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  • ACOEM Files Comments with FDA Regarding Opioid Education for Prescribers

    December 7, 2011

    Division of Dockets Management (HFA-305)
    U.S. Food and Drug Administration
    5630 Fishers Lane, Room 1061
    Rockville, MD 20852

    Dear Sir or Madam:

    The American College of Occupational and Environmental Medicine (ACOEM) is pleased to submit comments on the Food and Drug Administration’s (FDA) draft document entitled “Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS” (Blueprint). The draft Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended-release opioids under the required risk evaluation and mitigation strategy (REMS) for these products (Opioid REMS).

    ACOEM is the nation’s largest organization representing the voice of the nation’s physicians who practice occupational and environmental medicine (OEM). The specialty is devoted to prevention and management of occupational and environmental injury, illness, and disability, and the promotion of health and productivity of workers, their families, and communities.

    ACOEM and occupational physicians are leaders in addressing occupational issues associated with prescription drug abuse. For example, ACOEM is recognized by the U.S. Department of Transportation for providing continuing medical education for medical review officers (MRO). An MRO is a person who is a licensed physician and who is responsible for receiving and reviewing laboratory results generated by an employer's drug testing program and evaluating medical explanations for certain drug test results.

    ACOEM publishes the Occupational Medicine Practice Guidelines to help providers provide effective evidence-based evaluation and treatment of occupational injuries and illnesses. They are intended to help improve or restore the health of those workers who incur occupationally related illnesses or injuries. The workers’ compensation system in each state provides a mechanism to ensure that medical care is provided to individuals when they suffer injuries at work. Most states provide unlimited care in an effort to cure and relieve the results of work-related injury or illness.

    ACOEM offers the following recommendations for your consideration: 

    • Evidence supporting safety and efficacy of long-term use of opioids is lacking. Factually, this is a major epidemic of deaths. Thus a lack of safety is being demonstrated. 
    • Numerous alternatives to opioids should be considered first. Many other strategies include non-steroidal anti-inflammatory medications, aerobic exercise, and strengthening exercise.
    • Patients must demonstrate functional gains. Without functional gains, end of life care being an exception, opioids should be stopped or tapered. 
    • Incorporate increased risks from multiple or high dose opioids. Although they are not long acting, these medications represent considerable risks.
    • In addition to being familiar with how to initiate therapy, modify dose, and discontinue use of opioids, we recommend that prescribers need to be familiar with monitoring use of opioids. 
    • Prescribers need to be educated on increased risks associated with doses measured as higher morphine equivalents (MEQs). Narcotic medications vary in their effectiveness of relieving pain. The same number of milligram doses of different narcotics may indicate different strengths. For example, 1 milligram of oxycodone is equivalent to 1.5 milligrams of morphine, while 1 milligram of hydrocodone is equivalent to 1 milligram of morphine. Patients on 120 MEQs or more (or some other dose and/or duration threshold trigger) should be assessed for effectiveness, tolerance and whether safer options exist to manage the pain. 
    • We recommend including a discussion of the use of quality clinical practice guidelines for the management of chronic non-malignant pain with opioid medications. ACOEM has provided the its Guidelines for the Chronic Use of Opioids at no charge to the medical community. 
    • Providers should understand and be able to appropriately utilize substance abuse testing as another screening tool for appropriate opioid use, addiction, abuse or diversion. 
    • We urge FDA to consider recommending the use of PPAs as is widely customary in numerous guidelines.

    Thank you for your consideration of these comments.

    Sincerely,

    T. Warner Hudson MD, FACOEM, FAAFP
    President
    American College of Occupational and Environmental Medicine


    1See www.acoem.org/uploadedFiles/Knowledge_Centers/Practice_Guidelines/Chronic%20Pain%20Opioid%202011.pdf.