Pharmacovigilance spontaneous reporting in health care

University dissertation from Linnaeus University Press

Abstract: Ekman, Elisabet (2013).Pharmacovigilance – spontaneous reporting inhealhtcare. Linnaeus University Dissertations No 132/2013. ISBN: 978-91-87427-24-4. Written in English.Pharmacovigilance in healthcare is essential for safe drug treatment. Spontaneousreporting is the most common source of information in the context ofimplementing label changes and taking a drug off the market. However,underreporting is found to be very prevalent. One way to decrease underreporting isto include different categories of healthcare professionals in such reporting and toinvestigate attitudes towards and incentives for reporting adverse drug reaction(ADR)s.As nurses form the largest group of health professionals, a sample of nurseswere allowed and encouraged to report ADR during a 12 month period after theyhad received training in pharmacovigilance. A questionnaire posted to physiciansand 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 reactionwas listed in the summary of product characteristics (SPC).After training, the nurses produced relevant reports and three years after theintroduction of nurses in the reporting scheme, more than half of the respondingnurses were aware of their role as reporters. Both nurses and physicians stated thatthe most important factor for reporting a suspected ADR was the severity of theADR and an ADR arising in response to a newly approved drug. A web-basedreporting system was deemed to facilitate the reporting. In spontaneous reports ofTdP, citalopram was reported as a suspected drug. However, neither QTprolongations, nor TdP, were labelled in the SPC. ED was reported for allantihypertensive drugs including angiotensin II type I blockers. A positiveinformation component (IC), assessing the disproportionality between the observedand the expected number of reports, was found indicating that ED was reportedmore often in association with antihypertensive drug classes, except for angiotensinconvertingenzyme inhibitors.This thesis demonstrates the importance of pharmacoviglilance in healthcare interms of capturing new signals. By including nurses as reporters, the overall safetyof drugs might improve. Information and education are needed to secure safetreatment when applying drugs.