BY
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, IN THE SPIRIT OF WALTER R. CLEMENT BS., MS., MBA., BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“THE OPIOID WAR AGAINST PATIENTS IN PAIN”
January 12, 2016
Thomas Frieden, MD, MPH
Director
Centers for Disease Control and Prevention 1600 Clifton Road
Atlanta, GA 30329-4027
Re: Docket No. CDC-2015-0112; Proposed 2016 Guideline for Prescribing Opioids for Chronic Pain
Dear Dr. Frieden:
On behalf of our physician and medical student members, the American Medical Association (AMA), the largest physician organization in the U.S., appreciates the opportunity to review and comment on the Centers for Disease Control and Prevention’s (CDC) Proposed Guideline for Prescribing Opioids for Chronic Pain. We commend CDC’s decision to open up a period of public comment to allow a broader group of important stakeholders the opportunity to provide their unique perspectives on the public health challenges related to the intersection of pain management, prescription opioid use, and opioid diversion, misuse, and unintentional overdose.
The AMA shares with CDC the goal of reducing the burden of harm from controlled substances, including opioid analgesics. The individual and family tragedies and societal costs attributable to opioid- related overdose, emergency department visits, deaths, and addiction are deeply concerning. To make meaningful progress towards ending this epidemic, a broad-based public health approach is required.
This approach must balance patients’ needs for comprehensive pain management services, including opioid analgesics when clinically appropriate, with efforts to promote appropriate prescribing, reduce diversion and misuse, promote an understanding that substance use disorders are chronic conditions that respond to treatment, and expand access to treatment for individuals with substance use disorders.
As it has done in addressing so many other serious epidemics, the AMA applauds CDC for treating the epidemic of opioid overdose deaths as a high priority. We continue to recommend that CDC’s efforts in this area be aligned with those of other federal partners, including the White House and its Office of National Drug Control Policy, the Interagency Pain Research Coordinating Committee and its National Pain Strategy, the National Institute on Drug Abuse, the Substance Abuse and Mental Health Services Administration, the Department of Health and Human Services, and the U.S. Surgeon General.
The White House initiative announced in October 2015 is designed to forge a collaborative effort involving multiple stakeholders in the medical community working towards a single set of measureable objectives. This collaborative effort includes commitments from the AMA, the American Dental Association, and the American Osteopathic Association, as well as other medical specialty societies and state medical associations. In a separate effort to engage the physician community more directly to implement solutions to opioid misuse and harm, the AMA formed a Task Force of national medical specialty society
AMA
to:
Thomas Frieden, MD, MPH January 12, 2016
and state medical association partners to promote appropriate pain care and reduce opioid-related harm by encouraging physicians to register for and consult their state’s prescription drug monitoring program, access available high quality educational offerings intended to reduce opioid misuse and harm, expand the use of naloxone, and reduce the stigma commonly experienced by patients with chronic pain or substance use disorders (www.ama-assn.org/go/endopioidabuse).
GENERAL COMMENTS ON CDC METHODS AND RECOMMENDATIONS
While the discussion under several of the specific draft recommendations has been revised and/or amplified based on designated stakeholder input and provides additional clarity, the recommendations themselves are largely unchanged from the initial draft.
Accordingly, while the AMA supports many of the recommendations, we continue to have serious concerns that some either contain a degree of specificity not supported by the existing evidence or conflict with official Food and Drug Administration (FDA)-approved product labeling for opioid analgesic products. It seems incongruous that virtually all of the specific guidelines carry a graded recommendation that CDC believes should “apply to all patients with chronic pain and that…most patients should receive the recommended course of action,” given the limitations of the evidence, especially where CDC experts’ opinions are the essential foundation for the recommendation.
States regulate the practice of medicine and many already have adopted opioid prescribing guidelines that were developed by a coalition of state-based stakeholders, including physicians and other health care professionals, public health officials, patients and patient advocates, and policy makers working together to ensure balance.
The low or very low quality of evidence supporting the proposed CDC guidelines has the potential to create considerable confusion in the states. While CDC has acknowledged that the guidelines are advisory in nature and they do not intend for state legislators, professional licensing boards, hospitals, insurers, courts, or others to “officially” implement or follow specific elements of the guidelines, this is not a practical or realistic expectation given the national respect that comes with a guideline issued by CDC.
Accordingly, concerns remain about potential unintended consequences for patients depending on how specific elements of the guidelines (as written) may be interpreted, implemented, or enforced. Some patients with chronic pain who have maintained functional improvement on stable opioid doses are already experiencing difficulties in keeping their current source of care and/or finding physicians who are willing to treat them.
While the summary and introductory discussion acknowledge that “the guideline does not focus broadly on pain management,” and “it is important that patients receive appropriate pain treatment,” the guideline otherwise lacks a patient-centric view, other than to note that for patients who are already maintained on “high opioid dosages,” “providers should empathetically review benefits and risks of continued high dose opioid therapy and should offer to work with the patient to taper opioids to safer dosages.”
