title: E-pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions.
abstract: OBJECTIVE
  Computer-assisted signal generation is an important issue for the prevention of adverse drug reactions (ADRs). However, due to poor standardization of patients' medical data and a lack of computable medical drug knowledge the specificity of computerized decision support systems for early ADR detection is too low and thus those systems are not yet implemented in daily clinical practice. We report on a method to formalize knowledge about ADRs based on the Summary of Product Characteristics (SmPCs) and linking them with structured patient data to generate safety signals automatically and with high sensitivity and specificity.
  
  
  METHODS
  A computable ADR knowledge base (ADR-KB) that inherently contains standardized concepts for ADRs (WHO-ART), drugs (ATC) and laboratory test results (LOINC) was built. The system was evaluated in study populations of paediatric and internal medicine inpatients.
  
  
  RESULTS
  A total of 262 different ADR concepts related to laboratory findings were linked to 212 LOINC terms. The ADR knowledge base was retrospectively applied to a study population of 970 admissions (474 internal and 496 paediatric patients), who underwent intensive ADR surveillance. The specificity increased from 7% without ADR-KB up to 73% in internal patients and from 19.6% up to 91% in paediatric inpatients, respectively.
  
  
  CONCLUSIONS
  This study shows that contextual linkage of patients' medication data with laboratory test results is a useful and reasonable instrument for computer-assisted ADR detection and a valuable step towards a systematic drug safety process. The system enables automated detection of ADRs during clinical practice with a quality close to intensive chart review.
authors.affiliation: Department of Paediatric and Adolescent Medicine, University Hospital Erlangen, Erlangen, Germany. antje.neubert@uk-erlangen.de
authors.forename: Antje
authors.initials: A
authors.lastname: Neubert
authors.forename: Harald
authors.initials: H
authors.lastname: Dormann
authors.forename: Hans-Ulrich
authors.initials: HU
authors.lastname: Prokosch
authors.forename: Thomas
authors.initials: T
authors.lastname: Bürkle
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Rascher
authors.forename: Reinhold
authors.initials: R
authors.lastname: Sojer
authors.forename: Kay
authors.initials: K
authors.lastname: Brune
authors.forename: Manfred
authors.initials: M
authors.lastname: Criegee-Rieck
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis*; D042241:Early Diagnosis; D006801:Humans; D051188:Knowledge Bases; D060735:Pharmacovigilance
keywords: ADR reporting system; adverse drug event; adverse drug reaction; computer-assisted pharmacovigilance; decision support systems; knowledge base