Department of Transportation update

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1 Department of Transportation update October, 2014 Michael Berneking, M.D. Medical Director, Concentra, Grand Rapids, Michigan [Go to View, Master, Slide Master to enter presentation title here or remove text Arial 10]

2 Objectives To provide an update on recent and coming changes to medical related issues within the Department of Transportation National Registry of Certified Medical Examiners (NRCME) Sleep Apnea Updates Exemptions Medical Marijuana SGLP 2 Inhibitors Bus Driver certification with Insulin

National Registry of Certified Medical Examiners A list of medical examiners that are trained to specifically determine the physical qualifications to operate a commercial motor vehicle (CMV) These

3 National Registry of Certified Medical Examiners A list of medical examiners that are trained to specifically determine the physical qualifications to operate a commercial motor vehicle (CMV) These examiners will are specifically trained to administer the exams to determine which drivers meet the standards They are to have an understanding of the demands of the CMV driver They have a standard curriculum, a certification exam and a recertification process to ensure continued proficiency

4 Why is this important? This is necessary to improve the quality and standardization of medical certification Prior to implementation there was a large variability in the quality of exams and the understanding of the medical standards Any licensed medical professional may do these exams Most physicians in this country do not have a thorough understanding of the physical standards or the demands of the CMV driver Ensuring all examiners are trained is anticipated to greatly increase safety.

5 Does it really matter? In a word, yes February 16, year old bus driver transporting students to school pulled out in front of a fully loaded tractor trailer One 11 year old child was killed and 5 others sustained serious injuries. Source: NTSB 5

6 The NTSB cited several factors in the crash The driver listed orthopedic, psychiatric, and alcohol use on his long form He was taking clonazepam, tramadol, and drank alcohol daily The examiner did not address these issues or obtain medical records They concluded The commercial driver s license medical examiner did not thoroughly evaluate the school bus driver for medical conditions that could have disqualified him from receiving a commercial driver s license. Source: NTSB 6

7 How does this affect the industry? Employers and drivers will no longer be able to go to any provider, but have to pick one from the National Registry of Certified Medical Examiners (NRCME) The NRCME is easily accessed online This program is in effect as of May 21, 2014

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9 Becoming a Certified Medical Examiner 16 Scope of practice includes physical examinations Professional licensure: - Doctors of medicine - Doctors of osteopathy - Advanced practice nurses - Physician assistants - Chiropractors Criteria Requirements Attend educational program Pass written exam Perform certification exams and complete documentation in accordance with FMCSA standards and guidelines

10 Examiner Responsibilities 17 Core tasks Be aware of physical, mental, and emotional demands on CMV drivers Know requirements of 49 CFR , including advisory criteria (guidelines) Apply medical protocols in performing physical exam described in Be familiar with 49 CFR

11 Maintaining Certification 18 Maintain State licensure and supporting documents Medical Examination Reports and medical examiner certificates for 3 years Train NRCME refresher training at least every 5 years NRCME recertification test every 10 years Report Submit monthly MCSA-5850 reports Provide copies of exam reports and certificates within 48 hrs of request Changes to previous reports

12 Minor changes made to the Medical Examination Added Intrastate checkbox Added CDL checkbox Added Update Previous checkbox Added Exemption explanation (if necessary) Requirements for verification of identity, license number and type are under discussion 12

13 Minor changes made to the Medical Examiner s Certificate License and State merged National Registry ID added Added CDL checkbox Added Intrastate checkbox 13

14 49 CFR (g) 3 (3) Once every calendar month, beginning May 21, 2014, the medical examiner must electronically transmit to the Director, Office of Carrier, Driver and Vehicle Safety Standards, via a secure FMCSAdesignated Web site, a completed Form MCSA 5850, Medical Examiner Submission of CMV Driver Medical Examination Results. The Form must include all information specified for each medical examination conducted during the previous month for any driver who is required to be examined by a medical examiner listed on the National Registry of Certified Medical Examiners 14

15 Fatigue and FMCSA This is an area of interest and concern for the FMCSA Pressure from NTSB, public sector, insurance industry and others to adequately address this issue Hours of service changes and OSA Medical Expert Panel are outgrowths of this

Why is this important? Grand Rapids Press, 18 September 2008 This is a highly prevalent problem that is just now moving in to the mainstream of public awareness.

