CDC Guidelines Create Confusion in Opiate Prescribing Regulations

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By R Carter

Confusion on caps for opiates

News and blog posts continue quoting different values for caps on opiates Each sights the CDC as the basis for those caps, as well as how and to which physician groups they apply. But the CDC has recommended 50-90 MME, a guideline directed at primary care providers treating chronic pain. Confusion occurs when other entities such as state medical boards, hospitals and clinics are quoted and claim their guidelines are based on recommendations from the CDC.

The variations exist because the CDC was clear that their recommendations were “Guidelines” and nothing more. For example, the State Medical Board of Ohio has adopted 120 MME as its cap for all physicians treating any type of pain, acute or chronic.

Readers assume a state or local facility has adopted CDC recommendations verbatim. Without carefully reading through all available information, or taking the time to understand how jurisdictional policies work, it’s easy to see where the confusion comes from.

Regulations or Practice Privileges

To clarify, the CDC has made recommendations only. They are not regulations nor are they laws. Regulations are implemented by State Medical Boards, hospitals and clinics and usually carry with them a penalty for non-compliance. For example, a state medical board which is empowered to grant a state medical license, can take disciplinary action to resend that license. A local hospital or clinic which grants practice privileges, can take disciplinary action to resend practice privileges, but only within the confines of that facility. Regardless of the method used, the results of disciplinary action is the loss of the ability to practice and prescribe.

I’m not defending the CDC’s position. At this time I still remain skeptical of the source data, methods and interpretation of the results. This post is part of my fact checking efforts to verify at a low level, the findings in which the CDC has based its recommendations. For example, the 2016 CDC Guidelines quote this key resource, “Clinical evidence review for the CDC guideline for prescribing opioids for chronic pain – United States, 2016” in which the findings were as follows:

Findings

Main findings of this updated review are consistent with the findings of the 2014 AHRQ report. In summary, evidence on long-term opioid therapy for chronic pain outside of end-of-life care remains limited, with
insufficient evidence to determine long-term benefits versus no opioid therapy, though evidence suggests risk of serious harms that appears to be dose-dependent.

CDC Stacks

Therefore the CDC has chosen to make guidelines base on the short term effects of opiates and the outcomes of opiate naive patients. This is paramount to comparing apples and oranges. Based on the source data alone there is no basis to suggest that adverse outcomes, either addiction or overdose deaths are comparable to those of opiate naive patients taking opiates for less than 3 months. Also concerning is the fact that while opiate risk and outcome data exists for end-of-life care, rather than using that data, the CDC chose to use data from opiate naive patient populations.

For an organization like the CDC, with a stated goal of developing chronic pain guidelines, to ignore such data sources and apply standards from a lesser equivalent population, raises questions about the motives and integrity of the organization. It’s almost as if there was a conscious choice to use data sets from those groups which have the highest risk for bad outcomes.

It’s these type of judgments which brings into question the integrity of the expert panel assembled to produce this report. And it’s why the Washington Legal Foundation takes issue with the CDC’s findings as well.

Having said this, at the heart of the CDC’s message and intent, that of reducing the incidence of inappropriate prescribing by providing guidelines for non-specialist, I am in agreement with the intent and goals as well as those directed at reducing opiate abuse and misuse. Furthermore as I investigate, my concerns continue to shift away from the CDC’s guidelines and focus more on how those guidelines have been used by state and local entities, because the conclusions drawn by the CDC have misinformed those regulating bodies.

Transcripts of CDC press release from March 15, 2016.

Exerts from CDC Guidelines

This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care

This guideline provides recommendations for the prescribing of opioid pain medication by primary care clinicians for chronic pain (i.e., pain conditions that typically last >3 months or past the time of normal tissue healing) in outpatient settings outside of active cancer treatment, palliative care, and end-of-life care

The recommendations address the use of opioid pain medication in certain special populations (e.g., older adults and pregnant women).

The recommendations do not address the use of opioid pain medication in children or adolescents aged <18 years…

Some of the recommendations might be relevant for acute care settings or other specialists, such as emergency physicians or dentists, but use in these settings or by other specialists is not the focus of this guideline.
Readers are referred to other sources for prescribing recommendations within acute care settings and in dental practice…

such as the American College of Emergency Physicians’ guideline for prescribing of opioids in the emergency department; the American Society of Anesthesiologists’ guideline for acute pain management in the perioperative setting; the Washington Agency Medical Directors’ Group Interagency Guideline on Prescribing Opioids for Pain, Part II: Prescribing Opioids in the Acute and Subacute Phase; and the Pennsylvania Guidelines on the Use of Opioids in Dental Practice.

