Professional Criticism of CDC Guidelines

CDC Issues Final Guidelines for Opioid Prescribing: PPM Editorial Board Responds

This is a 6-page article, with some thoughtful criticism of the guidelines, addressing some of their striking shortcomings.

The initial draft guidelines were met with sharp criticism from a number of medical organizations, including the American Academy of Pain Medicine (AAPM), American Medical Association (AMA), and the American Academy of Pain Management.

To measure the pulse of pain physicians, Practical Pain Management solicited responses from our editorial board members. What follows are the reactions from

1. Jennifer Schneider, MD, a pain and addiction specialist;
2. Gary W. Jay, MD, FAAPM, FACFEI, a pain practitioner;
3. Leonard Goldstein, DDS, PhD, a licensed dentist and acupuncturist  

CDC Recommendations Fall Short—Ignore Important Aspects of Pain Management

By Jennifer P. Schneider, MD, PhD

I have learned that too many well-intentioned prescribers are solely focused on relieving chronic pain without understanding the need for risk assessment and without recognizing that a major goal of treating chronic pain is to improve the patient’s functioning.

At the other extreme are clinicians who believe there is no, or a minimal, role for opioids in the treatment of chronic pain.

Neither of these approaches is in the patient’s best interest

Why The Recommendations Fall Short

There is nothing new about the recently published CDC guidelines. The 12 recommendations are a mixture of guidelines that have been in existence for many years, along with some useless or irrelevant recommendations as well as statements that are not evidence based and that will be a disservice for many patients if they are followed.

Here is my review of each recommendation:

#1. Agree. “Non-drug therapy and nonopioid therapy should be considered first”

#2. Disagree. PT is important but is not stressed in the guidelines. I agree that “Goals need to be established on the first visit and subsequent visits should assess improvements in both pain and function.”

But I don’t agree that assessment of improvement in pain and function “that outweighs the risks to patient safety” is the main reason to continue opioids. The main reason is the improvement in the patient’s pain and function.

In my opinion, function should be stressed more. Patients should be asked—at every visit—to describe specific activities that they can do at home, and to explain the length and intensity of those activities

When a patient reports that “PT didn’t work,” rather than recording in the chart that PT failed, a conversation should be started so the patient understands the goals of PT and the important role of activity in minimizing the progression of muscle weakness and disability.

#3. Reality check.

With regards to “periodic discussions with patients [about] known risks and realistic benefits of opioid therapy”

when there’s a box to check on each visit confirming that the matter was discussed the reality is that the box usually gets checked, but the provider doesn’t actually take the time to discuss the matter. This is unfortunate.

#4. Unacceptable omission. “When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release.” I agree.

But there is no mention in this guideline of what to do when the opioid is continued!!!! This is an unacceptable oversight.  

good reasons for using the ER formulation, including:

• Less-frequent dosing means less clock-watching and longer pain relief,
• Less-frequent dosing results in smoother blood levels and therefore more constant pain relief.
• Smoother blood levels result in fewer CNS effects such as euphoria.
• Value on the street.
• Delay makes switching difficult. The longer you wait to switch a patient from an IR to ER formulation, the harder it becomes to make the switch.

The bottom line is, when you have a patient with chronic pain on a stable opioid dose, don’t leave him or her on a round-the-clock IR formulation; transfer as soon as possible to the ER.

#5. Numbers are arbitrary.

“When opioids are started, clinicians should prescribe the lowest effective dosage. . . and carefully reassess evidence of individual benefits and risks when increasing dosage to 50 morphine milligram equivalents (MME) per day.” This is true, and you should assess the benefit of whichever dose you are prescribing, not just if it is ≥50 MME/day; there is no evidence that a dose higher than 50 mg morphine has specific features.

The same is true of the next statement that clinicians “should avoid increasing dosage to ≥90 MME/day or carefully justify a decision” to prescribe this dose.

These are arbitrary numbers.

Is it okay then to not carefully justify a decision to prescribe 70 or 80 MME/day? These decisions should be based on the patient’s functionas well as pain relief no matter what the dose, along with the patient’s willingness to be engaged in other recommended activities such as physical therapy, exercise, and counseling if there are behavioral health problems.

#6. Not detailed enough to be helpful.

“Long-term opioid use often begins with treatment of acute pain.” This is true, but these guidelines specifically state they are for chronic pain, not acute.

There is no reason to throw in recommendations for acute pain, especially when they are absurd

I take issue with the following statement: “Prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.” Where is the guidance?

The fact is, there are many different types of acute pain, and it is often difficult to assess the expected duration.

The guideline goes on to say: “Three days or less will often be sufficient; more than 7 days will rarely be needed.”

How can they recommend this without having any idea of the specific injury, surgery, or event?

#7. Nonopioid therapies should be addressed.

This guideline suggests “seeing a patient at 1 to 4 weeks after starting opioid therapy for chronic pain, and following up at least every 3 months or more often”… Absolutely.

