Tobacco Cessation Medication for Commercial Drivers Seeking FMCSA Medical Clearance
Quitting safely on the road
Guideline regarding use of Chatix (Varenicline) and Bupropion (Zyban, Wellbutrin, or generic) in commercial drivers seeking FMCSA medical clearance - 6/15/2008
NOTE: This is an internal document, for guidance to Affinity Occupational Health staff.
APPLIES TO: All drivers seeking Medical Clearance under 49CFR390.5, who are currently taking varenicline or bupropion, or considering such treatment for tobacco cessation.
PREAMBLE: Treating tobacco use and dependence is important in all occupations especially commercial drivers. Its prevalence is exceedingly high among some driver subgroups; perhaps double that of the general population. And it poses an obvious risk to safe operation of vehicles, being the leading preventable cause of death in the United States. It increases the risk of sudden loss of control of a motor vehicle from conditions such as sudden cardiac arrest, myocardial infarction, stroke and transient ischemic attack. Cardiovascular and cerebrovascular conditions are among the leading medical causes of large truck crashes.
Nicotine dependence is a DSM IV substance dependency disorder. Like other types of substance dependence, pharmacotherapy is an important part of treatment. Varenicline and bupropion are FDA-approved tobacco cessation prescription medications, as are over-the-counter Nicotine Replacement Therapies (NRT).
However, varenicline has been associated with changes in mood and behavior, which led to a cautionary FDA notice 5/16/08 followed by an advisory statement from the FMCSA administrator: http://www.fmcsa.dot.gov/statement-5-23-08.htm
These neurobehavioral changes are important, particularly because FMCSA guidance stipulates that drivers cannot be certified if they are taking medications which impair their ability to safely operate a motor vehicle. Mood and behavior changes of the type reported could affect driving safety.
Further, bupropion has been associated with seizures. It is also associated with insomnia which may lead to sleep deprivation and daytime drowsiness. Mood and behavior changes can occur in bupropion users with a history of mental illness. And, in depressed patients up to age 24 (but not beyond), the risk of suicide is increased (manufacturer’s statements).
AOH clinicians are faced with a prudential judgment when assessing a driver who is or may be using these medications. On one hand, successful tobacco cessation greatly reduces the risk of incapacitating cardiovascular and cerebrovascular events, which would clearly benefit public safety. In fact, heart attack rates begin to drop within 2 weeks after tobacco cessation. On the other hand, there is a small but real chance of important mood and behavioral changes during varenicline treatment, which could impair judgment and possibly affect safe vehicle operation. And, bupropion side effects can potentially pose risks.
To help AOH clinicians make this judgment in commercial driver exams, the following guidance is presented:
1. Provide brief clinician cessation counseling to all drivers who use tobacco. Please use the "Five A's" and the "Five R's” format in Chapter Three of the United States Public Health Service Guideline, Treating Tobacco Use and Dependence, available at: http://www.surgeongeneral.gov/tobacco/treating_tobacco_use08.pdf
This also gives you guidance to help drivers who are not ready to quit (“The Five R’s”).
A single-page summary is found at http://www.ahrq.gov/clinic/tobacco/clinhlpsmksqt.htm
2. For drivers who are in a contemplative phase of readiness to quit, discuss the options of telephonic coaching and of seeing their primary care provider (PCP) to consider medication prescribing.
3. Advise the driver that quitting smoking can be stressful itself, as many smokers use tobacco to cope with stress. Advise the driver that if this is not a good time for them to quit because of stress, anxiety or mood issues, they should first discuss those issues with their PCP and perhaps a mental health provider prior to embarking on tobacco cessation. If they have symptoms that concern you, and especially if you are considering prescribing yourself, administer a screening tool, such as the Prime MD Depression Screen:
http://www.psy-world.com/prime-md_print1.htm
If they score 5 or more points on this version of that screen, advise they must address this with a primary care or mental health provider first before considering tobacco cessation medications while in-service.
4. Advise the driver of the need to be alert to side effects of any prescription medications which can affect safe vehicle operation, especially until they are certain how they respond to a new medicine or dosage increase. This is true of the side effects of insomnia from bupropion and drowsiness from varenicline. Advise the driver that the safest time to start any new medication or to increase the dose is during time away from work. Note that treatment with varenicline involves a dose increase on the eighth day and with bupropion on the fourth day.
