’Arbitrary’ dose/quantity thresholds harm patients, drive illicit drug use

The American Medical Association wants a major overhaul to the CDC’s 2016 opioid prescription guidelines, charging that that the guidelines are unintentionally harming patients and accelerating the opioid epidemic.

“The AMA is urging the CDC to remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline,” the AMA wrote in a statement.

The U.S. opioid epidemic no longer appears to be primarily driven by opioid prescriptions ,and the AMA pointed out that physicians reduced opioid prescribing by over 44% since 2012. However, the drug overdose epidemic has gotten worse, now primarily fueled by illicitly manufactured fentanyl, fentanyl analogs, heroin, methamphetamine, and cocaine—a development that AMA Board of Trustees Chairman Bobby Mukkamala, MD, argued was triggered by undertreatment of pain as a result of “arbitrary” dosing and quantity thresholds recommended in the 2016 guidelines.

“Patients with painful conditions need to be treated as individuals,” Mukkamala wrote in a letter to the CDC Injury Center’s Board of Scientific Counselors. “They need access to multimodal therapies including restorative therapies, interventional procedures, and medications. These include non-opioid pain relievers, other agents, and opioid analgesics when appropriate.

“Instead, patients with pain continue to suffer from the undertreatment of pain and the stigma of having pain,” he continued. “This is a direct result of the arbitrary thresholds on dose and quantity contained in the 2016 CDC Guideline. More than 35 states and many health insurers, pharmacies, and pharmacy benefit managers made the CDC’s 2016 arbitrary dose and quantity thresholds hard law and inflexible policy.”

A major issue, according to the AMA’s June 2020 letter to the CDC, is that many states, health plans, and pharmacy chains misapplied the CDC guidance to institute strict, specific limits on opioid prescribing—for example, Walmart and CVS Caremark placed a 7-day hard threshold on prescribing, and more than 30 states have enacted laws with opioid prescribing restrictions ranging from 3 to 14 days, including many with morphine milligram equivalents (MME) limits and other restrictions.

“CDC’s threshold recommendations continue to be used against patients with pain to deny care,” Mukkamala wrote. “We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”

In its statement, the AMA noted that its comments mirror those of the Opioid Workgroup, which recently issued a report outlining “the foreseeable misapplication of the guidelines” and suggested a series of revisions that would help to relieve some of these problems. Namely, the Workgroup’s report argued that:

  • Much of the guideline’s supporting text was not balanced and was missing key studies, and it focused heavily on the risk and potential harms of opioids while paying less attention to the potential benefits, or the risks of not taking opioids or undertreating pain.
  • There were several points at which the guidelines could be misapplied and potentially lead to patient harm.
  • The guideline paid too little attention to racial/ethnic disparities and inequities in how pain is perceived, valued, and managed.
  • While it is important to have opioid prescribing benchmarks, specific opioid dose thresholds can be misapplied as absolute cutoffs.
  • Certain specific conditions are named in the guidelines, while others are not, potentially leading to interpretation regarding whether pain is “real” or “worthy” of certain types of treatment.

The Injury Center’s Board of Scientific Counselors voted on July 16 to endorse the Workgroup’s report, with few amendments.

“Patients with pain need the CDC to be their advocate and urge it to rescind the perceived limits on opioid therapy doses or days,” Mukkamala told the Board of Scientific Counselors. “We have an opportunity here to care for these patients responsibly with your help.”

According to the CDC, a revised opioid prescribing guideline will likely be posted for public comment sometime in late 2021.

John McKenna, Associate Editor, BreakingMED™

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