I think that I posted when they announced that they were going to renew the 2016 guidelines, that over my 5+ decades of watching bureaucrats… when an existing rule/law/regulation gets re-opened to improve it… it seldom makes things better…. more often than not… things get worse. With this version of the opiate dosing guide, there is only five “experts” with at least one returning from the original committee… there is some 20 pages of footnotes and references and one ENTIRE PAGE – containing abt 12 references with the first name listed as a author on all these references is one of the five “experts” on this edition of the guidelines.
Since the publishing of the 2016 guidelines, a physician published a article – which basically created the genealogy of the MME system – which showed that the conclusions of the MME system have no science behind them nor double blind clinical trials. Yet these five “experts” referenced the same MME system as to determine “recommended” daily opiate limits. Since pain management is dealing with a subjective disease. There are no definitive tests to determine if the pt is in pain nor the intensity of their pain and the typical chronic pain pt… their intensity of pain will vary – sometimes dramatically – day to day and/or within a single 24 hr period.
In June, 2022 a SCOTUS ruling (9-0 vote) https://www.pharmaciststeve.com/supreme-court-tells-cops-to-stop-playing-doctor-but-will-they-listen-or-back-to-business-as-usual/ basically told the DEA that they cannot use objective criteria when judging a prescriber in how they treat/dose opiates for pts dealing with subjective diseases – like pain. Here we are a few months later with the CDC coming out with objective criteria … suggesting how prescribers should dose opiates in treating chronic pain. If SCOTUS tells the DEA not to use objective criteria to decide if a prescriber is properly treating a chronic pain pt. Then how can it be legal for FIVE “experts” to create objective criteria in how prescribers should treat chronic pain pts. Isn’t that why a person gets a medical degree and passes the state’s medical licensing boards… to practice medicine and treat pts. The practice of medicine can be broken down into two primary functions – diagnosing the medical issue(s) that the pt is dealing with and starting, changing, stopping a pt’s therapy.
Isn’t the CDC attempting to supersede the FDA dosing guidelines and interfere with the professional discretion granted to the prescriber by the state licensing board ?
The CDC Replaces Flawed 2016 Opioid Prescribing Guideline with a Flawed 2022 Opioid Prescribing Guideline
Responding to medical experts, including the American Medical Association, who have been complaining for years that the Center for Disease Control and Prevention’s 2016 Guideline for Prescribing Opioids for Chronic Pain lacked a strong basis in the evidence—and after it issued an Advisory in 2019 stating the Guideline was misinterpreted and “misapplied” by state lawmakers and health care practitioners—the CDC announced it was going to revise the Guideline before the end of 2022. Unfortunately, 38 states have already cast the flawed 2016 Guideline in stone by enshrining—and misapplying—all or part of it in statutes that dictate how health care practitioners may treat patients in pain.
In February of this year, the CDC released a draft of the revised Guideline and requested comments. I provided my comments here. In those comments, I stated. “Notwithstanding the well‐intentioned exhortations and disclaimer in the draft 2022 opioid prescribing guideline, the recommendations change very little from those put forth in 2016.”
The CDC goes to great lengths to stress throughout the draft 2022 Guideline that the document is meant to serve as a list of suggestions and recommendations and is by no means intended as a mandate, emphasizing that physicians should use their best clinical judgment to provide individualized treatment to their patients. However, I commented, “The CDC guideline will inevitably become interpreted and adopted as hard and fast rules by state and local governments, pharmacies, health plans, and third‐party payers, despite guideline warnings against doing so.”
I also criticized the draft for suggesting dosages based on “morphine milligram equivalents” of opioids:
For example, the guidelines still rely on Morphine Milligram Equivalent (MME) dose recommendations, even though there is no pharmacologic or biochemical basis for relying on equianalgesic conversion factors.
The use of MME conversion tables is nothing more than junk science. As Dr. Nabarun Dasgupta of the University of North Carolina Injury Prevention Center has written:
Contrary to conventional wisdom, conversion values are not based on pharmacologic properties. Instead, they arose 60 years ago from small single‐dose clinical studies in postoperative or cancer populations with pain score outcomes; toxicologic effects (e.g., respiratory depression) were not evaluated.
