Background: New Pharmacovigilance legislation allows patients to report adverse drug reactions
(ADRs) directly to competent authorities in all European Union (EU) member states. Patient
reporting is available in Portugal since July 2012. In 2013, the National Pharmacovigilance System
(SNF) had received 3461 spontaneous ADR reports, of which only 1.4% (n=50) were reported by
patients. Underreporting remains a reality in Portugal, although patient reporting could be one of
the measures to reduce the rate of underreporting by healthcare professionals (HCP).
Objectives: The aim of this study was to describe the attitudes and knowledge of the patients
regarding spontaneous reporting and the reasons and opinions that can influence patients ADR
underreporting.
Methods: A descriptive-correlational study was performed looking for patients’ attitudes and
knowledge regarding spontaneous reporting. A 6-months survey was conducted from June to
November 2013 in general adult patients from a community pharmacy in Coimbra, Portugal, that
used prescribed medicines or OTC-drugs. Attitudes and opinions were surveyed in a closedanswer
questionnaire using a Likert scale. Incomplete questionnaires and answers from
healthcare professionals were excluded from data analysis. The data were analyzed using
descriptive statistics, χ2 tests and Spearman’s correlation coefficients.
Results: A total of 1084 questionnaires were collected with a response rate of 81,1% and 948
completed questionnaires were selected for analysis. Of the respondents, 44.1% never heard
about SNF. Younger people and those with a higher education were significantly more likely to be
aware of SNF. Only 1 patient had previously reported an ADR directly to SNF. Reporting ADRs
indirectly through an HCP was preferred by 62.4%. The main reasons for patients reporting
spontaneous ADR would be the severity of the reaction (81,1% agreed or strongly agreed) and
worries about their own situation (73,4% agreed or strongly agreed). Only weak and moderate
correlations were found between studied statements.
Conclusions: Patients are most likely to do a spontaneous report about a severe reaction or if
they are worried about the symptoms. Tailored and proactive information on ADR reporting and
educational interventions on patients could increase the number of reports from patients in
Portugal
