Across-Country Viewpoints on Sleepiness during Driving

Charles F. P. George, Larry J. Findley, Melissa A. Hack, and R. Douglas McEvoy

University of Western Ontario London Health Sciences Centre, London, Ontario, Canada; Sleep Disorders Center of Northern Colorado, Aspen Medical Center, Loveland, Colorado; Gwent Sleep Centre, Royal Gwent and St. Woolas Hospitals; Newport Chest Clinic, Newport, South Wales, United Kingdom; Sleep Disorders Unit, Repatriation General Hospital, Daw Park; School of Medicine, Flinders University, Bedford Park, Adelaide, South Australia

	THE CASE

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Mr. Z is a 45-year-old man with a history consistent with sleep apnea syndrome. The major risk factor is obesity, and he has a body mass index of 32.5 kg/m². He had a sleep study that showed severe obstructive sleep apnea (OSA). The respiratory disturbance index (RDI) was 54 episodes per hour, and the nadir in oxygen saturation was 75%. He was titrated on continuous positive airway pressure (CPAP) but has been having a difficult time using it for the last four months. His CPAP adherence data shows that he uses it approximately 3-4 nights per week and for an average of 3.8 hours on these nights. He is a salesman and drives 20,000-40,000 miles each year. He denies previous fall-asleep crashes. He admits to getting drowsy while driving, and he often pulls into rest stops to nap when driving longer distances.

	THE QUESTION TO ADDRESS

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What steps should be taken about the risk of driving?

	INTRODUCTION

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Patients with sleep apnea have increased motor vehicle crashes (MVCs) (1-17), and some data suggest that crash risk increases as RDI increases. (13). Thus, for physicians treating OSA, this case illustrates a common yet often difficult problem. And in dealing with this (and similar) cases, we must address three aspects of the problem that include: (1) understanding why our patient is still sleepy and how we can quickly intervene to increase alertness while driving; (2) educating our patient about his risk of driving and stressing his responsibility to society of operating a motor vehicle in a safe fashion; and (3) fulfilling our legal obligations as physicians with respect to reporting patients to the local authorities. It is this third question for which "Across-Country Viewpoints" are most varied and thought provoking.

Despite our differing geography, our clinical management of Mr. Z is fairly consistent and uniform. As clinicians, each of us wants Mr. Z to be successfully treated for sleep apnea. Although we have chosen to use CPAP as the first (and most effective) treatment, we recognize that there are alternatives that we may need to consider (such as palate surgery or mandibular advancement appliances). We endeavor to understand both clinical and nonclinical (i.e., social) reasons for poor compliance with therapy. Establishing trust and rapport with him is first and foremost in this or any clinical interaction. His occupation involves substantially more driving than average and as such he has greater exposure for potential crashes. His occupation may also engender insufficient sleep, thereby increasing sleepiness and risk. And although Mr. Z appears to be a reliable witness and has insight into his limitations (" . . . he admits to getting drowsy while driving . . . ."), and even though he invokes important countermeasures to sleepy driving (18-20) (" . . . pull[ing] into rest stops to nap . . . ."), we must still highlight the importance of good sleep hygiene. Then problems with CPAP are systematically addressed mask size and fit, adequacy of pressure (is it too high or too low?), or the need for humidity and/or intranasal steroids, etc. If we can ensure effective CPAP therapy, risk of MVCs will be reduced to normal (17, 21-25). Compliance with CPAP is an ongoing issue in any patient with sleep apnea. Previous data suggest that four hours' use of CPAP may be the "norm" (26), although higher (subjective) compliance is reported (23, 25). Still, we don't have any data on the minimal CPAP usage that will prevent MVCs. And although his current usage seems low, it may be sufficient. At present, effective treatment is defined by the consultant responsible for the patient.

When it comes to actually assessing driving risk and fulfilling our legal obligations as physicians with respect to reporting patients to the local authorities, it is here that there is the most variability in our "Across-Country Viewpoints."

