Aftermath of the CDC Guideline

Three Years Down the Road: The Aftermath of the CDC Guideline for Prescribing Opioids for Chronic PainJoseph V. PergolizziJr., Melanie Rosenblatt, Jo Ann LeQuang – April 2019

In March 2016, the Centers for Disease Control and Prevention (CDC) in Atlanta prepared a far-reaching guideline aimed at helping primary care physicians (PCP) better treat chronic pain.

However, rates of prescribing were starting to decrease markedly years before the CDC guideline was published.

Although the guideline was written for primary care physicians (PCPs) and framed in the context of PCPs managing patients with chronic noncancer pain, the gravitas of the document and its issuing agency gave considerable weight to its principles.

The CDC guideline was framed as principles, which are summarized here:

Short summary

Comment

1

Nonpharmacologic and nonopioid pharmacological therapies are preferred for chronic pain. When using opioids, combination therapy with a nonopioid analgesic is preferred

2

Establish treatment goals and use of opioids only as long as improvements in pain and function outweigh the risks

Elevation of “functional improvement” to be the equivalent of pain control is not based on the evidence. Some patients, for example, the bedbound, may need pain relief but never achieve much functional benefit from pain control

3

Physicians should discuss risks and benefits of opioids with patients before starting opioids and periodically thereafter; there are patient and clinician responsibilities in opioid therapy

4

Immediate-release opioids are preferred over extended-release or long-acting opioids

The CDC cautions that transdermal products require special patient education and are “often misunderstood.” However, there are reasons for the use of different opioid formulations that may override this blanket advice

5

Start with the lowest effective dosage and do not increase over 90 MME per day

Equianalgesic calculations (MME) are estimates and vary even among experts. Non-experts may have trouble establishing the MME for various opioid products. MME tables are in flux

This cutoff rate does not appear to be supported by evidence but is an arbitrarily set value. It may not meet the needs of many long-term opioid patients

6

For acute pain, prescribe opioids for 3 days or fewer and rarely for over 7 days

While this may be true in many cases, there is no evidence that this is a good fit for all pain patients

7

Harms and benefits should be assessed within 1–4 weeks after starting opioids and at least quarterly thereafter

The CDC said that if benefits do not outweigh harms, patients should be tapered to lower doses or discontinued. Shared decision-making should be involved in discontinuing opioids and selecting other analgesic options

8

Risk factors should be assessed periodically and plans made to mitigate risk

9

Prescription drug monitoring program (PDMP) data should be checked to be sure the patient is not taking too many opioid or dangerous drug combinations

The CDC advises that checks should be made every time a prescription is added and at least quarterly even if nothing new is added

Note that not all states have a PDMP and few programs effectively share their data with other states

10

Urine drug testing should be done at the outset of opioid therapy and at least annually

Urine drug testing is well established in this setting but it is unclear why urine screens could be limited to once a year

11

Opioids and benzodiazepines should not be taken concurrently

There may be cases where a patient taking opioids may require short-term benzodiazepine use

12

For patients who develop opioid use disorder, physicians should arrange for evidence-based treatment

The CDC does not define opioid use disorder, explain how it would be diagnosed, or advise as to what sort of treatments might be appropriate; this puts an undue burden on a primary care physician who is likely not equipped to manage this scenario. Opioid detoxification and rehabilitation are extremely challenging clinical situations that require significant expertise to manage effectively

At first glance, there were some omissions in these 12 points, at least as far as pain specialists were concerned.

None of the guidance mentioned patient or provider education.

The guidance did not mention abuse-deterrent formulations (ADFs) of opioids, although the Food and Drug Administration was advocating for their wider use and continues to view them as an important weapon in the fight against opioid misuse

The guidance also does not explain how to diagnose “opioid use disorder” and how physicians are to arrange for evidence-based treatment. Numerous rehabilitation programs for opioid use disorder exist but may not be accessible to all patients in all parts of the country.

Finally, the cutoff rate of 90 morphine milligram equivalents (MME) per day is challenging on three fronts:

  1. First, there may be situations (particularly with long-term use) where the patient has developed tolerance to the point that high doses of opioids are needed.
  2. Second, an arbitrary dose limitation does not account for the clinical differences among patients that may have a profound effect on drug dosage, for example, patient weight, concomitant medications, individual metabolism, and comorbid conditions.
  3. Finally and perhaps most importantly, while MME appears on the surface to be a useful metric in that all opioids can be converted to this denominator and thus easily compared, morphine equivalence is far from an exact science. In practice, equianalgesic conversions are estimates, and different physicians or clinics may arrive at different MME values for the same drugs

There are other curious omissions in that the guidance seems to want to limit the dose but steers patients toward higher-risk products.

Likewise, there is no mention of abuse-deterrent formulations that have been shown to be safe, effective, and less appealing to those who want to tamper with the oral products. Since abuse-deterrent formulations are more expensive, this may again be an effort to find the least expensive opioid rather than the safest one.

In response to the CDC guideline, the Centers for Medicare and Medicaid Services (CMS) established new regulations as of 1 January 2019, which limit how opioids can be prescribed and dispensed.

See Medicare Patients Face New Rx Opioid Rules in 2019.

Pharmacists and insurance companies then have the right to reject certain opioid prescriptions.

Apart from short-circuiting the role of the prescribing physician, these new rules may place an undue burden on pharmacists having to spend time consulting with the many CMS beneficiaries who may have prescriptions that fall outside the CDC guidance.

