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Awareness among nurses about reporting of adverse drug reactions in Sweden
Linnaeus University, Faculty of Science and Engineering, School of Natural Sciences.ORCID iD: 0000-0003-4550-4598
Linnaeus University, Faculty of Health, Social Work and Behavioural Sciences, School of Health and Caring Sciences. (eHälsoinstitutet ; eHealth Institute)ORCID iD: 0000-0002-4295-7201
Linnaeus University, Faculty of Science and Engineering, School of Natural Sciences.
2012 (English)In: Drug, Healthcare and Patient Safety, ISSN 1179-1365, E-ISSN 1179-1365, Vol. 4, 61-66 p.Article in journal (Refereed) Published
Abstract [en]

Background: The purpose of this study was to investigate awareness among nurses regarding their new role as reporters of adverse drug reactions in Sweden and factors that may influence reporting by nurses.

Methods: In 2007, all nurses were included in the adverse drug reaction reporting scheme in Sweden. A questionnaire was sent to 753 randomly selected nurses in September 2010.

Results: Of the 453 (60%) responding nurses, 265 (58%) were aware that nurses were included in the reporting of adverse drug reactions. Sixty-one nurses (14%) stated that they had reported an adverse drug reaction. Fifteen percent (n = 70) of the respondents had received training about reporting of adverse drug reactions. Almost one third of these (n = 21, 30%) had reported an adverse drug reaction on at least one occasion. Among nurses without training, a smaller proportion (n = 40, 11%, P < 0.05) had reported an adverse drug reaction on at least one occasion. The two factors considered most important by nurses for reporting were the severity of the adverse drug reaction and if the reaction was to a newly approved drug. A majority of the nurses (n = 397, 88%) were interested in a training course in pharmacology as part of their ongoing professional development. One third (32%) of all nurses stated that one reason for not reporting a suspected adverse drug reaction was that the physician responsible did not regard the reaction necessary to report.

Conclusion: We found that more than half of the study population of nurses in Sweden were aware of their new role as reporters of adverse drug reactions, but few of the responding nurses had reported an adverse drug reaction. Given that training seems to be associated with high reporting frequency, we suggest more training in pharmacovigilance for nurses.

Place, publisher, year, edition, pages
2012. Vol. 4, 61-66 p.
National Category
Nursing Pharmaceutical Sciences
Research subject
Health and Caring Sciences; Natural Science, Biomedical Sciences
Identifiers
URN: urn:nbn:se:lnu:diva-21312DOI: 10.2147/DHPS.S31103OAI: oai:DiVA.org:lnu-21312DiVA: diva2:547297
Available from: 2012-08-27 Created: 2012-08-27 Last updated: 2017-12-07Bibliographically approved
In thesis
1. Pharmacovigilance: spontaneous reporting in health care
Open this publication in new window or tab >>Pharmacovigilance: spontaneous reporting in health care
2013 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

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 (ADR)s.

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 enzyme inhibitors.

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.

Place, publisher, year, edition, pages
Linnaeus University Press, 2013. 56 p.
Series
Linnaeus University Dissertations, 132/2013
Keyword
Pharmacovigilance, adverse drug reaction, spontaneous reporting, nurses, physicians, attitudes, torsades de pointes, erectile dysfunction
National Category
Medical and Health Sciences
Research subject
Natural Science, Biomedical Sciences
Identifiers
urn:nbn:se:lnu:diva-26820 (URN)978-91-87427-24-4 (ISBN)
Public defence
2013-05-08, N2007, Smålandsgatan 26a, Kalmar, 13:00 (Swedish)
Opponent
Supervisors
Available from: 2013-06-19 Created: 2013-06-19 Last updated: 2017-05-30Bibliographically approved

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Ekman, ElisabetPetersson, GöranTågerud, Sven

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