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

  • Published: British Journal of Clinical Pharmacology, December 2012
  • Authors: Ravera, S. P. Monteiro, J. J. de Gier, T. van der Linden, T. Gómez-Talegón and F. J. Álvarez
  • Date Added: 02 Jun 2017
  • Last Update: 02 Jun 2017
  • Format: doc

Objectives:

The study describes standardized and harmonized criteria to categorize medications according to their potential to impair fitness to drive. The study proposes a European categorization system of medications that impair driving that covers all the most frequently prescribed medications.

Methodology:

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.

Key Findings:

  • 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).

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