	A VIEWPOINT FROM CANADA

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For the clinician, determining driving risk is still an inexact science. Although the risk may be increased, is it increased a little or a lot? Is a little risk okay, and if so, how much can we tolerate? The relationship between RDI and crashes is not conclusively shown in each study. Given the variability in scoring of RDI (27), its not surprising that there is no RDI cutoff above which motor vehicle crashes are certain, so I cannot rely on RDI by itself. What about sleepiness while driving? There is evidence to suggest that fall-asleep crashes are more likely to happen when people are sleepy (7-9, 28). Still, there is no data that identifies which sleepiness metrice.g., patient self-report, Epworth Sleepiness Scale (ESS), Multiple Sleep Latency Test (MSLT)can reliably predict collisions.

After addressing the clinical issues of CPAP usage and compliance and of sleep hygiene, I then review with him the adverse effects and health risks of untreated OSA. We review the potential for cardiovascular complications. I then remind Mr. Z that when he has poor quality sleep, he may not be as alert as normal, that he is not sharp, that his reactions are slowed, and that it is harder to maintain attention. As such he is at risk for accidentsof any kindat home, at work, operating a power tool, climbing a ladder, etc. Such mishaps can occur, not necessarily because he will fall asleep but because he will be inattentive. If he is sleepy at intersections, he should know that he is not alert, not sharp, and at greater risk for collisions.

Still, just because he is inattentive does not guarantee he'll have a collision. In the province of Ontario, the rate of collisions for all licensed drivers is 0.05 ± 0.05 MVCs per driver per year. In other words, I will have roughly one accident every 20 years. And many OSA patients may never have any accidents (13, 25).

Nonetheless, having reminded him that he has a responsibility to himself, his family, and to public safety, I inform the patient of the law in Ontario (and seven of the 11 other Canadian provinces and territories [29, 30]). Section 203(1) of the Ontario Highway traffic act states ". . . Every legally qualified medical practitioner shall report to the Registrar (of Motor Vehicles) . . . every person 16 years of age . . . . who, in the opinion of the medical practitioner, is suffering from a condition that may make it dangerous for the person to operate a motor vehicle." Although Section 203(2) protects me from litigation, this still does not help me in assessing driving risk. Despite this statutory duty to report, I am not the "license police" but a patient advocate. My job is to better treat him to reduce the risk. Having done the best I can, and with the patient fully aware of the requirements of law, I notify the Ministry of Transportation that Mr. Z has OSA, is under treatment, and that as long as he is compliant with therapy, he is not at risk for driving. Mr. Z must then take responsibility for proper sleep hygiene and CPAP usage.

Any sleepy individualpatient or notis at risk for motor vehicle collisions. We must all be vigilant.

	A VIEWPOINT FROM THE UNITED STATES

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During his next clinic visit, I would discuss the causes, diagnosis, consequences, and treatment of sleep apnea. I would give handouts with overviews on these topics. I then would review with him the following written statement about driving and sleep apnea:

You have been diagnosed with sleep apnea, a condition which may adversely affect your driving. People with sleep apnea often have a three to four increased rate of motor vehicle crashes or other accidents. These accidents may cause serious injury or death to you or others. If you have had an accident or frequent near accidents due to sleepiness or inattention, you should stop driving or operating dangerous machinery until your sleep disorder has been treated and you are no longer sleepy or inattentive while driving. It is your responsibility not to drive if you are inattentive while driving. If you drive or fly professionally, you must report your sleep disorder to the doctor who certifies you fit for this profession.

I believe these warnings place the burden of safe driving upon the patient and not upon me.

As a physician I must obey the law of my state. I have obtained legal advice from an attorney. He tells me that, like many but not all states, Colorado does not require me to report a driver with sleep apnea. My state discourages such reporting by not giving me any protection from litigation for disclosing private medical information to the state without a written request from the state. On this basis, my attorney has advised me not to report any patient to the state without the patient's written permission. There may be rare circumstances with a certainty of grave danger that require a report to the driver's license agency. These circumstances have legal risks for the physician who reports or fails to report patients (31).

