Six Common Assumptions in the Opioid Management Debate
Within all these contentions, certain assumptions commonly remain unexamined – rarely do people stop to question whether these assumptions are justifiable by the available science. The following is a list of common assumptions within the debate about using long-term opioids for the management of chronic pain. After each assumption, a brief review of the published empirical research provides an examination of the degree to which the assumption is justifiable.
1. When used for chronic pain, addiction to opioid medications is rare.
In the late 1990’s and early 2000’s, an almost ubiquitous belief in healthcare was that addiction to opioid medications is rare. While not as widespread today, it is still commonly assumed (see, for some examples, these sites here or here).
In part, this belief was due to two studies that at one time were commonly cited -- one by Porter and Jick1and the other by Portnoy and Foley.2 The Porter and Jick study was a retrospective chart review of patients prescribed opioids in an emergency room. Published as a one-paragraph letter to the editor, the study involved the brief use of opioids (presumably a single prescription) in a sample of emergency room patients and found that rarely did the initiation of opioids in this setting lead to problems with addiction. The study was subsequently used to justify long-term use of opioids in a chronic population – despite the differences in treatment (short- versus long-term use of opioids) and patient populations (acute pain versus chronic pain). Portnoy and Foley reported on 38 cases of long-term use of opioids for chronic pain and found only two individuals who developed “management problems,” their brief description for behaviors indicative of addiction. Both studies were hailed as evidence that opioid use for chronic pain rarely results in addiction.
Since this time, a number of studies and meta-analyses on the rates of opioid medication addiction have been published. Subsequently, a greater appreciation has emerged of the various factors that make it difficult to determine how often addiction to prescription opioids occurs. These factors are the limited generalizability for different patient populations, differences in the operational definitions of addiction, and differences in how addiction is diagnosed across providers.
In their systematic review of predominantly clinical trials of opioid medication, Fishbain, et al.3 found differences in rates of addiction between studies that excluded patients with prior histories of substance dependence and studies that included such patients. They also found differences in whether the study was a prospective clinical trial or a retrospective study. Combining all the studies, they found that the rate of addiction was 3.27%.
It might be argued that this estimate is low, relative to what we might expect in typical patients who seek opioid management in pain clinics. Clinical trial participants are dissimilar to patients seeking care in the typical pain clinic. Such study participants commonly have less comborbidity (and therefore are healthier) than typical clinic patients. Moreover, the afore-mentioned percentage represents clinician-identified addiction, but the rate of aberrant urine toxicology screens (an indicator of loss of control, or addiction) in these studies was significantly higher at 20.4%. This figure may represent an over-estimation of the rate of addiction, as one aberrant finding may not warrant an addiction diagnosis. However, the fact that the figure is so much higher than clinician-identified diagnoses suggests that the true rate may be somewhere in between 3.27 and 20.4%.
Indeed, Fishbain, et al., comment on the lack of operational definition for diagnosing addiction in their review of the published studies. Clinical judgment in the face of having no operational definition for diagnosis is apt to lead to poor inter-rater reliability, something necessary for determining rates of a diagnosis, such as addiction. In this light, the standardization of urine toxicology screens is apt to provide substantially greater reliability and therefore validity to identifying rates of addiction.
In their meta-analysis of studies on the prevalence of aberrant prescription drug use behaviors, Martel, et al.4 found a range between 5% and 24%. Of course, such behaviors alone do not constitute addiction, but rather a pattern of such behaviors is typically considered to indicate addiction. However, this range suggests that those who do exhibit a pattern would occur at a higher percentage rate than the finding established by Fishbain, et al. Indeed, Chabel, et al.5 in their study of addiction rates using an older version of DSM criteria, found a rate of 27.6%. Hojsted & Sjogren6 reviewed the literature and found a range of addiction between 0% and 50%.
In all, what these studies suggest is that rates of addiction vary for different populations. Addiction is probably rare for those who have never taken an opioid and are obtaining their first prescription of an opioid medication, particularly if they do not have a prior or concurrent history of other substance dependence. That is to say, the risk that the first prescription of an opioid will lead to addiction down the road is likely quite low for those who have no history of substance dependence. However, the rate of addiction is likely not rare for the population of patients of a pain clinic that engages in long-term opioid management. Moreover, if such patients have a prior or concurrent history of substance dependence, the risk for addiction to prescription opioids is apt to be even higher.
