Final report; 3 April 2005 1 Epilepsy and Driving in Europe A report of the Second European Working Group on Epilepsy and Driving, an advisory board to the Driving Licence Committee of the European Union. __________ Members: Mr Joël Valmain European Commission, DG TREN. Dr Jaume Burcet Darde Spain. Dr Bernhard Gappmaier Austria. Dr John Kirker Ireland. Prof Guenter Kraemer Germany. Dr Nicole Markschies Germany. Dr Mikael Ojala Finland. Dr Eric Schmedding, Belgium. President Dr Anders Sundqvist Sweden. Dr Elena Valdès Spain. Prof Hervé Vespigniani, France. Dr Graham Wetherall, United Kingdom. Secretary Dr Jörgen Worm-Petersen Denmark. Consultants: Prof D Chadwick UK Prof Van Donselaar The Netherlands Prof Ettore Beghi Italy Dr Marc de Krom The Netherlands Mrs Maria Teresa Sanz-Villegas European Commission, DG TREN The SEWGED had meetings on 5th May 2004; 20th October 2004; 19th and 20th January 2005 and 2nd and 3rd March 2005. 1 Final report; 3 April 2005 2 Contents 1. Introduction 4 Historical background A practical problem: the question of compliance 2. The search for a criterium 6 The impact of epilepsy on road safety The effect of regulations on accident rates Statistical studies Risk assessment: theory Two kinds of risks An acceptable risk for the individual: comparison to other risks The measuring standard: the "COSY" and the chance of causing an accident Recommendation 1 The calculation of increased risk for group 2 Comparison of risk ratios: group 2 vehicles compared to cars. Recommendation 2 An estimation of the risk for the population The driving risk of alternative transport Recommendation 3 3. When does the patient reach this risk-threshold? The influence of the seizure-free interval in different situations 14 First unprovoked epileptic seizure What happens in the first year? What happens after five years? The first unprovoked cryptogenic seizure The first provoked epileptic seizure Epilepsy: multiple seizures The remaining risk of recurrence after a given seizure-free period A possible consequence: limited licence Recommendation 4 4. Less quantifiable factors 18 Unfavourable factors Unfavourable factors for recurrence of seizures Unfavourable factors because of impairments Unfavourable factors because of other variables Favourable factors Other factors The epilepsy syndrome EEG Medication Driving time Recommendation 5 5. Legal issues 21 Who should do the assessment? The question of immunity The legal status of a statistical decision Legal obligations Should taxi drivers etc. be included in group 2, if so, should the risk assessment be equally severe? Recommendation 6 2 Final report; 3 April 2005 3 6. The medical criteria as recommended 23 First unprovoked seizure First provoked seizure Seizures occurring exclusively in sleep Seizures without influence on driving ability Sporadic seizures Seizures after curative epilepsy-surgery Underlying progressive disease Break-through seizures Seizures after decrease or change of anti-epileptic medication Epilepsy Other loss of consciousness 7 Overview of the regulations 30 Notification by the patient Compulsory notification Licensing decision Impairments The period of driving validity Table : proposed guidelines for group 1 Table : proposed guidelines for group 2 8 Other items discussed 33 9 References 35 10 Annexes 39 Annex 1: The questions put to the working group Annex 2: Glossary of terms Annex 3: The calculation of increased risk for group 2 Annex 4: Other data used for calculation Annex 5: Recommendations for the future 3 Final report; 3 April 2005 4 1. Introduction The cumulative incidence of epilepsy is at least 4% of the population. The prevalence of active epilepsy in the adult population is 4 to 10 in 1000 people (Hauser et al. 1996; Goodridge et al. 1983). For the European union we assumed a value of 6 in 1000. Of these patients, a substantial number hold a drivers licence (Sonnen 1995). In general, driving is experienced as one of the top concerns of people with epilepsy, as is noticeable in the daily practice of any neurologist. In surveys, driving is listed as a first or second concern by people with epilepsy, after the wish to be seizure-free (Gilliam et al. 1997; Taylor et al. 2001; Fisher et al. 2000). On the other hand, driving while having active epilepsy clearly poses an increased risk, ( Krauss et al. 1999; Berg et al. 2000) while drivers with epilepsy who are in compliance with driving restrictions and with medication intake pose no excess danger (Krauss 1999). This makes the topic of “epilepsy and driving” of importance to neurologists and the regulators of driver licensing alike. HISTORICAL BACKGROUND In the European Union, the regulations about driver licensing used to differ greatly among member states. (Fisher et al 1994) With the support of the European government, this led to the formation of European workshops on driving licence regulations in May 1995 and March 1996 organised by the International League against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE)(Sonnen 1995 and 1997). The