The authors of influential federal guidelines for opioid prescriptions for chronic pain said Wednesday that doctors and others in the health care system had wrongly implemented their recommendations and cut off patients who should have received pain medication.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” the researchers wrote in a paper published in the New England Journal of Medicine.

They said some health care players had used the guidelines to justify an “inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages,” when the guidelines did not actually endorse those policies. The authors did not identify stakeholders other than clinicians who they said have misapplied their guidance, but advocates have also accused insurance companies and state agencies of using the guidelines to inappropriately withhold treatment from some patients.

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The new paper comes three years after the Centers for Disease Control and Prevention published the prescribing guidelines, which were meant for primary care physicians treating chronic pain in adults. It follows growing appeals from patient advocates, pain doctors, and some addiction experts for the CDC to clarify that its guidelines were just recommendations. Advocates have argued that strict limits on prescriptions were leaving patients who had been on stable dosages for years unable to stay on their regimens and sometimes pushed them to illicit opioids or even suicide.

The authors of the 2016 guidelines — Dr. Deborah Dowell and Tamara Haegerich of the CDC, and Dr. Roger Chou of Oregon Health and Science University — said in their new essay the recommendations were not meant to be used to withhold drugs from people who need them, and outlined instances of their misapplication.

One example: The guidelines say that “clinicians should … avoid increasing dosage” to 90 or more morphine milligram equivalents per day or to “carefully justify” such a decision. That did not mean prescribers should automatically cut dosages that were already above that threshold, the authors say, “yet it has been used to justify stopping opioid prescriptions or coverage.”

“We know little about the benefits and harms of reducing high dosages of opioids in patients who are physically dependent on them,” they wrote.

Still, the researchers say patients who are able to safely decrease their doses face lower risks of overdose, and some experts believe that long-term opioid use actually increases pain sensitivity.

The 2016 guidelines were meant for patients suffering from chronic pain not tied to cancer, palliative care, or end-of-life care. But in the new paper, the authors said that there were reports of them wrongly affecting care for other patients, including those with cancer or during acute sickle cell crises.

The authors also emphasize that the guidelines should not be applied to the doses of medications that are used to treat opioid addiction.

In parts, the new essay reads as a defense of the guidelines, which are voluntary but have faced heavy scrutiny in the years since they were published. The authors note that their original paper features suggestions for treating patients on high-dose opioids, including how to taper prescriptions safely while minimizing withdrawal symptoms. “Though some situations, such as the aftermath of an overdose, may necessitate rapid tapers, the guideline does not support stopping opioid use abruptly,” they write. They also argue that actions by some clinicians, such as halting opioid prescriptions or no longer seeing chronic pain patients, “could represent patient abandonment.”

The federal guidelines were an effort by the CDC to implement safer prescribing practices among primary care physicians, who write the vast majority of painkiller prescriptions. They seem to have accelerated the decline in outpatient opioid prescribing that began in 2012, experts say.

An analysis published last fall found that in January 2012, nearly 6,600 opioid prescriptions were dispensed per 100,000 people, but that fell to 4,240 by December 2017. From March 2016 until December 2017, an estimated 14.2 million fewer prescriptions were filled than if previous trends continued. There were nearly 1.3 million fewer high-dose prescriptions written, as well.

The new essay is not the only step taken by the CDC to clarify its guidelines.

After physician groups argued that insurers seized on the guidelines to deny treatment for some patients, the agency in February wrote to the American Society of Clinical Oncology, the American Society of Hematology, and the National Comprehensive Cancer Network to acknowledge that clinicians and insurers should also consider the clinical practice guidelines each group has issued. The CDC reply was released publicly on April 9.

The Food and Drug Administration announced this month it is providing clinicians more information about how to safely decrease doses for patients who are dependent on opioid medications.

The CDC also recently responded to an ad hoc group of physicians, who call themselves HP3: Health Professionals for Patients in Pain, who have urged the agency to clarify the “misapplication” of its guidelines. The group organized a letter signed by more than 300 doctors who complained the guidelines harm patients with severe pain who may have been taking high doses of opioids for years without becoming addicted.

In an April 10 reply, CDC Director Dr. Robert Redfield wrote that the agency was “working diligently to evaluate the impact” of the guidelines and “clarify its recommendations to help reduce unintended harms.”