2. Opioid medications are effective pain relievers for patients with chronic pain.
Kroenke, et al.7 reviewed the literature on the effectiveness of short-term use of opioids. They found that opioid medications are modestly better at reducing pain than placebo. However, they found that opioid medications are slightly less effective than non-narcotic pain medications on functional outcomes. Ballantyne and Shin8 reviewed the literature on the effectiveness of long-term opioid medication use. They found that long-term use is likely ineffective.
In their meta-analysis, Martell, et al.4 found that opioid medications are in fact no better than placebo when it comes to reducing pain.
A more recent study by Chen, et al.9 showed that, among a sample of chronic pain patients obtaining opioid management over a period of seven years, the relative dose of opioids had no relationship to pain levels. That is to say, some in the sample increased their dose and some in the sample decreased their dose over the years, but neither the increases nor the decreases affected self-reported pain levels. Given these findings, the assumption that opioids are effective seems far from evident.
This lack of effectiveness also seems apparent in large-scale epidemiological studies of people with chronic pain. For instance, Eriksen, et al.10 conducted such a study and compared those who manage their pain with opioids with those who do not manage their pain with opioids. They found that use of opioids was associated with greater pain and poorer quality of life. Fredheim, et al.11 similarly found that the vast majority of patients managing pain on opioids continue to report high to very high levels of pain.
All these data indicate that we should not assume long-term opioid management is an effective treatment for chronic pain.
3. Opioid medications increase the functioning of patients with chronic pain.
Kidner, et al.12 showed in a large study that actually the opposite is true. They found that, as patients take more opioid medications, they are less likely to return to work. In the general population too, daily use of opioid medications for pain is associated not with employment but unemployment.13 In the epidemiological study cited earlier, Eriksen, et al.10 also found that the use of opioids was associated with not working.
Volinn, et al.14 studied worker’s compensation low back pain cases and compared those who received opioids with those who did not receive opioids. They found that the odds for chronic work loss were up to 14 times higher among those who obtained opioids.
In a prospective study of injured workers with chronic low back pain, Franklin, et al.15 found that, among those who remained on opioids at one year post-injury, only 26% showed improvement. Improvement was defined as a 30% reduction in pain and a 30% increase in functioning.
A similar previous study showed that the use of opioids early after onset of a low back injury is significantly associated with 69 more days of disability than those who do not obtain opioids.16
In a primary care clinic population, Ashworth, et al.17 found in a prospective study that the use of opioids for low back pain was associated with slightly worse self-reported measures of functioning at six-month follow-up.
In all, these data indicate that short- and long-term use of opioids is associated with increasing disability, not reducing disability.
4. Opioid medications keep chronic pain patients out of the emergency room.
Wisniewski, et al.18 found that chronic pain patients who obtain long-term opioid management have greater utilization of emergency rooms, not less.
In a very large study of Arkansas Medicaid and Healthcore enrollees, Braden, et al.19 also found a similar association between long-term opioid management and increased emergency room visits.
In a sample of patients within a large health management organization, Deyo, et al.20 also found a positive relationship between the use of opioids and an increased rate of emergency room visits. The finding remained true even after controlling for health comorbidities and hospitalizations.
These findings are obviously relevant to the assumption that the use of opioids prevents the need for seeking care in emergency rooms. Indeed, the findings suggest the opposite.
5. It is unethical to withhold pain management from patients with chronic pain.
While it may in fact be unethical to withhold pain management from patients, pain management does not equate to opioid management. There are numerous conventional ways to manage chronic pain, some with better empirical outcomes, such as interdisciplinary chronic pain rehabilitation programs.21, 22, 23 Given these options, it is reasonable to acknowledge that adequate chronic pain management can be provided without resorting to the use of opioids.
One might actually argue that long-term opioid management is questionably unethical. When patients start on opioids, they generally require minimal doses. However, over time, they develop tolerance to the medication.24 In other words, as patients take opioids over time, the medications lose their effectiveness. Subsequently, patients on such medications develop the need for periodic dose increases in order to maintain the same level of pain relief. Over the years, patients commonly develop tolerance to even the highest conventionally agreed upon dosing schedules. Now, here is the rub: many patients who manage chronic pain with the use of long-term opioids are middle-aged or younger; given their relatively young age, most of these patients will still have many years left to live by the time they become tolerant to the highest doses of opioids.
