RT info:eu-repo/semantics/report
T1 Establishment of framework for classification/categorisation and labelling of medicinal drugs and driving
A1 Álvarez González, Francisco Javier
A1 Gómez Talegón, Trinidad
A1 Fierro Lorenzo, María Inmaculada
A2 Universidad de Valladolid. Facultad de Medicina
K1 Automóviles - Conducción - Drogas
AB The establishment of criteria for a European categorisation will have to serve most of the needsof all parties involved: health professionals, drug regulatory agencies, drug manufacturers andpatients. Clear warnings and symbols are needed so patients use their medicines in the mostoptimal (and safest) way possibleThe DRUID WP4 expert group established and agreed that, according to its influence on theability 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 aftertaken into account the conditions of use of the medicine on the European Union market:1. Pharmacodynamic and pharmacokinetic data2. Pharmacovigilance data (including prevalence of unwanted effects reported in the SmPC)3. Experimental and epidemiological data4. Additional data derived from the Patient Information Leaflet (PIL) and existing categorisationsystems5. SynthesisBásically conditions of use of the medicine, pharmacodynamics, pharmacokinetic data, andpharmacovigilance data (including prevalence of unwanted effects) were derived from theSmPC, while section 3 was based on a scientific literature serach. Additional data stepconsisted 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 previouscategorisations (if available) of the medicine in Belgium, France, Spain as well as to theICADTS list.After evaluating all the available data, a provisional category was assigned to each activesubstance. The provisional category was proposed and discussed during WP4 meetings wherea final and definitive category was assigned and approved by all WP4 partners.
YR 2011
FD 2011
LK http://uvadoc.uva.es/handle/10324/16548
UL http://uvadoc.uva.es/handle/10324/16548
LA eng
NO DRUID: Proj. No TREN-05-FP6TR-507.61320-51804
NO Biología Celular, Histología y Farmacología
DS UVaDOC
RD 23-abr-2024