On November 3, the CDC published the final version of the 2022 Clinical Practice Guideline for Prescribing Opioids for Pain. The Guideline no longer recommends MME dosage thresholds, but it still urges practitioners to be cautious about prescribing more than 50 morphine milligram equivalents of opioids per day, stating :
Many patients do not experience benefit in pain or function from increasing opioid dosages to ≥50 MME/day but are exposed to progressive increases in risk as dosage increases. Therefore, before increasing total opioid dosage to ≥50 MME/day, clinicians should pause and carefully reassess evidence of individual benefits and risks. If a decision is made to increase dosage, clinicians should use caution and increase dosage by the smallest practical amount.
To prevent the recommendation from being “misapplied,” the Guideline adds the following disclaimer to the above paragraph:
The recommendations related to opioid dosages are not intended to be used as an inflexible, rigid standard of care; rather, they are intended to be guideposts to help inform clinician‐patient decision‐making.
Alas, the 2022 Guideline still includes the now‐discredited MME conversion table that providers can refer to when prescribing opioids.
The Guideline recommendations are still primarily based on “Type 3” and “Type 4” evidence, evidence with important limitations.
If the past is prologue, expect the Guideline’s suggestion to use caution approaching a dose of 50 MME to morph into another de facto mandate as lawmakers, pharmacies, and insurance plans fixate on that number. As Josh Bloom and I have written before:
When a government agency “recommends” a policy, it’s akin to a recommendation from Tony Soprano; it is inevitably interpreted as a mandate, obeyed by state and federal agencies, health insurers, and even pharmacies.
Perhaps most egregiously, the rationale of the 2022 Guideline remains predicated on the flawed assumption that overprescribing opioids caused the overdose crisis. There is no correlation between prescription volume and the nonmedical use or addiction to prescription opioids. And the percentage of people aged 18 or older addicted to prescription pain pills has been unchanged at less than one percent this entire century. The CDC should follow the evidence and abandon this mistaken premise.
Finally, as I concluded in my comments on the draft proposal back in February 2022:
1‑The Centers for Disease Control and Prevention should not be issuing opioid prescribing guidelines. Professional specialty organizations, overseen by practicing clinicians and clinical educators, are the institutions that should be issuing standard of care and best practices guidelines.
2‑The CDC guideline will inevitably become interpreted and adopted as hard and fast rules by state and local governments, pharmacies, health plans, and third‐party payers, despite guideline warnings against doing so.
3‑The 2022 guideline very closely resembles the 2016 guideline and is based on weak evidence; in the case of Morphine Milligram Equivalent recommendations, the guideline is pharmacologically unsound, and the conversion tables are based largely on decades‐old subjective studies that didn’t even examine toxicologic effects such as respiratory depression rates.
4‑The overdose crisis is largely caused by a growing population of nonmedical drug users intersecting with increasingly dangerous drugs being developed for the black market fueled by drug prohibition. Efforts to address the problem through reductions in opioid prescribing have only exacerbated the situation by driving nonmedical users to more dangerous drugs while depriving pain patients of necessary relief.
5‑The Centers for Disease Control and Prevention should abandon its efforts to establish a prescribing guideline and defer to the professional institutions usually charged with establishing best practices.
Nothing in the just‐published Guideline makes me want to reconsider that conclusion.
Filed under: General Problems
Thank you for the facts , and I agree with you totally on the fallacies in the cdc recommendations . I am patiently waiting for the pendulum to swing back to common sense in pain management , but am mad as heck at the current status. Our enormous Methodist hospital system here in Houston, tell patients before surgery that only Tylenol with codeine will be on board for pain management. No wonder alcohol deaths are up so high, too!! I am very discouraged as I am not actively working behind a pharmacy counter advocating for my pain mgmt customers!!
Keep up the fight!
Nena Marshall RPh
MY question is (for those of us with foggy brains due to horrible Untreated pain), what is the very bottom end or short layman version? Will this Accually help us?
The “optimist” will say that pain pts will/may get better pain management… me on the other hand – I am going to wait until the DEA comes out with their interpretation of what the “words” in this 200+ pages actually means to them and how they are going to change – if any- how prescribers can treat chronic pain
JMO,,, not until they call off the dea,,and doctors can believe the federal government can NEVER,EVER,, arrest a doctor again for prescribing a medicine for hysical ain from a medical condition,,jmo,,,and AMEN on the foggy brain,,those who still have their meds,,don’t get that at all,,but u r correct,,it is very very hard to concentrate on dotting an eye,,when u can’t even stand to type,,great point Mr.Frink,maryw