Key stakeholders have just published an urgent plea to avoid “forced opioid tapering” in legacy chronic pain patients who take doses of opioids that exceed the CDC limit of 90 MME

Forced tapering results not only in inadequate analgesia but can also precipitate withdrawal symptoms, exacerbate functional deficits, and alarm and confuse patients and their families

Finally, we see “inadequate analgesia” pointed out as a “real” issue, not just a problem with a patient’s attitude or resilience.

Suicide rates in much of the USA have increased over 30% since 1999, and the CDC has listed that one of the warning signs that a person may be at risk for suicidality is “unbearable pain”

There are many factors driving opioid overdose mortality, including the increasing incursion of illicit fentanyl into street opioids (particularly heroin)

Behind the headline-making opioid crisis, there is the second and more silent public health crisis of untreated chronic pain.

I’m thrilled that this article also points out the dangers created by a sudden “deficit” of opioids.

While it is difficult to get hard statistics to make comparisons…

This is because the CDC never carried out the follow-up studies about the outcomes of these guidelines they issued.

…it appears that physicians are increasingly unwilling to prescribe opioid analgesics, even in patients in whom they would be clearly indicated

This is the first time I’ve seen mention of patients for whom opioids are clearly indicated. Everything else written about opioids makes it sound like they’re never appropriate for any kind of chronic pain.

A qualitative study on 48 adults who had taken opioids for chronic pain reported stigmatization, loss of autonomy, and vulnerabilities regarding their opioid use, which were unintended consequences of the CDC opioid policies.

I doubt very much that these outcomes were unintended.

In Canada, British Columbia initially adopted the CDC guideline for its own physicians but has since decided to re-evaluate them because of their limitations, in particular in terms of how to manage patients taking higher doses of opioids for chronic pain.

There is much good in the CDC guideline, in particular in that it recommended using opioids in a more measured and careful way and seeking out nonpharmacologic and nonopioid pharmacologic therapies when workable.

And few pain patients would disagree with this. We’re always trying to minimize our opioid consumption by using alternative treatments therapies and supplements.

However, it is urgent that we deliver to all healthcare professionals more comprehensive education in pain therapy and pain medications, including but not limited to opioids, and that we continue to treat chronic pain patients with compassion and effective therapy rather than fear.

Urging doctors to treat patients with compassion instead of fear is also a new concept in published studies and articles.

Historically, opioids have been overprescribed and, in some instances, inappropriately prescribed, but the answer is not overcompensation in the opposite direction to the point that chronic pain patients (and indeed some acute pain patients and even postoperative patients) are denied pain control or are being forcibly discontinued from the analgesics on which they have come to depend.

The answer is not a cookie-cutter solution as the CDC might like to see implemented (no doses > 90 MME, opioids prescribed for no more than 7 days, and so on) but comprehensive, evidence-based training and education so that clinicians can make individualized decisions for each patient and deliver appropriate care.

Pain is a deeply personal experience

It has the power to jettison careers, destabilize families, and inflict tremendous functional and psychologic damage to those whose life it touches.

It can be hard even for physicians to truly appreciate the overwhelming personal catastrophe that severe chronic pain represents to individuals

I’m thrilled to see them referring to chronic pain as a “personal catastrophe”.

Everything else I’ve read about chronic pain and catastrophe has been to explain that our chronic pain is only bad and intolerable because we’re catastrophizing about it. This article actually points out that this is simply the reality for so many of us.

Even as we continue to confront the opioid crisis, we cannot abandon professional compassion and the alleviation of unnecessary suffering.

As clinicians, our mission must be to serve patients, not causes.

It’s good to see this article pointing out that doctors have an obligation to serve their patients, not serve anti-opioid causes or simplistically minimize opioid milligrams as the only measure of success (regardless of what their bosses tell them).

In conclusion, there is evidence that suggests that opioid overprescribing was correcting itself, albeit slowly, as far back as 2012

At least some professionals are noticing this, even as others stick their heads firmly in the sand and pretend that all opioids are evil.

While pockets of overprescribing still exist in many areas, physicians have become aware of misuse and abuse and adjusted prescribing accordingly

Pain is an ancient medical complaint, but pain medicine is one of the newest specialties.

As such, we pain specialists may feel that we lack the numbers, infrastructure, organization, and gravitas to bring our expertise to full measure in the wake of what could be called dual public health crises

This is a time for pain specialists to speak up and speak out.

It’s wonderful to see this open call for doctors to step up and defend their patients from these cruel restrictions of pain medication.

1 thought on “Aftermath of the CDC Guideline

  1. Kathy C

    They could have referred to New Mexico, since their PMP went into effect in 2011, and due to a heroin problem since the 90’s, they instituted guidelines even more strict them the CDC back in 2014 and earlier. None of it reduced drug use, suicides, or overdoses, and deaths. In the interest of public shaming one town with the worst rates of heroin addiction, published the results of all autopsies involving opioids. Half of the deaths attributed to “opioids” were old sick people, with multiple medical conditions. The rest were obvious overdoses due to illegal drug use. This is a town where in the 19090’s people were exposed to heroin and other drugs in jail.

    Only recently did the local media discuss, illegal drugs, the coverage used the word opioids or opiates, that was while the use of methamphetamine increased. Now the illegal drug peddlers are selling Fentanyl laced pills that look like prescription drugs, and people are dying from those. The media has been very deceptive in their coverage of this topic, rarely mentioning people with chronic pain. New Mexico never had any “Pill Mills” but they still claim they are on every corner.

    They cracked down in New Mexico before the federal crack down, and it led to more deaths. Of course at the some time, they had virtually no treatment programs. The state epidemiologist is still claiming they are at the forefront, only because they had a couple of unsupervised methadone programs. The state is still pushing 12 step programs while misleading the public about the amount of “treatment” available.

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