While still somewhat inconclusive, research on methadone maintenance patients and non-human mammals suggest that once tolerant to opioids people will remain largely tolerant for up to years after cessation of the use of opioids.25, 26, 27 The potential meaning of these findings is that stopping the use of opioid pain medications for some period of time does not necessarily resolve the problem of tolerance. Once patients become tolerant to opioids, they may remain tolerant for the foreseeable future even if they stop using the medications.
We now routinely see this presentation in the field. Beginning in the mid-1990’s, long-term opioid management became the treatment of choice for chronic pain syndromes. For the next two decades, patients were routinely managed on opioids. Now with fifteen to twenty years of such experience, we commonly see patients who have been on opioids for many years and are tolerant to the highest conventionally agreed upon doses. Many are only in their mid-life years and yet they have exhausted opioids as a treatment option.
What if, in the future, they have an altogether different and serious acute injury? What if they later in life develop cancer? What if they have a need for an unrelated surgery and need to manage their post-surgical pain? What are they going to use for pain management in these situations?
Might it not be unethical to maintain patients on long-term opioids, allowing them to become tolerant to the highest does, if they still have many years of their life yet to live?
6. Patients will suffer if long-term opioid management is withheld from them.
Proponents of opioid management are often surprised to learn that most people with chronic pain do not manage their pain with opioid medications. Breivek, et al.28 found in an epidemiological study of European countries that 19% of the general population had chronic pain. In further follow-up interviews of the those with chronic pain, they found that 5% take long-acting opioids and 23% take short-acting opioids. In a later study, Fredheim, et al.11 found that only 15% of people with chronic pain used opioids to manage their pain. Among those reporting their pain as severe or very severe, 11% used opioids. In the United States, the rate of opioid use among patients with chronic pain is similar. Toblin, et al.29 found that a quarter of the population has chronic pain. Among people with chronic pain, they found only 15% use prescription opioids to manage their pain.
Even among patients who are readily offered opioid management on a long-term basis, most of them will voluntarily stop using opioids even though they remain in pain30 (cf. also, Fredheim, et al.31).
What these studies show is that the vast majority of people with chronic pain do not take opioid medications to manage their pain. As such, a reduction in the practice of long-term opioid management would not lead all people with chronic pain to suffer. It would not even lead a majority to suffer.
Numerous studies consistently show that patients who remain on long-term opioid management are those who, on average, have significantly higher rates of mental health and substance abuse problems.32, 31, 33, 34, 35, 36, 37 These factors are also highly associated with addiction to prescription opioids.38, 39, 40
Would a reduction in the practice of long-term opioid management lead this minority of patients to suffer? Many advocates for opioids assume that it would.
In light of the above-cited research, though, this assumption is unwarranted. As stated, multiple studies show that the long-term use of opioids does not significantly reduce pain or increase functioning. Would suffering really result if we curtailed a practice that isn’t effective?
Moreover, one might counter that it’s a questionably unethical that we relegate long-term opioid management to those with the greatest vulnerabilities – those with chronic pain and comorbid mental health and substance abuse problems. These patients are the most susceptible to dependency and addiction. And hasn’t increasing rates of abuse and addiction been what the field has witnessed over the last fifteen to twenty years?41, 42 If we, as healthcare providers, were honest with ourselves, we would have to admit that it is a commonplace to see highly distressed patients who report high levels of pain and disability despite long-term use of opioids. Worse yet, we are also witness to chronic pain patients who, because of their psychological vulnerabilities, simply lose control of their use of opioids and become addicted. And we see it too often. The research cited above simply backs up our common clinical observations.
Rather than being concerned by widespread suffering if the field stopped the practice of long-term opioid management, we should be concerned about the present realities of our field. The most vulnerable subpopulation of people with chronic pain has been exposed to opioids on a long-term basis. In turn, we have a dramatic problem of suffering in the form of opioid addiction, overdose, and diversion in our country. It is not unethical to reduce the practice of long-term opioid management for this population. Indeed, in light of the fact that we have an empirically supported treatment option that is more effective, it might just be the most ethical thing to do.
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Date of publication: January 11, 2015
Date of last modification: October 5, 2019