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  • ACOEM Urges FMCSA to Withdraw Proposed CMV Medication Form

    January 25, 2016

    Docket Services
    U.S. Department of Transportation
    1200 New Jersey Avenue, SE
    West Building. Ground Floor, Room W12-140
    Washington, DC 20590-0001

    Re: Docket No. FMCSA-2015-0180

    To Whom It May Concern:

    On behalf of the American College of Occupational and Environmental Medicine (ACOEM), we welcome the opportunity to comment on the Federal Motor Carrier Safety Administration’s (FMCSA’s) proposed Information Collection Request titled 391.41 CMV Driver Medication Form.

    ACOEM has long been a proponent of FMCSA providing appropriate tools for use by those medical examiners with appropriate training and knowledge to determine the medical fitness of the commercial motor vehicle (CMV) driver. The proposed Medication Form, however, falls far short of being able to adequately assess whether a driver will be impaired by medications or an underlying medical condition. The current process used by many examiners (either simply asking the driver if they have side effects or requesting a note from the treating provider) is clearly inadequate. Therefore, for this reason we urge FMCSA to withdraw the ICR to provide time for further revisions.

    Of particular concern, is that the proposed form does not go far enough to address the use of opioids by drivers and the rapid increase in adverse effects of opioid use. Several FMCSA sponsored Evidence Based Reviews and recommendations from Medical Expert Panels and FMCSA’s Medical Expert Panel have consistently recommended against permitting those on opioids from operating commercial motor vehicles due to the increased risk of crash and the inability to distinguish those who are impaired from those who are not. FMSCA should strive for a form that becomes the standard of practice that requires the treating provider and examiner to be aware of medications and conditions, including opioid use.

    But the truth is many health care providers do not fully understand the safety risks and responsibilities of the CMV driver and would rely on their patient’s statement to complete the form. The form would then be reviewed by a commercial medical examiner (CME), who may have minimal to no training in pharmacology, to determine whether to accept the statement of the treating provider. This only serves to generate more paperwork, with no but substantive improvement over the current process.

    We are aware that the original proposed version of this form and even versions that had been provided to FMCSA back to the time of the 2006 Schedule II Medication Panel had significantly more content. This content would have at least given the treating provider and examining physician a clearer understanding of the impairment risks of the medications of concern.

    At a minimum, any form used should incorporate some of the recommendations from the MRB and MCSAC Joint Task 14-3: Schedule II Controlled Substances and CMV Drivers such as those below:

    A. Recommendations: The MRB and MCSAC believe that a driver should not be qualified medically to operate a CMV while he/she is under treatment with narcotics or any narcotic derivative without exception.
    1. However, while the current exception remains in the Federal Motor Carrier Safety Regulations (FMCSRs) (see 49 CFR 391.41(b)(12)(ii)), the MRB and MCSAC recommend that FMCSA provide the following guidelines regarding use of narcotics to CMEs:
    a. A CME should consider whether the underlying medical condition requiring the use of the narcotic(s) is sufficiently impairing to affect whether a driver is qualified medically to perform safety-sensitive duties, including driving a CMV.
    b. A driver should not be under the influence of narcotics while performing safety-sensitive duties, including driving a CMV.
    c. If a driver uses narcotics while off duty, he/she must not use the narcotic for a minimum of 8 hours (if using short-acting narcotics) or 12 hours (if using long-acting narcotics) before resuming safety-sensitive duties, including driving a CMV.
    d. The CME should consider using the CMV Driver Medication Questionnaire or similar document to aid in determining the qualification of the driver. The CME should consider obtaining medical records to ensure that the use of the narcotic medication(s) or narcotic derivative is consistent with current best practices for chronic pain and disease management.
    e. If it is determined that the driver can be qualified medically, certification should be for no more than 1 year.
    f. The CME should consider disqualifying a driver for the usage of other impairing or habit-forming drugs when used in combination with a narcotic or narcotic derivative.

    It is also essential that, with the use of any standardized form, FMCSA follow recommendation IV of that group, in order to provide the CME with a better understanding of the pharmacology of the medications they are being required to evaluate:

    IV. Education for CMEs Regarding Medications that may Impair Driver’s Ability to Operate a CMV Safely
    A. Several classes of medications have the potential to affect adversely the driver’s ability to operate a CMV safely.
    B. Recommendations:
    1. Therefore, FMCSA should educate the CME regarding safety concerns related to such medications and advise the CME that during the certification process particular attention should be given to the following classes of medications: Anticoagulants, Antivirals, Anxiolytics, Barbiturates, Chemotherapeutic Agents, Experimental, Hypoglycemic, Investigational, Mood-ameliorating, Motion Sickness, Narcotic, Sedating Antihistaminic, Sedative, Steroid drugs, and Tranquilizers; as well as medications with a U.S. Food and Drug Administration (FDA) Black Box warning of side effects that include syncope, loss of consciousness, seizure provoking, arrhythmia, hypoglycemia, and psychosis.

    While the medical form may be seen by some as a step in providing the examiners tools to determine whether the driver presents a risk to himself or others on the highway, it is insufficient in its proposed form. Many of those on the national registry have little or no training in pharmacology and the pharmacokinetics and side effects of potentially impairing medications. At the same time, drivers’ personal providers, who will complete this form, will generally rely on information from the driver to determine whether they have had any side effects from the medication, rather than a more informed and objective analysis.

    Thank you for your consideration of these comments. Please contact Patrick O’Connor, ACOEM’s Director of Government Affairs, if you have additional questions or need additional information. He can be reached at 202-223-6222 or by e-mail at patoconnor@kentoconnor.com.

    Sincerely,

    Mark A. Roberts, MD, PhD, MPH, FACOEM
    President

    Natalie P. Hartenbaum, MD, MPH, FACOEM
    Chair, Transportation Section