Keywords
risk perception
pharmacovigilance system
ADR reporting
Abstract
Introduction. The use of medicines involves trade-offs between their therapeutic benefits and inherent risks. Several studies show that numerous adverse drug reactions (ADRs) could be avoided by increasing patients’ awareness of medicine’s risks. Even though drug labels enclose relevant information about risks and benefits, this information often requires patient education and overall health literacy to improve medication adherence, thereby preventing ADR frequency.
Aim. To describe patient awareness of ADR risks and the Portuguese Pharmacovigilance System.Methods.A questionnaire comprising 27 questions was conducted at a health centre in Coimbra, Portugal. This study included ninety-one patients. Risk perception was scored as positive (≥2.5 points) or negative (<2.5 points). Results were analysed by SPSS v 27.0.
Results. This work highlights poor patient perceptions of risk with a rate of negative responses of 85,7%. Although some responders were aware of the possibility of reporting ADRs, only some participants were familiar with the Portuguese Pharmacovigilance System. Additionally, only five patients – out of the vast majority of those who had previously encountered ADRs – reported the event to INFARMED.
Conclusion. Patient low literacy regarding ADRs and the national reporting systems need to be urgently improved. Patient-centred communication strategies for recognising regulatory requirements and standards of product safety are important measures to achieve effective awareness through routine reporting within the Pharmacovigilance systems.
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