16 Why is this important? Grand Rapids Press, 18 September 2008 This is a highly prevalent problem that is just now moving in to the mainstream of public awareness. We, as health professionals are obligated to improve the quality of health in the communities we serve whether that is a city or a factory. Sleep disorders don t just impact the worker but the lives of potentially thousands

17 Normal Sleep The rise of the industrial and information age has not helped 1910 average American adult got 9 hours of sleep 1975 this had decreased to 7.5 hours Now stands at 6.8 hours per night National Sleep Foundation, 2005

18 Causes of sleepiness The number one cause of daytime sleepiness is lack of sleep! 70 million people are not getting adequate sleep NIH Sleep Apnea 40 million Source:NHLBI Insomnia 32 million Americans affected Circadian Rhythm Disorder Restless Leg Syndrome 4% of the US population Scofield et al: Sleep:31, Narcolepsy 200,000 people Bruxism Drugs!

19 CMV Drivers and Shift Length One study of CMV drivers showed: Those who worked a 10 hour shift got an average of 5.4 hours of sleep during their off shift It dropped to only 3.8 hours when they worked a 13 hour shift A similar result was found in airline pilots Mitler et al. The sleep of long-haul truck drivers. N Engl J Med 1997; 337:

20 Sleep Apnea Common term for one of many sleep related breathing disorders. Includes: 1. Central sleep apnea 2. Obstructive sleep apnea, adult and pediatric 3. Various hypoventilation/hypoxemia syndromes 4. Upper airway resistance syndrome International Classification of Sleep Disorders, 2 nd ed. 2005

Obstructive Sleep Apnea Symptoms: snoring, excessive daytime somnolence, nocturnal snorting and gasping, witnessed apneas Other symptoms include headaches, fatigue, myalgias,

21 Obstructive Sleep Apnea Symptoms: snoring, excessive daytime somnolence, nocturnal snorting and gasping, witnessed apneas Other symptoms include headaches, fatigue, myalgias, dizziness. Patients will often self medicate OTC s or EtOH! Pathophysiology: Airway occlusion during sleep leading to apnea followed by an arousal as CNS attempts to restart breathing

22 Consequences Acute Sleepiness, poor concentration, mood changes, poor performance and attention Chronic Hypertension, depression, substance abuse, increasing risk of CVA and/or MI, arrhythmias. Higher risk for sudden night time death, pulmonary hypertension.

23 Some Effects of Sleep Deprivation on Drivers 1. Slowed higher cognitive processes 1. Attention 2. Visual information processing 2. Increased errors of omission. 3. Slowed response time These effects are have a linear response to increasing deprivation Jackson, et al: Sleep 31:,

Predicting CMV Driver risks Limited study of truck drivers found several variable to help predict likelihood of driver falling asleep behind the wheel Epworth sleep scale Night driving Use of

24 Predicting CMV Driver risks Limited study of truck drivers found several variable to help predict likelihood of driver falling asleep behind the wheel Epworth sleep scale Night driving Use of medication to stay awake Longer than 13 hours driving Short sleep duration (< 6 hours of sleep) Look for these in your drivers! Heaton et al, Identifying variables that predict falling asleep at the wheel among long haul truckers, AAOHN: 56;

