FDA

Seeking to Clarify Its Opioid Prescribing Guidelines, CDC Joins FDA in Decrying ‘Mandated or Abrupt Dose Reduction’

The CDC's advice has been widely interpreted as requiring involuntary tapering of medication so it does not exceed an arbitrary threshold.

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Acknowledging the suffering caused by "misinterpretation" of the opioid prescribing guidelines it published in 2016, the U.S. Centers for Disease Control and Prevention (CDC) yesterday sought to clarify that it never recommended imposing involuntary dose reductions on chronic pain patients. In a letter to physicians who had objected to that widespread practice, CDC Director Robert Redfield emphasized that his agency "does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm." Redfield described several steps the CDC is taking to research the impact of its guidelines and correct misunderstandings that have led to abrupt withdrawal, undertreated pain, denial of care, and in some cases suicide.

"I have seen many patients harmed by widespread misapplication of the Guideline," said Stefan Kertesz, a University of Alabama at Birmingham pain and addiction specialist who helped organize a March 6 letter on the subject that was signed by hundreds of health professionals. Kertesz welcomed the CDC's response, which came the same day that the Food and Drug Administration (FDA) issued a warning about the risks of involuntary or fast opioid tapering.

"Bravo CDC and FDA!" Kertesz wrote on Twitter, calling it "a great day for patients with pain," since "two federal agencies have spoken forcefully AGAINST mandated or precipitous #opioid reductions in chronic pain patients." Sally Satel, a Washington, D.C., psychiatrist who worked with Kertesz on the letter to the CDC, said, "We are so grateful to the CDC for its essential clarification."

The CDC's guidelines, which were intended for primary care physicians, said doctors "should avoid increasing dosage" above 90 morphine milligram equivalents (MME) per day, or at least "carefully justify a decision to titrate dosage" above that level. But the CDC did not say that patients who were already taking daily doses higher than 90 MME, many of whom have been functioning well for years, should be forced below that threshold. Instead it said "clinicians should work with patients to reduce opioid dosage or to discontinue opioids" if they determine that the risks outweigh the benefits.

"The recommendation on high-dose prescribing focuses on initiation," Redfield writes. "The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy." Furthermore, "the Guideline also recommends that the plan be based on the patient's goals and concerns and that tapering be slow enough to minimize opioid withdrawal, e.g., 10 percent a week or 10 percent a month for patients who have been on high-dose opioids for years."

In its "safety announcement" yesterday, the FDA said it had "received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased." It said the consequences "include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide."

Redfield said the CDC is communicating with providers and health systems to "clarify the content" of its advice, to "emphasize the importance of developing policies consistent with the Guideline's intent," and to "highlight recommendations within the Guideline, including tapering guidance, options for non-opioid treatments for chronic pain, and communicating with patients." The CDC is also conducting "systematic reviews of the scientific literature that has been published since the Guideline was released" and sponsoring "four extramural research projects that are examining unintended consequences of tapering and discontinuation."

The March 6 letter to the CDC included reports from hundreds of patients who have experienced those consequences. "Undertreated pain is killing me!" wrote a Syracuse, New York, patient with osteoarthritis and tethered spinal cord syndrome. "You don't know me, you don't walk in my shoes, you don't have my nerve damage, and you don't have to live with the thought of will today be the day that I kill myself because I can't take the pain anymore," said a patient in Washington, D.C.

"I am experiencing ridiculous effects from the CDC document as my doctors, including pain management specialists, are going to great lengths to deny my access to any kind of opioid," wrote a patient in Albany, California. "I'll probably be getting liver failure from taking so much Tylenol. This policy is just cruel. Every patient is an individual and should be treated with care and respect so they can live a functional life—and not given inappropriate or ineffective medication."

A patient in Little River, South Carolina, who suffers from chronic pain caused by failed back surgery, fibromyalgia, and Sjogren's syndrome, an immune system disorder, said she has "a kind wonderful pain doctor" who "can't give me enough medicine to control my pain" because of the way the CDC's guidelines have been interpreted. A patient with multiple painful conditions, including "sciatica, severe stenosis, osteoarthritis, fibromyalgia, degenerative disc disease, cervical disc degeneration, three bulging discs, two failed spinal fusions that left me with severe nerve damage, cholecystitis, pancreatitis, neuropathy, [and] radiculopathy," said she had been "abandoned" by her doctor even though she had been on "the same stable high dose" for six years.

Acknowledging the "personal testimonies from patients across the country," Redfield said, "We agree that patients suffering from chronic pain deserve safe and effective pain management. CDC is committed to addressing the needs of patients living with chronic pain while reducing the risk of opioid-related misuse, overdose, and death."

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25 responses to “Seeking to Clarify Its Opioid Prescribing Guidelines, CDC Joins FDA in Decrying ‘Mandated or Abrupt Dose Reduction’

  1. arbitrary threshold

    Did you know that all thresholds are arbitrary? Did I just blow your mind?

