In Portugal, this system is based on spontaneous
ADR reports made by healthcare professionals.[
3] These reports can be made using paper,
telephone, e-mail or through an online form,[4]
and they consist of a description of an adverse
event supposedly caused by a medicine. Spontaneous
ADR reporting has been described as
an efficient method for detecting drug safety
signals.[5] However, under-reporting is a major
issue undermining the effectiveness of spontaneous
reporting. Several studies suggest that less
than 10% of detected ADRs are effectively reported
to medicine regulatory authorities.[6,7] In
addition, the spontaneous ADR report rate in
northern Portugal was 90 reports/million inhabitants
in 2009, which is highly unsatisfactory
according to the WHO recommendations (200
reports/million inhabitants[8]).