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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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An Editorial (see additional contributors' comments below)

 

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.)

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

Last updated on: April 15, 2019
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