title: Definition of variables required for comprehensive description of drug dosage and clinical pharmacokinetics.
abstract: OBJECTIVE
  Electronic clinical decision support systems (CDSS) require drug information that can be processed by computers. The goal of this project was to determine and evaluate a compilation of variables that comprehensively capture the information contained in the summary of product characteristic (SmPC) and unequivocally describe the drug, its dosage options, and clinical pharmacokinetics.
  
  
  METHODS
  An expert panel defined and structured a set of variables and drafted a guideline to extract and enter information on dosage and clinical pharmacokinetics from textual SmPCs as published by the European Medicines Agency (EMA). The set of variables was iteratively revised and evaluated by data extraction and variable allocation of roughly 7% of all centrally approved drugs.
  
  
  RESULTS
  The information contained in the SmPC was allocated to three information clusters consisting of 260 variables. The cluster "drug characterization" specifies the nature of the drug. The cluster "dosage" provides information on approved drug dosages and defines corresponding specific conditions. The cluster "clinical pharmacokinetics" includes pharmacokinetic parameters of relevance for dosing in clinical practice. A first evaluation demonstrated that, despite the complexity of the current free text SmPCs, dosage and pharmacokinetic information can be reliably extracted from the SmPCs and comprehensively described by a limited set of variables.
  
  
  CONCLUSIONS
  By proposing a compilation of variables well describing drug dosage and clinical pharmacokinetics, the project represents a step forward towards the development of a comprehensive database system serving as information source for sophisticated CDSS.
authors.affiliation: Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
authors.forename: Anna V
authors.initials: AV
authors.lastname: Medem
authors.affiliation: Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
authors.forename: Hanna M
authors.initials: HM
authors.lastname: Seidling
authors.affiliation: European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK.
authors.forename: Hans-Georg
authors.initials: HG
authors.lastname: Eichler
authors.affiliation: Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Kaltschmidt
authors.affiliation: Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Metzner
authors.affiliation: Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
authors.forename: Carina M
authors.initials: CM
authors.lastname: Hubert
authors.affiliation: Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany.
authors.forename: David
authors.initials: D
authors.lastname: Czock
authors.affiliation: Department of Clinical Pharmacology and Pharmacoepidemiology, University of Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany. walter.emil.haefeli@med.uni-heidelberg.de.
authors.forename: Walter E
authors.initials: WE
authors.lastname: Haefeli
mesh_terms: D004305:Dose-Response Relationship, Drug; D050316:Medical Order Entry Systems; D010599:Pharmacokinetics
keywords: Clinical decision support system (CDSS); Dosage; Drug label; Electronic summary of product characteristics (e-SmPC); Pharmacokinetics; Summary of product characteristics (SmPC)