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

ABSTRACT: 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 o

SUBMITTER: Sandberg A 

PROVIDER: S-EPMC8622083 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature