Ekman, Elisabet (2013).
Pharmacovigilance – spontaneous reporting in
. Linnaeus University Dissertations No 132/2013. ISBN: 978-91-
87427-24-4. Written in English.
Pharmacovigilance in healthcare is essential for safe drug treatment. Spontaneous
reporting is the most common source of information in the context of
implementing label changes and taking a drug off the market. However,
underreporting is found to be very prevalent. One way to decrease underreporting is
to include different categories of healthcare professionals in such reporting and to
investigate attitudes towards and incentives for reporting adverse drug reaction
As nurses form the largest group of health professionals, a sample of nurses
were allowed and encouraged to report ADR during a 12 month period after they
had received training in pharmacovigilance. A questionnaire posted to physicians
and nurses investigated their knowledge and attitudes towards reporting.
Spontaneous reports of torsade de pointes (TdP) and erectile dysfunction (ED)
were scrutinized with respect to the reported drugs, risk factors and if the reaction
was listed in the summary of product characteristics (SPC).
After training, the nurses produced relevant reports and three years after the
introduction of nurses in the reporting scheme, more than half of the responding
nurses were aware of their role as reporters. Both nurses and physicians stated that
the most important factor for reporting a suspected ADR was the severity of the
ADR and an ADR arising in response to a newly approved drug. A web-based
reporting system was deemed to facilitate the reporting. In spontaneous reports of
TdP, citalopram was reported as a suspected drug. However, neither QT
prolongations, nor TdP, were labelled in the SPC. ED was reported for all
antihypertensive drugs including angiotensin II type I blockers. A positive
information component (IC), assessing the disproportionality between the observed
and the expected number of reports, was found indicating that ED was reported
more often in association with antihypertensive drug classes, except for angiotensinconverting
This thesis demonstrates the importance of pharmacoviglilance in healthcare in
terms of capturing new signals. By including nurses as reporters, the overall safety
of drugs might improve. Information and education are needed to secure safe
treatment when applying drugs.
Linnaeus University Press, 2013. , 56 p.
Pharmacovigilance, adverse drug reaction, spontaneous reporting, nurses, physicians, attitudes, torsades de pointes, erectile dysfunction