No Shortcuts to Safer Opioid Prescribing

No Shortcuts to Safer Opioid Prescribing

https://www.nejm.org/doi/full/10.1056/NEJMp1904190

Since the Centers for Disease Control and Prevention (CDC) released its Guideline for Prescribing Opioids for Chronic Pain in 2016,1 the medical and health policy communities have largely embraced its recommendations. A majority of state Medicaid agencies reported having implemented the guideline in fee-for-service programs by 2018, and several states passed legislation to increase access to nonopioid pain treatments.2 Although outpatient opioid prescribing had been declining since 2012, accelerated decreases — including in high-risk prescribing — followed the guideline’s release.2,3 Indeed, guideline uptake has been rapid. Difficulties faced by clinicians in prescribing opioids safely and effectively, growing awareness of opioid-associated risks, and a public health imperative to address opioid overdose underscored the need for guidance and probably facilitated uptake. Furthermore, the guideline was rated as high quality by the ECRI Guidelines Trust Scorecard. In addition, the CDC (including the authors of this Perspective, who were also authors of the Guideline) engaged clinicians, health systems leaders, payers, and other decision makers in discussions of the guideline’s intent and provided clinical tools, including a mobile application and training, to facilitate appropriate implementation.4

Efforts to implement prescribing recommendations to reduce opioid-related harms are laudable. Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations. A consensus panel has highlighted these inconsistencies,5 which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice. The panel also noted the potential for misapplication of the recommendations to populations outside the scope of the guideline. Such misapplication has been reported for patients with pain associated with cancer,5 surgical procedures,5 or acute sickle cell crises. There have also been reports of misapplication of the guideline’s dosage thresholds to opioid agonists for treatment of opioid use disorder. Such actions are likely to result in harm to patients.

We need better evidence in order to evaluate the benefits and harms of clinical decisions regarding opioid prescribing, including when and how to reduce high-dose opioids in patients receiving them long term. The CDC developed the guideline on the basis of the best available evidence, with input from a multidisciplinary group that included experts in pain management as well as representatives of patients and the public. In situations for which the evidence is limited, it is particularly important not to extend implementation beyond the guideline’s statements and intent. And yet in some cases, the guideline has been misimplemented in this way.

For example, the guideline states that “Clinicians should…avoid increasing dosage to ≥90 MME [morphine milligram equivalents]/day or carefully justify a decision to titrate dosage to ≥90 MME/day.”1 This statement does not address or suggest discontinuation of opioids already prescribed at higher dosages, yet it has been used to justify abruptly stopping opioid prescriptions or coverage.5 This recommendation also does not apply to dosing for medication-assisted treatment for opioid use disorder. The CDC based the recommendation on evidence of dose-dependent harms of opioids and the lack of evidence that higher dosages confer long-term benefits for pain relief. However, we know little about the benefits and harms of reducing high dosages of opioids in patients who are physically dependent on them.

Patients who are able to successfully taper their opioid use are likely to have a lower risk of overdose, and evidence is accumulating that they might experience reduced pain.4 Other patients may find tapering challenging; could face risks related to withdrawal symptoms, increased pain, or unrecognized opioid use disorder; and if their dosages are abruptly tapered may seek other sources of opioids or have adverse psychological and physical outcomes. Policies should allow clinicians to account for each patient’s unique circumstances in making clinical decisions.

The guideline offers guidance for caring for patients who are already taking opioid dosages of 90 MME or more per day long term, including guidance on when tapering the dose might be appropriate, the importance of empathetically reviewing risks associated with continuing high-dose opioids, collaborating with patients who agree to taper their dose, maximizing nonopioid treatment, and tapering slowly enough to minimize withdrawal symptoms. Patients exposed to high dosages for years may need slower tapers (e.g., 10% per month, though the pace of tapering may be individualized).1 Success might require months to years. Though some situations, such as the aftermath of an overdose, may necessitate rapid tapers, the guideline does not support stopping opioid use abruptly.1

Guidelines can improve patient outcomes when they lead to policies that reduce harm, while offering support and coverage for underused services (e.g., nonpharmacologic strategies, naloxone coprescribing, and treatment for opioid use disorder). However, policies invoking the opioid-prescribing guideline that do not actually reflect its content and nuances can be used to justify actions contrary to the guideline’s intent. The CDC has engaged quality-improvement organizations, payers, federal partners, state health departments, and others in discussions to encourage adherence to recommendations while avoiding actions that might cause harm. For example, the CDC worked with the American Society of Addiction Medicine to clarify that dosage thresholds in the guideline should not direct dosing of medication-assisted treatment for opioid use disorder.

