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  • ACOEM Comments to FDA on Opioid Prescribing Activity

    March 15, 2018

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

    Re: FDA–2017–N–6502

    To Whom It May Concern:

    On behalf of the American College of Occupational and Environmental Medicine (ACOEM), I am providing comments in response to the January 30 hearing held by the U.S. Food and Drug Administration — “Opioid Policy Steering Committee: Prescribing Intervention — Exploring a Strategy for Implementation.”   

    The current national dialogue about the use of opioids in medical treatment provides an example of the tension between process and outcomes — with the discussion increasingly focused on the importance of functional outcomes as the best assessment measure for opioid effectiveness. The recent creation of new strongly outcome-oriented guidelines and standards for opioid treatment offered by multiple organizations, is a signal of the importance of creating consistent, agreed-upon, outcome measures to achieve value. If more providers prescribing opioids were focused on similar functional outcomes as their treatment goal, the health system as a whole would be better equipped to reduce opioid abuse.1

    Functional outcomes refer to the patient’s ability to perform everyday activities such as exercise, driving, walking, household duties, and work. It is well known that opioids are not the only, nor best, treatment for non-acute pain. In addition, their use should not be extended beyond the generally short period needed to assuage acute pain. However, physician who are not monitoring the patient’s functional progress and are recording only pain scale responses are likely to over-prescribe opioids. The major reason providers are not following these goals is that they are not included in the routine medical record nor is functional status a required element in the electronic health record (EHR).

    We are requesting that the FDA petition the Office of the National Coordinator for Health Information Technology (ONC) to investigate the feasibility of requiring an element reflecting patient function be added to the EHR. Assessment of patient function is the mainstay in determining when opioids may be needed, how long they should be continued and how to prescribe them in a chronic pain setting.

    We note that numerous tools are available for assessing functional improvement. The AMA and the CDC opioid guidelines suggest that clinicians use validated instruments such as the three-item “Pain average, interference with Enjoyment of life, and interference with General activity” (PEG) Assessment Scale to track patient outcomes.2,3,4 However there are also other validated functional scales available.   

    The CDC guidelines emphasize the use of non-pharmacologic and non-opioid treatment as a first step. If functional recovery does not occur, an opioid may be considered as a second step only when treatment goals have been clearly established with the patient and a validated instrument, such as the PEG, has been completed to establish a baseline.5  During opioid therapy the provider is to emphasize the primary goal of improvement in function even when pain is still present. Guidelines from virtually all other societies, including ACOEM’s specific guidelines6 for opioid use and Washington state’s opioid guidelines, focus on functional performance of the patient as the primary outcome and factor determining treatment.  

    While not specifically related to opioids, the consistent use of care focused on functional outcomes has been shown to decrease the cost of medical care and the resulting disability from an injury in working populations. Thus, benefits from the addition of this element to the EHR are likely extend significantly beyond the isolated population of those eligible for opioid use.

    Opioid prescribing activity is unlikely to conform to guideline recommendations and thus decrease inappropriate prescribing unless functional elements are available in the EHR. Therefore, ACOEM requests that the FDA encourage ONC to include this element in the EHR in order to address the opioid crisis.

    Thank you for your consideration of these comments.


    Charles M. Yarborough III, MD, MPH, FACOEM 



    2CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016

    3Krebs EE, Lorenz KA, Bair MJ, et al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009;24:733–8.

    5Recommendation 1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate (recommendation category: A, evidence type: 3). CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016.

    6https://www.mdguidelines.com -- ACOEM Guidelines Opioids April 2017 -- including tracking functional activities and discontinuing opioids when no functional gain is achieved.