title: The role of electronic healthcare record databases in paediatric drug safety surveillance: a retrospective cohort study.
abstract: OBJECTIVE
  Electronic healthcare record (EHR)-based surveillance systems are increasingly being developed to support early detection of safety signals. It is unknown what the power of such a system is for surveillance among children and adolescents. In this paper we provide estimates of the number and classes of drugs, and incidence rates (IRs) of events, that can be monitored in children and adolescents (0-18 years).
  
  
  METHODS
  Data were obtained from seven population-based EHR databases in Denmark, Italy, and the Netherlands during the period 1996-2010. We estimated the number of drugs for which specific adverse events can be monitored as a function of actual drug use, minimally detectable relative risk (RR) and IRs for 10 events.
  
  
  RESULTS
  The population comprised 4 838 146 individuals (25 575 132 person years (PYs)), who were prescribed 2170 drugs (1 610 631 PYs drug-exposure). Half of the total drug-exposure in PYs was covered by only 18 drugs (0.8%). For a relatively frequent event like upper gastrointestinal bleeding there were 39 drugs for which an association with a RR ≥4, if present, could be investigated. The corresponding number of drugs was eight for a rare event like anaphylactic shock.
  
  
  CONCLUSIONS
  Drug use in children is rare and shows little variation. The number of drugs with enough exposure to detect rare adverse events in children and adolescents within an EHR-based surveillance system such as EU-ADR is limited. Use of additional sources of paediatric drug exposure information and global collaboration are imperative in order to optimize EHR data for paediatric safety surveillance.
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.|Dutch Medicines Evaluation Board, Utrecht, the Netherlands.
authors: Sandra
authors: S
authors: de Bie
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors: Preciosa M
authors: PM
authors: Coloma
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.|Campania Regional Center of Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Pharmacology Section, Second University of Naples, Naples, Italy.
authors: Carmen
authors: C
authors: Ferrajolo
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors: Katia M C
authors: KM
authors: Verhamme
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.|Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, University of Messina, Messina, Italy.
authors: Gianluca
authors: G
authors: Trifirò
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors: Martijn J
authors: MJ
authors: Schuemie
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.|Dutch Medicines Evaluation Board, Utrecht, the Netherlands.
authors: Sabine M J M
authors: SM
authors: Straus
authors: Agenzia Regionale di Sanità della Toscana, Florence, Italy.
authors: Rosa
authors: R
authors: Gini
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.|PHARMO Institute, Utrecht, the Netherlands.
authors: Ron
authors: R
authors: Herings
authors: Società Italiana di Medicina Generale, Florence, Italy.
authors: Giampiero
authors: G
authors: Mazzaglia
authors: Pedianet-Società Servizi Telematici SRL, Padova, Italy.
authors: Gino
authors: G
authors: Picelli
authors: Department of Statistics, Universita di Milano-Bicocca, Milan, Italy.
authors: Arianna
authors: A
authors: Ghirardi
authors: Department of Clinical Epidemiology, Aarhus University Hospital Aarhus, Denmark.
authors: Lars
authors: L
authors: Pedersen
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.|Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.|Inspectorate of Health Care, The Hague, the Netherlands.
authors: Bruno H C
authors: BH
authors: Stricker
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors: Johan
authors: J
authors: van der Lei
authors: Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
authors: Miriam C J M
authors: MC
authors: Sturkenboom
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards / Q000706:statistics & numerical data*; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D016208:Databases, Factual / Q000592:standards / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D057286:Electronic Health Records / Q000592:standards / Q000706:statistics & numerical data*; D005062:European Union; D006801:Humans; D007223:Infant; D060735:Pharmacovigilance; D012189:Retrospective Studies
keywords: EU-ADR; active drug safety surveillance; electronic healthcare records; paediatric drug safety; pharmacovigilance; safety monitoring