5. Advise the driver of the phenomenon of mood changes and behavioral disturbances in some users of varenicline, and if applicable, bupropion. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. Advise drivers that most (but not all) episodes of serious psycho- behavioral disturbance during varenicline treatment occurred in individuals with a past history of either psychosis or mood disorders.
6. Inquire carefully about past history of diagnosed mental health issues, especially psychoses, psychotic episodes, or mood disorders. Ask if the driver has ever been diagnosed with depression, currently feels a blue mood or sense of depression most of the time, had ever used an antidepressant, has a past diagnosis of an anxiety disorder, feels anxious most or all of the time presently, or has ever been treated with an anti-anxiety medication.
7. Ask specifically about any past history of suicide gestures, attempts, or persistent suicidal ideation. If you encounter a driver who has a remote past history of this (> 2 years), but has no current mental health issues, they may be endorsed to remain in service while receiving treatment with bupropion provided they are 24 years or older. Do not approve in-service use of varenicline in these drivers. They would need to be out of service during the course of treatment (usually 3 months) and during a period of withdrawal from the medication (usually 2 weeks).
8. Chronic schizophrenia is considered a permanently disqualifying condition among commercial drivers. But, people with a history of a resolved psychotic episode from other cause can be approved as commercial drivers if symptom-free greater than a year, and endorsed by their psychiatrist. If you encounter such a driver who seems qualified, do not approve use of varenicline or bupropion while in-service. Advise them that if they intend to use either prescription for smoking cessation, they would need to be out of service during the course of treatment (usually 3 months) and during a period of withdrawal from the medication (usually 2 weeks). If a driver is currently on the medication, withhold endorsement until they have finished it. The exception is stable chronic use of bupropion for treatment of their mental health disorder.
9. Some drivers with bipolar affective disorder can be approved as commercial drivers if stable and endorsed by their psychiatrist. If you encounter such a driver who seems qualified, do not approve use of varenicline or bupropion while in-service. Advise them that if they intend to use either prescription for smoking cessation, they would need to be out of service during the course of treatment (usually 3 months) and during a period of withdrawal from the medication (usually 2 weeks). If a driver is currently on the medication, withhold endorsement until they have finished it. The exception is stable chronic use of bupropion for treatment of their mental health disorder.
10. A current or past history of depression or anxiety disorder is common in the population and commonly encountered among commercial drivers. If a driver has a remote history of one of these mood disorders (greater than 2 years ago), has been advised by their provider that they no longer need medications, and have no current symptoms, they may be endorsed to remain in service while receiving treatment with varenicline or bupropion (but please see item 12 below).
11. If a driver is currently being treated with an antidepressant or an anti-anxiety drug, do not approve use of varenicline or bupriopion while in-service without correspondence with the treatment provider. If such a driver presents for DOT medical clearance, advise that approval to use either prescription while in-service would only be considered after you receive endorsement letters from the prescriber(s) of both the psychiatric medication and the tobacco cessation medication. These endorsements must specifically attest to proper patient selection and education, prescriber understanding of the patient’s safety-sensitive work, and lack of side effects. The exception is stable chronic use of bupropion for treatment of their mood disorder in a driver who has been endorsed by their provider.
12. As mentioned, most but not all episodes of neuropsychological changes with varenicline occurred in persons with current or past history of a mood disorder or psychosis. Because some episodes have occurred in an absence of such a history, advise all drivers considering varenicline that such effects could occur to them. Educate them of the signs and symptoms. Tell them that changes in dreams occurred in 20% of varenicline users during FDA-approved trials, and that post-marketing experience indicates it probably happens more often than that. If a driver taking varenicline is experiencing altered dreams which in any way disrupt their sleep, causes sleep deprivation, or are associated with daytime drowsiness, they must withdraw from the medication and remain off service until that is done. The above is true also of bupropion-associated insomnia.
If after reviewing all of the above you provide certification to a driver taking varenicline or bupropion, or advise them that they may consider its use when they see their primary care physician, advise them of the need to err on the side of safety. If they have concerns about side effects from the medication, they should discontinue driving and contact their treatment provider.
Brian D. Harrison, MD
Fellow, American College of Occupational and Environmental Medicine
