Jane Fagan UCD School of Medicine

Epilepsy and Medicine: Are current driving restrictions for people with discriminatory?

Introduction

Epilepsy is one of the most common neurological disorders with over 50 million people affected worldwide.[1] In , 40,000 people have a diagnosis of epilepsy and of these, 30% suffer from recurrent uncontrollable .[2] Seizures may be due to patient or medication factors and pose a significant risk to people with epilepsy [PWE] in every aspect of their lives, especially driving. Driving remains the most popular mode of transport with 16.7 of 26.5 million UK workers commuting via car. [3] However, PWE may be unable to drive for long periods due to breakthrough seizures causing discrimination in occupations which require a driving license. In this essay, I plan to examine the impact driving bans have on patients, the variability in driving regulations in different jurisdictions and finally what the future of traffic medicine holds for PWE.

Epilepsy and the impact of its diagnosis

Epilepsy is a chronic neurological condition characterised by recurrent unprovoked seizures.[4] Seizures are defined as “transient occurrence of signs and/or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.” [5] The cause for epilepsy is often idiopathic and diagnosis is made thorough history, physical examination, and investigations such as electroencephalograph (EEG). The 2017 International League Against Epilepsy guidelines identified three classifications of epilepsy: Focal, Generalised and Unknown onset depending on the area of the brain that is initially affected. [6] Focal onset seizures (previously known as partial seizures) start in one area of the brain but may propagate, causing mild or severe symptoms. During a focal , PWE usually retain consciousness and experience lip smacking, muscle flaccidity, repetitive jerking movements, sense of déjà vu, unusual smells or taste, among other symptoms. Generalised onset seizures occur without preceding or when both brain hemispheres are affected. Unknown onset is the term used when the origin of the seizure cannot be ascertained.

In terms of treating epilepsy, antiepileptic drugs (AEDs) are the mainstay of treatment with sodium valproate being the first line for most types of epilepsy. Monotherapy is thought to control epilepsy in 50% of patients, polytherapy controls epilepsy in 20% of patients and 30%

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Jane Fagan UCD School of Medicine of patients have refractory epilepsy.[7] Driving bans have the greatest impact upon the cohort of patients with refractory epilepsy since they may experience recurrent seizures despite the use of AEDs and are thus prohibited from driving for long periods. Although the treatment of epilepsy has advanced, a persistent challenge continues to exist in managing patients with refractory epilepsy as the epidemiological percentage has remained relatively stagnant.[8] Uncontrollable seizures have profound emotional and physical effects on patients, negatively impact patients quality of life. [9] The unpredictable nature of seizures confers a considerable risk to patients carrying out everyday tasks such as showering, cooking, or driving. This unpredictability may lead to patients becoming isolated for fear of seizures and being deprived of protective factors against developing mental illness such as exercise and social interaction. Indeed, this impact may be an explanation for the higher anxiety, depression, and psychosis rates seen in PWE. [10]

Besides the psychological impact of epilepsy, there are also financial considerations. A diagnosis of epilepsy may affect a patient’s ability to work, either through their own limitations or though stigmas and harmful myths that employers may hold concerning epilepsy. 50% of patients encounter difficulty finding and sustaining employment. [11] In addition, there is an economic burden created by lifelong healthcare and medication associated costs. Allers et al. performed a systematic review analysing the annual total cost of epilepsy per patient and discovered multiple countries to have costs in excess of €1,000.[12] Though antiepileptic medications are covered under the Long-Term Illness Scheme in Ireland, there is the cost of regular GP and consultant visits. While it is free to see a consultant neurologist on the public system, there are significant waiting times and delays leading PWE to access private care to expedite their diagnosis or management. The National Treatment Purchase Fund found that 22,649 people are on a neurology waiting list in November 2020 with over 6,916 of these waiting more than 18 months to see a neurologist.[13] During these waiting times, patients may be on insufficient doses of medication and may continue driving when it is potentially unsafe. To adequately manage the issue of road safety amongst PWE, we first need to identify, consider, and tackle the potential factors which may negatively impact patients epilepsy and affect their fitness to drive.

Epilepsy and Driving: What are the risks?

