加不良事件报告的根本原因。我们研究了芬兰的医疗保健专业人员（HCPs）如何看待额外监测，他们为何对于这些药品更愿意或不愿意报告不良事件，以及他们如何与使用接受额外监测药品的患者进行互动。
设计了一份匿名开放式问卷，并在赫尔辛基大学的电子表单门户上在线提供。邀请医生、护士和药剂师通过各自的行业或地区工会填写问卷。由两名独立编码员对开放式问题的答案进行内容分析。
药剂师对额外监测的理解最好，但同时并未认识到他们在加强监测方面的作用。只有40%与患者打交道的医疗保健专业人员始终或经常知道某一特定药品是否受到额外监测。一半（53%）的医疗保健专业人员不告知或很少告知患者有关额外监测的情况。18%的医疗保健专业人员报告接受过额外监测培训，而29%的人接受过一般不良事件报告培训。接受过培训的医疗保健专业人员中不良事件报告更为常见。
应通过组织定期教育活动并提高额外监测的可见度，增强医疗保健专业人员和患者对额外监测的认识。教育活动应强调额外监测对患者安全的重要性，并在医疗保健专业人员中促进报告文化。
