Opioid Prescribing and Monitoring - (Second Edition)
Primary Care Models for Pain Management

What Do the CDC Guidelines Mean for Patients on Long-Term, High-Dose Opioids?

The latest data are sobering: death by drug overdose is now the leading cause of mortality among Americans under 50 years of age. Drug overdose deaths in 2016 exceeded 59,000, or the rough equivalent of a commercial airliner crashing every day and killing everyone on board.1 This toll includes accidental overdose deaths and suicides from both illegal and prescribed opioid use; it may be exacerbated by patients’ comorbid disease or combined drugs (benzodiazepines) and alcohol use at the time of death.

In part to address the opioid overdose epidemic and promote safer use of opioids, the Centers for Disease Control and Prevention (CDC) released the CDC Guideline for Prescribing Opioids for Chronic Pain in 2016.2 The guideline is generally reasonable and conservative in its recommendations for how primary care providers (PCPs) should treat acute pain. Nevertheless, controversy has persisted over the appropriate treatment of patients with chronic pain (> 3 months) using high-dose opioids (> 90 mg morphine equivalents daily), which the CDC recommends be “carefully justified.”

Guideline Criticisms

The CDC is aiming to reduce the availability of Schedule II and III opioids, and in particular, higher-dose extended release forms, because these drugs have been associated with a higher incidence of overdose deaths. For clinicians treating chronic pain, however, the potential for a stochastically determined threshold of 90 morphine milligram equivalents (MME) to be universally applied to every case raises several important concerns.

First, some clinicians have heavily criticized use of the MME daily dose in this context.3 One major issue is the lack of a universally accepted method for opioid conversion.3 An online survey of 319 health care professionals, for example, revealed significant differences in how they determined opioid conversion to MMEs.4 While numerous references and online calculators can assist providers with such conversions, a comparison of these tools also suggested wide variability.5

Further, a narrow focus on the risks of high-dose opioids may falsely reassure providers that lower doses of opioids are safe. In fact, there is no completely safe opioid dose; an overdose can occur at any dose.2 Although the risk doubles as the dose rises from < 20 MME to between 20 and 49 MME, and the risk increases geometrically with dosage, there are no clear cutoff pinpoints when an overdose may occur in any given individual.6-8

Specifically, the MME does not take into account unique patient factors like age, drug-drug interactions, comorbidities, weight, and renal/hepatic function, to name a few.3 Note, some patients receiving higher doses of opioids may be sicker and more likely to have medical comorbidities, and therefore may be taking multiple medications, all of which contribute to risk of overdose. Likewise, pharmacogenetic polymorphism (allotypic variation) can lead to interindividual variability in drug response, which may lead to alterations in efficacy, safety, and tolerability of medications.9-10

Understanding the Risks

The CDC guidelines are not intended to limit the ability of pain specialists to prescribe beyond 90 MME.2 Even so, it is important that practitioners understand: when a high-dose opioid prescription may be appropriate, what documentation is needed to justify the medical necessity when it is, and how to manage the situation when it is not.

As pain specialists, we know that opioids can play a role in the long-term treatment of chronic pain in many cases and that high-dose opioids (> 90 MME) may be warranted on occasion. As conscientious practitioners, we certainly do not intend to cause harm or contribute to opioid use disorder. Nevertheless, we also must recognize that 65% of abused prescription opioids are accessed through a friend or family member who received that prescription from a physician.11 This all-too-common scenario should give us pause when we’re considering prescriptions that can be lethal to the opioid-naïve.

In addition, high-dose opioid prescriptions are often synonymous with long-acting preparations. These long-acting opioids place patients at increased risk for overdose, especially upon initiation.12 A high dosage and long-term duration of opioids further increase the risk for overdose and opioid use disorder.7,8,12 Increased opioid doses correlate with dose-dependent tolerance, hypogonadism, hormonal imbalances, and immune suppression.13 More than 90% of patients treated with high-dose opioids also experience side effects, such as drowsiness and constipation, the former of which is usually overcome within 2 weeks of dosage adjustment due to physical tolerance.14,15 Scherrer et al have reported that long-term opioid use generally correlates to psycho-
emotional issues, such as depression.16

Patients on long-term opioid therapy also can exhibit psychomotor impairment, which can increase their risk of falls, injuries, and traffic accidents.17,18 Some older studies, though, have shown that long-term opioid therapy does not have an adverse effect on motor vehicle response time compared to the distraction of untreated pain.19-21 Further, chronic opioid use negatively correlates with the ability of patients to return to meaningful work.22

Given that all of these issues may significantly impact a patient’s quality of life and functionality, practitioners should carefully consider the context of each patient’s psychosocial situation when prescribing high-dose and long-acting opioids. In general, we find that patients under consideration for such opioids fall into 2 categories. The first category includes patients on lower-dose therapy for whom we are considering an escalation to higher doses. The second category includes “legacy” patients already established on higher doses.

