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

https://www.practicalpainmanagement.com/resources/news-and-research/too-little-too-late-us-government-backtracks-opioid-discontinuation

Jeffrey Fudin, PharmD, and Jeff Gudin, MD, PPM Co-Editors-At-Large:

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.” )

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. Many of these panel members were affiliated with PROP (physicians for responsible opioid prescribing) who submitted a petition to the FDA in 2012 requesting harsh and unreasonable restrictions on opioids; this was rejected by FDA in 2013. [PPM covered FDA’s rebuttal in PROP versus PROMPT: FDA Speaks].

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.”

A group of Pharmacy Pain Clinicians recently surveyed over 100 opioid prescribers throughout the United States to determine the level of variation within and between clinicians in opioid tapering methods (data pending presentation/ publication). Outcome analysis overseen by Amelia Persico, PharmD, suggested that although the majority of providers surveyed were pain specialists, 15% were not comfortable tapering opioids at all; morphine daily dose influenced taper confidence; and taper-motivation was largely motivated by CDC guidelines rather than medical reasons or patient specific factors.

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.

“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.”

Every professional who has prescribed opioids should become familiar with this Drug Safety Announcement in its entirety, as there are other important elements. A change in opioid tapering practices is the only way to prevent more patients from suffering because their prescribers did not know enough about opioids and the consequences of sudden stopping or rapid tapering.”(See Dr. Schneider’s take on tapering from 2012, even before the CDC guideline came out,  as well as and a more recent look at safe tapering practices with Courtney Kominek, PharmD.)

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.

Norm Shealy MD, PhD:
“t 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.

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Filed under: General Problems