In medicine, doctors are constantly weighing up the risks and benefits of a situation before formalising a decision. Driving a vehicle requires multiple skills which drivers must often

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Jane Fagan UCD School of Medicine perform simultaneously such as attentiveness, coordination, expeditious reaction times and decision making. Thus, strict regulations and requirements must be fulfilled prior to obtaining a licence. These requirements includes the notification to the National Driving License Service [NDLS] of medical conditions such as epilepsy which may affect a person’s ability to safely drive a vehicle. Current literature shows three main risks associated with PWE and driving: the risk of having a seizure while driving, the risk of antiepileptic drugs affecting fitness to drive and the risk of patients lying about seizures and continuing to drive. I will discuss these risks, correlate them with other medical conditions and then comment on how best to attenuate them.

Firstly, it is important to quantify the risk of having a seizure when driving. Literature suggests that PWE are more likely to be involved in road traffic accidents (RTAs) – relative risks of between 1.47, 1.62 and 1.73 have been established when compared to people without epilepsy [14, 15] – yet very few of these accidents are fatal. Sheth et al. [16] found that alcohol was 156 times more likely and other medical conditions, like diabetes, were 26 times more likely to be responsible for fatal crashes. Furthermore, Hansotia et al [17] found that only 11% of all RTAs involving PWE involved seizures with the majority being due to driver error. These studies highlight the need for reconsideration of the harsh driving bans imposed upon PWE considering the risk of RTAs in PWE is comparable to medical conditions, like cardiovascular disease, which do not carry driving restrictions.[18]

Antiepileptic drugs are the primary treatment in epilepsy and without their creation, there would most likely still be embargos on PWE obtaining a licence. Though revolutionary to patients in many ways, AEDs don’t come without some liability. The most common side effects of AEDs include lethargy, drowsiness, fatigue, dizziness, and headaches all of which may impair PWEs’ ability to drive safely and may interfere with PWEs day to day lives. [19] However, Sundelin et al studied 29,000 patients to assess if AED use in PWE was associated with an increase in serious RTAs and failed to find a correlation.[20] The real risk lies within the fact that worrisome side effects may encourage non-adherence of medications among PWE, increasing the risk of RTA to double in non-compliant patients.[21] Doctors have a role to play in curtailing this risk by inviting patients to discuss side effects of medications. Therefore, thoughtful deliberation between patients and doctors regarding changing medication or trialling discontinuation is extremely necessary. However, clinicians may abstain from changing medications despite persistent side effects for fear of triggering a seizure, thus further rendering PWE ineligible to drive. This is a concern for patients as well, Sultan et al found that participants with epilepsy

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Jane Fagan UCD School of Medicine

“identified driving eligibility as a barrier to identifying the optimal drug regimen for their epilepsy”. [22] PWE should not have to suffer intolerable side effects or inadequate therapeutic doses for fear of seizing. In fact, clinicians could use the periods of driving cessation to thoroughly examine current doses and medications as a prophylactic measure to decrease the risk of future seizures and potentially accidents.

The final risk associated with driving and epilepsy is that of dishonestly. Driving regulations which are overly prohibitive run the risk of PWE not complying with them for fear of losing their independence. If restrictions are too stringent, there is a risk of PWE lying to doctors about individual seizures or completely concealing their diagnosis. This paradoxically leads to an increased risk for PWE as they are not receiving regular medical care and thus may be on suboptimal doses of AEDs or not taking AEDs at all. Krumholz et al [23] found that approximately half of PWE who drive do not report their condition to regulatory authorities and that less restrictive driving regulations such as a shorter seizure free interval (SFI) “may actually reduce the cumulative crash risk posed by epilepsy on the whole”. Moreover, a study in Norfolk found that a sixth of PWE concealed seizures from their GP due to the following three factors: “current employment, possession of a driving licence, and the psychological correlates of epilepsy”.[24] To counteract this risk, doctors need to know the correct driving regulations and be proficient in factually counselling patients. In a study which assessed doctors of all grades in Belfast on the driving regulations for PWE, only 18% were aware of the correct regulations, which may be a direct consequence of the paucity of teaching hours traffic medicine is afforded in medical school curriculum. [25] Traffic medicine is a fundamental area of medicine – as it encompasses multiple specialities and is integral to offering safe and controlled care to all road users, therefore merits allocation.

Assessing fitness to drive for people with epilepsy.

Having discussed the risks epilepsy poses to driving, it is now pertinent to discuss how this risk is assessed and how different jurisdictions quantify the risk. In Ireland, the NDLS require that PWE report their diagnosis when applying for or renewing driving licenses. In addition, the NDLS mandates that individuals with one seizure have a SFI of six-months and individuals with multiple seizures required a twelve-month SFI before returning to drive.[26] A literature search was conducted to assess if a one-year SFI was used in other jurisdictions and what the evidence for its use was. The European Directive 2009/112/EC was enacted into law in 2009 and aimed to harmonise the differences in driving bans in European states. The regulations advise a one-year SFI for PWE in the group one category and a ten-year SFI and

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Jane Fagan UCD School of Medicine ten-year anti-epileptic medication free period to apply for a group two HGV licence.[27] Other countries such as America have less cohesive guidelines which vary greatly depending on the state laws. For example, there is no set SFI required in and has a system based upon favourable/unfavourable modifiers for lengthening the SFI. The variability among driving regulations as seen in figure one suggests that the evidence regarding fitness to drive guidelines in PWE is limited and obscure. Therefore, there is a necessity for the establishment of evidence-based guidelines for PWE. This was conveyed by 82% of who concurred that there is an exigency for more research on how to evaluate fitness to drive in PWE. [28]

Country in question Mandatory reporting by Length of SFI required for physician required PWE America [29] Varies by state Differs from 3-12 months [30] Varies by state Differs from 1-24 months (Yes, in Southern Australia) Ireland + Europe [27] No 1 year [31] N/A Complete ban on PWE driving [32] No 2 years Figure 1 – The various SFIs required before PWE can return to drive in various countries

A further consideration regarding driving regulations for PWE is that of mandatory reporting, either by doctors or PWE. There is no mandatory reporting required by doctors in Ireland and thus the onus is on patients to report any seizures or changes in their condition to the NDLS. When a patient has a seizure, they must report it to their GP who will advise the patient to inform the NDLS and cease driving until they have a SFI of six/twelve months. Certain clinicians feel that the lack of mandatory reporting from doctors poses a risk to other road users [33] but there is no evidence to prove this opinion is correct. In fact, research has shown that there may be less reporting of seizures in jurisdictions where mandatory reporting is enforced. [34] Personally, I think that it should be the patients responsibility to report seizures as this is a more autonomous process which enables more honest and forthcoming discussions between health care professionals and patients. However, it is of the upmost importance that clinicians are comfortable with assessing fitness to drive and informing patients of relevant driving restrictions. Unfortunately, it would appear that this is not happening. A paper found that only 21% of patients with first presentation of seizures received factual advice regarding driving restrictions.[35] In conducting research for this essay, I struggled to find clear and coherent information on what the regulations were regarding

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Jane Fagan UCD School of Medicine reporting seizures to the NDLS. Even an acquaintance who had recently had a seizure was unaware of his duty to report his seizure.

The future of driving and epilepsy

Having considered the current driving regulations for PWE, I would like to suggest certain changes which may ameliorate some of the difficulties PWE face in their everyday lives regarding driving cessation. Driving a vehicle is integral to our day to day lives and was listed as the number one concern in a US survey amongst PWE [36] and yet PWE are limited by their diagnosis when driving. Current driving regulations are based upon the SFI which has been shown to be a reliable predictor of future seizures. However, other factors warrant consideration when assessing fitness to drive in PWE. A preferable system would be one which evaluated a patients individual risk by examining factors such as compliance to medications, the presence of auras with seizures, previous RTAs, and abnormal EEG results. These factors have been studied and shown to increase or decrease the risk of car accidents and would allow for a more rounded assessment of fitness to drive. [37, 38, 39] As well as this, more research is needed to correct the inconsistencies in the suggested time of SFI. Drazkowski et al found that a reduction in the SFI from 12 to 3 months did not result in a significant increase in seizure related crashes in [40] and data from Sheth et al. has shown “there is that there is no difference in accident rates between US states requiring a long (6–12 months) or short (3 months) SFP”. [7] Moreover, if long driving bans are continued to be employed, there needs to be alternative modes of transport offered to PWE. One example of this is having free or discounted public transport for PWE when they are banned from driving. In fact, this was the case from 2018-2020, but the incentive has recently been discontinued with little backlash.[41] This simple measure would ensure that PWE are better able to comply with medical advice regarding driving cessation and would support PWE to attend hospital medical appointments.