Patients Under Consideration for Dose Escalation

For the first group of patients, physicians should first reevaluate the clinical situation to see if alternative treatment options may help provide improved pain control and function. Opioids should always be used in the context of a comprehensive multimodal pain treatment program. Physical therapy, acupuncture, chiropractic treatment, biofeedback, psychological counseling, and other modalities may be available, depending on the patient.

Often, chronic pain patients are physically deconditioned and/or obese. In general, they may be significantly impaired in self-care.23 Physicians should encourage patients to lose weight and offer assistance in developing a home exercise program that can be maintained. Importantly, practitioners must recognize that the failure of patients to maintain a home exercise regimen or healthy weight can result in an increase of chronic pain; however, it is not incumbent upon the practitioner to escalate a patient’s dosage in this circumstance. Consider, for example, that the standard of care prerequisites for gastric bypass surgery include mandatory participation in psychological counseling and documented compliance with a weight loss protocol. The intent here is to minimize treatment failure. Similarly, practitioners should be careful to avoid dose escalation in cases that carry a high likelihood of treatment failure.

Physicians should review patients’ treatment plans with them and exclude depression, abuse, and misuse as possible causes of increased opioid needs. Escalation should be considered in cases where only a high opioid dose can achieve a sustained increase in functional benefit and quality of life, while alternative methods of medical treatment cannot. Prior to any dose escalation, clinical goals should be discussed with patients. These may include the ability to work a full 8-hour shift, the ability to sleep through the night, the ability to participate in physical therapy treatment, and other benchmarks.

In all instances, objective findings will help to document the treatment’s efficacy. Further, physicians should make clear to their patients that continuation of an escalated dose is contingent on meeting these objective goals. Throughout the treatment regimen, the risks should also be continually reassessed, and opioids should be continued only as long as the functional and analgesic benefits outweigh the risks. If the risk-to-benefit ratio reverses at any point, physicians should reconsider and modify their treatment plan, potentially leading to a reduction or discontinuation of opioids.

Discussing Exit Strategy Before Escalation

It is essential that physicians discuss an “exit strategy” with patients prior to any dose escalation, with a clear understanding that the trial has clearly defined and objective goals, so that patients understand the circumstances in which the opioid dose will be continued or tapered. Too often, practitioners fail to have this conversation, and patients incorrectly believe that “feeling a little better” will be a satisfactory justification for dose escalation of opioid medication. It is not.

In the context of the CDC guidelines, rigorous justification of dose escalation beyond 90 MME is necessary, and weaning should commence when the predetermined criteria are not met. This is the same standard of care as in other areas of medicine. Physicians would discontinue a new medication if a diabetic “felt better” while taking it but had worse blood sugar and HgA1C measures, for example. Relying solely on a patient’s subjective self-reports of pain relief is clearly insufficient to justify the use of high-dose opioid medications.

Assessment and Documentation Tools

The goal of prescribing opioids is to reduce suffering by facilitating functional restoration/improvement and/or improvements in quality of life. In this regard, several tools may help provide appropriate documentation of improvement through comparisons of pre-treatment and post-treatment ratings (Table 1, page 26).6,24,25

A pain scale such as the visual analog scale (VAS) is often included in such documentation, but is insufficient on its own to justify opioid use. It is particularly important that physicians document functional improvement to justify ongoing opioid prescription. Measures may range from improvement in simple self-care activities of daily living to improvement in exercise tolerance and a return to work. Thus, a functional improvement scale and/or a disability scale (eg, BPI) should be an integral part of the justification. Additionally, an overarching quality of life assessment, such as the Patient Global Impression of Change, can provide the best measure of the overall impact of pain reduction on quality of life through a reduction of suffering.26 Physicians should also include opioid risk stratification (or assessment of opioid misuse) based on a scale such as the Opioid Risk Tool (ORT) or other validated abuse/misuse tools, as well as urine toxicology monitoring, when appropriate.2

While not essential, additional documentation in support of an opioid dose’s medical necessity can be provided by using an emotional scale to assess improvements in the psycho-emotional aspects of pain.27 In addition, a sleep scale can assess improvements in insomnia due to chronic pain as well as evaluate drowsiness, a common side effect of opioids. Finally, it’s important to document medication tolerability for an ongoing prescription. To this end, the prescribing physician should perform a thorough review of systems to document the absence of any significant side effects that might necessitate dose reduction or discontinuation.

