Regulation Awareness and Experience of Additional Monitoring among Healthcare Professionals in Finland

Healthcare (Basel). 2021 Nov 11;9(11):1540. doi: 10.3390/healthcare9111540.


Background: 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.

Purpose: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: additional monitoring; adverse event reporting; black triangle; pharmacovigilance.