title: The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses' reporting.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Public Health and Community Medicine, the Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.
authors.forename: Sofia A
authors.initials: SA
authors.lastname: Karlsson
authors.forename: Ingela
authors.initials: I
authors.lastname: Jacobsson
authors.forename: Marit Danell
authors.initials: MD
authors.lastname: Boman
authors.forename: Katja M
authors.initials: KM
authors.lastname: Hakkarainen
authors.forename: Henrik
authors.initials: H
authors.lastname: Lövborg
authors.forename: Staffan
authors.initials: S
authors.lastname: Hägg
authors.forename: Anna K
authors.initials: AK
authors.lastname: Jönsson
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000451:nursing*; D006801:Humans; D060735:Pharmacovigilance; D013548:Sweden
references.citation: BMC Health Serv Res. 2011 May 29;11:134
references.pmid: 21619706
references.citation: Eur J Clin Pharmacol. 2007 Jun;63(6):613-8
references.pmid: 17404719
references.citation: Eur J Clin Pharmacol. 2009 Jan;65(1):43-6
references.pmid: 18825377
references.citation: Drug Saf. 2006;29(5):385-96
references.pmid: 16689555
references.citation: Pharmacoepidemiol Drug Saf. 2006 Mar;15(3):179-84
references.pmid: 16184621
references.citation: Prof Nurse. 2000 Feb;15(5):300-4
references.pmid: 10986953
references.citation: Br J Clin Pharmacol. 2014 Jul;78(1):170-83
references.pmid: 24372506
references.citation: Pharmacoepidemiol Drug Saf. 2007 May;16(5):532-7
references.pmid: 17072915
references.citation: J Nurs Manag. 2014 Apr;22(3):322-30
references.pmid: 24754750
references.citation: Dan Med Bull. 1996 Apr;43(2):141-55
references.pmid: 8741207
references.citation: BMJ. 2000 Apr 15;320(7241):1036
references.pmid: 10764362
references.citation: Br J Clin Pharmacol. 1996 Oct;42(4):423-9
references.pmid: 8904613
references.citation: Pharmacoepidemiol Drug Saf. 2012 Jun;21(6):597-602
references.pmid: 22337264
references.citation: Br J Clin Pharmacol. 1995 Aug;40(2):173-5
references.pmid: 8562303
references.citation: Lancet. 2000 Oct 7;356(9237):1255-9
references.pmid: 11072960
references.citation: Drug Healthc Patient Saf. 2012;4:61-6
references.pmid: 22826643