title: Use of administrative hospital database to identify adverse drug reactions in a Pediatric University Hospital.
abstract: OBJECTIVE
  The aim of the study was to detect adverse drug reactions (ADRs) in pediatric inpatients using the medical administrative database "Programme de Médicalisation des Systèmes d'Information" (PMSI) and to compare these cases ADRs with those spontaneously reported to a regional PharmacoVigilance (PV) Centre.
  
  
  METHODS
  The study was conducted from January 2008 to December 2011 in the Children University Hospital of Toulouse (Midi-Pyrénées, South-west France). From PMSI database, all discharge summaries including selected ICD-10 codes (10th International Classification of Diseases) were analyzed. All ADRs spontaneously reported by the Children Hospital of Toulouse and registered in the French PV Database (FPVDB) were included. The capture-recapture method was applied to estimate the incidence of ADRs.
  
  
  RESULTS
  During the study period, we identified 60 reports from the PMSI database and 200 from the FPVDB. The rate of "serious" ADRs was higher in PMSI reports (74.6 % vs 38.9 %, p < 0.0001). The most frequent ADRs reported were musculoskeletal (12.4 %) and central (11.3 %) ADRs in PMSI database versus cutaneous (22.4 %) and general (17.5 %) ADRs in FPVDB. The most frequently suspected drugs were antineoplastic drugs (31.1 %) in PMSI database versus anti-infectives (38.2 %) in FPVDB. The estimated number of ADRs was 717 [95 % confidence interval (CI) 513, 921], and the incidence of ADRs among admissions was 0.6 % (95 % CI 0.4, 0.8).
  
  
  CONCLUSIONS
  Use of PMSI database improves from around 30 % detection of ADRs in children. In comparison with classical pharmacovigilance database, it also allows to detect different ADRs and drugs, thus enhancing safe medicine use for pediatric patients.
authors.affiliation: Department of Medical and Clinical Pharmacology, Centre Midi-Pyrénées de PharmacoVigilance, de Pharmacoépidémiologie et d'Informations sur les Médicaments, Toulouse University Hospital, Toulouse, France, genevieve.durrieu@univ-tlse3.fr.
authors.forename: G
authors.initials: G
authors.lastname: Durrieu
authors.forename: A
authors.initials: A
authors.lastname: Batz
authors.forename: V
authors.initials: V
authors.lastname: Rousseau
authors.forename: E
authors.initials: E
authors.lastname: Bondon-Guitton
authors.forename: D
authors.initials: D
authors.lastname: Petiot
authors.forename: J L
authors.initials: JL
authors.lastname: Montastruc
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual / Q000706:statistics & numerical data*; D005260:Female; D005602:France; D006776:Hospitals, Pediatric / Q000706:statistics & numerical data*; D006785:Hospitals, University / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D060735:Pharmacovigilance