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The Opioid Crackdown: Have We Gone Too Far? Part III
Part three of this series examines what happens when government guidelines and recommendations such those in as the CDC Guideline for Prescribing Opioids for Chronic Pain are used to make rules and regulations about medications that leave little or no room for physicians’ discretion and individual patient needs. How does this impact people who depend on these medications to avoid suffering and have a decent quality of life?
In a medical presentation, addiction expert, primary care physician, and researcher, Stefan Kertesz, M.D. from the University of Alabama, Birmingham, said he believes that the 2016 “CDC Guideline for Prescribing Opioids for Chronic Pain” – “the manifest” now guiding medical use of opioid medications for chronic pain – is “mostly sound” and “a relatively high quality product.” However, he expressed great concern about “emerging practices that defy the CDC Guideline, misconstrue epidemiology, misunderstand the complexity of what causes addiction, and suspend our customary rules of medical decision-making.” He added, “Ethical expectations that are core to being a health provider are being violated in the care of pain patients.”
Are Universal Opioid Prescription Cut-Offs Stipulated?
Dr. Kertesz is talking about such practices as establishing “cut-offs” or strict upper limits when prescribing opioids. Even though the CDC Guideline makes no such stipulations and has no authority to restrict prescribing, it appears that a growing number of medical facilities and physicians have interpreted its recommendation concerning dosages that way. (To be able to compare dosages of different opioids in like units, all opioids can be converted to an equivalent of one medication, morphine, using a morphine equivalent dose calculator to calculate “morphine milligram equivalents” or MME/day.)
To illustrate his concerns, Kertesz showed a photo of an actual flyer from a doctor’s office that reads (literally), “Beginning February 2017 Morphine Equivalency Dosing WILL decrease until CDC guidelines are met by June 2017. Target is 90 mg of Morphine equivalency per day, or less. All medication adjustments will be based on this new clinic policy.”
What does the CDC Guideline, in fact, say? Pointing out that the higher the dosage, the higher the risk of overdose death from opioids, its recommendation does recommend special caution at total daily dose thresholds of 50 to 90 MME. As an upper limit it specifies that clinicians should avoid increasing opioid daily dosages to no more than the equivalent of 90 MME. Yet it adds, “or carefully justify a decision to titrate dosage to more than that.” Note the the leeway for physicians to use their judgment about higher dosages in consideration of individual patients’ needs. There’s also advice to consider consultation with pain specialists. (Some states have their own rules concerning thresholds for opioid prescribing.)
- 90 mg of hydrocodone (9 tablets of hydrocodone/acetaminophen 10/325)
- 60 mg of oxycodone (~2 tablets of oxycodone sustained-release 30 mg)
- ~20 mg of methadone (4 tablets of methadone 5 mg)
Be aware, too, that as the CDC Guideline acknowledged, dosage recommendations reflect limited scientific evidence. Kertesz emphatically concludes, “When you make morphine equivalency guidelines mandatory, it’s in violation of the CDC guidelines.” (See box below on the voluntary nature of the Guideline.)
“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. The recommendations in the guideline are voluntary, rather than prescriptive standards. They are based on emerging evidence, including observational studies or randomized clinical trials with notable limitations. Clinicians should consider the circumstances and unique needs of each patient when providing care.”
Introduction, 2016 CDC Guideline for Prescribing Opioids for Chronic Pain
People Already on Opioids for Chronic Pain
According to an article on CNN.com early this year, “…when the US Centers for Disease Control and Prevention established new guidelines on prescribing opioids, it recommended that long-term opioid users be weaned or tapered off pain pills.” In fact, it did no such thing.
The reporter went on to cite a recently published review of the scientific literature in the prestigious Annals of Internal Medicine on dose reduction or discontinuation of long-term opioid therapy for chronic pain and concluded that it found that chronic pain patients who taper off opioids can have a better quality of life. The authors actually concluded, “Very low quality evidence suggests that… pain, function, and quality of life may improve with opioid dose reduction.” Of the 67 studies they reviewed, the authors considered only three to be of “good” quality.
When I asked him how a review like this even got published, one prominent physician [who chooses not to be named] stated, “It’s bias, pure and simple. The zeitgeist often influences what gets published. Go against it, you’ll meet resistance. Go with it, normal objectivity goes out the window. The push against opioid medications is a moral crusade.”
