title: Parental reporting of adverse drug events and other drug-related problems in children in Finland.
abstract: OBJECTIVE
  Drug-related problems (DRPs) are common in paediatric pharmacotherapy, but few studies describe them from the parents' perspective. In the present survey, we have investigated the lifetime prevalence and type of DRPs in children in Finland.
  
  
  METHODS
  This was a population-based survey of a random sample of 6,000 children below 12 years of age in 2007. A questionnaire was sent to their parents. The final response rate was 67% with a study population of 4,032. The main outcome measure was the lifetime prevalence and type of DRPs.
  
  
  RESULTS
  The lifetime prevalence of DRPs was 21% (95% CI 20-22). The most common (82%) of the 1,346 reported DRPs were adverse drug events (ADEs). The prevalence of ADEs was 17% (95% CI 16-19), that of other DRPs 5.2% (95% CI 4.5-5.9). The prevalence of serious ADEs was 0.4% and that of unexpected ADEs was 0.8%. The most common system involved in the ADEs was the gastrointestinal tract, comprising 34% of the 1,106 ADEs. The most common of the 240 other DRPs were problems with the administration and dosing of medicine (86%). Overall, 64% of DRPs were related to anti-infectives.
  
  
  CONCLUSIONS
  One fifth of the Finnish children below 12 years of age had experienced DRPs. Appropriate counselling, including possible adverse drug reactions and dosing directions, is important for parents and children at both the prescribing and dispensing of medicines for paediatric patients. Reporting of any suspected serious or unexpected ADEs is an essential part of efficient pharmacovigilance in paediatrics.
authors.affiliation: School of Pharmacy, Social Pharmacy, Faculty of Health Sciences, University of Eastern Finland, P.O. Box 1627, 70211 Kuopio, Finland. Leena.Lindell-Osuagwu@uef.fi
authors.forename: L
authors.initials: L
authors.lastname: Lindell-Osuagwu
authors.forename: K
authors.initials: K
authors.lastname: Sepponen
authors.forename: S
authors.initials: S
authors.lastname: Farooqui
authors.forename: H
authors.initials: H
authors.lastname: Kokki
authors.forename: K
authors.initials: K
authors.lastname: Hämeen-Anttila
authors.forename: K
authors.initials: K
authors.lastname: Vainio
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D005387:Finland; D006306:Health Surveys; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008508:Medication Errors / Q000706:statistics & numerical data; D010290:Parents; D060735:Pharmacovigilance; D015995:Prevalence