Index I N D E X Page Introduction 3 Deliverable D1 “Drugs and medicines that are suspected to have a detrimental impact on road user performance” 5 - Executive summary 7 - Introduction 9 - Epidemiological data 12 - Pharmaco-Epidemiological data: overview table 17 - Illicit Drugs with an Influence on Driving Performance 19 - Medicinal Drugs with an Influence on Driving Performance 26 - Classification of Medicinal Drugs According to their Influence on Driving Performance and Warning Systems in European Countries 32 - Glossary 41 - Acknowledgements 41 - References 42 Deliverable D2 “Inventory of State-of-the-Art road side drug testing equipment” 45 - Executive summary 47 - Introduction 49 - List of Devices 51 - Cross-reactivities of the “AMPHETAMINE” type devices 75 - Cross-reactivities of the “METHAMPHETAMINE” type devices 77 - Cross-reactivities of the “CANNABIS” type devices 79 - Cross-reactivities of the “COCAINE” type devices 80 - Cross-reactivities of the “OPIATES” type devices 82 - Cross-reactivities of the “BENZODIAZEPINES” type devices 86 - List of Manufacturers and Distributors 88 i ROSITA project - Conclusions 93 - References 102 Deliverable D3 “Operational, user and legal requirements across EU member states for roadside drug testing equipment” 103 - Executive summary 105 - Introduction 108 - Legal Requirements 109 · Austria 109 · Belgium 110 · Czech Republic 112 · Denmark 113 · Finland 114 · France 115 · Germany 117 · Greece 118 · Iceland 119 · Ireland 120 · Italy 121 · Luxembourg 123 · The Netherlands 124 · Norway 125 · Poland 126 · Slovenia 127 · Spain 129 · Switzerland 130 · United Kingdom 132 - Operational Requirements on Roadside Test Devices for DUID 134 - Summary of the Findings 142 - Conclusions and Outlook 146 - Acknowledgments 147 - Appendix: “Questionnaire for the identification of operational, user and legal requirements across EU Member states for roadside testing equipment” 148 Deliverable D4 “Evaluation of different road side drug tests” 167 - Executive summary 169 - Introduction 170 - Methods 171 - Subjects: Demographic Data 174 - Operational Aspects 176 ii Index - Analytical Evaluation: Amphetamines 180 - Analytical Evaluation: Benzodiazepines 190 - Analytical Evaluation: Cannabinoids 193 - Analytical Evaluation: Cocaine 201 - Analytical Evaluation: Opiates 205 - Problems in the Execution of the Tests and Reading of the Results 209 - Summary of the Comparison of the Analytical Fluid 211 - Summary of the Performance of Onsite tests 213 - Conclusions 228 - Abbreviations 229 - Acknowledgments 230 - References 231 Deliverable D4a – Finland 233 Deliverable D4b – Scotland 259 Deliverable D4c – Germany 271 Deliverable D4d – Belgium 305 Deliverable D4e – Norway 323 Deliverable D4f – Spain 355 Deliverable D4g – France 373 Deliverable D4h – Italy 381 Deliverable D5 “General conclusions and recommendations” 393 - Conclusions and Recommendations 395 iii ROSITA project iv Index ROSITA Roadside Testing Assessment Coordinator: Dr. Alain VERSTRAETE v Deliverable D1 – Drugs and Medicines that are suspected to have a detrimental impact on road user performance Introduction This book contains all the reports (deliverables) from the Rosita project. All these reports can be downloaded from our website “www.rosita.org”, but we thought that it would also be useful to have them in the form of a printed book. The Rosita project ran during 1999 and 2000 in 8 European states. A total of 9 European Institutes for Legal Medicine and Toxicology and 3 companies worked together on the 5 different project targets. The following Institutes and Companies were official Rosita Partners: No. Name Country 1. University of Gent (Project Management) Belgium 2. National Public Health Institute, KTL Finland 3. University of Glasgow, Forensic Medicine & Science UK 4. Institute of Legal Medicine, Homburg Germany 5. National Institute of Forensic Sciences, NICC, Brussels Belgium 6. National Institute of Forensic Toxicology, NIFT, Oslo Norway 7. University of Santiago de Compostela Spain 8. Institute of Legal Medicine, University of Strasbourg France 9. Centre of Behavioural and Forensic Toxicology, University of Padova Italy 10. Roche Diagnostics Belgium 11. Securetec Detektions-Systeme AG Germany 12. Dade Behring GmbH Germany Official partners of the Rosita project The Rosita study has been divided into 5 workpackages covering the following five key questions: 1. What are the drugs/medicines that are suspected to have a detrimental impact to road users performance? 2. What is the state-of-the-art roadside testing equipment for urine, sweat and saliva? Are there other tests that can be used to evaluate the impairment of the driver at the roadside? 3. What kind of operational, user and legal requirements exist across Member States of the European Community for roadside testing equipment? 