Fortunately, my state does not have mandatory reporting of patients with sleep disorders because mandatory reporting probably discourages the evaluation and treatment of sleep apnea. Routine reporting of sleep apnea patients should not be legally required and should be avoided by physicians unless future studies clearly show the wisdom of this practice.

If I practiced in a state that requires reporting of patients with sleep disorders affecting driving, I would use the wording of the state statute and American Thoracic Society (ATS) guidelines for such reporting (32). Unfortunately, these guidelines are not supported by all research findings. According to the ATS, high-risk patients have severe sleep apnea with excessive sleepiness. Several large studies of clinical and nonclinical populations do not demonstrate a relationship between severity of sleep apnea (10, 11) or measured sleep latency (3, 10) and MVC rate. Finally, the ATS guidelines rely upon self-report of accidents and poor driving to classify a high-risk driver. Recent work has shown that patients with sleep apnea underestimate their driving impairment (33) and often fail to report serious crashes to their physicians (24).

	A VIEWPOINT FROM THE UNITED KINGDOM

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Mr. Z has a diagnosis of severe sleep apnea syndrome (the combination of excessive sleepiness and a positive sleep study) and there is irrefutable evidence that, without treatment, he is statistically at increased risk of involvement in a road traffic accident (2, 10, 12, 13). The common regulation in the European Union is the Directive of the Council. Disorders incompatible with driving are listed within this, and although sleep apnea syndrome and sleepiness are not specifically mentioned, the Directive states that a Driving License should not be held by any one suffering from any disorder (even if not mentioned) likely to compromise safety on the roads, except if by authorized medical advice. The Driving and Vehicle Licensing Authority (DVLA) is the regulating body in the UK, and in normal circumstances, it remains the responsibility of Mr. Z to inform the DVLA at the time of diagnosis of sleep apnea syndrome.

I have a responsibility to inform him of the risks related to sleepiness and to discourage him from driving until treated effectively. I advise Mr. Z that the police would have access to medical records if he were involved in a vehicle accident and failure to notify the DVLA could be considered an offense and his insurance company may withdraw cover. In addition, I'm keen to include his next of kin in these discussions and would notify the General Practitioner of the difficulties that Mr. Z is experiencing.

After optimizing his CPAP, I perform subjective and objective measurements of daytime sleepiness and record his compliance data. There is much debate regarding the ideal test, or battery of tests, necessary to examine a sleepy driver, and although this remains undecided, I collect a range of indicators, including a simple performance test (34). Although these tests have no official validity or status, they may be useful either to convince the patient that he is very sleepy or, if within published normal limits, to reassure me, the clinician, that the level of sleepiness/performance is not abnormal.

If Mr. Z refuses to accept that he remains sleepy and needs further treatment, I would offer a second opinion and try to persuade him to stop driving. In the case of Mr. Z, this may have considerable financial implications. Although I believe that every effort should be made to provide effective treatment for Mr. Z, if this fails, my final option is to breach patient confidentiality and notify the DVLA of the potential risk presented by Mr. Z. This raises important legal issues and before disclosing the information to the DVLA, I would inform Mr. Z of my decision and confirm this in writing. Even if Mr. Z were to bring a case against me, my care would meet professional standards as described in a recent case concerning epilepsy and driving (35). Indeed, the UK General Medical Council specifically allows a breach of medical confidentiality if this protects others from potential harm.

These views may not be representative of all sleep specialists in the UK, but I believe this provides the most logical series of steps to be taken concerning the risk of driving in the light of current knowledge regarding sleep apnea syndrome, sleepiness, and existing regulations. Taking a hard line from the outset is unhelpful because if a sleep unit gets a reputation for stopping people from driving, then patients will not present for diagnosis and treatment, the worst situation in any country.

