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Too Little, Too Late: US Government Backtracks on Opioid Discontinuation

April 11, 2019
Three years after the CDC published its guideline on opioid prescribing for chronic pain, the FDA steps in to address the harm it may have caused patients living with chronic pain.
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I've gone through the press release.  And the devil is in the details. There's less here than meets the eye. I don't want to appear ungracious in the face of "success," but... I'm not convinced these two recent announcements actually change policy in any fundamental way.  I sense this is a political delaying action to avoid having to admit that CDC was fundamentally wrong when they bought into ... fraudulent claims about dangers of opioids.  It's  not a change of heart and there's a long way to go before practical improvements arrive in doctor treatment of patients denied opioid therapy.  

The Director of CDC letter has doubled down on several "initiatives" which appear to assume that the original assumptions and declarations of the guidelines were correct - which they weren't, and for which there is abundant published proof that they weren't.  You've seen many of the themes in my published work, both in single-author and dual-author papers.   The myth of over-prescribing is still alive and well.  We need to kill it conclusively.

Specifically:

  • CDC claims to be doing a review with AHRQ of literature published since March 2016.  Among the areas of review are non-pharmacologic non-invasive therapies.  AHRQ published what may be the definitive systematic review of this area in June 2018 - but they tried to rig their summary level findings to put the best possible face on the very weak medical evidence behind this area of medicine.  There's a lot of harmful quackery hiding in the many small-scale "trials" of "alternative therapies" which don't directly compare with opioid analgesics or properly document protocols for the addition of such therapies as adjuncts to "usual therapy - namely NSAIDS and opioids.  Steve Nadeau and I have written in Practical Pain Management on this topic.
  • CDC  also claims to be doing reviews for the Quality Improvement Collaborative.  But the underlying assumption of that Collaborative is that "safety improvements" are needed in prescribing practices.  And that premise is highly debatable.

From publications that go back as far as the Cochrane review of 2010, we know that incidence of substance abuse associated with medically managed opioid analgesics is possibly as low as 0.5%.  Incidence of substance abuse or overdose diagnoses in post-surgical patients  treated with opioids for pain is on the order of a maximum of 0.6%, and incidence of chronic opioid prescribing in post-surgical patients is less than 5% in even the most failure prone surgical procedures (total knee replacement), and shows no increase above background prescribing rates in non surgical patients, in some common procedures.   With such low incidence rates, I rate the chances of "improving safety" of opioid prescribing as zero to nil.  It's just another camouflage for discouraging opioid prescribing and threatening doctors with sanctions if they prescribe high amounts.

So my instinct is to acknowledge incremental progress, and then get busy forcing the immediate recall and repudiation of the entire guideline document and all state legislation or regulation that incorporates it.  We likely won't be able to avoid a rewrite effort for "some" kind of guideline, because doctors won't reenter pain management practice without a shield from sanctions;  they'll want to be "guided".  The HHS Task Force draft points in many of the right directions if they can translate it into actionable recommendations to Congress that allow doctors to use their judgement, and give them meaningful education to develop that judgment. 

David Cosio, PhD, ABBP:

Rather than further policing the actions of some prescribers, it may be more important to ask why they are discontinuing in this manner. It is not only the regulations that have been imposed but also the general fear that comes with using opioids that has led to this problem. So, the first thing needed is further education on appropriate opioid prescribing and reimbursement for support staff that is necessary to provide a multimodal approach.

The FDA does seem to offer some guidance, but it is confusing and incomplete. They first say, for example, there are no standard opioid tapering schedules, but then propose a general 10 to 25% reduction every 2 to 4 weeks? They also suggest that a multimodal approach to pain management, including mental health support, be in place prior to initiating an opioid analgesic taper. If about 50% of patients who suffer from chronic pain obtain their care from a primary care provider, then a multimodal approach may not be accessible due to insurance regulations or may not be available in the clinic where they seek their care. Furthermore, many patients may not embrace this approach and thus this holds the prescriber hostage.

The FDA also recommends frequent follow-up appointments, again not recognizing that in some clinics there is a wait of up to three months to see a general practitioner.

Courtney Kominek, PharmD, BCPS:

Some providers have taken a strong 'opioid-phobic' stance following these guidelines. I’ve seen people discontinued from opioids or referred for tapering in which it was clinically inappropriate. Not all patients should be tapered from opioids. I continue to encourage the use of universal risk mitigation and precautions as well as indivisible assessment of the analgesic and functional benefit compared to risks and make individualized patient decisions from that risk-benefit analysis.

Norm Shealy MD, PhD:

It is becoming more and more clear that the FDA is responsible for the opioid epidemic. Any physician who is not caught up in pharmaceutical ties knows to withdraw their patients from opioids slowly.

Srinivas R. Nalamachu, MD:
Typical FDA, nothing new and very generic with no guidance.

Add your thoughts on our LinkedIn conversation or email the editors at ppmeditorial@verticalhealth.com

 

Last updated on: April 15, 2019
Continue Reading:
What’s the safest, effective way to taper a patient off of opioid therapy?
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