A European approach to categorizing medicines for fitness to drive: outcomes of the DRUID project

Br J Clin Pharmacol. 2012 Dec;74(6):920-31. doi: 10.1111/j.1365-2125.2012.04279.x.


Aims: 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.

Publication types

  • Review

MeSH terms

  • Accidents, Traffic / legislation & jurisprudence
  • Accidents, Traffic / prevention & control*
  • Automobile Driving / legislation & jurisprudence*
  • Drug-Related Side Effects and Adverse Reactions*
  • Europe
  • European Union
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Legislation, Drug*
  • Pharmaceutical Preparations / classification
  • Risk Assessment


  • Pharmaceutical Preparations