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The guideline formulated by the Centers for Disease Control and Prevention (CDC) in an effort to curb opioid overdose-related deaths included a recommendation for steep reductions in opioid doses for patients taking high doses of the drug for chronic pain — including individuals with no evidence of drug addiction or misuse.1 This guideline has had dire consequences for patients and the physicians who treat them, according to critics.2
The guideline formulated 12 overarching recommendations, including a preference for the use of nonopioid vs opioid treatments and for the use of immediate- vs extended-release or long-acting opioids when initiating therapy. The guideline also urged clinicians to weigh the benefits and harms of opioid therapy soon after initiation of therapy and frequently thereafter and to use precaution when considering escalating doses to ≥90 morphine milligram equivalents/day. Four recommendations were based on low-level evidence and 7 on very low-level evidence. Additionally, in its review of clinical evidence, the guidelines committee chose to include only trials on the effectiveness of long-term opioid therapy with observation periods more than a year, despite that the majority of trials examining this issue had active treatment durations totaling 12 weeks or less.1-3
The CDC guideline, formulated for primary care providers, does not apply to opioid prescribing for active cancer treatment, palliative care, and end-of-life care, and states that these are “voluntary, rather than prescriptive standards.” Despite this mention, a number of jurisdictions have used the guideline as a basis for restrictive laws and regulations. According to the National Conference of State Legislatures, as of April 2018, 28 states had enacted legislation setting limits for opioid prescribing, including restrictions governing the length of the course of treatment for patients newly initiated on opioids and caps on morphine milligram equivalents.4 The Department of Veterans Affairs codified the guideline’s recommendations into a statutory requirement 3 months before the CDC guideline was even finalized. Many hospital systems followed suit and imposed mandatory maximum dose standards based on the guideline’s recommendations.5,6 An extreme example is a law currently under consideration in Oregon, which if enacted would require that beginning in 2020, patients with chronic pain on Medicaid must have their opioid doses tapered to zero.7
Michael Miller, MD, a board-certified general and addiction psychiatrist and past president of the American Society of Addiction Medicine, told Clinical Pain Advisor that, while American Society of Addiction Medicine supports the effort the CDC has made in trying to combat the opioid overdose crisis, forced dosage reductions in legacy patients — those with chronic pain who have been receiving high-dose opioids for extended periods of time — represent a problematic strategy. “The guideline was really written to prevent the development of a new generation of patients on high-dose opioids and to suggest alternatives to opioids for acute injuries or for chronic nonmalignant pain when they aren’t strictly necessary,” he noted.
In an interview with Clinical Pain Advisor, Gary W. Jay, MD, clinical professor in the department of neurology at the University of North Carolina, Chapel Hill, stated that the CDC’s recommendation to limit opioid prescribing stems from both alarming statistics indicating that 99% and 83% of the world’s hydrocodone and oxycodone supplies, respectively, are consumed in the United States and from those showing an exponential rise in opioid-related mortality. However, the contribution of prescribed opioids to the increase in overdose deaths is contentious. In an editorial published in the American Journal of Public Health, researchers in the CDC’s Division of Unintentional Injury Prevention argue that the classification used by the CDC to estimate prescription opioid-related deaths also includes many deaths resulting from the use of illicit opioids, particularly heroin and fentanyl. The authors of the editorial estimate that, while official CDC statistics indicate sharp increases in prescription opioid-related deaths from 2014 to 2016, up to which point deaths involving synthetic opioids such as fentanyl were excluded, prescription opioid-related deaths were shown to have remained stable since 2012. With this more conservative method of estimation, the death toll ascribed to prescription opioids in 2016 was estimated at half the official number: from 32,445 to 17,087.8
An editorial published in Pain Practice before the final approval of the CDC guideline contended that the guideline is “well-intentioned but lacks sufficient rigor and clinical flexibility, and might have the unintended consequence of unfairly limiting the medical needs of legitimate patients [with pain].”9 More recently, in a provocative article published in the October 2018 issue of Disease-a-Month, Dr Jay wrote, “The members of the medical profession have diminished their prescribing of opioids for their patients out of apparent fear of reprisal, state or federal government sanctions, and other concerned groups. Diminishing former dosages or deleting the opioid medication, preferably in concert with the patient, often results in inequitable patient care. Enforcing sanctioned decreases or ceasing to prescribe from their former required/established opioid medications precipitates patient discord.”2
“Physicians are being told that if a patient does not want to cut down on their medications, they should do it anyway, without their approval,” said Dr Jay. “Patients who are being deprived of the high doses of opioids that they need to function are being presented with 3 impossible choices,” he noted. “One, you can be totally nonfunctional. Two, you can go out and try to substitute some other form of opiate that would help you function, possibly heroin. Or, you can commit suicide. Nobody’s looking at the marked increase in the number of patients who have forcibly and without their own approval had their opioid levels dropped below the level at which they were functional. It’s an abomination.”
References
1. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain — United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49.
2. Jay GW, Barkin RL. Perspectives on the opioid crisis from pain medicine clinicians. Dis Mon. 2018;64(10):451-466.
3. Centers for Disease Control and Prevention. Clinical evidence review for the CDC guideline for prescribing opioids for chronic pain – United States, 2016. CDC Stacks. 2016. Accessed October 25, 2018.
4.Tayeb BO, Barreiro AE, Bradshaw YS, Chui KK, Carr DB. Durations of opioid, nonopioid drug, and behavioral clinical trials for chronic pain: adequate or inadequate? Pain Med. 2016;17(11):2036-2046.
5. National Conference of State Legislatures. Prescribing Policies: States Confront Opioid Overdose Epidemic. Published April 5, 2018. Accessed October 24, 2018.
6. Lawhern RA. A White Paper: Prescription Opioids and Chronic Pain. April 2, 2018. Accessed October 21, 2018.
7. Facher L. Tapered to zero: In radical move, Oregon’s Medicaid program weighs cutting off chronic pain patients from opioids. STAT. August 15, 2018. Accessed October 25, 2018.
8. Seth P, Rudd RA, Noonan RK, Haegerich TM. Quantifying the epidemic of prescription opioid overdose deaths. Am J Public Health. 2018;108(4):500-502.
9. Pergolizzi JV Jr, Raffa RB, Zampogna G, et al. Comments and suggestions from pain specialists regarding the CDC’s proposed opioid guidelines. Pain Pract. 2016;16(7):794-808.
