AAPM Raise Concerns Over CDC Opioid Guidelines
The Centers for Disease Control and Prevention (CDC) recently drafted a guideline for prescribing opioids for chronic pain. The guidelines cover a variety of essential topics related to chronic pain management, including performing end-of-life care, having risk-and-benefit conversations with patients, the dangers of prescribing opioids with benzodiazepines, and many other important topics.1,2
However, according to the American Academy of Pain Medicine (AAPM), the CDC’s current guidelines actually may be misleading practitioners, giving recommendations based on a flawed evidence review process that excludes a wide breadth of relevant studies.
This could negatively impact the quality of patient care, as the recommendations seem to be more focused on "mitigation of societal risk in response to an epidemic of opioid misuse and abuse, as opposed to quality evidence-based clinical management of pain," noted the association.
The CDC guidelines "are not an evidence-based clinical practice guideline in the conventional sense, in which the clinical trial literature addressing a particular question is reviewed thoroughly and systematically to guide practice recommendations,” the AAPM wrote in a letter to the CDC.
Instead, the CDC raised the bar for study inclusion to one year of outcome reporting, essentially eliminating all data related to opioid efficacy recorded between 3 months to 1 year, noted Daniel B. Carr, MD, President-Elect of the AAPM during a press conference held during the associations annual meeting in Palm Springs, California. This is a concerning omission, as the guidelines are intended for the treatment of pain that lasts past 3 months, he noted.
The association has raised theses concerns before, and like other entities, including Cochrane Collaboration and the Food and Drug Administration (FDA), does accept evidence from clinical trials that last less than one year.
“Now, as a result of setting the threshold duration of clinical observations for efficacy and effectiveness so high that no studies met inclusion criteria for review in the current document, these same and other advisors [Drs. Chou and Ballantyne, and others] have introduced negative bias that could lead to recommendations that adversely impact patient care,” noted the letter.
The AAPM is an interdisciplinary society focused on furthering progress into the safety, efficacy, and cost-effectiveness of evidence-based care for pain management. The group is a member of the CDC’s Stakeholder Review Group and is tasked with reviewing the CDC guideline draft “to improve the specificity and applicability of the recommendations,” according to the CDC website.3
However, the AAPM expressed disappointment in its letter to the CDC, stating that “no substantive changes have been made” since the last time the AAPM described these concerns to the CDC. The AAPM published its own clinical guidelines in 20094 and noted that core principles of the CDC’s own guidelines are far different.
For example, the CDC guideline says providers should implement additional precautions “when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should generally avoid increasing dosage to ≥90 MME/ day.” But according to the AAPM, quoting that dose level is wrong, considering scientific evidence documents individual genetic and environmental factors that can cause varying responses to opioid medications.
“This was the same conclusion reached by the US Food and Drug Administration (FDA) in its 2013 response to the Citizens’ Petition requesting limits on routine opioid daily dose and duration of treatment,” Dr. Carr noted.
The CDC guideline concerns with opioid treatment of acute pain, in which it recommends three of four days-worth of medication as sufficient “for most nontraumatic pain not related to major surgery.” This section also deserves revision, as it seems to stem from guidelines used in emergency departments for nontraumatic or nonsurgical acute pain.
However, many conditions that may fall under that category have been known to have more protracted courses, like pancreatitis and sickle cell disease. So there is a concern physicians would misinterpret the recommendation to be a blanket policy for all acute pain conditions. Instead, the AAPM recommends informing doctors that patients’ pain severity and duration can vary, but rarely exceeds 1 to 2 weeks for most nontraumatic or nonsurgical pain.
“For those patients who require an opioid for longer than 3 days, the additional copays and cost of returning to a physician for a follow up prescription would be burdensome. Other practical difficulties for many seeking to return to a physician's office include scheduling logistics or continuing acute pain,” the association noted.
“While the proposed guidelines may in theory have a positive impact on some of the public health issues regarding opioid abuse, addiction, and overdose, there is also an obligation to protect the ability of physicians to meet the legitimate needs of their patients.” And there is also concern that the guidelines may not be aligned with the statements put forth by the FDA.
The AAPM has not been the only entity publicly critical of the CDC’s new guidelines. Massachusetts Senator Elizabeth Warren also recently sent a letter to the CDC, calling for more areas of research to be investigated, including the long term effects of opioid use on children, the effects of fentanyl, and the possible benefits of medical marijuana.
The Core Expert Group is responsible for the consultation and review of the CDC guidelines and includes CDC scientific staff, as well as representatives from state agencies and professional societies, including the Society of General Internal Medicine, American Academy of Family Physicians, and American College of Physicians. More info about the CDC guidelines can be found here. The AAPM is a member in the CDC guideline’s Stakeholder Review Group, which includes a litany of professional organizations, such as the American Academy of Neurology, the American Academy of Pain Management, the American Chronic Pain Association, the American Society of Anesthesiologists, and many more. More information about the AAPM can be found here.