It then advises “if the benefits do not outweigh the harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.” The problem with this is the implication that if the benefits do outweigh the risks then there is no need to optimize other therapies.

This is precisely what’s wrong with this entire document—it doesn’t clearly make the point that “other therapies” such as nonopioid medications for neuropathic pain, PT, osteopathic manipulation, injections, behavioral health treatment, etc.—are not just for those who’ve failed opioids, but rather should be considered for everyone as a part of an integrated approach right from the start.

Risk Assessment Recommendations

A necessary aspect of prescribing opioids concerns risk assessment, but the next 5 recommendations tackle the topic without giving practical advice or emphasizing what’s important.

#8. Definition of risk is confused.

They have lumped together situations that do not present any significant risk with those that should mandate not prescribing opioids by anyone other than an addiction specialist/pain specialist.

#9. Lacks interpretation.

looking for dangerous combinations is not the main reason for checking the PDMP: The main reasons are to see if the patient has been getting opioids from more than one source; whether or not and when he/she has been filling the prescriptions

#10. Patients should never expect to be tested—urine drug testing (UDT) should be done randomly

“Use UDT before starting opioid therapy and consider testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.” Yes, but this recommendation is not specific enough to be useful for the following reasons:

Too many prescribers make UDT a routine part of every visit. This takes away a key element of what makes these tests useful—the element of surprise

Surprises is exactly what I don’t want at a doctor’s visit. When every patient is subjected to this deliberately sneaky way of “catching” cheaters, it destroys trust.

It is also important for the patient to provide the time and date when he last took each of the drugs that you prescribed and are testing for, and for you to document this.

The problem is that many opioids are metabolized to other opioids that also appear in the urine.

#11 Ideal versus reality.

Pain specialists agree that it’s best to avoid concurrent opioid and benzodiazepine use. But because benzos are effective for treating anxiety, muscle spasm, and insomnia, which are common in patients with chronic pain, the combination is often used.

#12. Patients with substance use disorder need special treatment.

“Clinicians should offer or arrange treatment [usually medication-assisted treatment with buprenorphine/naloxone or methadone in combination with behavioral therapies] for patients with opioid use disorder.” Diagnosis and treatment of drug addiction (called “opioid use disorder” in the language of the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition) is a specialty onto itself.

Summary

Few clinicians will take the time to read the entire 52-page report, with its 222 references, lengthy tables, and erudite discussion of the quality of various studies. Most of them will at most read the one-page listing of the 12 recommendations, or even more likely, the digested versions that have appeared recently in most newspapers and online. Thus, they will see only the wording that I have dissected in this commentary.

Of the 12 recommendations for prescribing opioids, the majority deal with risks, harms, and limiting maximum doses, and those that actually address prescribing tend not to be specific enough and to ignore important aspects of treating the patient and making decisions. The recommendations could have been a great deal more useful.  

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We Got Where We Were Going—Someone Please Right the Ship!

By Gary W. Jay, MD, FAAPM, FACFEI

For some perspective, I’d like to reflect on where we’ve been and how we got here

it’s important to remember that many of the hymns were written by reputable physicians about the positive, evidence-based medicine (including Cochrane Reviews) that focused on interdisciplinary pain centers (Level A).

Then, the insurance companies said: “No More” and stopped (or cut) reimbursement for physical therapy (PT), psychological services, occupational therapy (OT), and other modalities that benefited patients by increasing their functionality, much more than did pharmacotherapy.

Where did that leave us pain specialists? With little to offer but medication and/or invasive interventions.

The bottom line: good pain medicine was being practiced but when we were forced to stop using the interdisciplinary approaches that had been so successful, we were left with medication management.

The insurers, in their magnificent conceit, determined that PT, psychotherapy, and OT would not be reimbursed in an interdisciplinary pain center.

How Insurance Companies Changed the Rules and the CDC Let Them

You may remember “back in the day” when insurers allowed 4 to 6 PT visits but most patients needed 8 to 12 sessions for it to be most helpful. Getting approval for additional PT typically took weeks, so by the time more visits were permitted, restarting PT was often too late to be helpful.

Unfortunately, the CDC never informed the insurance industry that evidence-based medicine demonstrated that interdisciplinary pain centers saved money and helped patients. Nope! They said nothing about this then, or in the CDC Guidelines now.

The one tool physicians thought they had control of—prescribing opioids—they are now being “guideline-pressured” not to use.

What’s Wrong with This Picture?

The CDC Opioid Guidelines fail to indicate what documentation is required for a trial of therapies. Let’s not even go into the enormous amounts of money called “escalating deductibles” that may need to be spent to obtain such care—office visits and even medication—so that a patient can feel less pain and become more productive.