Dr Krumholz in a Neurology editorial stated that driving restrictions for PWE should “aim to strike a balance between public safety vs the promotion of opportunities and optimal quality of life for people with epilepsy,” [42] Currently more is needed to be done. Ban et al. proposed a system whereby maximum driving times are set for PWE depending on their SFI. It stands to reason that the less time a PWE spends at the wheel, the lower the risk of them having an RTA is.[43] This would facilitate the safe return of driving to PWE but in a more controlled fashion. Another improvement which is needed for PWE is that of equitable access to

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Jane Fagan UCD School of Medicine insurance extortionate rates or are not being considered by insurers at all. This may tempt PWE to lie about their epilepsy but they can jeopardise claims by falsifying medical information or face legal prosecution. With the prospect of self-driving cars [44] and the potential of new molecular patterns which could be used to predict seizure risk [45], the future of traffic medicine holds potential to greatly improve the quality of life of PWE. However, the most paramount advancement required is to find a cure for this debilitating disease. Epilepsy has existed since 2000 BC[46] and yet there are still uncertainties regarding the pathogenesis and PWE continue to be unfairly discriminated against in all aspects of life.

Conclusion

I chose this topic after an acquittance recently had a seizure after missing one dose of his medication and as a consequence was banned from driving for one year. This one slipup has had a considerable effect on his employment prospects when he leaves university this summer. He will not be able to seek employment where driving is a pre-requisite, which according to the RAC is a requirement for almost one in five job adverts.[47] Having researched various driving regulations in Ireland and across the world, I believe that the current restrictions for PWE in Ireland are too inflexible and do not leave scope for the nuances of the simple mistake of omitting a medication dose. It is too simplistic and unfair on PWE to dictate their lives on the basis of restrictions “largely based on expert opinion, practical experience, and political necessity rather than on strong scientific evidence”.[48] Doctors need to advocate for their patients and assess the impact driving bans have on individual patients. Let’s not allow patients with epilepsy to be limited any further by their diagnosis. I conclude that it is possible to have evidence-based driving regulations for PWE which mitigate the risk of harm to others without depriving PWE of their motoring independence. Ireland is a global leader in traffic medicine with recent analysis ranking Ireland as the fourth safest country in the world for road safety.[49] Whilst accepting that road safety is the priority for traffic medicine, I believe that there is scope for discussions regarding the discriminatory driving restrictions specifically applied to PWE.

Word count: 2984 words

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Jane Fagan UCD School of Medicine

References

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16. Sheth SG, Krauss G, Krumholz A, Li G. Mortality in epilepsy: driving fatalities vs other causes of death in patients with epilepsy. Neurology. 2004 Sep 28; 63(6):1002- 7. 17. Hansotia P, Broste S. The effect of epilepsy or diabetes mellitus on the risk of automobile accidents. N Engl J Med. 1991;Jan 3; 324(1):22-6. 18. Gavin P. Winston, Stephan R. Jaiser. Western driving regulations for unprovoked first seizures and epilepsy, Seizure, 2012;Vol 21,5, pp 371-376 19. Epilepsy Scotland. Side effects of anti-epileptic drugs. Available from: https://www.epilepsyscotland.org.uk/wp- content/uploads/2019/09/2_Side_effects_of_AEDs.pdf 20. Sundelin HEK, Chang Z, Larsson H, et al. Epilepsy, antiepileptic drugs, and serious transport accidents: a nationwide cohort study. Neurology 2018;90:e1111–e1118. 21. Edmondstone WM. How do we manage the first seizure in adults? J R Coll Physicians Lond 1995;29:289–294 22. Sultan M, Thomas RH. Self-driving cars: a qualitative study into the opportunities, challenges and perceived acceptability for people with epilepsy. Journal of Neurology, Neurosurgery & Psychiatry 2020;91:781-782. 23. Krumholz A, Fisher RS, Lesser RP, Hauser WA. Driving and epilepsy: A review and reappraisal. JAMA. 1991;265:622–626. 24. Dalrymple J, Appleby J. Cross sectional study of reporting of epileptic seizures to general practitioners. BMJ. 2000;320(7227):94-97. 25. R. Kelly, T. Warke, I. Steele. Medical restrictions to driving: the awareness of patients and doctors. Postgraduate Medical Journal, 75 (1999), pp. 537-539 26. RSA. Medical Fitness to Drive Guidelines (Group 1 and 2 Drivers). [Dublin] RSA; 2020 [Updated July 2020] Available from: https://d1l0gza1nowsqe.cloudfront.net/wp- content/uploads/sites/4/2020/07/NDLS-Sla%CC%81inte-Tioma%CC%81int-GL- 2020_WEB-002.pdf 27. Commission Directive 2009/112/EC of 25 August 2009 amending Council Directive 91/439/EEC on driving licences. Available from: https://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=OJ:L:2009:223:FULL&from=EN 28. Markhus, R, Henning, O et al. EEG in fitness to drive evaluations in people with epilepsy — Considerable variations across Europe. Seizure. 2020; Vol 79, p56-60 29. Joshi CN, Vossler DG, Spanaki M, Draszowki JF, Towne AR. “Chance Takers Are Accident Makers”: Are Patients With Epilepsy Really Taking a Chance When They Drive? Epilepsy Currents. 2019;19(4):221-226. 30. Bird, S. Epilepsy, driving and confidentiality. Australian family physician. 2005; Vol 34, no 12, pp 1057-1058 31. Ashima Nehra, Sweta Singla, Swati Bajpai, Shrividhya Malviya, Vasantha Padma, Manjari Tripathi. Inverse relationship between stigma and quality of life in India: Is epilepsy a disabling neurological condition? Epilepsy & Behavior, Volume 39, 2014, pp 116-125, 32. Inoue, Y., Ito, M., Kurihara, M., Morimoto, K. and (2004), Epilepsy and Driving in Japan. Epilepsia, 45: 1630-1635. 33. Sokol Daniel. Should healthcare professionals breach confidentiality when a patient is unfit to drive? BMJ 2017; 356 :j1505 34. Drazkowski JF, Neiman ES, et al. Frequency of physician counselling and attitudes toward driving motor vehicles in people with epilepsy: comparing a mandatory- reporting with a voluntary-reporting state. Epilepsy Behav.2010;19:52-4.

