Work Package 4 - Classification
Work Package-leader: Javier Alvarez, Universidad de Valladolid, Spain
A large proportion of the population habitually drives while taking medicinal drugs (either in acute or chronic use). While medicinal drugs are not the main factor to be considered when looking at the causes of road traffic accident, their importance is continually growing. In that way, the White Paper "European Transport Policy for 2010: time to decide" aims to reduce the accident mortality rate by 50 % by 2010. To this end, the White Paper addresses the issue of "to combat the scourge of drink-driving and find solutions to the issue of drugs and medicines".
The prescription of medicinal drugs is an everyday factor in clinical practice, and even though safer and more effective medicinal drugs are being commercialized every day, some of them can deteriorate psychomotor performance, which can affect a person’s ability to drive safely.
The work package classification will have an output both for physicians/pharmacists and other health professionals, as well as the patients taking these medicinal drugs, by two major actions: categorization of the medicinal drugs on driving ability, and propose appropriate labelling systems regarding medicinal drugs and driving.
This Work package has four objectives:
- To review of the existing i) classification/categorisation systems and ii) labelling systems regarding medicinal drugs and driving.
- To propose and agree on the criteria and the methodology on the establishment of a European i) classification/categorisation system and ii) labelling system of medicinal drugs and driving.
- To develop of a methodology to continuously update the i) classification/categorisation system and ii) labelling system on medicinal drugs and driving.
- To propose of a classification/categorisation system for the relevant therapeutic groups of medicines available in the market.
For the achievement of these objectives work package 4, has issued three research tasks.
Tasks 4.1, Review of existing classification efforts, will focus on the first objective. As a background, this task will use the current Belgian, Spanish and French categorization systems on medicinal drugs and driving. This task will also benefit from the work done by ICADTS and other organizations.
Task 4.2, The establishment of criteria for a European categorisation, based on expert consensus, will focus on the second objective of the Work Package, and contribute to the third objective.
With this aim, Task 4.2 will propose a methodology to achieve the criteria for a European categorisation with experts in DG SANCO, DG TREN and EMEA (the EU’s medicinal drug regulatory authorities), experts involved in developing existing categorisation systems and experts from relevant drug manufacturers.
Emphasis will be given to methodologies for assessing impairment, warnings and guidelines for allowing categorisation for individual medicinal drugs and how to maintain the classification system.
A set of criteria will be derived for consensus development as well as the procedures for maintaining the criteria and conditions under which these activities can be embedded for establishing a future framework.
Task 4.3, Establishment of framework for classification/categorisation and labelling of medicinal drugs and driving, will focus on the fourth objective of the work package, and contribute to the third objective.
With this aim, Task 4.3, will provide a classification/categorisation system for the relevant therapeutic groups of medicines available in the market, including newly available drugs during the timeframe of the project DRUID.
Furthermore, Task 4.3, based on Task 4.2, will provide a mechanism for modifying the classification, based on new evidence, if necessary.