There are a number of pain specialists who have successfully used opioids to treat their patients without incident. I saw more than 36,000 patients in my interdisciplinary pain center over 25 years—and never had a death, overdose, or concurrent use with a benzodiazepine.

Now, physicians aren’t supposed to trust their patients because it’s the physicians’ fault that they prescribed opioids, and the patients’ fault that they “did bad things with them,” purposely or not.

The CDC guidelines are blaming two innocent parties for a crisis they had no hand it: legitimate patients and good doctors.

This situation makes me angry for a few reasons:

• The “Guidelines” provide an excuse for some physicians not to treat pain at all because their personal risk is too high.
• Some physicians will think it’s perfectly fine to prescribe some opioid in lower dosages (under 50 mg morphine equivalents), as suggested in the “Guidelines.” After all, how could that be bad? Let me count the ways….
• What about all the patients on higher doses of opioids—for years??? Physicians may become intimidated by the “Guidelines” and attempt to provide pain relief using only nonopioids and analgesics, and then direct patients to a “pain specialist” who may be scarce or unavailable.

For these reasons, I fear many patients will not receive adequate and needed pain relief.

New Reason to Just Say “No”

As noted above, I believe the CDC response offers a “Big Chill” to physicians looking for a reason to stop seeing pain patients—a new, federal “guidance” reason. I won’t even comment on those who were responsible for the guidelines, and what their political alliances were.  

And for those of us who know other mechanisms to assist patients, exactly who is going to provide reimbursement for those services when the deductible is already excessive and growing, and the patient doesn’t have the finances to afford an interdisciplinary attempt at care? What’s left? Medications!

There seems to be a total lack of recall about the long and successful record of treating both chronic non-cancer and cancer patients who took their pain medications with reasonable outcomes and without “a problem.”

It appears foolish to look only at the lack of evidence-based medicine studies of long-term opioid use, when the vast majority of pain specialists have had no problem working with them and giving patients what they needed to return to being healthy, functioning individuals.

Examine the Literature

Today, more women are surviving breast cancer. But the chemotherapy required to halt the cancer often induces a painful peripheral neuropathy. Although the cancer is gone, they are left with pain.

There are over 180,000 women in the UK and even more in the US who have great difficulty obtaining pain medications for their peripheral neuropathy because their lives are no longer at risk from cancer.

Their oncologist is finished and has provided a fine outcome. They are alive but in pain. Will their PCPs be comfortable prescribing “pain meds” for that?

Some patients may need opioids in larger doses than the “Guidelines” say since the “Guidelines” can’t prevent the development of receptor site tolerance (which does NOT mean addiction to those who chatter on about it).

Also, consider the patient with a premorbid pain history using polymodal/multimodal opioid pain treatment and who presents for a related or unrelated surgical procedure requiring analgesics.

Ultimately, it is the patients who are victimized and may rightly be horrified

We’ve been here before—in the name of “medical” and possibly “political” correctness—trying to fix the real problem of opioid over-dosage and death by causing more problems.  

CDC Issues Final Guidelines For Opioid Prescribing (Page 6)

Research Not Robust

In spite of strong objections to the initial document from several major medical societies, the final recommendations were not substantially changed.

The complete lack of response to thousands of comments shows the agency cares little about individuals in pain.

the American Medical Association (AMA) and the American Pain Society noted that the widespread lack of reimbursement for non-pharmacological therapies deters clinicians from ordering them.

Dr. Frieden said that the agency based its guidance on the best available research on chronic pain, which he admitted, is “not as robust as we’d like.”

With regards to little or no insurance coverage for nonpharmacological treatments, the director said the issue was discussed with physicians and patient groups.

Some medical societies took issue for initially setting numerical thresholds

In a January letter to the CDC, the American Academy of Pain Medicine, said that the dosage recommendation should not refer to any “arbitrary dose” and asked that the standard duration be extended to 2 weeks

In the final guidelines, tweaks were added but the numbers largely remained unchanged.

Were the comments even read, or were we just offered input to let out our frustrations? These folks must have been “too busy” to read them.

Response from Medical Groups Mixed

The American College of Physicians came out in support of them

In contrast, the AMA was “largely supportive.” …qualms with the “evidence base for some recommendations”; insurance coverage limitations for nonpharmacological treatment; “and the potential effects of strict dosage and duration limits on patient care,” among other things.

the President of the American Pain Society, told Medscape Medical News that the CDC improved the final recommendations by giving physicians more flexibility to operate around “specific numbers.” (Dr. Terman was one of 10 experts convened by the agency in January to review the initial guidelines.)

Dr, Terman is an example of the forces aligned against us. As an expert, he should have known better than to approve this pile of propaganda.

“The CDC has done a good job in trying to make a good faith effort to produce guidelines that help (physicians) avoid overprescribing, but not restrict (patients) who really benefit from opioids on an individual basis.”

This statement is just absurd. There was certainly *not* a “good faith effort”, as evidenced by the lack of response to comments.