4. How are usability (practicability), sensitivity, specificity and accuracy of available roadside test devices? 5. What can be recommended for the use of roadside testing equipment (in Europe)? Working for the Rosita project was, for most or all of us, a challenging but rewarding experience. Many people, who were employed by the contractors and police officers worked very long hours for this project, and we are very much indebted to them. Many companies, who were not Rosita contractors, supplied their tests at no or reduced costs. In addition, I would like to thank Dr. Gianpaolo Brusini, who has been our tireless webmaster and who has helped us enormously in the realisation of this book, and our scientific officer René Bastiaans of DG TREN of the European Union, who had the idea of launching the call for this project, who was present at many of our meetings to give us very valuable advice. Our contacts have shown us that the results of Rosita are well known all over the world (more than 400 people downloaded one or more of the deliverables and approximately 100 newspaper articles were devoted to Rosita), and we hope that this book also help in the dissemination of our results. Dr. Alain Verstraete Co-ordinator Gent, August 2001 3 ROSITA project 4 Deliverable D1 – Drugs and Medicines that are suspected to have a detrimental impact on road user performance Deliverable D1 Drugs and medicines that are suspected to have a detrimental impact on road user performance. Status P ROSITA Contract No DG VII PL98-3032 Coordinator: Alain VERSTRAETE Partners: The Toxicological Society of Belgium and Luxembourg (BLT) as subcontractor of University of Gent (RUG) Authors: Viviane MAES, Corinne CHARLIER, Olivier GRENEZ and Alain VERSTRAETE Date: 30 June 1999 PROJECT FUNDED BY THE EUROPEAN COMMISSION UNDER THE TRANSPORT RTD PROGRAMME OF THE 4th FRAMEWORK PROGRAMME 5 ROSITA project 6 Deliverable D1 – Drugs and Medicines that are suspected to have a detrimental impact on road user performance EXECUTIVE SUMMARY Driving is a complex task where the driver continuously receives information, analyses it and reacts. Substances that have an influence on brain functions or on mental processes involved in driving will clearly affect the driving performance. Different studies provide information about the influence of illicit drugs and licit medicines on driving performance: They can be classified into three main types: epidemiological studies, pharmaco-epidemiological studies and experimental studies. Epidemiological studies are necessary to estimate the importance of the problem. They can be conducted in three different ways: · Descriptive epidemiological studies: the prevalence of psychoactive drugs in the driving population is determined on representative samples selected according to various criteria: the whole driving population, injured or killed drivers, drivers suspected of driving under the influence. The most important European studies are summarised in the report. · Responsibility analysis studies: in these studies, the authors try to determine the responsibility of drivers involved in road traffic accidents, to establish if drug use contributes to accidents or not. The responsibility is determined without knowledge of the results of the drug analysis. A study by Drummer (1045 killed drivers) and another one by Terhune (1882 killed drivers) are discussed as examples of responsibility analysis studies. · Studies with control groups: the results of the test group are compared with the same drug analysis performed on a control population consisting of matched drivers or non-responsible subjects. Very few epidemiological studies have included a control population. Pharmaco-epidemiological studies are very useful as they compare the number of accidents in drivers for whom medicines are prescribed with the number of accidents in a matched control population. The results of the major reports are summarised in the present work. However, this kind of study is difficult to perform with illicit drugs, for easily understandable practical and ethical reasons. Experimental studies consist in the administration of different doses of medicines or of placebo to selected volunteers. The effects on psychomotor performance and/or on driving skills are measured by laboratory tests, in driving simulators or by real driving experiments. While there is an abundant literature on the subject, methodologies are not well standardised and comparisons of different studies with sometimes conflicting results are difficult to perform. Illicit drugs possibly influencing driving performances are then presented, with epidemiological and experimental data if available: · Cannabis (used as marihuana, hashish,