Even guideline-concordant care can be challenging. Implementing recommendations with individual patients takes time and effort. An unintended consequence of expecting clinicians to mitigate risks of high-dose opioids is that rather than caring for patients receiving high dosages or engaging and supporting patients in efforts to taper their dosage, some clinicians may find it easier to refer or dismiss patients from care. Clinicians might universally stop prescribing opioids, even in situations in which the benefits might outweigh their risks. Such actions disregard messages emphasized in the guideline that clinicians should not dismiss patients from care, which can adversely affect patient safety, could represent patient abandonment, and can result in missed opportunities to provide potentially lifesaving information and treatment.1

Effective implementation of the guideline requires recognition that there are no shortcuts to safer opioid prescribing (which includes assessment of benefits and risks, patient education, and risk mitigation) or to appropriate and safe reduction or discontinuation of opioid use. Starting fewer patients on opioid treatment and not escalating to high dosages in the first place will reduce the numbers of patients prescribed high dosages in the long term. In the meantime, clinicians can maximize use of nonopioid treatments, review with patients the benefits and risks of continuing opioid treatment, provide interested and motivated patients with support to slowly taper opioid dosages, closely monitor and mitigate overdose risk for patients who continue to take high-dose opioids, and offer or arrange medication-assisted treatment when opioid use disorder is identified. The CDC offers several tools to assist, including a pocket guide on tapering, a mobile app and online training with motivational interviewing components, and information about nonopioid treatments for pain.4 We are also working to identify ways to integrate recommendations into medical education and to support best practices among the next generation of medical professionals.

Appropriate implementation of the guideline includes maximizing use of physical, psychological, and multimodal pain treatments. However, these therapies have not been used, available, or reimbursed sufficiently. The CDC has supported research to better define the evidence and coverage gaps for nonopioid pain treatments and has articulated the need to improve insurance coverage.2,4 Efforts to support more judicious opioid use will become more successful as effective nonopioid treatments are increasingly available and used.

The CDC is evaluating the (intended and unintended) impact of the guideline and other health system strategies on clinician and patient outcomes and is committed to updating recommendations when new evidence is available. The CDC is funding the Agency for Healthcare Research and Quality to conduct systematic reviews on the effectiveness of opioid, nonopioid pharmacologic, and nonpharmacologic treatments for acute and chronic pain. Results of these reviews will assist in identifying research priorities and determining when evidence gaps are sufficiently addressed to warrant a guideline update or expansion. Until then, we encourage implementation of recommendations consistent with the guideline’s intent.

6 Responses

  1. “The CDC developed the guideline on the basis of the best available evidence, with input from a multidisciplinary group that included experts in pain management” Oh, BULL. The “multidisciplinary group” consisted pretty much entirely of addiction treatment specialists with ZERO experience in pain management and considerable financial stakes in addiction treatment centers & suboxone…as total a conflict of interest as could be imagined.

    and who the heck are the ECRI, & why should their opinion matter? On what do they base their assessment?

    & they’ve dragged out the phrase “unintended consequence” again; I seriously doubt that any of the consequences were unintended or unforeseeable, especially given that no one, certainly not the CDC, has done ANYTHING official toward evaluating what the effects of the guidelines have been until very recently, when the number of deaths & letters of outrage from medical professionals, patients, and ethicists have finally gotten too overwhelming to ignore.

    Moreover, “Clinicians might universally stop prescribing opioids, even in situations in which the benefits might outweigh their risks.” …”might”? “MIGHT”?? What planet are these people on, that they can actually use that word in that sentence, when tens or hundreds of thousands of pain patients across the country have been vilely abandoned by thousands of doctors?

    And they still act as if there’s any sane or scientific reason to implement the frigging guidelines; “Effective implementation of the guideline requires recognition…” What is required is recognition of the fact that the guidelines are a complete disaster, and useless for their supposed goal of “safer opioid prescribing” when what is needed is something that actually addresses the real problem; ILLEGAL drugs. The ONLY thing the guidelines have successfully done is massively increase the mortality rate of CPPs via suicide and pain-related deaths, and cause unspeakable, unnecessary suffering to millions of people.