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35. Edmondstone WM. How do we manage the first seizure in adults? J R Coll Physicians Lond 1995;29:289–294 36. Gilliam F, Kuzniecky R, Faught E, Black L, Carpenter G, Schrodt R. Patient-validated content of epilepsy-specific quality-of-life measurement. Epilepsia. 1997;38:233-236 37. Ma BB, Bloch J, Krumholz A, et al. Regulating drivers with epilepsy in Maryland: results of the application of a consensus guideline. Epilepsia 2017;58:1389-1397. // find link to meta-analysis 38. R.S. Fisher, M. Parsonage, M. Beaussart, P. Bladin, R. Masland, A.E.H. Sonnen, et al. Epilepsy and driving: an international perspective. Epilepsia, 35 (3) (1994), pp. 675-684 39. L.J. Bonnett, C. Tudur-Smith, P.R. Williamson, A.G. Marson. Risk of recurrence after a first seizure and implications for driving: further analysis of the multicentre study of early epilepsy and single seizures. BMJ, 341 (2010), p. c6477 40. Drazkowski JF, Fisher RS, Sirven JI, et al. Seizure‐related motor vehicle crashes in Arizona before and after reducing the driving restriction from 12 to 3 months. Mayo Clin Proc 2003; 78: 819– 825. 41. Bermingham, D. Bus Éireann to end Epilepsy Ireland discount. (Sep 2020) Irish Examiner Available from: https://www.irishexaminer.com/news/arid-40047092.html 42. Krumholz A, Berg AT. Epilepsy and transportation: Moving through the confusion. Neurology. 2018;0:1-2 43. Ban, T, Kawai, K, Nambu, K, Iseki, H , Masamune, K. Estimating the risk of fatal traffic accidents posed by drivers with epilepsy in Japan: A comparison with traffic accidents caused by sudden death of occupational drivers. Epilepsy and Seizure. 2018;vol 10, no1 pp 1-10 44. Sultan M, Thomas RH. Self-driving cars: a qualitative study into the opportunities, challenges and perceived acceptability for people with epilepsy. Journal of Neurology, Neurosurgery & Psychiatry 2020;91:781-782. 45. Marion C. Hogg, … , David C. Henshall, Jochen H.M. Prehn. Elevation of plasma tRNA fragments precedes seizures in human epilepsy. J Clin Invest. 2019; 129(7): 2946-2951 46. Rohaid Ali, Ian D. Connolly, et al. Epilepsy: A Disruptive Force in History, World Neurosurgery. 2016; Vol 90, pp 685-690;1878-8750. 47. Makwana, B. Driving as an employment qualification - technical paper update. Oct 2018. Available from: https://www.racfoundation.org/motoring-faqs/mobility#a19 48. Krumholz A. Driving issues in epilepsy: past, present, and future. Epilepsy currents, 2009; 9(2), 31–35.

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