Although the guideline is expressly focused on prescribing opioids for chronic pain, by crafting the firstrecommendation as “nonpharmacologic and nonopioid pharmacologic therapies are preferred for chronic pain,” CDC cannot disavow an obligation to frame the pain management discussion in a balanced fashion. The AMA, therefore, asks that CDC include patient advocates in its formal review of these and other comments to ensure that patient needs are adequately addressed.
The AMA has great respect for the core mission and activities of CDC that are designed to protect the health of the public. Individuals from a variety of disciplines and settings with specific expertise were chosen for the expert panel, a reflection of the challenges faced in trying to address this complex public health issue in a balanced fashion.
The expert panel was charged with the most significant assignment in this process. It appears, however, that only a limited number of clinicians who are actively managing chronic pain patients were included. While it is necessary to integrate various disciplines because of the complex nature of prescription drug misuse and addiction, the process moving forward would benefit from a balanced Advisory Committee that includes patient advocates, as well as clinicians from various medical specialty and practice settings representing a diverse set of views and experiences in treating chronic pain and opioid use disorder, and limiting participation of individuals aligned with public policies that may have a predictable effect on the recommendations.
This type of approach is even more important when the evidence-base is limited, thereby requiring a consensus-type approach and the use of “expert opinion.” The AMA asks, therefore, that before commencing with the formal review and consideration of revisions submitted by stakeholders, CDC broaden the Advisory Committee by inviting patient advocates and clinicians, including physicians, pharmacists, and dentists, who treat a broad base of patients with pain.
The AMA would be pleased to recommend physicians from member organizations of the AMA Task Force to Reduce Opioid Abuse to help accomplish this.
Finally, the change in terminology from “low quality” or “very low quality” evidence to category 3 or 4 evidence is not helpful to the reader and primarily serves to camouflage the criticism derived from issuing “strong” recommendations based on low quality evidence. Because the guidelines may eventually be used by a broad range of stakeholders as described earlier, the AMA recommends that CDC clearly identify the quality of the evidence used by returning to the easily understandable and common sense language used in the original draft.
SPECIFIC COMMENTS ON CDC RECOMMENDATIONS
Recommendation #1:
Non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks to the patient (recommendation category A, evidence type 3).
Expanding the discussion on various non-opioid pharmacologic therapies is a helpful revision. Clearly, the use of acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) for musculoskeletal pain and certain antiepileptic or antidepressant drugs for neuropathic pain are well-established treatments. While it is true that NSAIDs can be helpful for mild-moderate musculoskeletal pain, the risks associated with both the acute and chronic use of these drugs should not be minimized. Much attention has been devoted to limiting the use of NSAIDs to the lowest dose for the shortest duration of time (Alliance for Rational Use of NSAIDs; http://nsaidalliance.com).
The evidence review concludes that “several non-pharmacologic and non-opioid pharmacological treatments have been shown to be effective in managing chronic pain.” The evidence presented for the effectiveness of non-pharmacologic approaches focuses on cognitive behavioral therapy (CBT), exercise therapy, and integrative, multimodal therapies. While some modest short-term effects are apparent, none of these studies are sufficient to conclude that such approaches can be widely implemented and are effective for long-term use. Broad-based, effective implementation would require large-scale changes in the public and private payer communities and better evidence to inform the most effective non-pharmacologic approach for various chronic pain conditions.
Furthermore, access to non-pharmacologic and non-opioid pharmacological treatments and reimbursement for them are often inadequate, especially for multidisciplinary care (http://www.painmed.org/files/minimum-insurance-benefits-for-patients-with-chronic-pain.pdf). The National Pain Strategy specifically identifies that a pressing need exists to assess insurer practices such as prior authorization, step therapy, fail-first protocols, specialty tier payment structures, and other limits on reimbursement for multidisciplinary care treatments that act as barriers to effective care.
Moreover, it is not clear how many primary care clinicians (the target audience of these guidelines) are proficient in offering important non-pharmacologic approaches, including mindfulness, focused imagery, biofeedback, relaxation, or CBT, which at its most comprehensive implementation requires a multidisciplinary approach performed by various experts. This recommendation may be interpreted as requiring a “fail-first” approach of all available treatments for chronic pain before opioids should even be considered.
We ask that CDC clarify that it does not support fail-first protocols or other policies meant to inhibit access to care, especially for serious illnesses and conditions such as chronic pain.
We also reiterate our concerns about the evidence base used to inform the guidelines. It is unclear from the discussion whether the standard for the non-pharmacologic and non-opioid pharmacological treatments also required randomized trials with a study duration of one year to be included in the efficacy analysis.
The methodology description notes that evidence for the guideline is built on systematic reviews conducted in 2009 and 2014, with an update of the 2014 review. However, the inclusion criteria for opioid efficacy studies were changed from a best-evidence approach in 2009 to a one-year, randomized
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