liu.seSearch for publications in DiVA
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • harvard1
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • oxford
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses reporting
University of Gothenburg, Sweden.
Region Östergötland, Center for Diagnostics, Department of Clinical Pharmacology. Linköping University, Department of Medical and Health Sciences, Division of Drug Research. Linköping University, Faculty of Medicine and Health Sciences.
University of Umeå Hospital, Sweden.
Nordic School Public Health NHV, Sweden; Jonköping County Council, Sweden.
Show others and affiliations
2015 (English)In: European Journal of Clinical Pharmacology, ISSN 0031-6970, E-ISSN 1432-1041, Vol. 71, no 5, 631-636 p.Article in journal (Refereed) Published
Abstract [en]

In March 2007, a legislative amendment was issued in Sweden compelling nurses to report all suspected adverse drug reactions (ADRs) to the national pharmacovigilance system. The aims of this study were to describe the status of ADR reporting, before and after the implementation of the legislative changes, and to describe the general characteristics of suspected ADRs reported by nurses. The Swedish pharmacovigilance system during the study period constituted six regional centres responsible for the handling of all spontaneous ADR reports within their region. In this study, we identified all individual ADR reports from 2005 and 2010, analysed in depth the ADR reports from two regional centres and collated information about the reporter and the nature of the reported ADR. From the two regional centres, a total of 898 and 1074 reports were submitted in 2005 and 2010 respectively. Nurses submitted 31 % (275 reports) of the reports in 2005 and 24 % (260 reports) in 2010. Nurses reporting of serious ADRs was 3 % (seven reports) in 2005 and 7 % (17 reports) in 2010 with reporting of unlabelled ADRs at 4 % (11 reports) in 2005 and 17 % (45 reports) in 2010. Most of the serious and/or unlabelled reactions were related to vaccine administration (14 reports in 2005 and 36 reports in 2010). The overall ADR reporting by nurses did not appear to increase after the change in reporting legislation. The proportion of serious and/or unlabelled ADRs reported by nurses did however appear to increase during the same period. Taken together, our data suggests that further pro-active measures should be considered in order to involve nurses in the reporting of suspected ADRs.

Place, publisher, year, edition, pages
Springer Verlag (Germany) , 2015. Vol. 71, no 5, 631-636 p.
Keyword [en]
Adverse drug reaction; Spontaneous reporting; Pharmacovigilance; Nurses
National Category
Clinical Medicine
Identifiers
URN: urn:nbn:se:liu:diva-118037DOI: 10.1007/s00228-015-1839-6ISI: 000353059900013PubMedID: 25845655OAI: oai:DiVA.org:liu-118037DiVA: diva2:813062
Available from: 2015-05-21 Created: 2015-05-20 Last updated: 2017-12-04

Open Access in DiVA

fulltext(335 kB)76 downloads
File information
File name FULLTEXT01.pdfFile size 335 kBChecksum SHA-512
6595c4d6f1219e9c069a780dcbf7648acdc31a70a78213c232541c20b2d1926fa0aa1e70ae28218d2130a0b749bf09b550264a3b3b32b8a7374d2809f893c4d0
Type fulltextMimetype application/pdf

Other links

Publisher's full textPubMed

Authority records BETA

Jacobsson, IngelaLövborg, HenrikHägg, StaffanJönsson, Anna K

Search in DiVA

By author/editor
Jacobsson, IngelaLövborg, HenrikHägg, StaffanJönsson, Anna K
By organisation
Department of Clinical PharmacologyDivision of Drug ResearchFaculty of Medicine and Health Sciences
In the same journal
European Journal of Clinical Pharmacology
Clinical Medicine

Search outside of DiVA

GoogleGoogle Scholar
Total: 76 downloads
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

doi
pubmed
urn-nbn

Altmetric score

doi
pubmed
urn-nbn
Total: 160 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • harvard1
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • oxford
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf