Summary for the
January 10, 2007 Medical Review Board Public Meeting

United States Department of Transportation
Federal Motor Carrier Safety Administration
Medical Review Board
Meeting Minutes

The Medical Review Board (MRB) of the U.S. Department of Transportation's (DOT) Federal Motor Carrier Safety Administration (FMCSA) was convened on January 10, 2007 at the Department of Transportation, Washington, D.C. The meeting was open to the public.

MRB Members Present:
Dr. Kurt Hegmann, Chairperson
Dr. Gunnar Andersson
Dr. Michael Greenberg, Co-chairperson
Dr. Barbara Phillips
Dr. Matthew Rizzo

FMCSA Staff:
*Larry Minor, Director of the Office of Bus and Truck Standards and Operations
Dr. Mary D. Gunnels, Chief, Physical Qualifications Division
Kaye Kirby, Team Leader, Medical Review Board
Pearlie Robinson, Co-Leader, Medical Review Board
Madeline Boyd, FACA Officer

*Designated Federal Official

Other FMCSA Staff:
Anthony Critelli
Teresa Doggett, Physical Qualifications
Christine Hydock, Physical Qualifications
Pam Pelcovits, Office Director, Policy, Plans, and Regulations
Linda Phillips, Physical Qualifications
Frederic Wood, FMCSA Fellow

Other:
Natalie Hartenbaum, MD, MPH, Schedule II Drugs Expert Panel member

FMCSA Contractors:
Ellison Wittels, MD, FMCSA Senior Medical Consultant
Stephen Tregear, DPhil, ECRI
Dave Burns, Manila Consulting Group
Laurie Conly, Manila Consulting Group
John Sheridan, Manila Consulting Group
Maria Soto, Manila Consulting Group
Jennifer Duru
Veronica Parham-Dudley
Dellaoise Saunders, Wright Solutions

Members of the Public:
Jacquelin Branche, Virginia Department of Motor Vehicles
Todd Dells, Trucker News
Gerald Donaldson, Advocates for Highway and Auto Safety
Earl Eisenhart, Edison Electric Institute
Katie Hathaway, American Diabetes Association
Ryan Mead, United Parcel Service
Gary Moffitt, Road Ready
Stephen Owings, Road Safe America
David Potts, American Trucking Association
Melissa Theriault, Owner-Operator Independent Drivers Association
Don Vancil, Road Ready
Joel Whiteman, Road Ready

Larry Minor, director of the Office of Bus and Truck Standards and Operations, called the third public meeting of the MRB to order, noting that he is the DFO for the meeting.

The MRB requested, in a departure from normal process, that Natalie Hartenbaum, MD, MPH, explain the issues involving Schedule II drugs. Dr. Hartenbaum, a member of the Medical Expert Panel (MEP) that reviewed the evidence report on the licit use of Schedule II drugs, said that a significant number of crashes in all transportation modes can be attributed to the effects of prescription and over-the-counter drugs. She noted that many prescription drugs carry manufacturer labels that warn about drowsiness as well as impaired reaction time, cognitive function, and psychomotor function. She also voiced concern that some individuals may misuse prescribed and over-the-counter drugs, even when supervised by a physician. Dr. Hartenbaum said the MEP was concerned about use of multiple medications, in addition to Schedule II drugs, and changes in medication use. The MEP felt that Schedule II drugs have a high potential for abuse and can create dependence.

Dr. Stephen Tregear of ECRI was charged by FMCSA with developing an evidence-based research report. His literature search was aimed at identifying studies from which the panel would develop answers to several research questions, such as: Does the licit use of a Schedule II drug represent an increased risk for a motor vehicle crash? Does the licit use of a prescribed Schedule II drug affect mood and behavior, cognitive, behavioral, or psychomotor function, or driving ability on a driving simulator? Finally, there were several other research questions that focused on more specific areas of inquiry—differences in doses, pharmacokinetics, drug interactions, and specific questions about crash risk. Noting that the background rate of crashes among all commercial motor vehicle (CMV) drivers is approximately 0.08 per driver per year, Dr. Tregear explained that evidence pertaining to crash risk among users of Schedule II drugs must control for this fact. Consequently, case reports and most uncontrolled case series studies do not constitute good evidence.