The combined use of these scales can show the overall improvement in a patient’s condition that would help justify the medical necessity of high-dose and long-acting opioid medications. Documenting these evaluations is essential and should be done before and after any change in the patient’s plan. Individual states and licensing boards have varying requirements regarding prescribing controlled substances—be sure to comply with the mandates wherever you practice! Though not an exhaustive list, Table 2, page 27, provides suggestions regarding documentation for treating chronic pain.27 Especially with high-dose opioids, it is important for physicians to document that the benefits outweigh the risks, and that lower-dose opioids and other treatments have failed to help the patient meet functional, analgesic, and quality-of-life goals.

Table 1: Validated Tools for Screening and Assessing Patients With Chronic Pain

Table 2. Selection of Recommended Documentation

“Legacy” Patients

The second group of patients to consider are “legacy” patients who have been on high-dose opioids for a prolonged period of time. While the 3-month mark has often been defined as the entry point to “chronic pain,” practitioners often fail to recognize that some painful conditions may resolve over a longer course of time. In studies comparing spinal fusion versus conservative care for low back pain and spinal decompression versus conservative care for sciatica, for example, surgically treated patients achieved significantly more pain relief for the first few months.28,29 After 1 year, however, the studies found no difference in patient disability. Importantly, physicians should consider that patients may eventually fail to derive functional benefit from chronic opioid use.

Routine reevaluation of these patients is essential. When appropriate, a revisited work up may include a review of old records, functional assessments, and reaffirmation of the patient agreement and treatment goals. Practitioners should resist indiscriminate escalation of opioid dosage in chronic pain patients if loss of efficacy occurs. Opioid rotation may be appropriate in this circumstance if the patient’s condition has not changed; the potential effects of incomplete opioid cross-tolerance in managing the transition, particularly in the first few weeks, should be taken into account, however. Emphasis should be placed on nonopioid treatments, and the doctor and patient should jointly review the treatment plan to reinforce the use of multimodal treatments. A change in the patient’s condition would warrant a fresh evaluation to seek out other potentially treatable sources of increased pain.

In some cases, a patient’s habitual use is based largely on dependence, and continuation of the medication is no longer justified (this scenario is not unique to opioid use: many patients continue to take antidepressant medications well beyond the recommended 9 months).30 A trial of tapering or weaning from opioid medication should be considered periodically for all patients on high doses. Physicians should then allow sufficient time on the lower dose (minimum of 3-4 weeks) before reassessing the patient to minimize the potential impact of withdrawal symptoms on assessment measures.

Weaning a patient from opioid medications is absolutely indicated whenever the risks outweigh the benefits. Examples of such circumstances include a loss of efficacy, failure to meet treatment goals, the addition of concomitant medications or the development of comorbidities that increase risk of overdose, the emergence of aberrant behavior, and the development of opioid-induced hyperalgesia or other unacceptable side effects. Additionally, weaning may be mandated by a patient’s employer or insurance plan or requested by a patient due to social stigmatization. In these instances, dose reduction of 5% to 20% per week or slower is generally well tolerated.31

At any dose, appropriate risk mitigation strategies are essential components of an opioid prescription plan (Table 3).6,12,27 Urine drug testing (UDT) should be performed at least annually, and a review of the patient’s file in the local prescription drug monitoring program (PDMP) should be done at least quarterly (individual states may have stricter requirements).2 Higher-risk patients, which may include patients on high-dose opioids, require more frequent risk mitigation and follow-up than lower-risk patients. Patients on high-dose opioids also may be good candidates for a prescription of naloxone.27,31

Table 3: List of Risk Mitigation Strategies

Conclusion

The rise in opioid prescriptions over the past few decades, coincident with an exponential increase in opioid overdose deaths, influenced the development of the CDC Guideline for Prescribing Opioids for Chronic Pain, aimed at PCPs. Many of the recommendations within the guidelines are well accepted as the standard of care in treating chronic pain; however, much controversy remains regarding the use of high-dose (> 90 MME) opioids for chronic non-malignant pain. High-dose opioids may be appropriate in the setting of a multimodal treatment plan when the functional and analgesic benefits outweigh the risks of therapy, and alternative forms of treatment have failed to demonstrate efficacy. In this context, appropriate application of risk mitigation strategies and adequate patient follow-up to objectively document benefit and risk are essential. Numerous tools can assist physicians with a more objective assessment and documentation of patient progress necessary to justify the use of high-dose opioids. (For more on assessment, see Chapter 4).

Last updated on: April 29, 2019
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Assessment and Monitoring of Pain: Current Tools
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