Deadline Nears for Public Comments on Revised CDC Opioid Guideline
/By Pat Anson, PNN Editor
The public comment period on the revised draft of the CDC’s opioid prescribing guideline ends Monday, April 11th. So far, over 4,200 comments have been submitted in the Federal Register. You can leave a comment and read the ones already submitted by clicking here. A final revised guideline is not expected to be released by the CDC until late this year.
Like the original guideline, the revised version still maintains that opioids should not be used as a first line or routine therapy for pain, but takes a more flexible approach to dosing. Providers are urged to weigh the individual needs of each patient and not take a one-size-fits-all approach to pain care.
“It’s important to point out that the guideline is not final and the step that we’re at now is a real critical point in the process to wrestle with and get feedback,” Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control, told PNN in February.
“And that’s why it’s important that we hear from readers of Pain News Network to get feedback, to get that experience, so as we move toward a final guideline, we can incorporate that feedback. We hope that insurers, medical community, law enforcement and others will also review the guideline and provide feedback.”
Does 50 MME replace 90 MME?
Perhaps the most controversial change in the opioid guideline is the elimination of dose thresholds. The original guideline strongly encouraged providers not to exceed doses of 90 morphine milligram equivalents (MME) per day. That 90 MME limit has been dropped from the revised draft, but providers are still urged to be cautious about going over 50 MME because higher doses have “diminishing returns in benefits relative to risks.”
That change has led to significant confusion about what CDC is trying to do. Many patients are concerned that 50 MME will be seen as the new recommended limit, a dose they consider low for severe pain.
“Does the 50 MMEs replace the 90 MMEs? This is asking for more and more suicides. Much of the proposed guidelines are the same except you removed 90 MMEs and replaced it with 50 MMEs. Go back to the beginning and start over,” Pamela Hoard wrote in her comment.
“It is ridiculous to put a numerical number, such as 50 MME/day, to a risk/benefit outcome when there is no scientific evidence to support MME's,” wrote Joe Benotz, who said he was a pharmacist. “Using unvalidated MME to guide dosing opioid pain meds has in the past led to significant harms to pain patients. Continued use of MME numbers will cause more harm in the future.”
“I'm a doctor in Michigan who has lost his license because of the 90 MME requirement. It doesn't matter if you add caveats, prosecutors see a limit and it becomes the law. The 50 MME ‘suggestion’ is even worse,” wrote Jonathan Roberston.
The anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) posted a letter in the Federal Register supporting many of the guideline changes, including the cautionary language about exceeding 50 MME. PROP continues to maintain that long-term use of opioids is too risky.
“Available evidence indicates modest benefits of opioids for acute pain relative to placebo, while benefits for chronic pain have not been shown,” PROP said. “New evidence also demonstrates significant risks of high dose opioids (>50 MME/day) and shows that alternatives to opioids often provide equal or superior benefit with a markedly better safety profile. These are important findings which PROP fully supports being widely disseminated to medical professionals and to the public.”
Medical Societies Weigh In
Other medical societies and physician groups generally support the guideline changes, but with important caveats. The American Society of Anesthesiologists (ASA) is concerned about the CDC making new recommendations for treating postoperative pain that are based on “inconsistent” evidence from a small number of clinical trials.
“The agency fails to recognize the complexities around the many different types of surgery that require different forms of pain control, especially that some patient populations may need more pain relief and different therapies than others,” the ASA said in a letter that basically told the CDC to stay in its lane.
“ASA recommends that the agency note in the updated Guideline that clinicians defer to professional medical society guidelines and standards of care for surgical procedures. Medical specialty societies, including ASA, are the experts in perioperative pain care, including postsurgical pain, and are best suited to develop clinical guidelines in this specific area.”
In a move apparently timed to preempt the CDC, the ASA recently joined the American Medical Association and 13 other medical societies in releasing new advice for managing postoperative pain in “complex patients,” such as those with chronic pain and those taking opioids prior to surgery. The societies said patients should be allowed to stay on opioids before, during and after surgery.
Other medical organizations urged the CDC to avoid the mistakes of the past, such as allowing insurers, states, regulators and law enforcement to adopt its voluntary recommendations as inflexible standards of practice.
“It is imperative that the CDC assure the new guidelines emphasize not only support for safe, quality pain care, but also strive for clarity to prevent rigid application of the guidelines and prevent misunderstandings and misapplications that may result in substandard care and needless suffering by patients with unrelieved pain,” said Maureen Cooney, DNP, President of the American Society for Pain Management Nursing.
Other professional societies took offense that their particular specialties were omitted or only briefly covered in the revised guideline.
The American Society of Regional Anesthesia and Pain Medicine urged the CDC to include a “robust discussion” on the use of nerve blocks, epidural steroid injections and other interventional pain procedures.
The American Association of Neurological Surgeons said it was “disappointed” that the revised guideline “fails to adequately explore” implanted neuromodulation devices such as spinal cord stimulators.
And the American Psychological Association was offended by “the obvious, and unfortunate, omission of clinical hypnosis” from the guideline as an alternative pain therapy.
