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Establishment of Framework for Classification/Categorisation and Labelling of Medicinal Drugs and Driving

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Establishment of Framework for Classification/Categorisation and Labelling of Medicinal Drugs and Driving Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.3.1 Establishment of framework for classification/categorisation and labelling of medicinal drugs and driving Due date of deliverable: 30.06.2011 Actual submission date: 30.06.2011 Revision date: 22.09.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.3.1 Establishment of framework for classification/categorization and labelling of medicinal drugs and driving Page 1 of 135 Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners ‐ Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) ‐ Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) ‐ Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) ‐ Katerina Touliou (CERTH-HIT, Centre for Research and Technology Hellas, Greece) ‐ Michael Heiβing (BASt, Bundesanstalt für Straßenwesen, Germany). Task 4.3 leader: F. Javier Alvarez (UVa, Spain) Work Package Leader: F. Javier Alvarez (UVa, Spain) Project Co-ordinator: Horst Schulze (BASt, Germany) Project Funded by the European Commission under the Transport RTD Programme of the 6th Framework Program DRUID 6th Framework Programme Deliverable D.4.3.1 Establishment of framework for classification/categorization and labelling of medicinal drugs and driving Page 2 of 135 Table of contents List of Abbreviations ...................................................................................................................... 4 List of Tables ................................................................................................................................. 5 List of Figures................................................................................................................................ 7 1. Introduction.............................................................................................................................. 10 1. 1. Input from other DRUID tasks.......................................................................................... 11 1.2. Input from previous experience of partners and national activities in the field ................. 11 1.3. Classification/categorisation system for the relevant therapeutic groups of medicines available in the market ............................................................................................................. 11 1.4. Structure of Deliverable 4.3 .............................................................................................. 12 1.5. List of Annexes.................................................................................................................. 13 1.6. References........................................................................................................................ 13 2. A European approach to categorize medicines according to their driving impairment: Outcomes of the DRUID project.................................................................................................. 14 2.1. Introduction ....................................................................................................................... 14 2.2. The DRUID categorisation/labelling on medicines and driving......................................... 16 2.3. The DRUID methodology on categorisation on medicines and driving. ........................... 18 2.4. A mechanism for modifying the classification, based on new evidence. .......................... 24 2.5. Discussion......................................................................................................................... 24 2.6. Next steps and recommendations .................................................................................... 25 2.7. References........................................................................................................................ 26 3. Internal document: Position paper on Harmonization of procedures for classification/labelling on medicines and driving (2008) ................................................................................................. 28 3.1. Introduction ....................................................................................................................... 28 3.2. Evaluation by following different steps.............................................................................. 29 4. Distribution of categorized medicines within DRUID categories............................................. 37 4.1 Number of medicines categorized by ATC groups ............................................................ 37 4.2 Category percentage.......................................................................................................... 38 4.3 Number of medicines assigned to each category.............................................................. 38 4.4 Multiple categories and categorisation depending on the medicine in combination.......... 46 5. Alphabetical list of the medicines categorized with the DRUID WP4...................................... 51 6. The DRUID Patient-oriented information .............................................................................. 111 7. Categorisation and labelling of medicines approved by the EMA january 2008-september 2010........................................................................................................................................... 131 8. Conflict of interest…………………………………………………………………………………..135 DRUID 6th Framework Programme Deliverable D.4.3.1 Establishment of framework for classification/categorization and labelling of medicinal drugs and driving Page 3 of 135 List of Abbreviations ADR: Adverse Drug Reaction ADHD: Attention deficit/hyperactivity disorder AFSSAPS: Agence Française de Sécurité Sanitaire des Produits de Santé (French Health Products Safety Agency) ATC: Anatomical Therapeutic Chemical classification system CHMP: Committee for Medicinal Products for Human Use DRUID: Driving Under the Influence of Drugs, Alcohol and Medicines EC: European Commission EMA: European Medicines Agency eMC: Electronic Medicines Compendium EU: European Union HCP: Health Care Professional ICADTS: International Council on Alcohol, Drugs and Traffic Safety IMB: Irish Medicines Board MHRA: Medicines and Healthcare products Regulatory Agency PIL: Patient Information Leaflet SmPC: Summary of Product Characteristics WP: Work Package DRUID 6th Framework Programme Deliverable D.4.3.1 Establishment of framework for classification/categorization and labelling of medicinal drugs and driving Page 4 of 135 List of Tables Table 1: Text of SmPC section 4.7 on Effects on ability to drive and use machines. Version september 2009, in force 1st May 2010. Table 2: Relationship of the undesirable effects category in the SmPC to the DRUID categorisation system. Table 3: Undesirable effects that can impair the fitness to drive grouped by system organ class Table 4: Number of medicines categorized by ATC groups Table 5: Number of medicines from the ATC-Group, A-ALIMENTARY TRACT AND METABOLISM, categorized in each DRUID category Table 6: Number of medicines from the ATC-Group, B-BLOOD AND BLOOD FORMING ORGANS MEDICINES, categorized in each DRUID category Table 7: Number of medicines from the ATC-Group, C-CARDIOVASCULAR SYSTEM MEDICINES, categorized in each DRUID category Table 8: Number of medicines from the ATC-Group, D-DERMATOLOGICALS MEDICINES, categorized in each DRUID category Table 9: Number of medicines from the ATC-Group, M-MUSCULO-SKELETAL SYSTEM MEDICINES, categorized in each DRUID category Table 10: Number of medicines from the ATC-Group, N-NERVOUS SYSTEM MEDICINES, categorized in each DRUID category Table 11: Number of medicines from the ATC-Group, R-RESPIRATORY SYSTEM MEDICINES, categorized in each DRUID category Table 12: Number of medicines from the ATC-Group, S-SENSORY ORGANS MEDICINES, categorized in each DRUID category Table 13: Medicines with multiple categorisations and depending on the medicine in combination, according to the ATC code. Table 14: Alphabetical list of the medicines categorized with the DRUID WP4 Table 15: Example of information to the patient and Categorisation and labelling of some available A-Alimentary tract and metabolism medicines on driving. Table 16: Example of information to the patient and Categorisation and labelling of some available B-Blood and blood forming organs medicines on driving. Table 17: Information to the patient based on the categorisation and labelling of the C - Cardiovascular system medicines on driving. Table 18: Example of information to the patient and Categorisation and labelling of some available D-Dermatologicals medicines on driving.
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