One former member of the CDC panel that established the guidelines, Dr. Lewis Nelson, who chairs the Department of Emergency Medicine at Rutgers New Jersey Medical School, says the new essay is “basically, the FAQ that goes along with the policy statement.”

“It’s very clear that when the guidelines were being assembled, a lot of attention was paid to the fact that people shouldn’t be rapidly tapered off opioids, because it leads to a terrible withdrawal syndrome and complicates their lives,” he said. “But it wasn’t just doctors who misinterpreted the guidelines. It was also regulators and legislators. Unfortunately, some must have just read the bullet points.”

A few of the HP3 organizers have relationships to industry. Among them is Dr. Daniel Alford, a professor of medicine at Boston University, which runs a continuing medical education program called Scope of Pain that receives backing from opioid makers. Another is Dr. Richard Dart, who directs the Rocky Mountain Poison and Drug Center and also heads the RADARS System, which tracks prescription drug abuse and is supported, in part, by subscriptions from pharmaceutical companies, including opioid makers.

Such ties prompted concern from Dr. Andrew Kolodny, who heads the Opioid Policy Research Collaborative at Brandeis University and is executive director of Physicians for Responsible Opioid Prescribing, an education and advocacy group.

“I think the CDC is simply reiterating what is in the guidelines,” he said. “But the only thing that troubles me is they might be accepting these reports of misapplication of the guidelines as accurate, when I believe they’ve been exaggerated. There’s been an effort to ‘controversialize’ the guidelines.”

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  • My wife has been taking 40mg of oxycodone for years. She was going to a pain management clinic for 2 years, because her primary care physician stopped prescribing her opioids due to these guidelines and referred her to the clinic. The clinic is very bad with their paperwork and records. So, they had tried her on a fentanyl patch for one month about one year ago. It did not work for her, so she asked to be put back on the oxycodone pills. So, they did. They only gave her the fentanyl that one month, discontinued it, and put her back on the pills. Well last month when she went in for her regular appointment and they kicked her out, and cut her off cold turkey. They said she failed her last 3 drug screens in may, october, and early december. The doctor absolutely refused to talk to her, like she had seriously offended him. And the reason she had failed the 3 drug screens is because they said she was supposed to be taking fentanyl for all 3 of them, but she really wasn’t. And I believe that they black balled her, because she can’t get another pain clinic to treat her anywhere locally, around Knoxville, TN.
    I am very desperate to help her somehow, but even her PCP won’t help her. We have seen him for years, and now I have made her an appointment with a brand new PCP, because I don’t know what to do. I doubt a new doctor is gonna help her, but I am desperate. She has a lot of pain. She really needs more than what the pain clinic is giving her, but it was a “low dosage clinic” and she was taking what she could get to help. We feel like you constantly have to walk on egg shells to not get kicked out. I’ve been paying twice my copay for two years because they say they are a specialist. But, my insurance says you’re not supposed to pay that unless they are doing a procedure. But, I never said anything other than one time, and they insisted that they were right, and I was scared she’d get kicked out for it. And they were bent out of shape about it for years after I debated with them about it.
    So, now when she actually did go to a new pain clinic, the old pain clinic kept such bad records, that when they sent her chart to the new place, the new clinic said, it shows her being kicked out of that clinic in april, but she failed a drug screen in December, so they refused to treat her.
    My wife has had kidney stones since she was 9. I have been married to her for 15 years and I have witnessed at least 100 kidney stones. She has graves disease(thyroid) which I think has caused a lot of problems, including a heart attack, due to an 85% blockage in her right coronary artery at age 28. She has chronic pancreatitis which causes her tremendous pain and to become an instant type 2 diabetic. She had a cyst from the pancreatitus which they drained over 2 liters of fluid out of and then had to have a surgeon at Vanderbilt University scrape out the rest of it a year ago. She has diverticulitis that also causes a lot of pain. She was sepsis and gained 70 pounds of fluid weight before dhe had that cyst drained and scraped out. Now she has swelling again and has gained about 30 pounds recently. Oh and we went to the ER last night and she now has a mass in her bladder that we have an appointment with the urologist to examine.
    My wife has a tremendous amount of pain, and she has suffered for longer than I have known her. And for the last 15 and a half years that I have known her, she has been living in misery. But, when she had medicine, at least the pain was bearable. But now she has nothing to help her. I don’t know if she’s gonna last if she doesn’t get help. She has mentioned, well, I don’t wanna say on here, but drastic measures, that I don’t want to happen. And she really, truly don’t want to happen either. But things are desperate.
    Can you please tell me, if there is a way to appeal to someone to get her help. Can we see what is on her record, or appeal what is on her record. I would really appreciate it if you could tell me if there is a way to get an advocate for her. I don’t know who I should even ask. I would be willing to pay an attorney or an advocate to help her. But, I don’t know who that would be. Please help me if you can. I can’t handle watching my wife in pain anymore. I will greatly appreciate any advice, direction, help, or anything you can do to help me very very very much!!!!!! Thank you!!!!

