Introduction Smartphone applications (apps) for pharmacovigilance present an opportunity for integration as cost-efective
healthcare service intervention into basic healthcare services in low-resource settings. This study aimed to (i) evaluate the
implementation of the Med Safety app in Burkina Faso, and (ii) compare the characteristics of the reports sent by the Med
Safety app with those sent on paper form.
Methods The study had two components: (i) a cross-sectional online survey assessing the Med Safety app, and (ii) a retrospective
analysis
comparing
the
characteristics
of the
Med Safety
reports
with
those
of the
paper form,
received
by
the

National
Pharmacovigilance
Centre
of Burkina
Faso
(CNVPS), from
January
1, 2021 to
December 31, 2022. We
evaluated

the
success of the
implementation
of the
Med Safety
intervention
using measures
of acceptability,
usefulness and feasibility.

This
assessment involved
a set
of 14 items rated
on a 4-point Likert
scale. Acceptability,
feasibility,
and usefulness were

determined
based on achieving
a total
score
higher than
the
mean. Subsequently,
we
computed
the
proportion
of participants

whose
overall
score
for
all items exceeded
the
mean. Continuous and categorical
variables
were
compared
using the
Wilcoxon

rank-sum
test
and
the
Chi2
test,
respectively.
The
signiicance
level
of
the
statistical
test
was
set
at
5%.
Results

The survey participation rate was 51.9% (160/308). Half of the respondents were in the 35-44 age group (50.6%),
and participants were predominantly male (71.9%). The Med Safety app was acceptable, feasible, and useful to 58.1% of
respondents. The most useful features of the app were “reporting” (53.1%), “news” (13.6%) and “watch list” (12.4%). During
the
period,
a total
of 1,472 reports
were
received,
including 357 (24.3%) through
Med Safety
and 1,115 (75.7%) through

the
paper form.
The reports
of adverse
events
following
immunization received
at the
CNVPS numbered
974 (66.2%), these

were
related
to
COVID-19
vaccines,
with
256
(26.3%)
through
the
Med
Safety
and
718 (73.7%)
through
the
paper
form.
The

median
time to
submit the
reports
to
the
CNVPS was
159 (IQR
59–187) days
for
the
Med Safety
and 166 (IQR 107–281)

days
for
the
paper
form
(p < 0.001).
Conclusion

In Burkina Faso, the Med Safety was found to be acceptable, useful, and feasible by users surveyed. In addition,
and compared
to
the
paper form,
the
app reduces
the
time to
submit a report,
and with
increase
in use, the
reporting

timeframe
could
be
further
improved.

Med Safety, reporting adverse events