    “The CDC has supported research to better define the evidence and coverage gaps for non-opioid pain treatments”….there ARE no effective non-opioid pain treatments, you morons! And the few that provide *some* relief for *some* patients have almost universally been tried by the very people who’ve had their opiate pain meds ripped away; that’s WHY they ended up on opiates: nothing else helped. The few who do get relief from “alternatives,” from CBD to whatever, should definitely have them covered & easily available, however.

    The group of moronic governors who wrote the CDC to protest the mealy-mouthed, slight backpeddling of the guidelines must immediately be forced to undergo an intensive, FACT-based re-education program, along with the all the media in the country. And the guidelines themselves need to be forcefully shoved down the memory hole. An d the DEA needs to get off its cushy, easy train of raking in millions of dollars of seized assets from raids of legit doctors, and either go back to trying to do something about the free party illegal drug suppliers have been having for the last couple of years, or the entire country needs to grow a brain and implement a sane policy on drugs. Portugal is a great example; their number of deaths & drug usage overall has plummeted greatly since they legalized everything. Not that that will ever happen in this insane, quasi-Puritanical country. Millions will continue to die from alcohol & tobacco, for which NO actual positive use exists, while millions of others will continue to be sentenced to sadistic torture for no reason.

  2. Here’s what I wrote to my state medical society:

    Dear Dr Griffin:

    Please review this 5th article in 2 days, about CDC guidelines.

    “I was abandoned from medical care like countless other patients on long-term opioids,” she says. “We are now treated as parolees, not patients. We’re viewed as unmanageable liabilities that threaten the freedom and livelihoods of healthcare professionals across every point of continuum of care…. The doctor/patient Relationship has been almost completely destroyed. That relationship is now a punitive one. What took the CDC so long?”

    My question for you and Montana Medical Association:
    Why sign on to Know Your Dose, sponsored by the Attorney General of Montana,
    And devised by ASIPP (American Society if International Pain Physicians)
    What is still taking so long?
    What don’t we know now?
    Just Data baby!
    As you will recall
    These are the thematic phrases from the MMA leadership program I was honored to be a part of, Lo these many years ago.
    These topics were brought to MMA even before then.
    Yet the response from MMA:
    Crickets.

    I think MMA has some ‘splainin to do,
    to patients
    Member physicians like myself
    And
    Families of disenfranchised patients.
    For sure
    The board of Medicine and their
    Special Assistant Attorneys General
    DOJ
    DEA
    All have accountability for this.
    I eagerly await the statements from MMA leadership about an action plan for restoring care to opiate refugees. People just barely holding on. Please help them.

    Let’s take a stand for restoring the sacred and scarred physician/patient relationship.

    Let’s seriously take on bringing a patients bill of rights to Montana.

    Perhaps we could propose some type of commission to look at some of these tragic cases, and make corrections,
    And support any physician who wants to stand by the opiate refugees. None of them has been able to obtain any support from
    The Governor
    Senators
    Congressional Representatives
    MMA
    BOME
    Or state legislators

    https://tonic.vice.com/en_us/article/xwnxkw/cdc-finally-clarifies-its-opioid-painkiller-restrictions?utm_source=tonicfbus

    Looking forward to hearing from you.

    Mark Ibsen MD
    MMA member since 1993.
    Previous secretary Flathead Medical Society
    Previous president Lewis and Clark County Medical Society.

  3. NEWS FLASH!!Now they are demanding toxicology screens BEFORE your prescription is filled.if you are lucky enough to have a local pharmacy that will actually fill for you.i am not sure how it will work.but mail order prescripts are now demanding tox screen reports,I cant imagine wh

  4. As Doctor K. said, assuming there is an unsafe dose assumes there is a safe dose, ..and that is wrong too. Did we forget that it was almost NEVER an ethical Doctor/Prescribing issue, but an illicit use issue, which can’t be stopped by ANY MEANS?
    And why are we still listening to the CDC? They should be sued for misrepresenting facts and looking at opiate misuse through a lens that they ground themselves, for whatever reason. Surely there was some reason. A bad one.

  5. Definition of insanity: repeating the same action expecting a different result. This approach and wheel spinning has been done now for 15 years or more. Read my posts on Siobhan Reynolds’ testimony to Congress in 2007: https://doctorsofcourage.org/siohban-reynolds-2007-testimony-part-1/ and https://doctorsofcourage.org/siobhan-reynolds-testimony-part-2/ . Same complaints, same focus on rules, etc. She at least pointed at the elephant in the room. People need to learn what will really made a difference. That knowledge is available on DoctorsofCourage.

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