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). 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 categorization systems; 5. Synthesis. Basically 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 search. 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. This deliverable is divided into three parts. Chapter 2 includes a description of the methodology used for the categorisation and labelling of medicines and driving used within DRUID Task 4.3. It should be noticed that the Training Manual used by DRUID partners for the categorisation/labelling of medicines regarding driving is provided in Annex 1. Chapter 3 includes an earlier (2008) document for internal use produced by the French partners to present guidelines regarding DRUID criteria for categorisation and labelling. Chapter 4 shows some general figures regarding the number of medicines categorized in each category within the DRUID project. Chapter 5 is an alphabetical list of the medicines categorized in the DRUID WP4. Chapter 6 shows some examples of information oriented to patients with regard to medicines and driving. Chapter 7 shows the medicines approved by the EMA since January 2008, as well as the DRUID categorisation for these medicines. This deliverable includes 17 annexes. While Annex 1 is the Training Manual used by DRUID partners for the categorisation/labelling of medicines regarding driving, Annexes 2-17 included categorisation/labelling and patient-oriented information for each ATC medicines group categorized. Within each annex the following information is included: • A chapter analysing the relation between the diseases for which the medicines are used, the medicines and fitness to drive. • Categorisation and labelling on medicines and driving • Patient-oriented information on medicines and driving • Fact Sheet for each medicine categorized (available for ATC N-Nervous system and R06-Respiratory System - Antihistamines). (Author/publisher) This document is available at https://www.bast.de/Druid/EN/Home/home_node.html
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