COMMENTARY

New CDC Opioid Guideline: The Good, the Bad, the Ugly

Charles E. Argoff, MD

Disclosures

May 13, 2016

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This is Dr Charles Argoff, professor of neurology at Albany Medical College and director of the Comprehensive Pain Center at Albany Medical Center in Albany, New York.

New Guideline for Opioid Prescribing From the CDC

This blog will focus on the Centers for Disease Control and Prevention (CDC) guideline for prescribing opioids for chronic pain.[1] This is a document that was just published, and it's intended for primary care providers, which includes both physicians and nonphysicians, who are treating individuals with chronic pain.

Chronic pain in this guideline was defined as 3 months or more of persistent pain or pain past the time of normal healing in an outpatient setting. The guideline is specifically intended for individuals with chronic pain who are 18 years or older, outside of any active cancer treatment, palliative care, or end-of-life care. Some of the recommendations may also be relevant for acute settings, such as for emergency medicine or dentistry, but that was not the focus of the guideline.

I'd like to bring up a couple of scenarios in which this guideline might be used and then focus on the 12 recommendations and identify the good, the bad, and potentially the ugly. Two scenarios where this guideline might be used include: (1) a primary care provider who is considering treatment with opioid therapy for a new patient; and (2) a primary care provider who's not a "pain specialist," but is currently treating somebody with opioid therapy on a chronic basis. They might be treating chronic pain in their mind successfully using doses that exceed recommendations but are safely using them.

The guideline's purpose is to "improve communication between clinicians and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term therapy including opioid use disorder." Who could argue with that as well as reducing overdose and death? Who could argue with the next point? "Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient's clinical situation, functioning, and life context." That makes perfect sense. These recommendations are put forth as voluntary, and the authors are supporting these recommendations on "emerging" evidence including observational studies, which some of the authors of guidelines would say is of little value from an evidence-based point of view, or randomized controlled trials.

The authors do recommend looking at the patients' unique needs, and that's important. They describe the process, how they actually went about looking at this guideline, and how they made the recommendations. It was a very detailed literature review. I'm not sure if the disclosures section of the guideline reveals how many of the authors have any experience with long-term management of chronic opioid therapy. I know that there may have been disclosures with respect to industry and other business relationships. I think that if this guideline is going to be mandated upon us clinicians, it should have at least been written and developed by people who have an active practice in which they manage people with chronic opioid therapy and who may have a little bit of insight other than just reading a study and summarizing its results.

Let's look at the 12 recommendations from this guideline, with the first recommendations on initiating or continuing opioids.

Recommendations on Initiating or Continuing Opioids

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.

They offer no randomized controlled trial data to recommend that nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. They do address this, but that's their first recommendation. However, there may be general consensus that that may be a reasonable thing to do.

2. Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.

Generally this makes sense, but what about a patient with Parkinson disease, a spinal cord injury, multiple sclerosis, or with postlaminectomy pain who isn't in a position where they're likely to have improved function? This guideline suggests that function needs to be improved. How inhumane is it to have that kind of statement without any context? That's an important weakness that I'd like to highlight.

3. Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.

This is an absolutely important point.

Opioid Selection, Dosage, Duration, Follow-up, and Discontinuation

This is very important because we need to also keep in mind that there may be a time that comes when we realize that opioid therapy may not be appropriate for a person and might need to be discontinued.

4. When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.

This would mean that if a clinician decided using their best clinical judgment that a person had chronic pain around the clock of sufficient intensity to warrant an opioid (which is basically the indication of long-acting opioids), that person should be treated with immediate-release opioid, which won't allow them to initially have that around-the-clock benefit. What is the basis for this? Many of the extended-release agents have starting doses that are equal to or even lower than immediate-release doses. This doesn't make sense clinically or when considering what is available in our armamentarium at this time. Why would I switch somebody if I could get it right the first time? This needs to be examined at some point for more patient-specific reasons.

5. When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day.

It is very important to recognize that dose does matter. However, there is a subset of people for whom higher-dose therapy can be appropriate, and this recommendation does recognize that.

6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than 7 days will rarely be needed.

In general, this may be true. We don't need more dentists prescribing an opioid for 60 days for a wisdom tooth extraction in a teenager. This is a solid recommendation that we can use to improve prescribing and safety for our patients. I hope that all will heed this unless there are specific circumstances that can be documented that preclude following this recommendation.

7. Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh 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.

It's not just try one opioid and you're done. You might get to the point after rotating opioid therapy and using multimodal approaches—which is not addressed in this guideline at all in any significant way—and really trying to see how opiate therapy might fit in. That makes perfect sense despite the absence of randomized controlled trials. Why would we consider continuing a therapeutic approach that isn't having its intended goal of meeting clinical endpoints in a safe and effective way? So, this makes sense.

Assessing the Risk and Addressing the Harms of Opioid Use

8. Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present.

This is a very sound recommendation.