    1. The one’s under doors aren’t.

      1. Oh yeah? Do you build houses around where the doors will be?

      2. I basically make about $6,000-$8,000 a month online. It’s enough to comfortably replace my old jobs income, especially considering I only work about 10-13 hours a week from home. I was amazed how easy it was after I tried it?

        HERE? http://xurl.es/Reason43

    2. I basically make about $6,000-$8,000 a month online. It’s enough to comfortably replace my old jobs income, especially considering I only work about 10-13 hours a week from home. I was amazed how easy it was after I tried it?

      HERE? http://www.Theprocoin.com

  2. I have read many times that only something like 1% of those who try heroin get addicted, and that most of those who get addicted quit on their own (while still alive!).

    I have known a couple of people who tried heroin and left it.

    The opioid crisis is just another government expansion opportunity beloved of both the alt-right and the ctrl-left.

    1. Addiction is a hard term, a lot of times it is used to mean “likes something to the detriment of other things.”

    2. Yes, that is true. Most people just aren’t that prone to addiction. Withdrawals suck, but once past that, most people can leave it.
      And then some people will probably find something to be addicted to no matter what, whether it be drugs, gambling, sex, whatever.

    3. I never knew those on the alt.right to care about that much, maybe at all.

  3. So the CDC writes a “Dear Colleague” letter that makes certain “recommendations” and then acts all shocked that anybody could possibly interpret a man holding a gun to your head and “suggesting” that you might want to do what he tells you to do is actually issuing a threat. “No, no! We never said you had to do this, we just suggested that if you know what’s good for you you’ll completely voluntarily offer to do this of your own accord.”

    1. Jerryskids|4.11.19 @ 1:27PM|#
      “So the CDC writes a “Dear Colleague” letter that makes certain “recommendations” and then acts all shocked that anybody could possibly interpret a man holding a gun to your head and “suggesting” that you might want to do what he tells you to do is actually issuing a threat….”

      The taxes paid to the IRS are ‘voluntary’. Unless you decide you’re rather not ‘volunteer’ to pay…

      1. The CDC doesn’t have any enforcement authority. They can’t hold a gun to anyone’s head over their guidance. The gun here doesn’t belong to the CDC, or the FDA, it belongs to the DEA. If the DEA starts treating the CDC guidance as more than a suggestion, neither the CDC, nor the FDA have the power/authority to make the DEA knock it off.

        1. The CDC “guidelines” bore a suspicious resemblance to “guidelines” from the DEA Office of Diversion Control.

        2. The state medical boards have all the power.

          The Feds, if you do not have a DEA license you are out.

          Even if you are a pathologist or diagnostic radiologist and prescribe nothing.

          So correct the CDC has no authority. Yet the state board will use those guidelines as if they were law.

    2. The problem child in this issue isn’t the CDC or FDA, it’s the DEA, which has been hammering down on doctors over prescription narcotics for years, even before the current “opioid crisis”. Many doctors and/or clinic / hospital managers were probably afraid that the DEA would come down on them over opioid prescriptions above the CDC guidelines.

      1. In the 2000s in Florida, the DEA would randomly send armed teams into pain clinics to seize patient records. They’d kick everyone out, and we wouldn’t be getting our prescriptions on those days. …yeah some of them weren’t exactly legit places, but some were. The DEA (and apparently juries) seem to think a patient swallowing a months of pills at once and dying is the doctors fault.

  4. CDC Director Robert Redfield emphasized that his agency “does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm.”

    In a cooler world, he would have gone on to say “And anyone who thought that’s what our guidelines meant is a colossal moron.”

    Unfortunately, the only safe interpretation to governmental guidelines is over-correction.

    1. “In a cooler world, he would have gone on to say “And anyone who thought that’s what our guidelines meant is a colossal moron.””

      The moron here misinterpreting the CDC guidelines is the DEA.

  5. Like when you have to have affirmative action but can’t have quotas.

  6. If only we had more government guidelines to help us.

  7. “We didn’t mean to screw patients who already needed high-dose medication, just future patients who might need it!”

    Get fucked with a rusty spork then tell us how an aspirin is doing for you asshole. Even if they didn’t mean to discontinue current patients, they sure as shit meant to mandate dosage caps going forward. 90mg ME is nothing. After years of chronic pain you need hundreds of mgs a day. There’s nothing medically wrong with that. You can take thousands per day with little ill effect (and once you’re taking hundreds, OD is impossible at any dose without serious additional non-opiate drugs).

  8. Personally I want everyone who has had any part in implementing or promulgating this bullshit to be struck down with severe non-terminal pain then have to live under their own fucking rules.

  9. CDC Director Robert Redfield emphasized that his agency “does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm.” Many Doctors are not qualified to “titrate” Opioids and Benzodiazepines from their patients ANYWAY!! They do not understand “can result in patient harm” or “consult with other Professionals or Specialist “OUTSIDE OF YOUR SCOPE OF PRACTICE”! Many Physicians are IDIOTS and need to stick to what they know, which is “GENERAL PRACTICE”. They should not be able to prescribe, refill, titrate and/or detox anyone from anything that they do not specialize in (PERIOD)

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