25 Driver fell asleep at the wheel. Woke up as truck leaving highway. Flipped rig as trying to steer back on the road.

26 3/16/06, Tuscon, AZ Driver fell asleep at the wheel

27 June 29, 2009 I-44 near Miami, Oklahoma Traffic stopped for a minor accident further up A CMV driver operating his tractor-trailer did not react to the stopped vehicles and initially collided with a Land Rover SUV but continued on to override a Hyundai Sonata, a Kia Spectra, and a Ford minivan. 10 people died, 6 injured including the driver of the tractor-trailer NTSB cited the following: that the probable cause of this accident was the Volvo truck driver s fatigue, caused by the combined effects of acute sleep loss, circadian disruption associated with his shift work schedule, and mild sleep apnea, which resulted in the driver s failure to react to slowing and stopped traffic ahead by applying the brakes or performing any evasive maneuver to avoid colliding with the traffic queue. The driver did not report his sleep apnea on any of his physical examinations Source: Highway Accident Report Truck-Tractor Semitrailer Rear-End Collision Into Passenger Vehicles On Interstate 44 Near Miami, Oklahoma June 26, 2009, NTSB Number: HAR-10/02, NTIS Number: PB He was charged with and pled guilty to 10 counts of vehicular manslaughter. He only got 10 years probation though Source: Truck driver pleads guilty in deadly Oklahoma crash that kills 10, including a north Texas family. 2 August 2010, Valerie Wigglesworth, Dallas Morning News

28 This is why sleep apnea and the CMV driver matters.

29 What this means. It is estimated that excessive driver sleepiness is implicated in 31-41% of CMV accidents Gurubhagaratula et al. Am. Jour. Resp & Crit. Care Med Translates annually to: 1512 less fatal accidents 26,950 less injury accidents 280 less deaths

30 Productivity is also impacted National Sleep Foundation (NSF) showed: 51% of workers state sleepiness has an impact on their job Those who work more than 60 hours in a week made 10% more errors. Result: over 18 billion dollars estimated annual lost productivity.

31 Current regulations CFR (b)(5) states: A person is physically qualified to drive a CMV if that person has no established history or clinical diagnosis of a respiratory dysfunction likely to interfere with his/her ability to control and drive a CMV safely Sleep apnea is considered a respiratory disorder The regulation is very general The medical expert panels have varying recommendations Results in high variability between examiners when it comes to screening and qualifying drivers at present.

32 Medical Expert Panel Who should not drive Drivers who have self reported excessive sleepiness while driving Drivers who have had a sleep related crash Individuals with a BMI of greater than 33 kg/m 2 pending a study evaluation Individuals non-compliant with treatment Individuals with an Apnea/Hypopnea Index greater than 20/hour until treated Source: Expert Panel Recommendations: Obstructive Sleep Apnea and Commercial Motor Vehicle Driver Safety. Ancoli-Israel et al. January 14, 2008

Who should be evaluated In a word, everyone However the examiner is looking for specific findings in the history and exam Historical features Witnessed apneas Chronic snoring Daytime sleepiness

33 Who should be evaluated In a word, everyone However the examiner is looking for specific findings in the history and exam Historical features Witnessed apneas Chronic snoring Daytime sleepiness Family history of sleep apnea Examination Age BMI > 28 kg/m2 Small jaw Small airway (Mallampati score) Large neck size (> 17 inches in men, 15.5 in women) Comorbid Illnesses Hypertension Diabetes Hypothyroidism that is untreated Source: Expert Panel Recommendations: Obstructive Sleep Apnea and Commercial Motor Vehicle Driver Safety. Ancoli-Israel et al. January 14, 2008

34 How to screen Assess drivers for any evidence that a sleep disorder may exist It is recommended this evaluation should based on multiple, well evaluated criteria both subjective and objective using a number of available clinical prediction models. Once this is completed the examiner is able to place the driver into one of three categories 1. No evidence of sleep disorder, certify appropriately 2. Possible sleep disorder, limited certification pending an evaluation 3. Probable sleep disorder, no certification until evaluated

35 OSA Prediction Models for Clinical Assessment 35 Clinical assessment identifies drivers at risk for OSA. No single clinical criterion is definitive for diagnosing OSA. Clinical Prediction Models have been developed to improve the sensitivity of clinical assessment: Criteria selected have been compared to OSA sleep study results. Many models are available to the examiner. Models use the same symptoms and signs, and vary ONLY in cut points and combinations. Models have similar sensitivities (76% 96%) and specificities (13% 54%). Drivers at risk for OSA can then be referred for a sleep study. STOP BANG Model Snore Tired Observed Apneas Blood Pressure BMI Age Neck Gender

H.R. 3095 On October 13, 2013, President Obama signed H.R. 3095 into law. The law mandates that any new or revised requirement providing for the screening, testing, or treatment.

