Breaking the Code: Patient Associations' Perspectives on Adverse Drug Reaction Reporting in Portugal–Interim Results

• Published in: Drug safety 2023-11, Vol.46 (11), p.1250-1250
• Main Authors: Pereira, M R, Fernandes, J P, Sepodes, B, Silva, M, Torre, C
• Format: Article
• Language: English
• Subjects: Channels; Patients; Perception; Pharmacovigilance; Questionnaires
• ISSN: 0114-5916; 1179-1942

Introduction: Spontaneous reporting is crucial in pharmacovigilance [1]. In Portugal, any citizen can report an adverse drug reaction (ADR) since 2012. Patient input provides a deeper understanding of ADR impact [2]. Patient Associations (PA) are an opportunity to boost pharmacovigilance, since they assume a privileged position with patients [3]. Objective: The aim of our study was to assess the perception of PA about the process of reporting ADRs by their members. Methods: A descriptive cross-sectional study was conducted through an online questionnaire to gather information in three domains: awareness of ADR reporting importance, reporting channels, and RAM Portal. Likert-scales were used and responses were coded in an ordinal scale ("strongly disagree", "disagree", "neutral", "agree" and "strongly agree"). The online questionnaire was released on April, 27th and is still accepting answers. A total of 133 Portuguese PA were invited to participate in the study. Results: A total of 51 questionnaire responses were collected up to June, 1st. From the respondents, 41.1% (n=21) had more than 500 members. The majority of PA (39.2%; n=20) considered their members don't understand the importance of reporting ADRs for medication safety. Only 7.8% (n=4) assumed that their member knew it was possible to report an ADR autonomously. 66.7% of respondents (n=34) shown that members don't know where to report if they experience an ADR while 94.1% (n=48) had the perception that their members do not know what is "Portal RAM". When asked if PA members felt comfortable making a reporting electronically, 64.7% (n=33) expressed their disagreement. Of the PA, 33.3% (n=17) considered the phone to be the most accessible channel for reporting an ADR. Despite only 5.9% (n=3) of the PA have a link to the "Portal RAM" on their website, the majority (72.6%; n=37) strongly agree that their involvement it the future reformulation of the reporting form of the Portal would be important. Conclusion: Our findings suggest the need to increase awareness among patients about the importance of reporting ADRs and the available channels for doing so. To improve ADR reporting, is crucial to ensure that reporting platforms are user-friendly and meet the needs of patients. Engaging Patient Associations 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