Driver health & wellness Update on initiatives from the FMCSA MRB Gina C. Pervall, MD Chief, Medical Advisory Board Maryland Department of Transportation Motor Vehicle Administration Bus Industry Safety Council Summer Meeting June 2019

review Medical Advisory Experts Regulations and Guidelines Example of Regulatory Guidance Certified DOT Medical Examiner (CDME)

Federal Motor Carrier Safety Administration FMCSA Established within the Department of Transportation on January 1, 2000 Regulates the trucking industry Mission is to reduce crashes, injuries and fatalities involving large trucks and buses.

Medical review board (MRB) Five-member advisory committee (2006) Provides advice and recommendations to the Secretary of Transportation and the FMCSA Administrator on the development and implementation of science-based physical qualification standards ensuring that drivers are physically qualified to operate commercial motor vehicles

MRB Primarily make recommendations to modify or add standards for drivers Current physical qualification standards, 49 CFR 391.41(b)(1- 13), may not address newer standards of medical practice Discuss medico-legal aspects of commercial driving, and the impact of new technologies Meetings open to the general public

Other experts Medical Expert Panel (MEP) Independent physicians convened to review evidence in research reports about a question or topic Motor Carrier Safety Advisory Committee (MCSAC) 17 experts from the motor carrier safety advocacy, safety enforcement, industry, and labor sectors that provide recommendations to the FMCSA on motor carrier safety programs and motor carrier safety regulations

49 CFR 391.41 - Physical qualifications “A person is qualified to drive if driver has no medical condition that interferes with the ability to control and operate a CMV safely; or condition that could result in sudden incapacitation.”

Disqualifying conditions 49 CFR 391.41 (b)(1) - Loss of foot, leg, hand, or arm (b)(2) - Impairment of hand/finger that interferes with prehension or power grasping; or arm, foot or leg that interferes with ability to perform tasks of operating a CMV (b)(3) - Diabetes requiring insulin November 2018

Disqualifying conditions 49 CFR 391.41 (b)(4) - MI or CAD accompanied by syncope, dyspnea or CHF (b)(5) - Respiratory dysfunction like to interfere with ability to operate a CMV (b)(6) - High blood pressure likely to interfere with the ability to operate a commercial motor vehicle safely

Disqualifying conditions 49 CFR 391.41 (b)(7) - Rheumatic, arthritic, orthopedic, muscular, neuromuscular or vascular disease which interferes with… (b)(8) – Epilepsy or other condition like to cause LOC or loss of ability to control a commercial motor vehicle (b)(9) - Mental, nervous, organic, functional, or psychiatric disorder likely to interfere with the ability to operate...

Disqualifying conditions 49 CFR 391.41 (b)(10)- Distant visual acuity worse than 20/40 in each eye with or without correction OR FOV worse than 70 degrees in each eye and ability to recognize colors of traffic signal (b)(11)- Inability to perceive forced whispered voice in better ear at < 5 feet OR average hearing loss in better ear greater than 40 decibels with or without hearing aid

Disqualifying conditions 49 CFR 391.41 (b)(12)- Uses any drug or substance, including Schedule I, an amphetamine, a narcotic, or other habit-forming drug Non-schedule I drug or specific substance, except when use is prescribed by a licensed medical practitioner (b)(13) - Current diagnosis of alcoholism

Regulation vs guideline Regulation is an authoritative rule 49 CFR 391.41 - Physical qualifications for drivers Standards must be followed by medical examiner Guideline Statement that sets forth policy on the regulation Recommendation that the medical examiner should follow Intended as standard of practice for medical examiners

Regulatory guideline Intended as standards of medical practice for CDME MRB makes recommendations to FMCSA for updates and changes on medical topics of concern Proposed changes to current standards and guidelines are subject to public-notice-and-comment and relevant rulemaking processes Based on Evidence Reports

Evidence reports Comprehensive search of the literature Address several key questions posed by the FMCSA Answers will provide information useful in updating current medical examination guidelines Question: Are individuals with medical condition at an increased risk for a motor vehicle crash when compared to comparable individuals who do not have the disorder?

Example of developing regulatory guidance

Transient ischemic attack (TIA)/stroke 49 CFR 391.41(b)(9) A person is physically qualified to drive a commercial vehicle if that person "Has no mental, nervous, organic, or functional disease or psychiatric disorder likely to interfere with his/her ability to drive a commercial motor vehicle safely."

Evidence report on stroke Evidence Report: Stroke and Commercial Motor Vehicle Driver Safety Executive Summary (2008) Key Question 1: Are individuals who have experienced a stroke at an increased risk for a motor vehicle crash (crash risk or driving performance)? Key Question 2: If so, can neuropsychological testing of individuals who have experienced a stroke predict crash risk? Key Question 3: Among individuals who have experienced a TIA (transient ischemic event), what is the risk of experiencing a future stroke?

