title: Paediatric adverse drug reaction reporting: understanding and future directions.
abstract: BACKGROUND
  Severe adverse drug reactions (ADRs) are an important cause of childhood morbidity and mortality. 95% of ADRs are likely not reported, less than 25% of marketed drugs can be advertised as safe and effective in children; yet over 50% of Canadian children receive prescription drugs annually.
  
  
  OBJECTIVE
  To increase understanding of reported ADRs in Canadian children.
  
  
  METHODS
  A retrospective analysis of 1193 suspected ADRs reported to Health Canada (January 1998 - May 2002). These data were a paediatric subset of the Canadian Adverse Drug Reaction Information System database.
  
  
  RESULTS
  58.6% of ADRs were for children over 13 years. 61% of reports were defined by Health Canada as serious. Case outcomes include: death (n=41) and recovered with sequelae (n=14). 4 reports of interacting drugs had fatal outcomes. Drugs most frequently cited include: isotretinoin (n=56), paroxetine (n=42), methylphenidate (n=41), amoxicillin (n=40), and valproic acid (n=32). Most frequent reaction descriptors include: psychiatric disorders (isotretinoin and paroxetine) and nervous system disorders (valproic acid, bupropion and carbamazepine). Causal links between suspected ADRs and clinical outcomes have not been established.
  
  
  CONCLUSIONS
  Current ADR reporting is insufficient to improve patient safety. More detailed reporting, including case outcomes, is needed. Mandatory ADR reporting is unlikely to improve underreporting. Trained surveillance personnel located in major health centres and solely dedicated to ADR reporting may provide a more accurate determination of ADRs in Canadian children.
authors.affiliation: Faculty of Pharmaceutical Sciences, University of British Columbia, Canada. bcarleton@popi.ubc.ca
authors.forename: Bruce C
authors.initials: BC
authors.lastname: Carleton
authors.forename: M Anne
authors.initials: MA
authors.lastname: Smith
authors.forename: Michaela N
authors.initials: MN
authors.lastname: Gelin
authors.forename: Susan C
authors.initials: SC
authors.lastname: Heathcote
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D002170:Canada / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D012189:Retrospective Studies; D016019:Survival Analysis