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Attitudes among hospital physicians to the reporting of adverse drug reactions in Sweden
2009 (English)In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 65, 613-618 p.Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES: This study was designed to investigate attitudes to and incentive for reporting adverse drug reactions (ADRs) in general and towards nurses as reporters of ADRs in particular in a sample of hospital physicians.

METHOD: A questionnaire was sent to 1,201 randomly selected hospital physicians.

RESULTS: The main factors for the decision to report an ADR were the severity of the reaction, a reaction to a new drug, and an unusual reaction. The most important factor for refraining from reporting was that the reaction was well known. There were no significant differences between males and females or between age groups in these aspects. A majority were positive or neutral to nurses as reporters. Only 6% stated that their willingness to report ADRs would be affected in a negative way if nurses were involved in the program for reporting.

CONCLUSIONS: The results of this survey showed that inclusion of hospital nurses as reporters will not decrease the reporting rate from the physicians.

Place, publisher, year, edition, pages
Berlin Heidelberg: Springer, 2009. Vol. 65, 613-618 p.
Keyword [en]
Adverse Drug Reaction, Reporting Systems, Spontaneous reporting, Hospital physicians, Attitudes, Nurses
National Category
Medical and Health Sciences
Research subject
Natural Science, Biomedical Sciences
Identifiers
URN: urn:nbn:se:lnu:diva-26673DOI: 10.1007/s00228-008-0564-9OAI: oai:DiVA.org:lnu-26673DiVA: diva2:629578
Available from: 2013-06-17 Created: 2013-06-17 Last updated: 2017-12-06Bibliographically 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, Elisabet

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