(P-062) Motives to Report Adverse Drug Reactions to the National Agency: A Survey Study Among Healthcare Professionals and Patients in Croatia, the Netherlands, and the UK

Background: Healthcare professionals (HCPs) and patients have various motives to report adverse drug reactions (ADRs) to their national agency. These motives may differ between countries.

Objectives: To assess to what extent motives of HCPs and patients to report ADRs differ between countries.

Methods: HCPs and patients from Croatia, the Netherlands, and the UK were asked to complete a web-based survey containing questions regarding demographics and ADR reporting. HCPs and patients could select all motives for reporting that applied to them with a total of 23 and 24 motives in the questions respectively. Descriptive statistics are presented and Chi-square tests were used to test for differences across the countries with effect sizes calculated using Cramer’s V.

Results: In total, 296 HCPs and 423 patients were included (60% and 31% from Croatia, 19% and 44% from the Netherlands, and 21% and 24% from the UK, respectively). For most of the motives to report or not to report an ADR there were no differences between the countries. Most HCPs’ from all countries would be motivated to report an ADR if there was a strong suspicion of causality (89%), if it concerned a severe/serious ADR (86%), and if it concerned an ADR for a new, recently marketed drug (77%). Most patients from all countries agreed that they would report an ADR if it concerned a severe ADR (96%), if the ADR influenced their daily activities (91%), if they were worried about their own situation (90%), and if the ADR was not mentioned in the patient information leaflet (87%). Differences across the countries (P <0.05 and V≥0.21) were observed for 3 (13%) and 4 (17%) of the HCP and patient motives respectively. For HCPs, these differences were seen in motives related to legal obligation, black triangle medicines, and regarding the reporting of well-known ADRs. For patients, these differences were seen in motives related to a linkage between the ADR report and the medical notes, complexity and time taken to report, medicines purchased on the internet, and the reporting of embarrassing ADRs.

Conclusions: HCPs’ and patients’ motives to report or not to report ADRs to their national agency were largely similar across the three countries. Such motives can be used in general strategies to promote and increase ADR reporting. The observed differences provide guidance to further fine-tune ADR reporting at a national level.