title: Adverse drug reaction reporting by nurses: analysis of Italian pharmacovigilance database.
abstract: OBJECTIVE
  The aim of this study was to describe the pattern of adverse drug reaction (ADR) reports sent by Italian nurses after the enactment of the law involving them in the pharmacovigilance system. We also compared the quantity and quality of reports by nurses with those of reports by hospital physicians sent in the same period.
  
  
  METHODS
  We analysed the reports sent to the Italian pharmacovigilance database by nurses from January 2004 to December 2010. Only reports with ADRs causality assessment defined as definite, probable or possible were included in the analysis. The nurses' reports were compared with those sent by hospital physicians in the same period. We excluded from this analysis reports associated with vaccines.
  
  
  RESULTS
  A total number of 1403 reports by nurses have been evaluated. The percentage of nurses' reports of ADRs, which were serious, were 22.9% lower than the 44.9% of reports by physicians, whereas the proportion of probable ADR reports were higher among nurses than hospital physicians (76% vs 67%). Nurses put more emphasis than physicians on application site disorders (log OR = 0.91, 95%CI = 0.55-1.27), skin reactions (log OR = 0.81, 95%CI = 0.70-0.92) and nervous system reactions (log OR = 0.28, 95%CI = 0.11-0.44), whereas physicians more frequently report blood, platelet and liver disorders. Six drugs are present in both the top 10 drugs reported by nurses and hospital doctors.
  
  
  CONCLUSIONS
  This study gives evidence for the potential capacity of nurses to improve the detection of ADRs.
authors.affiliation: Pharmacology Unit, Reference Centre for Education and Communication within the WHO Programme for International Drug Monitoring, University of Verona, Verona, Italy.
authors.forename: Anita
authors.initials: A
authors.lastname: Conforti
authors.forename: Sibilla
authors.initials: S
authors.lastname: Opri
authors.forename: Paola
authors.initials: P
authors.lastname: D'Incau
authors.forename: Laura
authors.initials: L
authors.lastname: Sottosanti
authors.forename: Ugo
authors.initials: U
authors.lastname: Moretti
authors.forename: Fernanda
authors.initials: F
authors.lastname: Ferrazin
authors.forename: Roberto
authors.initials: R
authors.lastname: Leone
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data* / Q000639:trends; D016208:Databases, Factual / Q000706:statistics & numerical data* / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions; D007558:Italy / Q000453:epidemiology; D024802:Nurse's Role; D060735:Pharmacovigilance; D010819:Physician's Role