Opioid Prescribing: Dosage Threshold or Ceiling? – No Life Limited By Pain – Posted by Katie Duensing, JD, SPPAN Assistant Director for Legislative and Regulatory Affairs, Mar 27, 2016,
Prescribing opioid analgesics to treat pain has never been under as much scrutiny as it is right now, and both patients and prescribers are feeling the pressure.
But patients have their lives at stake.
And while these practice guidelines are all well-intentioned, they often create as much confusion as they resolve.
No, these guidelines are NOT well-intentioned. The CDC attempted to sneak these restrictions through the government process without allowing comment or opposition to the rules so clearly devised by the addiction and recovery industry.
In fact, hardly a week goes by that the American Academy of Pain Management isn’t contacted by a concerned clinician or patient who is trying to better understand his or her rights and responsibilities, as well as best practices and legal requirements, pertaining to using opioids to treat pain.
While all aspects of practice guidelines elicit questions, it is the relatively novel use of dosage thresholds that is prompting questions around the nation.
Clinicians are asking:
- “What is a dosage threshold? Is it equivalent to a ceiling dose?”
- “What do I do if a patient requires more medication than my state’s dosage threshold?“
- “Must I lower a dosage that has proven to be effective and well-tolerated by the patient?”
- “How will the CDC guidelines work alongside the already existing state guidelines?”
Unfortunately, the answers to those questions are highly dependent upon one’s locale, profession, qualifications, the condition being treated, and more.
Academy staff members have invested considerable time over the past few months analyzing these guidelines to better understand their current status, to identify opportunities for improvement, and ultimately, to help our members offer the best possible care to their patients.
What Is a Dosage Threshold?
Generally speaking, a dosage threshold is the dose in mg/day of morphine equivalent dose at which a clinician is either recommended or required to reevaluate their patient’s treatment plan and progress in certain ways.
The range of actions is broad. In some states, reaching the dosage threshold will merely trigger a recommended reevaluation of the patient and the use of caution. Elsewhere, reaching the dosage threshold will necessitate a mandatory consultation with a pain management specialist.
Perhaps, though, it is just as important to understand what a dosage threshold is not.
A dosage threshold is not a dosage ceiling in any currently promulgated guideline that either
(1) has the force and effect of law at the time of writing (statutes and regulations), or
(2) is the currently adopted guideline or policy statement of a state medical board or other similar agency responsible for licensing and disciplining physicians.
This means that
while prescribers may have to meet certain evaluation and documentation requirements if they exceed a dosage threshold,
they do not have to keep all of their patients below that threshold,
nor should they feel pressured to titrate doses downward for patients who are living healthy and productive lives on an effective and well-tolerated dosage higher than the threshold.
These thresholds are intended to issue a “proceed with caution” warning to prescribers, and are not intended to overrule the prescriber’s clinical judgement.
This is a disingenuous statement because the CDC knows very well how these “guidelines” will be taken as absolute rules by legislators, insurance companies, and doctors.
So long as practitioners
- proceed cautiously,
- heed guideline requirements and/or recommendations,
- document compliance with those requirements and recommendations, and
- act in good faith and within their scope of practice,
they should feel comfortable in prescribing the appropriate dosage of medication required for each patient’s specific needs, whether that dosage exceeds the state’s dosage threshold or not.
So long as practitioners proceed cautiously, heed guideline requirements and/or recommendations, document compliance with those requirements and recommendations, and act in good faith and within their scope of practice, they should feel comfortable in prescribing the appropriate dosage of medication required for each patient’s specific needs, whether that dosage exceeds the state’s dosage threshold or not.
I don’t think think it’s as important that “they should feel comfortable in prescribing” as that “they should be able to prescribe” without all the meddling and unreasonable restrictions.
The chart below illustrates how inconsistent the actions triggered by the currently adopted dosage thresholds are around the country.
How the CDC Guidelines Affect Dosage Thresholds
The CDC’s Guideline for Prescribing Opioids for Chronic Pain states that when opioids are started, clinicians should prescribe the lowest effective dosage.
This is how my doctors and I always treated my pain, never using any more medication than needed. The exceptionally reasonable part of this is that it includes the words “effective dosage”, which is usually found by trial and error over time.
Further, clinicians should
use caution when prescribing opioids at any dosage,
should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and
should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.
With the first dosage threshold set at 50 MME/day, and a “soft limit” set at 90 MME/day, these would be the most restrictive dosage thresholds set to date.
These numbers have been fabricated by the same people who based the CDC guidelines on admittedly incorrect statistics and admittedly scant evidence.
There are no fixed doses for opioids because of the great variety of responses to these medications, so these numbers are completely arbitrary and not based on medical reality.
The Academy has significant concerns with this particular recommendation in the proposed guidelines, which you can read about in the comments that were submitted to the CDC during its open comment period.
As recommendations, the guidelines will not be, per se, binding. However, due to the deference historically given to the CDC, it is entirely possible that legislators and regulators will codify portions of the guideline, if not the entire guideline
If dosage thresholds are codified as legally binding ceilings, anything prescribed above and beyond those ceilings will result in a clinician violating the legal standard of care.
Even without codification of the recommendations, in legal settings, expert witnesses will point to this “soft limit” and suggest to judges and juries that prescribing in excess of this dose is tantamount to unprofessional conduct and malpractice.
Third-party payers, including Medicare and Medicaid, may begin to treat the “soft limit” as a ceiling dose, reducing reimbursement for higher doses and/or establishing prior authorization protocols that effectively ban higher doses.
Some Closing Words
When utilized appropriately, dosage thresholds are an opportunity for prescribers to pause, re-evaluate, and ensure that progress is being made and that patients are receiving optimal care for their conditions
However, when dosage thresholds are misunderstood or misused, they can create negative unintended consequences, potentially resulting in under-treatment for patients and harsh scrutiny for prescribers
Reining in prescribing in general may not be a bad idea, but reining in prescribing because of arbitrary limits that don’t combine your clinical expertise with thorough ongoing assessment of your patient is simply not good practice.