Establishment of framework for classification/categorisation and labelling of medicinal drugs and driving

Abstract

The establishment of criteria for a European categorisation will have to serve most of the needs of all parties involved: health professionals, drug regulatory agencies, drug manufacturers and patients. Clear warnings and symbols are needed so patients use their medicines in the most optimal (and safest) way possible The DRUID WP4 expert group established and agreed that, according to its influence on the ability to drive, a medicine could, regarding to driving, be categorized as followed: • category 0 (no or negligible influence on fitness to drive), • category I (minor influence on fitness to drive), • category II (moderate influence on fitness to drive), • and category III (severe influence on fitness to drive). The DRUID methodology on categorisation/labelling on medicines and driving. In summary, categorisation of a medicine on driving includes several steps of evaluation after taken into account the conditions of use of the medicine on the European Union market: 1. Pharmacodynamic and pharmacokinetic data 2. Pharmacovigilance data (including prevalence of unwanted effects reported in the SmPC) 3. Experimental and epidemiological data 4. Additional data derived from the Patient Information Leaflet (PIL) and existing categorisation systems 5. Synthesis Básically conditions of use of the medicine, pharmacodynamics, pharmacokinetic data, and pharmacovigilance data (including prevalence of unwanted effects) were derived from the SmPC, while section 3 was based on a scientific literature serach. Additional data step consisted of reviewing section 4.7 of the SmPC “Effects on ability to drive and use machines” and the PIL section on “driving and using machines” as well as reviewing the previous categorisations (if available) of the medicine in Belgium, France, Spain as well as to the ICADTS list. After evaluating all the available data, a provisional category was assigned to each active substance. The provisional category was proposed and discussed during WP4 meetings where a final and definitive category was assigned and approved by all WP4 partners.