Too Little, Too Late: Feds Backtrack on Opioid Discontinuation

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

Thousands of patients have been dispassionately forced into tapering their opioids, often inappropriately, due to fear from regulatory agencies following initiation of the 2016 CDC Guideline on Prescribing Opioids for Chronic Pain.

In addition to unnecessary suffering, this has resulted in opioid withdrawal due to due either rapid or misguided or inexperienced taper regimens.

The sad irony here is that three years later, the FDA is saying exactly what nationally recognized pain experts have been saying all along.  

In a safety announcement on April 9, 2019, FDA announced that it

“has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.”

(Update: The next day, the CDC came out with its own follow-up, not to the full HCP community, but to one doctor in particular. See the agency’s response here which states that

the CDC “does not endorse mandated or abrupt dose reduction or discontinuation” and that the CDC is “working diligently to evaluate the impact of the Guideline and clarify its recommendations.” )

See the letter here: https://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/5caf661d7f312m,nb0001bac1b8/1554998814907/Alford+Final+.pdf

The 2016 CDC guideline was born from an “expert” panel mostly consisting of addictionologists and non-pain experts, many of whom had conflicts of interest and strong partiality as anti-opioid zealots

Just recently, the article “International Stakeholder Community of Pain Experts and Leaders Call for an Urgent Action on Forced Opioid Tapering” cited forced tapering and opioid dose reductions as a large-scale humanitarian issue.

The authors pointed out that “…no data exist to support forced, community-based opioid tapering to drastically low levels without exposing patients to potentially life-threatening harms.”

Consensus guidelines were also publishedm, led by Kroenke and colleagues, titled “Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline.” This paper outlined a “failure to appreciate the importance of patient involvement in decisions to taper or discontinue opioids.”

As clinicians, we hopefully recognize the complexities of opioid prescribing. We recognize that because of tolerance, metabolic and pharmacogenetic factors, patients respond differently to different molecules of opioid and not all patients will respond to low doses.

Practitioners who prescribe opioids and are comfortable assessing the benefits and potential harms should recognize the above factors and appropriately titrate analgesics the way any class of drug should be titrated to effect in the appropriate patient.  

More thoughts from PPM Editorial Advisors & Contributors:       

Jennifer Schneider MD, PhD:

As a result of the 2016 CDC guideline on opioid prescribing, which has all too often been treated as regulations rather than a guideline, a huge number of patients with chronic pain have suffered increased pain, decreased function, desperately turning to illicit opioids to treat their pain, and a large number finally committing suicide.

It boggles the mind that the CDC never followed up their guideline with any information about how to appropriately taper opioids in patients on chronic opioids.

Three years after publication of the guideline, the FDA (not the CDC) has now figured out that there have been significantly negative consequences.

Three years! That’s 3 years too late for many patients.

The most pertinent information from the FDA announcement for health professionals, which should be widely disseminated, includes:

“In general, for patients who are physically dependent on opioids, taper by an increment of no more than 10-25% every 2-4 weeks. It may be necessary to provide the patient with lower dosage strengths fo accomplish a successful taper.

Yet many so-called doctors gave patients one more month and then nothing; taper to 0 in 1 month. This is malpractice and I hope they get sued.

“If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to pause the taper for a period of time, raise the opioid analgesic to the previous dose, and then once stable, proceed with a more gradual taper.”

I’m skeptical that this will happen. Perhaps that’s why the CDC held out so long before “clarifying” its guideline; they figured the damage would be done after 3 years of its misapplication.

So many anti-opioid laws have been passed and so many anti-opioid policies have become ingrained in the healthcare system, that these will take quite a while to unravel and return to sanity.

Richard A “Red” Lawhern PhD, Alliance for the Treatment of Intractable Pain:

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.

Yes, I agree. These “clarifications” aren’t enough to change existing policies.

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.

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

It’s just camouflage for discouraging opioid prescribing and threatening doctors with sanctions if they prescribe high amounts.

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.

So many patients who were doing well on opioids have had them taken away by their doctors, who are supposed to be practicing medicine, not law. Yet the opioids were not taken away for medical reasons, but rather because of policy issues.

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.

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?

This really sounds pretty silly, but that’s the problem when you peddle nonsense and then try to fix it without admitting you were wrong.

They also suggest that a multimodal approach to pain management, including mental health support, be in place prior to initiating an opioid analgesic taper.

Yet every famous pain clinic takes away opioids *before* teaching any other approaches. I’m glad to see this policy is being publicly chastised, though I doubt we’ll see much change any time soon.

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.

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.