(002) Breaking the Code: Patient Associations' Perception on Adverse Drug Reaction Reporting in Portugal

Background: Spontaneous reporting is crucial in pharmacovigilance, providing real-world clinical context and enhancing drug safety monitoring on post-marketing authorization stage. In Portugal, any citizen can report an adverse drug reaction (ADR) since 2012. Patient input provides a deeper understanding of adverse drug reaction (ADR) impact. Patient Associations (PA) are an opportunity to boost pharmacovigilance activities, since they assume a privileged position with patients.

Objectives: To assess the perception of PA about the process of reporting ADRs by their members in Portugal.

Methods: A descriptive cross-sectional study was conducted through an online questionnaire that was sent to all PA registered in Portugal. The data collection period was from April to June 2023.

Results: A total of 133 PA were contacted to participate in the study. Out of those, 53 associations responded to the questionnaire. 28.30% (n=15) disagreed that their members were aware of the importance/impact of ADRs for medication safety. When asked if PA members felt comfortable reporting ADR electronically, 62.26% (n=33) expressed their disagreement. 17 (32.08%) of PA identified the phone as the most accessible channel for reporting ADRs. Only 3 associations (5.66%) stated that their members were aware of the Portuguese Pharmacovigilance Portal (Portal RAM). The majority (73.58%; n=39) strongly agree that their involvement it the future reformulation of the reporting form of the Portuguese Pharmacovigilance Portal (Portal RAM) would be important. Only 3 associations (5.66%) have a link to the Portal RAM on their website. All associations agreed that partnerships between associations, Infarmed, and Regional Pharmacovigilance Units could enhance citizen participation and awareness in pharmacovigilance activities.

Conclusions: Our findings suggest the need to increase awareness among patients about the importance of reporting ADRs and the available channels for doing so. Engaging PA in this effort is particularly important, given their pivotal role for increasing awareness among patients. By partnering with PA, a reporting system that empowers patients could be developed fostering a reporting culture.