title: A European approach to categorizing medicines for fitness to drive: outcomes of the DRUID project.
abstract: OBJECTIVE
  To illustrate (i) the criteria and the development of the DRUID categorization system, (ii) the number of medicines that have currently been categorized, (iii) the added value of the DRUID categorization system and (iv) the next steps in the implementation of the DRUID system.
  
  
  METHODS
  The development of the DRUID categorization system was based on several criteria. The following steps were considered: (i) conditions of use of the medicine, (ii) pharmacodynamic and pharmacokinetic data, (iii) pharmacovigilance data, including prevalence of undesirable effects, (iv) experimental and epidemiological data, (v) additional data derived from the patient information leaflet, existing categorization systems and (vi) final categorization. DRUID proposed four tiered categories for medicines and driving.
  
  
  RESULTS
  In total, 3054 medicines were reviewed and over 1541 medicines were categorized (the rest were no longer on the EU market). Nearly half of the 1541 medicines were categorized 0 (no or negligible influence on fitness to drive), about 26% were placed in category I (minor influence on fitness to drive) and 17% were categorized as II or III (moderate or severe influence on fitness to drive).
  
  
  CONCLUSIONS
  The current DRUID categorization system established and defined standardized and harmonized criteria to categorize commonly used medications, based on their influence on fitness to drive. Further efforts are needed to implement the DRUID categorization system at a European level and further activities should be undertaken in order to reinforce the awareness of health care professionals and patients on the effects of medicines on fitness to drive.
authors.affiliation: Department of Pharmacotherapy and Pharmaceutical Care, University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, the Netherlands.
authors.forename: Silvia
authors.initials: S
authors.lastname: Ravera
authors.forename: Susana P
authors.initials: SP
authors.lastname: Monteiro
authors.forename: Johan Jacob
authors.initials: JJ
authors.lastname: de Gier
authors.forename: Trudy
authors.initials: T
authors.lastname: van der Linden
authors.forename: Trinidad
authors.initials: T
authors.lastname: Gómez-Talegón
authors.forename: F Javier
authors.initials: FJ
authors.lastname: Alvarez
mesh_terms: D000063:Accidents, Traffic / Q000331:legislation & jurisprudence / Q000517:prevention & control*; D001334:Automobile Driving / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005062:European Union; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000145:classification; D018570:Risk Assessment
chemical_list: D004364:Pharmaceutical Preparations