recommendations of these workshops were not reflected in an official European guideline or in European law. In these recommendations, as well as in an American consensus statement, control or remission of seizures, measured as the “seizure-free interval” is the main determinant in the assessment of the ability to drive (Sonnen 1997, Krumholz 1994) and it will be the subject of a large part of this report. Table 1 European Council Directive 91/439/EEC of 29 July 1991 on driving licences Official Journal L 237 , 24/08/1991 Group I Group II A licence may be issued or renewed subject to an Driving licences shall not be issued to or examination by a competent medical authority and to renewed for applicants or drivers regular medical check-ups. The authority shall decide on suffering or liable to suffer from epileptic the state of the epilepsy or other disturbances of seizures or other sudden disturbances of consciousness, its clinical form and progress (no seizure in the state of consciousness. the last two years, for example), the treatment received and the results thereof. European member states have to stay within a Council directive: they can be more restrictive, but not more liberal. (table 1: see references. Group 1 refers to categories A: motorbike and B: car. Group 2 refers to categories C: lorry and D: bus. – for a full explanation see European commission transport internet site) After the 1995 / 1996 workshops, national legislation was adapted to an important degree in several European countries, but remained unchanged in others. This situation led to a renewed call for harmonisation and the installation of several medical advisory boards like the working group on epilepsy and driving. The purpose of this report is to give an overview of current knowledge of the subject of epilepsy and driving and to give regulations for implementation in European law. It has to be stressed that rigorous scientific proof is not always sufficiently available for the decisions that have to be taken with regard to epilepsy and driving. In such cases, the best available evidence and reasonable estimates are used. The recommendations of the 1996 European working group stated: rules must be as liberal as possible, simple and clear (Sonnen 1997). They should also be based on calculated risk. A PRACTICAL PROBLEM: THE QUESTION OF COMPLIANCE In a period that the Belgian law required a 2-year period of seizure-freedom, even after a first epileptic seizure, a group of neurologists estimated that 70% of their epilepsy patients that were not allowed to drive still did so. (Schmedding 1996) Berg et al ( Berg et al.2000), asking a group of epilepsy- patients that were included in an epilepsy-operation programme and found that one third of them drove regularly, despite having frequent seizures. Many patients do not report their seizures to their doctor (Dalrymple J 2000), especially in countries with compulsory notification. There are reasons to think that by making the law more liberal, more people will adhere to it. (Sonnen 1997; Krumholz 1991) 4 Final report; 3 April 2005 5 More liberal rules may persuade people with seizures to undergo an assessment and stick to the rules for several reasons: -they may accept the rules as reasonable -they have the perspective of getting their licence back -they feel relieved of the responsibility and the uneasiness of doing something that may endanger other people, including their relatives. -they can drive legally and have an insurance Shorter seizure-free periods will also increase the reporting of seizures to their physician. One needs to realise that there is a relationship between the social expectation or need to drive and the number of people with active epilepsy that drive illegally. This has been shown in the study of Berg (Berg et al 2000): seasonal or irregular employment increases the chance of driving illegally (as does being male, young and having a licence). There is likely an inverse relationship with the availability of public transport. The number of experienced seizures is also likely to influence compliance with the rules. Compliance can only be increased if we can give an explanation of the risk-increase in terms that are understandable and convincing for the patient. 5 Final report; 3 April 2005 6 2. The search for a criterion THE IMPACT OF EPILEPSY ON ROAD SAFETY What is the impact of epilepsy on road safety? To establish this, several approaches are possible: a comparison of accident rates while applying different rules; a look at accident statistics or a calculation of risks based on a risk theory. 1 The effect of regulations on accident rates One of them is a comparison of accident rates while comparing the effect of different medical criteria, applied in different places or different periods. In a recent study, the rate of seizure-related crashes in one American State did not significantly increase after the necessary seizure-free interval required after having had multiple seizures was reduced from 12 to 3 months (Drazkowski et al.