36 H.R On October 13, 2013, President Obama signed H.R into law. The law mandates that any new or revised requirement providing for the screening, testing, or treatment... of individuals operating commercial motor vehicles for sleep disorders that is developed by the Federal Motor Carrier Safety Administration ( FMCSA ) must be adopted through a formal rule making procedure. The term sleep disorders specifically includes obstructive sleep apnea. the new law only applies to requirements implemented or enforced by the FMCSA on or after September 1, Therefore, any FMCSA requirements, rules, or guidance in place before September 1,2013, remain wholly unaffected. H.R does not ban the screening, monitoring, evaluation, and/or treatment of drivers. This means that medical examiners should continue to screen and monitor drivers for sleep disorders as they had prior to the law being enacted. 36

New Exemptions Starting in 2014 the FMCSA began posting applications for exemptions from both the hearing standard and the epilepsy standard If examiners have drivers that do not pass due to these

37 New Exemptions Starting in 2014 the FMCSA began posting applications for exemptions from both the hearing standard and the epilepsy standard If examiners have drivers that do not pass due to these two standards they may apply for an exemption to the FMCSA For epilepsy, the FMCSA seems to be following the MEP recommendations For hearing, the criteria are as of yet unknown Driver will need to contact FMSCA to apply. 37

Medical Marijuana 38 Many states have passed laws allowing the

For commercial drivers, marijuana is a Schedule 1 substance and

Drivers who use marijuana for any reason should be disqualified.

38 Medical Marijuana 38 Many states have passed laws allowing the use of marijuana for both medicinal and recreational purposes. For commercial drivers, marijuana is a Schedule 1 substance and is, therefore, prohibited. Drivers who use marijuana for any reason should be disqualified. The examiner should also document the reason for the use of the drug, as the condition may also be disqualifying.

SGLT2 Inhibitors New medications for the treatment of diabetes Class of SGLT 2 inhibitors includes dapagliflozin, canagliflozin, and empagliflozin Inhibits renal glucose reabsorption Results in

39 SGLT2 Inhibitors New medications for the treatment of diabetes Class of SGLT 2 inhibitors includes dapagliflozin, canagliflozin, and empagliflozin Inhibits renal glucose reabsorption Results in urinary glucose excretion As a result, urine will show large amounts of glucose when tested for drivers on this medication. Examiners will not be able to use the presence of glucose in the urine as evidence of glycemic control 39

How to properly certify an insulin using bus driver in Michigan This process changed with a law taking effect in June of 2010 If the operator has been a bus driver PRIOR to June 22, 2010 AND were

40 How to properly certify an insulin using bus driver in Michigan This process changed with a law taking effect in June of 2010 If the operator has been a bus driver PRIOR to June 22, 2010 AND were diabetic than the grandfather clause applies The driver does not have to be continuously employed or even with the same employer The driver does not have to have been on insulin before the law change, just diabetic. If these criteria are met, than the medical examiner makes the determination whether or not the driver has satisfactory control of his/her diabetes and if so, issues the BLUE State of Michigan School Bus Driver Certificate of Medical Fitness Since this is a state specific exam, it is NOT reported to the NRCME 40

How to properly certify insulin using bus drivers in Michigan EVERYONE ELSE!

qualified: issue regular white card with accompanied by exemption marked. The examiner should fill in insulin/diabetes.

the FMCSA or the waiver from the State of Michigan.

41 How to properly certify insulin using bus drivers in Michigan EVERYONE ELSE! Examiner evaluates and if satisfied that the diabetes is controlled and stable and driver is in all other respects qualified: issue regular white card with accompanied by exemption marked. The examiner should fill in insulin/diabetes. This IS reported to the NRCME since it is a Federal Exam The driver will have to obtain the appropriate exemption from the FMCSA or the waiver from the State of Michigan. Note that the waiver from the state only allows the driver to cross state lines if dropping off or picking up students. It does NOT apply to field trips or sporting events outside of the state. The driver would need a Federal exemption for this. 41

42 Questions? Thank you very much!

Updates in the examination of the Commercial Driver

Updates in the examination of the Commercial Driver Disclosures and Disclaimer No conflict of interest disclosures The views expressed are those of the author and does not reflect official policy of AASM,