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. With the March 15, 2016 release of the Center for Disease Control’s (CDC) Guideline for Prescribing Opioids for Chronic Pain, in addition to the proliferation of similar guidelines set forth by state statutes, regulations, medical boards, and departments of health, clinicians are acutely aware that their prescribing practices are being closely scrutinized. And while these practice guidelines are all well-intentioned, they often create as much confusion as they resolve. 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. 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.
What Are the Requirements in my State Relating to Dosage Thresholds?
Currently, only seven states have set dosage thresholds that trigger required or strongly recommended action: California, Colorado, Indiana, Ohio, Rhode Island, South Carolina, and Washington. Of these states, four recommend certain action upon reaching the dosage threshold and three require certain action upon reaching the dosage threshold. Because judges, juries, and medical boards will defer to these guidelines and often consider them the “standard of practice”, the Academy recommends that clinicians err on the side of treating state-issued recommendations as requirements, and practice accordingly, in order to avoid potential sanctions.
While only a handful of states have adopted dosage thresholds, their use does seem to be on the rise. However, it is important to note that none of the states that have implemented these thresholds have agreed on the best way to do so. While they all share a theme of caution and some variation on reevaluation, the dosage thresholds range from 60 to 120 mg/day in morphine milligram equivalent (MME) doses, and all differ in their requirements and recommendations pertaining to referrals, consultations, prescription monitoring program checks, consideration of opioid antagonists (naloxone), treatment plans, and more.
It is vital that all prescribers become familiar with the practice guidelines that are in effect within their own states. 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. 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. 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.
So, now that the CDC guidelines are final, how do they affect you? It is very important to realize the CDC guidelines are intended to be taken as recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care. 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. To ensure the best possible outcomes for your patients and your practice, it is vital that you understand what threshold dosages truly mean in your state.