New Data on Opioid Dose Reduction—Implications for Patient Safety

Could the data from these studies be much worse if they included the number of chronic pain pts who had their pain management abruptly curtailed,when a office practice is raided by the DEA/FBI/DOJ, the practice closed, all the pt’s medical records were confiscated and all those pts may have anything from close to 30 days supply of their pain medication to just maybe a couple of days or less.  So some pts may have the opportunity to wean themselves down, where others are basically thrown into cold turkey withdrawal.  I have heard horror stories from pts whose prescriber’s office had been raided and closed and the DEA stalled, denied, refused to provide the pts with copies of their medical records. This action by the DEA, almost assures that the chronic pain pts will not find to be accepted as a patient in another practice.  The data from these reports seem to be based on some sort of Insurance/PBM database, those pts being tossed to the curb by the DEA raiding a office practice and their pain meds abruptly discontinued without much documentation, may have not been  included in the data that was used to come to the conclusion of this study(s).

New Data on Opioid Dose Reduction—Implications for Patient Safety

In the US, prescribing of opioids for pain reached its peak in 2011 to 2012. By 2020, prescribing per capita had decreased to levels last seen in 1993.1 Whether that reversal delivered some mitigation to an escalating North American tragedy of drug-related deaths remains a matter of anxious debate. Few, however, would contest the view that this ongoing reversal bears with unique intimacy on the 8 to 10 million US individuals who receive prescribed opioids on a long-term basis, or who may yet need them.1 New research on prescription opioid dose reduction should cause us to look upon their situation with fresh eyes, and with concern.

Reductions and stoppages in these patients’ prescription regimens are likely to reflect varied motivations and understandings among physicians and other professionals who care for them. Some may reduce doses out of a belief that the dose reductions confer safety and well-being, a perspective reinforced by studies in which voluntary tapers are achievable or even salutary for some patients. However, it is likely that many clinicians are reacting to a fraught public discourse and to external pressures as well, including measures that rate the quality of their work. According to a metric issued by the National Committee for Quality Assurance and taken up by most payers, patients taking a daily dose more than the equivalent of 90 mg of morphine count as receiving poor care, regardless of their prior dose history.2 Such measures do incentivize either reduction or termination of the care relationship. Unsurprisingly, dose reductions and stoppage have become more common in recent years.3

Some retrospective studies found an association between dose reduction and poor outcomes, such as death by overdose, suicide, or mental health crisis, after comparing patients who underwent such reductions and others who did not. One limitation to such reports is that people who underwent reduction could have differed in important ways from those who did not. Differences in their risk could have spurred both the dose reduction and the outcome. For example, a patient with volatile behavior may be at risk for suicide, and that same volatile behavior could spur clinicians to alter prescriptions. Some may suggest that the dose reduction did not cause a subsequent suicide. If existing studies are confounded in this way, they render an unduly pessimistic portrait of the risk of harm resulting from prescription opioid reduction.

The new study by Fenton et al4 addresses these challenges with 2 methodological innovations. First, they apply an exposure-crossover design, in which each person serves as their own control in the assessment of event frequencies before and after the dose reduction. Second, they attempt to mitigate time-limited volatility in the period before and after dose reduction by focusing on outcomes occurring a full year after the taper was initiated (which they term postinduction).

The article by Fenton et al4 reports on 19 377 commercially insured and Medicare Advantage enrollees who underwent tapering (2008-2017) after a 12-month period of stable doses. Taper was operationalized as a 15% or more reduction in mean daily dose. The exposure-crossover method applies conditional regression models to compare periods after taper (12-24 months) with periods before in the same population, adjusting for clinical covariates such as drug- and alcohol-related diagnoses and demographic characteristics.

Fenton et al4 also report adverse outcomes. Compared with the period before dose reduction, the incidence of hospital or emergency department encounters for drug overdose or withdrawal was elevated by 57% (adjusted incident rate ratio, 1.57), in relative terms, and by 52% (adjusted incident rate ratio, 1.52) for mental health crisis in the 12 to 24 months following reduction.4 The elevations in observed risk were greater for patients whose baseline opioid dose was greater than the equivalent of 300 mg of morphine daily.4 Supplementary analyses comparing tapered patients with those not tapered were concordant: patients at stable dose remained at lowest risk, compared with patients whose doses were lower or higher.

By our count, this is the tenth retrospective comparative study to document an adverse association between opioid dose reduction and patient safety,513 although a gain in safety was shown in one other study.14 We caution that the article by Fenton et al,4 despite its strengths, still cannot fully resolve potential bias from unmeasured factors, because many aspects of the clinical story remain outside of the researchers’ database. Evidence derived from retrospective analysis demands our caution. For that reason, it is deeply regrettable that such caution was absent when many health systems, government agencies, and payers incentivized dose reduction on the basis of retrospective data that were subject to all the same limitations, and many more.15

How should clinicians and health systems respond today, in light of these evolving, cautionary findings on opioid dose reduction? Our view is that opioid dose reduction is likely to offer benefit for some, while harming others. The harms may include worsening pain, distress, or death. Given this uncertain balance of harm and benefit, it would be wise for health systems to stop promoting this change to care. A policy of tapering all patients to doses lower than a specified threshold cannot be supported from available evidence. Quality metrics that incentivize these policies, such as the High Dose Opioid criterion promulgated by the National Committee for Quality Assurance,2 are overdue for retirement. Indeed, experts who assisted the Centers for Disease Control and Prevention’s 2016 guideline urged that it not be adopted in the first place.16

What about individual care decisions? If an elective change to care involves both potential benefit and risk of serious harm, including loss of life, the longstanding norms of ethical medical care call for informed consent. We see no reason to set these norms aside when discussing dose reductions.

Clinicians will observe that, in some instances, consent will not be forthcoming, despite compelling evidence of harm resulting from prescription opioid therapy. To our view, a lack of consent does not compel a prescribing clinician to continue a treatment that they believe is actively harming that patient. However, that same clinician should proceed with reductions only after (1) documenting evidence of harm, (2) offering a plan to mitigate harm from the reduction, and (3) telling the patient what criteria will be used to decide whether the taper has failed or succeeded. When tapers fail, as many do, then clinicians must be open to reversing them. For this reason, the long-standing adage that opioid tapers must not be reversed, most recently cited in a draft revision to the Centers for Disease Control and Prevention’s opioid prescribing guideline,16 has been worn thin by studies such as this one and the many that precede it. To our view, that adage is not tethered to clear and compelling evidence. It should be set aside.

Finally, whenever consent is sought, it should be in the context of a serious conversation grounded in mutual respect, rather than an attempt to convince the patient to embrace something they do not really believe in. This is because patients—it has been overlooked far too often—are the moral equals of the people writing the prescriptions.

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