3/31/14. (- ) Continued push for ê HgbA1c (without regard for hypoglycemia). Pay 4 Performance. (+) Medications continue to advance.

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1 Kurt T. Hegmann, MD, MPH Rocky Mountain Center for Occupational & Environmental Health Dept. of Family and Preventive Medicine University of Utah Teach, Research, Clinic, Administration, Consultation Teaching and Research Grants (CDC/NIOSH); Utah Labor Commission. Some grants are/were transportation-related Take care of patients (primary to tertiary) Consultations >100 businesses, government entities, insurers, and unions FMCSA MRB Chair Remove for driving for 12mo if one severe hypoglycemic event. Certification for up to 1 yr. maximum. Sheth et al (2004) Mortality in epilepsy: Driving fatalities vs other causes of death in patients with epilepsy. Neurology 63; (- ) Continued push for ê HgbA1c (without regard for hypoglycemia). Pay 4 Performance. (+) Medications continue to advance. Less use of hypoglycemic- inducing agents Combination agents available that also do not cause (much/any) hypoglycemia (+) Continuous glucose monitoring equipment Alerts for hypoglycemia (+) Insulin pumps Supplemental oral questions for CDMEs? Supplemental forms for diabetics? Require recent testing? (e.g., glu, creat, A1c, Bruce exercise treadmill) What HgbA1c values acceptable? Require glucose logs/monitor printouts? If so, what is adequate compliance? What [ ] s? 1

2 Require ophthalmology exams, scoring of retinopathy? How much retinopathy is acceptable? If laser treatments, how many if any acceptable? Intraocular injections (e.g., Avastin, bevacizumab) The rest of the story (to date) Sheth et al (2004) Mortality in epilepsy: Driving fatalities vs other causes of death in patients with epilepsy. Neurology 63; Limited data from low quality studies Seizures: 1.13 to 2.16 increased MVC risk Significant risk reduction with reliable aura. No valid studies on likelihood of seizures on antiepileptic drugs Risk of seizure app. 2% after an eight-year seizure free period. (Ed: risk level not relevant to truck drivers) Limited data indicate decline in incidence of seizures after epilepsy surgery Risk declines with length of seizure-free periodapprox. 2 % after eight years. Recommendations-v2-prot.pdf 2

3 Seizure or episode of loss of consciousness resulted from known medical condition (e.g., drug reaction, high temperature, acute infectious disease, dehydration or acute metabolic disturbance) Defer certification until driver has fully recovered, has no existing residual complications, and not taking antiseizure medication. 14 Waiting period - Minimum 10 years off anticonvulsant medication and seizure free According to regulation, NOT certify if: Established history of epilepsy. Clinical diagnosis of epilepsy. Any other condition likely to cause loss of consciousness or any loss of ability to control a CMV. NOTE: If you choose to certify driver with established medical history of epilepsy, be sure to include in your documentation reference to the advisory criteria and all medical evaluation supporting 1 your decision. Minimum waiting period years seizure free and off anticonvulsant medication Maximum certification 1 year Recommend to certify if: Completed minimum waiting period seizure free and off anticonvulsant medication. Clearance from neurologist who specializes in epilepsy and understands functions and demands 16 of commercial driving. NOTE: Epilepsy medical guidelines are currently under review by FMCSA. While there have been no changes through the rulemaking process to 49 CFR (b)(8), current advisory criteria allow that some "drivers with a history of epilepsy/seizures off antiseizure medication and seizure- free for 10 years may be qualified to drive a CMV in interstate commerce. n Epilepsy, conditional cert. if: u Seizure free at least 8 years on or off anti- seizure medication. Stable medication at least 2 years. u Annual recertification n Single unprovoked sz conditional cert if: u Seizure free 4 years on or off anti- seizure medication. Stable medication at least 2 years. u Biennial (every 2 years) recertification 17 3

4 Untreated After First Seizure Actual Values Fitted Values 1% Threshold 2% Threshold y = e x R² = threshold of 1% and 2% at 9.9yr and 7.6yrs Articles: Gilad 1996 First Group 1993 Bonnett 2010 Marson 200 van Donselaar 1991 Kollar Approx. relative risk estimate ~ 4x Approx. absolute risk = 4.% Untreated After First Seizure Actu al Value s y = e x R² = threshold of 1% and 2% at 9.9yr and 7.6yrs Articles : Gilad 1996 First Group Single Unprovoked Seizure All seizure-free. All off AED except MEP. Conf. Report: yr MEP: MRB: Handbook: yrs Data: 10yrs. 4 yr. on OR off med yrs Actual Fitted 1% Threshold 2% Threshold y = e x R² = threshold of 1% and 2% at and months Articles Used: Cardosa 1993 Nakazawa 199 Aktekin 2006 MRCADWSG 1991 Bonnet 2010 Specchio 2001 Epilepsy, off AED All seizure-free.. Conf. Report: 10yr MEP: 8 yr. MRB: 10 yrs. Handbook: 10 yrs Data: 9 yrs

5 Epilepsy, ON AED All seizure-free. Conf. Report: DQ MEP: MRB: 8 yr. DQ Handbook: DQ Data: 14 yrs Actual Fitted y = e x R² = 0.71 Epilepsy - Treated threshold of 1% and 2% at 171. and months Articles Used: Cardoso 1993 Beghi 1988 Kalita 200 MRCADWSG 1991 Bonnet 2010 Specchio 2001 Callaghan 1988 Criteria Based on MEP in conflict with MRB recommendations Epilepsy diagnosis Seizure-free for 8 years, on or off medication If taking anti-seizure medication(s), medication plan should be stable (no changes in medication, dosage, or frequency administration)for 2 years. Annual recertification Single unprovoked seizure (no known trigger) Seizure-free for 4 years, on or off medication If taking anti-seizure medication(s), medication plan should be stable for 2 years. Recertification for drivers with a single unprovoked seizure ACOEM/Hartenbaum CDME Course should 27 be performed 2013 every 2 years. Science being relied on is/was not current. Examiners will be confronted with complex decision- making Levels of risk are calculable. Recommend calculating those risks and being sure the examiner is comfortable with those levels of risk Parkinson s Disease (PD) MEP Recommendations (0/28/2009, 09/1/09) (agreed to by MRB 01/06/2010) Insufficient evidence to predict crash risk Patient Risk Factors to consider in evaluation Movement restriction/ motor function Stage of PD Duration of PD Cognitive function Sudden onset sleepiness MEP recommended that PD precludes unconditional certification

6 Mild symptoms: Hoehn-Yahr Stage 1 or scored >90% on the Schwab-England Activities of Daily Living scale Tolerate meds without cognitive, motor or other SEs that might affect driving No sig. fluctuation in motor response (on-off effects) Satisfactory function on neuropsych battery assessing key cognitive function- should be within or above the normal range. No evidence of mood disorder or satisfactory control of mood disorder (referred to Psychiatric MEP) Evaluation every 6 months by appropriate specialistwritten documentation to CDME examiner 6