With regard to the relationship between the licit use of Schedule II drugs and crash risk, Dr. Tregear’s research team identified 648 potentially relevant studies. On retrieval, however, only 49 were found to be directly relevant or controlled. After reviewing the 49 studies in detail, the research team determined that none qualified for inclusion in their analysis. The primary reason for this was that many studies included both licit and illicit Schedule II drug users. Dr. Tregear noted that the inclusion of illicit drug users, who do not use the drugs at stable therapeutic doses, precludes one from using these studies to address the question of primary importance to FMCSA—what is the crash risk among licit users of Schedule II drugs?

Dr. Tregear presented data from several studies that evaluated the effects of Schedule II drugs on simulated driving ability, cognitive and psychomotor performance, and mood and behavior. He noted that studies were of two types—single-dose studies that evaluated the effects of the drugs in opioid-naïve individuals (those unaccustomed to taking the drug) and longer-term studies that examined the effects of Schedule II drugs on performance among longer-term licit users of the drugs who use them to treat legitimate medical conditions. Dr. Tregear noted the importance of reproducibility—more than one study of a reasonably-focused outcome that produced similar results—which was lacking among the studies. He noted that a few studies of a single dose of drugs supported the conclusion that some Schedule II drugs may have a negative effect on driving ability and cognition and psychomotor performance in naïve drug users; however, he also noted that data from longer-term studies did not provide support for the contention that Schedule II drugs continue to have a deleterious impact on these performance measures when used chronically to treat legitimate medical conditions.

Dr. Hartenbaum presented the recommendations of the MEP, one of which would specifically affect current regulations. The MEP recommended the removal of the current exception that allows a driver using prescribed Schedule II drugs to drive a CMV if the substance or drug is prescribed by a licensed medical practitioner who 1) is familiar with the driver’s medical history and assigned duties and 2) has advised the driver that the prescribed substance or drug will not adversely affect the driver’s ability to operate a CMV safely.

Dr. Hartenbaum reported that the MEP strongly recommends that FMCSA instruct the research team to lift restrictions on the inclusion criteria used in the evidence report described by Dr. Tregear. The panel suggested that the inclusion criteria should be changed so that drugs that fall into Schedule III and IV are also considered, that data from crash studies that included individuals who use prescription drugs illicitly be included, and that case-series and case reports be considered.

Other recommendations from the MEP included the expansion of the current random drug testing regimen to include a broader range of drugs, narrowing the definition of “prescription drug use” to exclude use of out-of-date prescription drugs and use of drugs prescribed to others; expanding safety education for both carriers and drivers on the effects of medications; and developing guidelines for examiners for deciding on return-to-work issues. Dr. Hartenbaum suggested that the MRB consider policies similar to the Federal Aviation Administration (FAA), which can restrict the type of equipment operated (e.g., local versus interstate trips); and consider a guideline for allowing resumption of driving duties after the termination of drug use.

During final deliberations, the MRB approved three motions:

1. That the FMCSA obtain additional information about how other entities (e.g., Federal agencies and non-U.S. transportation organizations) deal with similar issues,
2. That the FMCSA review the current drug test regimen with an eye to expanding it to include drugs not currently covered, and
3. That the absence of acceptable evidence-based research does not imply the absence of a potential effect that would adversely affect a driver’s abilities.

During public comment, Stephen Owings (Road Safe America) endorsed the expert panel’s recommendation to eliminate the exception for commercial drivers who are on Schedule II drugs. Earl Eisenhart (Edison Electric Institute) requested clarification on Dr. Phillips’ motion. Dr. Phillips explained that the motion should result in an assessment by FMCSA to determine what drugs should be added to pre-employment and random drug testing. Mr. Minor said that would be a considerable undertaking, as it would require working with the Office of the Secretary of Transportation and all other transportation modes covered by DOT.

Disclaimer: FMCSA considers evidence, expert recommendations, and other data; however, all proposed changes to current standards and guidance will be subject to public notice-and-comment and regulatory processes.

Click here to access Medical Expert Panel reports.

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