title: Methodologies for the detection of adverse drug reactions: comparison of hospital databases, chart review and spontaneous reporting.
abstract: OBJECTIVE
  To evaluate a methodology for adverse drug reactions (ADRs) detection through hospital databases.
  
  
  METHODS
  A retrospective analysis was conducted to identify ADRs using diagnostic codes from databases, later validated by chart review. An independent chart review was performed for comparison, as well as assessment of spontaneous reports.
  
  
  RESULTS
  325 ADRs were identified (prevalence of 2.41%, positive predictive value of 87.6%). Independent chart review identified 9% of ADRs at a cost of 35 person-hours (versus two person-hours in databases). There were seven spontaneous reports of ADRs.
  
  
  CONCLUSIONS
  Although not frequently used, the detection of ADRs through databases is a relatively less expensive, fast and effective methodology that can improve current pharmacovigilance systems.
authors.affiliation: Centre for Research in Health Technologies and Information Systems-CINTESIS, Faculty of Medicine, Oporto University, Oporto, Portugal. myworld_ana@hotmail.com
authors.forename: Ana
authors.initials: A
authors.lastname: Miguel
authors.forename: Luís Filipe
authors.initials: LF
authors.lastname: Azevedo
authors.forename: Fernando
authors.initials: F
authors.lastname: Lopes
authors.forename: Alberto
authors.initials: A
authors.lastname: Freitas
authors.forename: Altamiro Costa
authors.initials: AC
authors.lastname: Pereira
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D016208:Databases, Factual / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006761:Hospitals / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008875:Middle Aged; D017891:Pharmacoepidemiology / Q000379:methods; D011237:Predictive Value of Tests; D012189:Retrospective Studies