Here is what the CDC Guideline does state concerning patients with chronic pain (that is, pain continuing or expected to continue more than three months or past the time of normal tissue healing) who have been taking high dosages of opioids on a long-term basis: “These patients should be offered the opportunity to re-evaluate their continued use of opioids at high dosages… [They] might consider the possibility of opioid dosage reduction to be anxiety-provoking, and tapering opioids can be especially challenging after years on high dosages because of physical and psychological dependence [not to mention the distress felt from increased pain].” It goes on to say that clinicians should explain “in a nonjudgmental manner” that we now have a body of evidence showing that overdose risk is increased at higher dosages, as well as discuss risks and benefits of continued high-dosage opioid use.
For patients who agree to taper opioids, it’s advised that clinicians “collaborate with patients” on a tapering plan, recognizing that it might require a very slow process so the patient can adjust gradually to lower dosages. (Discontinuation of opioids requires slow tapering in order to prevent miserable withdrawal symptoms. Replacement medications such as buprenorphine can also be used.) Note the spirit of being non-dictatorial, collaborative, and sensitive to the individual patient’s needs and desires.
Certainly, some people report benefits from lowering high doses of prescription opioids. An August 2017 National Public Radio story described a man with multiple painful conditions who kept needing increasing doses of opioids from his physician. Although he got some initial relief with each increase, his pain still persisted. So he worked with his doctor to greatly cut the dose and also saw a psychologist. While he some pain is still present, both his mood and memory have improved. As a result, he said his life is “infinitely better.”
Harms of Involuntary Opioid Dose Reduction and Physicians’ Misinterpretations
The NPR story cited above quotes a different physician who said, “A certain group of people simply cannot come off [opioids.]” However, as suggested earlier, some have no say in having their dosages reduced or even cut off, even when there is no sound reason.
In a recent article at Slate.com, Dr. Kertesz and Sally Satel, MD, a psychiatrist and resident scholar at the American Enterprise Institute, said, “Every week, one of us receives notice of suicides and overdoses by patients across the country who are distraught in the wake of having their dosages reduced.” They share several stories of people who say they can’t live with the pain since being taken off opioids abruptly. One is that of a 53-year-old man whose long-term (since 2001) opioid therapy for multiple problems causing chronic intractable pain was suddenly stopped. The physician was afraid he’d lose his medical license. For six weeks, the man searched for help, refusing to pursue illegal drugs. Finally, when his wife was out one day, he went to his back yard and shot himself.
Although the CDC Guideline is meant for primary care physicians, many of them have little idea how to prescribe opioids and, I suspect, haven’t studied the recommendations. One young woman with a horribly painful chronic condition that flares up unpredictably has, for some time, been given a relatively small monthly dosage (20 MME) of two different kinds of opioids. One of them is tramadol, which is less tightly controlled than opioids like oxycodone. She told me she recently had a painful “attack” and asked her primary care physician for her tramadol prescription four days early. (She knew it was too soon to refill her stronger painkiller.) Her pharmacist at a large national chain indicated that the early refill request violated no policies and would be fine, but needed her physician’s okay. But the doctor refused, indicating that an early refill would violate a government guideline. (There is no such guideline.) So the suffering woman had to wait the four days, until the doctor would refill the prescription.
Kertesz and Satel state, “Amid regulations, pharmacy payment restrictions, and intimations that doctors are the major culprits in this epidemic, doctors are increasingly sensing pressure to reduce doses, even among patients who are benefiting from the medication and using it responsibly.” (To get a sense of what chronic pain patients face, check out WebMD’s Pain Management message board.) Kertesz asserts, “Involuntary dose reduction does not improve outcomes. Uncontrolled cessation risks harm and can, in fact, be treacherous.”
The final article in this series will address some common sense ways to address use of opioids for chronic pain as well as the very real problem of opioid addiction and overdoses in this country. It won’t include President Trump’s newly announced suggestion that we return to such remedies as Nancy Regan’s “Just Say No” anti-drug campaign from the 1980s. (How did that work for us?)
Additional Reading: The Opioid Crackdown: Have We Gone Too Far? (Part II)
Images Courtesy of iStock