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Opioid Prescribing and Tapering: Don’t Raise the Bridge; Lower the River

October 21, 2019
Comment on the 2019 HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics

Despite considerable improvement over the 2016 CDC Guideline on Prescribing Opioids for Chronic Pain, the new HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics is still substantially misdirected.1 Released in the fall of 2019, the new guide appears to “double down” on previous errors and hazards of the 2016 recommendations, even after the CDC and FDA tried to correct widespread misapplication last spring through safety communications.2,3 The new tapering and discontinuation guideline fails to address a river of abuse and patient abandonment that was created by the CDC prescribing guidelines in the first place, choosing instead to provide a largely cosmetic “raising of the bridge” that hundreds of thousands of individuals living with chronic pain are coerced to cross through forced tapers and doctor desertions.

In the author’s opinion, the new HHS guide fails to address five central issues, as highlighted below.

Where the HHS Guidelines on Opioid Tapering and Discontinuation Fail

Trials Data: Sean Mackey, MD, and several past presidents of the American Academy of Pain Medicine, have asserted to the Governor of Oregon in a public letter that no body of data exists to establish positive benefits from mandated tapers of prescription opioid pain relievers in any patient cohort.4 Thus, why are opioid tapers continuing to be recommended? What is the justification?

Risks and Benefits: There is no validated profiling instrument for accurately predicting the "risks and benefits" of opioid therapy in individual patients. Treatment decisions in individuals are not the same as studies conducted among general populations which identify and correlate factors with risks. Patients are individuals, not statistics.

The author outlines some major issues the HHS did not touch on in their new guideline. (Image: iStockPhoto)

Comparison of risks and benefits is a central theme of both the 2016 CDC prescribing guideline and the new tapering and discontinuation guidelines. But if no quantitative predictive measures of risk exist, then such a determination must continue to rely on the experience of individual physicians. An unreasonably hostile US regulatory environment has already suppressed opioid prescribing by 40% among all primary care clinics in Michigan;5 this statistic may be broadly representative. Professionals have been driven out of pain management practice in droves, as the US DEA, Department of Justice, States’ Attorney Generals, and State Medical Boards continue to conduct investigations into any physician still brave enough to prescribe these indispensable therapies.6

MMEs: Why has HHS ignored the fundamental repudiation by the American Medical Association of morphine milligram equivalent daily dose (MMEDD) as a measure of risk for establishment of best practices in pain management? AMA House of Delegates Resolution 235 (November 2018), reads as follows:7

“RESOLVED, that our AMA affirms that some patients with acute or chronic pain can benefit from taking opioid pain medications at doses greater than generally recommended in the CDC Guideline for Prescribing Opioids for Chronic Pain and that such care may be medically necessary and appropriate, and that it be further

“RESOLVED that our AMA advocate against misapplication of the CDC Guideline for Prescribing Opioids by pharmacists, health insurers, pharmacy benefit managers, legislatures and governmental and private regulatory bodies in ways that prevent or limit patients’ medical access to opioid analgesia and be it further

“RESOLVED that our AMA advocate that no entity should use MME (morphine milligram equivalents) thresholds as anything more than guidance, and physicians should not be subject to professional discipline, loss of board certification, loss of clinical privileges, criminal prosecution, civil liability, or other penalties or practice limitations solely for prescribing opioids at a quantitative level above theme thresholds found in the CDC Guideline for Prescribing Opioids.”

This resolution was reinforced by the AMA Board of Governors in June 2019. It repudiates the practice of "high prescriber letters" issued by state prosecutors, insurance companies, and pharmacy chains. Such letters effectively comprise a black listing of doctors and their sickest patients who are managed on opioid therapy at high dose levels.8

Mortality Rates: Data shows that there is no consistent cause and effect relationship between opioid prescribing rates and the overdose-related mortality rates.9,10 Twenty years of published CDC data reveals a strongly inverted demographic relationship between prescribing and mortality. Seniors over age 62 are prescribed opioids for pain about six times more often than youth under age 19. Yet overdose-related mortality in youth is six times higher than in seniors. Moreover, overdose-related mortality in seniors has been largely stable for the past 20 years, even as it has skyrocketed in youth. To a reasonable reader, these demographics conclusively disprove any cause and effect relationship between opioid prescribing and mortality.

The work of Nabarun Dasgupta PhD, et al, is also pertinent, in the largest demographic and epidemiological analysis published to date on overdose.11 His team reviewed medical records of just over 9 million North Carolina residents. There were 629 overdose deaths, half of which had an opioid analgesic prescription active on the day of death. Of 2,182,374 patients prescribed opioids, 478 overdose deaths were reported (0.022% per year). “Mortality rates increased gradually across the range of average daily milligrams of morphine equivalents,” he concluded.11

Patient Behavior vs Underlying Disease Dynamics: There is also no validated metric (other than physician experience) to distinguish between “drug-seeking behavior” and underlying disease progression or effects of under-treatment of pain. Lacking such a metric, physicians may be presented with a profoundly unethical choice between protecting themselves from censure and risking further compromises to the health of patients whom they may put into opioid taper programs.

Overall, it is time to recognize that while rapid tapering or abrupt discontinuation of patients maintained on opioid therapy is “a” problem, it is not “the” problem. Rather than a cosmetic “raising of the bridge,” in more careful tapering programs, US healthcare approaches instead need a lowering of the river of patient desertion, and outright withdrawal of the fatally flawed 2016 CDC guideline.

Last updated on: October 23, 2019
Continue Reading:
HHS New Clinical Guide Supports Concerns Over Abrupt Discontinuation and Tapering of Opioids
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