CDC

In this last exert the CDC is instructing state medical boards, local hospitals and clinics to seek guidance from other sources in developing guidelines for pain specialist and other medical specialties. This too has lead to unexpected outcomes as specialist try to make sense of the conflicting messages in the 2016 report. Notice again that each reference is from a source addressing acute pain not chronic pain. For an organization developing chronic pain guidelines, directing readers to sources for acute pain just doesn’t make sense on any level. The two are not the same. This view is echoed by Michael Miller, MD, past president of the American Society of Addiction Medicine. He say,

while American Society of Addiction Medicine supports the effort the CDC has made in trying to combat the opioid overdose crisis, forced dosage reductions in legacy patients — those with chronic pain who have been receiving high-dose opioids for extended periods of time — represent a problematic strategy. “The guideline was really written to prevent the development of a new generation of patients on high-dose opioids and to suggest alternatives to opioids for acute injuries or for chronic nonmalignant pain when they aren’t strictly necessary,” he noted.

Michael Miller, MD

While the CDC clearly stated in its original press release that their recommendations were for primary care providers treating chronic pain, the publication of their findings as general guidelines for chronic pain is misleading for prescribers who specialize in pain management.

The 90 mg cutoff applies only to primary care providers and is a guideline on when to transfer care to a specialist. It is not an all encompassing cap for all types of chronic pain and for all practice settings. Yet in the years since its release local entities have extended those guidelines to include groups not addressed in the CDC recommendations, such as post surgical patients.

By continuing to publish these findings as a general standard for chronic pain, absent of its target audience, the CDC compounds the confusion and guidance it provides. And in the three years since its release, there is growing evidence that this confusion is doing more harm than good as the number of suicide deaths following abrupt termination or forced reductions in opiates continues.

Subsequent to the original press release the CDC published, under the heading of “GUIDELINE FOR PRESCRIBING OPIOIDS FOR CHRONIC PAIN” the same information it provided in its initial press release.

Such summary guidelines hide and obscure the real truths and facts, which are, the CDC has no data on outcomes or risks for opiate use in chronic pain greater than one year and only inconclusive evidence for chronic pain greater than three months.

Further confusing the message from the CDC is the fact that every publication released by the CDC is primarily directed at educating the public about the risks of opiate misuse and abuse. The fact sheet above is a good example. With only one paragraph addressing guidelines while the remaining text, on two pages, is about the dangers of opiates.

Opiate dangers are not denied. But the failure of the CDC to have a separation of concerns with regards to patient populations and physician specialties, while trying to address opiate abuse and misuse in a single publication, only lead to more misunderstanding and confusion. As such some local hospitals are now advocating for opiate reductions as high as 80% for elective surgical procedures.

Where Do Regulations Restricting Opiates Come From?

The CDC makes policy. That policy should be clear and unambiguous. Actual regulation restricting opiates come from regulatory bodies at state and local levels, i.e. State Medical Boards, hospitals and clinics. Those which cite the CDC only, dismiss guidelines by other agencies and researchers which have challenged the CDC’s findings.

By implementing restrictions at state and local levels, through agencies which don’t directly affect how a physician is compensated for services, regulators avoid the Supreme Court decision [268 US 5}, which forbids governments agencies from practicing medicine. But these agencies accomplish the same end results by taking disciplinary actions against a prescriber’s license or staff privileges at a local facility.

Rewriting the Rules of the Game

As I back track references from the CDC’s 2016 Guidelines to other studies and the original research they are based on. Expand that search to other agencies such a those who define terminology, standards of measure, process and procedure for identification of adverse events related to poisoning and such. I see an effort to broaden the net on which the number of adverse events can be tied. The definition for poisoning alone has been so broadly defined that it gives license to tag as an adverse event, anything consumed by a human being, including nitrogen in the air we breath.

When such actions are taken without the means to filter out extraneous circumstances and conditions, I come away believing the game has been rigged from the beginning. With the rules redefined at the most basic levels, it appears the answers being sought are more likely to find their way into the data being captured. This gives the appearance of having the data doctored by the doctors.

Conclusions

I believe the public would be better served if the CDC were to take their original report and break it up into separate concerns. Those being education on abuse and misuse, guidelines for acute pain, for chronic pain, for primary care providers and specialist. This would allow state medical board and local facility to better structure regulations which address all patient populations rather than adopting the one size fits all regulations which currently exist.

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