	A VIEWPOINT FROM AUSTRALIA

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Mr. Z has severe sleep apnea. His occupation involves substantially more driving than average, and he admits to being sleepy when traveling long distances. It is clear that patients with severe sleep apnea, such as Mr. Z, have poorer driving simulator performance (11, 36-42) and two to seven times increased automobile accident risk than normal subjects (2, 3, 6, 10-15, 23, 43, 44). I have a responsibility therefore to inform him that he is at increased risk of an accident while he continues to drive without effective treatment. A 2- to 7-fold relative risk of accident might suggest the need for immediate drastic action. However, to insist that he stop or sharply reduce his driving may not be justified and must be balanced against the possible costs and hardship to him and his family (e.g., loss of employment).

Most patients with moderate to severe sleep apnea have never experienced a motor vehicle accident due to falling asleep, despite years of driving. I need to know more about the absolute rate of accidents in untreated sleep apneics and more about Mr. Z's driving behavior before I can make a determination about his level of risk and advise on risk reduction. The rate of accidents in the general driving population is low approximately one percent of drivers will have an accident each year (24). Of these accidents 1-2% will involve a fatality. If the relative risk among untreated sleep apneics were increased five-fold the accident rate per driver per year would be ~ 5%, still a relatively low figure and not sufficient in my opinion to demand that Mr. Z stops driving. A comparable increased relative risk of accidents due to sleepiness occurs for night versus day driving (45), yet there is no move to ban night driving. These purely statistical considerations, however, should be complimented by specific information about Mr. Z's driving behavior.

If multiple "near miss" episodes due to sleepiness are reported or there is severe sleepiness while driving (e.g., often asleep in stationary traffic), I would consider there to be a serious and immediate risk of a crash and would inform him accordingly. My primary obligation would remain to protect patient confidentiality, but my duty of care to the public would now assume far greater importance. Any jurisdiction in Australia might be expected to find me liable in the case of serious injury or death due to an accident caused by Mr. Z if I had failed to take reasonable steps to prevent him from driving in a dangerous manner. I would therefore ask him to stop highway and country driving immediately and offer to intercede on his behalf with his employer. I would ask him to use other risk minimization strategies, including: stop and nap when sleepy, avoid any alcohol before driving, and avoid night driving. I would make intensive efforts to institute effective treatment and arrange to review progress with him and his spouse at regular intervals. If effective treatment cannot be instituted expeditiously (e.g., within two months) and he refuses to limit his driving as advised, I would inform him that he has a legal responsibility under uniform National Driver Licensing Laws in Australia (46) to notify the State Licensing Authority that he has a medical condition likely to affect his driving. Failure to do so could expose him to criminal and civil liability. If after a reasonable time I have reason to believe that he has not advised the driving authority of his condition and that he is continuing to drive while seriously impaired, I would seek his consent to inform the State Licensing authority myself. If consent is not given, I would tell him that, reluctantly, and in the interests of public safety, I must inform the authority. Legislation in all Australian States and Territories but one (Tasmania) provides me with legal indemnity (46).

	SUMMARY

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Notwithstanding our geographic differences, we are in agreement about the medical management of the sleepy driver. However, our lack of consensus involves legal and societal issues. As long as differences exist in regional requirements to report sleep apnea patients to the driving authorities, and given the across-country legal differences, it will be not possible to espouse a common, "across-country" clinical decision algorithm to deal with this problem. Patient health concerns must always be first but at some point, public safety must supercede individual concerns. At present, our clinical ability and clinical outcome measures (apnea-hypopnea index, ESS, MSLT, simulator data, etc.) lacks sufficient sensitivity and predictive value to determine an individual's driving risk. Because the majority of sleep apnea patients do not have accidents, we should therefore design studies to be able to reliably identify this low-risk group and then exclude them from concern about driving. This would then leave a smaller, more manageable group on which to concentrate our resources. Finally, the wisdom of mandatory reporting of drivers with sleep apnea must be questioned because such reporting can discourage many sleepy drivers from being evaluated for sleep apnea.

	Footnotes

Correspondence and requests for reprints should be addressed to Charles F. P. George, University of Western Ontario, London Health Sciences Centre, Victoria Campus, 375 South St., London, ON, N6A 4G5 Canada. E-mail: cgeorge{at}uwo.ca

(Received in original form July 23, 2001 and accepted in revised form December 21, 2001).

	References

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