9. Clinicians should review the patient's history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

I'll just say that I'm extremely happy to be working in New York state, where, in order for me to properly prescribe, I am mandated, even if the controlled substance is an anticonvulsant for anticonvulsant purposes, to query our prescription monitoring program before prescribing. It's been invaluable just in picking up potential drug-drug interactions in situations where substance misuse was not even the issue. This is a very sound recommendation.

10. When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

This is not based upon a great deal of evidence, but it does make sense, and there are guidelines that are being developed at this time to address this very issue.

11. Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

The CDC itself has data to support a dramatic increase in unintentional overdose and death when these two classes of medications are combined,[2] making prescription monitoring programs so important. Even if your state doesn't mandate it, please look into these programs because sometimes we don't know what else a patient is taking.

12. Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

If you determine, after getting to know a patient and evaluating them, that among their diagnoses they have opioid use disorder, get that person help. That's important.

Cancer Pain vs Noncancer Pain: Is the Difference Relevant?

One thing that's not addressed is that this guideline only applies to noncancer pain, but when does somebody with cancer who has now lived 10 years past their cancer but developed chronic pain because of chemotherapy, radiation, or surgery become a "noncancer" pain patient? That's never been adequately understood.

One of my colleagues said, after reading this guideline, "Outstanding! This is great without any further fine-tuning." Another colleague said, "In my experience in palliative care and hospice care, taking care of people in that setting supports the importance of opioids. The need for opioids in a terminally ill patient with severe pain is irrefutable. It typically provides significant benefit in quality of life for a patient at the end of life." I could replace noncancer pain where that colleague said pain in the terminally ill, and that is irrefutable. If you look at long-term data, which the guideline authors say don't exist, we see many people who do well long term. Why are we discriminating against people who are living without cancer who experience chronic pain? It's irrefutable that the quality of life and comfort can improve in a subset of people who don't have cancer and who are on chronic opioid therapy for their chronic pain. That's really important.

I think that one could view some of the guideline classes as being biased. There are many people with chronic noncancer pain who have benefited from chronic opioid therapy, and there are certain groups out there who pain diminish and try to nullify that by saying that there must be some explanation why they're on opioid therapy. That's not appropriate, it's not fair, it's biased, and it's discriminatory.

The Realities of Evidence-Based Use of Opioid Therapy

The greatest strength of this guideline is a call for rational, thoughtful, and as safe as possible use of chronic opioid therapy. This is especially important for primary care providers who may not be as experienced and may not have had the educational background to take care of complicated patients with complicated drug regimens.

Many of the recommendations, such as nonopioid therapy and cognitive-behavioral therapy for chronic pain, may not be available to all patients. They may not be the most effective way to treat a pain condition. This is another "fail first instead of thinking about what is best for that patient" approach to taking care of somebody. Of course, how many times have you heard yourself or your peers saying that a therapy was chosen because that's what's covered? In other words, payers are not obligated to provide the kind of nonmedical and nonopioid cognitive-behavioral and physical rehabilitation strategies that this guideline puts forth as recommendations.

Although the CDC says that this guideline is voluntary, my opinion is that it will likely be used by regulatory authorities and payers to thoughtlessly limit access to chronic opioid therapy, even when people have already been established as being helped by these medications. They've been successfully used and are being successfully used by millions of people who have chronic pain.

I also think that part of the position that we're in, and we need to recognize this—it's not new to your ears—is that the majority of American healthcare providers, including both physicians and nonphysicians, do not receive adequate training in pain management. The result of entering our postgraduate and posttraining years without sufficient pain management training is default action for many people. The only thing you've ever been exposed to during the training is to prescribe an opioid medication even if it may not be the best option for that person. This is common in acute care settings and in the hospital.

Medications in the opioid class have been both overprescribed and underprescribed. They are generally optimally prescribed when used as part of a true multimodal approach for chronic pain treatment and monitored by the provider very carefully. Really, we should not throw the baby out with the bathwater. We need to use opioid therapy in the best possible way that we can. For an important subset of people who have chronic noncancer pain, chronic opioid therapy clearly is an important treatment option. It's my sincere hope that the CDC guideline will be followed in such a way by all to ensure that the millions of people who have benefited from opioids for many years will continue to have access to these medications, while those for whom these are not the best option will have access to other pain management treatments that may be more suitable for their needs.

If we are to truly practice evidence-based medicine as it was intended to be, then we will need to do so in an unbiased manner and work to use the best available published evidence in association with the experience of a clinician and the clinician's judgment to address the individualized needs of individual people who experience chronic pain. This is the true published definition of evidence-based medicine as defined approximately 20 years ago.[3] The fact that the CDC panel was not composed of people who actively treat people in pain with these therapies as well as others diminishes the guideline's value because although the recommendations are based on evidence, they are not truly evidence-based.

If you are viewing this blog, please do not forget the value of your clinical skills and your oath to relieve pain and suffering when you take care of your patients, such as people with chronic pain, and to take care of them as safely and effectively as possible.

I hope that you have found these comments helpful and informative. I'm Dr Charles Argoff.

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