Subject(s)
Hereditary Angioedema Types I and II , Humans , Finland/epidemiology , Prevalence , Female , Male , Incidence , Adult , Middle Aged , Adolescent , Hereditary Angioedema Types I and II/epidemiology , Hereditary Angioedema Types I and II/diagnosis , Hereditary Angioedema Types I and II/genetics , Young Adult , Child , Child, Preschool , Aged , Infant , Risk Factors , Age of Onset , Time FactorsABSTRACT
BACKGROUND: Adverse drug reaction (ADR) reporting has been studied relatively extensively in all the Nordic countries besides Finland, but no definitive solution to decrease under-reporting has been found. Despite many similarities in reporting, the most notable difference compared to other Nordic countries is that ADR reporting is completely voluntary in Finland. PURPOSE: The purpose was to examine if voluntary reporting influences healthcare professional (HCP) ADR reporting, why HCPs do not report all suspected ADRs, how could reporting be enhanced, and do we need to develop the process for collecting ADR follow-up (F/U) information from HCPs. METHODS: An open and anonymous questionnaire was developed and made available online at the e-form portal of the University of Helsinki. Trade and area unions distributed the questionnaire to their respective member physicians, nurses, and pharmacists. Two independent coders performed the content analysis of answers to open-ended questions. RESULTS: A total of 149 responses was received. Two fifths (38%) of the HCPs confirmed that they had not always reported suspected ADRs. The main reason for not reporting was that the ADR was already known. HCPs who had no previous ADR reporting experience did not report ADRs mainly because it was not clear how to report them. Seriousness (chosen by 76%) and unexpectedness of the reaction (chosen by 64%) were the most actuating factors in reporting an ADR. Only 52% of the HCPs had received ADR reporting training and only 16% of the HCPs felt that they had enough information about reporting. Most HCPs felt that ADR F/U requests are justified, and these requests did not affect their ADR reporting willingness. CONCLUSIONS: As in other Nordic countries, ADR under-reporting occurs also in Finland despite differences in reporting guidance. ADR reporting rate could be enhanced by organizing recurring training, information campaigns, and including reporting reminders to the patient information systems that HCPs use. Training should primarily aid in recognizing ADRs, educate in how to report, and promote a reporting culture among HCPs.
ABSTRACT
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.