Evidence report - TIA and Stroke Risk: Overall Findings Individuals are at an increased risk for stroke following a TIA when compared with their counterparts who did not experience a TIA (Strength of Evidence: Strong). The increased stroke risk is highest immediately following TIA (within one month) and decreases steadily out to five years following TIA (Strength of Evidence: Moderate). The entire evidence base of 13 studies (representing approximately 30,000 individuals) consistently reported an elevated risk of stroke in individuals who experienced a TIA compared with controls who did not experience a TIA. Separate analyses based on four moderate-quality cohort studies with data at multiple follow-up periods suggests that the increased risk is very high within the first month following TIA (at least 65 times higher than the risk for individuals who have not had a TIA) and drops rapidly during the first year. A small cumulative elevated risk continues to decrease steadily out to five years following TIA.

Stroke Risk after tia 65 times higher within first month 12 times higher within one year 1.6 times higher within five years

Recommendations to fmcsa All individuals who have experienced a single TIA be immediately excluded from driving a CMV. Individuals who have remained free from recurrent TIA or stroke for a period of at least one year and who are otherwise physically qualified may be considered qualified to drive a CMV. Expert Panel Recommendations: Stoke and Commercial Motor Vehicle Driver Safety January 2009

Updates to Regulations/Guidance Cardiovascular Diseases – 07, 09 Diabetes – 06, 11, 15 Driver Health and Wellness – 15, 16 Hearing – 08, 11 Kidney Disease - 08 Medical Examiner Handbook – 17, 18 Multiple Sclerosis – 10 Narcolepsy - 10 Obstructive Sleep Apnea – 08, 11, 12, 16 Parkinson’s Disease -10 Psychiatric Diseases – 08, 09 Schedule II Medications – 07, 13, 14 Seizures – 07, 08, 17 Stroke -09 Traumatic Brain Injury - 10 Vision – 08, 12, 15, 18

MRB meeting highlights Cardiovascular Diseases – 07, 09 Diabetes – 06, 11, 15 Driver Health and Wellness – 15, 16 Hearing – 08, 11 Kidney Disease - 08 Medical Examiner Handbook – 17, 18 Multiple Sclerosis – 10 Narcolepsy - 10 Obstructive Sleep Apnea – 08, 11, 12, 16 Parkinson’s Disease -10 Psychiatric Diseases – 08, 09 Schedule II Medications – 07, 13, 14 Seizures – 07, 08, 17 Stroke -09 Traumatic Brain Injury - 10 Vision – 08, 12, 15, 18

MRB meeting recent highlights September 2017: Consider factors for eliminating the need for an exception for seizure/epilepsy October 2016: OSA Guidelines – Joint MCSAC meeting September 2015: Driver Health & Wellness – Joint MCSAC July 2015: Consider factors for eliminating the need for an exception for diabetes and vision

July 2019 MRB meeting July 15th & 16th, 2019 “During the meeting, the MRB will revisit its July 2018 recommendations on revising the FMCSA Medical Examiners Handbook and discuss how to best provide educational materials on pharmacology to certified medical examiners. The MRB will also review a recently completed study assessing the safety performance of commercial motor vehicle drivers operating under the conditions of the Agency's vision exemption program.”

Commercial driver medical examiner CDME is an MD, DO, PA, NP, or DC licensed/certified/registered in accordance with State laws Completed DOT required training and passed the National Registry Medical Examiner certification test Listed on the FMCSA National Registry DOT certification based on regulations and regulatory guidelines

Insulin and dot certification Effective 11/19/2018 CDME makes determination for certification of drivers that have diabetes treated with insulin Certification process includes evaluation by “treating clinician” Treating Clinician must complete the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870 This is NOT certification Required in conjunction with Medical Examiner Report by CDME

Insulin and dot certification MCSA-5870 must have been completed within 45 days of exam Disqualified Unstable insulin regimen, severe eye disease, hypoglycemic episode within preceding 3 months Short-term Certification Lack of blood glucose self-monitoring New Medical Examination Report required after temporary or permanent disqualification

Medications Disqualifying medications: anti-seizure medications for seizure control and Schedule I drugs (heroin, cocaine, LSD, marijuana) What about: Chantix, Opioids, Methadone, Amphetamines, Benzodiazepines Antihistamines, etc. Examiner should obtain a written statement from the prescribing physician, but not required to accept CMV Driver Medication Form (2014)

MEDICAL Marijuana & CBD Schedule 1 substances, including marijuana and CBD are not permitted THC may be found in CBD products Medical marijuana “prescription” and legalization are not acceptable Dronabinol/Marinol (Schedule III)

Obstructive sleep apnea (OSA) Ongoing issue since 2008 2016 MRB recommended screening for driver’s with a BMI = 40 OR 33-39 and 3 or more other risk factors August 2017 – ANPRM withdrawn No FMCSA rules or other regulatory guidance….medical certification is based on examiner’s medical judgement rather than Federal regulation or requirement

Medical examiner determination Pending: Must complete follow-up within 45 days Current valid medical certificate may remain valid Short-term Qualification: New examination required at expiration Disqualification Current valid medical certificate becomes invalid CDME must submit determination to FMCSA by midnight following calendar day

Chief, Medical Advisory Board Gina C. Pervall, MD Chief, Medical Advisory Board Maryland DOT MVA 410-768-7371 gpervall@mva.maryland.gov