  • My wife & I are both chronic pain patients that were being “successfully treated” with opioid medications that we have been on “stable doses” of for “many years” then when the CDC put out this guideline the DEA, & OBN started forcing these “guidelines” on everyone’s doctors & the doctors are in fear of not only losing their medical license, but ending up like a lot of pain doctors that have been targets of the DEA & are now serving 20+ year prison terms. My daily dosage was cut from 160mg a day total to 60mg a day. That’s a 60% decrease when my condition gets worse every year & the areas of my body that are affected increase with time. The years I had been on that dose I had gone more than 5 years without missing a single day of work. After the cuts I lost my long time job & went through 3 more jobs over the next 18 months. Now I work a job at about 25% of the money I used to make & I don’t have insurance anymore & outside of work I don’t DO anything! I don’t feel like doing anything & most days I have trouble finding a reason to keep living. The entire situation is insane! You have doctors who go through more than a DECADE of schooling & then many who have decades of clinical experience on top of that, yet we are allowing people with most times a 2 years degree in criminal justice to 2nd guess & “over rule” these doctors & if a doctor has the guts to point that out or argue with the program at all they are threatened or worse. With the politics of it all & the hype from the media & from law enforcement you can’t really blame the doctors or even the CDC. They are just finally caving to the pressure from the DEA an agency that is “out of control” & that has NO OVERCITE! They alone decide what drugs are controlled or not & the criteria has NOTHING to do with SAFTEY! If anyone might actually want to take the drug then it’s labeled as high potential for abuse & if it has in the listed effects or side effects “euphoria” then that alone gets it on the control schedule. At bare minimum we need to “demand” from our elected officials that patient AND doctor protections are put in place in a medical bill of rights that will protect patients as well as their doctors from being targets of law enforcement & end up causalities & statistics of “the war on drugs”. The DEA should be able to “propose” changes but they should have to be approved by a 12 person panel that has “final authority”. This panel should be made up with half patients & the other half doctors & specialists & no changes to policy, scheduling, or availability of prescription drugs should be allowed unless approved by this panel & then only after months of public input from “outside” the political or law enforcement communities. Bottom line is this is supposed to be the United States of America & “supposed to be” a “free country”. We are “supposed to have basic human rights & freedoms” Have you ever noticed that every single law that gets written is a law telling us what we “can’t do”? With every new law our rights & freedoms are further eroded! There are NO laws hitting the books “giving us MORE rights or freedoms”. Only those that further take them away. And if the government is successful at telling us what medical procedures & treatments that we “can’t have” & they are allowed to set that president, then it’s only a matter of time before they start choosing “for us” on not only what we can’t have but next they will be deciding “for us” what treatments we “should have” and to me, that’s scarier than the ones they block access to. People are allowed to risk their lives in all kinds of foolish activities & even medical procedures like cosmetic surgery. We are allowed to use dangerous & harmful chemicals & drugs, many of which are at least “as addictive” as any prescription medication. For example, alcohol & tobacco. Why are these allowed but not others?? Even if you believe the bogus CDC stats on opioid related deaths that the media makes such a big deal about, & even if you pretend that 95% of those are “not” related to illicit drugs the number being thrown around to flame the hype is 46K deaths from ALL opioids for 2017. What they DONT TELL YOU is that during that same time period for 2017 the ALCOHOL related deaths were 88K! MORE THAN DOUBLE, so why isn’t there an outcry of “CRISIS” or “EPIDEMIC” for the alcohol problem? The fact is that the war on drugs is just a failed duplicate of the failed prohibition of alcohol in the 30’s only it has lasted nearly 50 years & spent trillions of tax dollars not to mention the inflation In the size & number of law enforcement agencies & their budgets. It has also made criminals out of literally millions of Americans. We incarcerate more than double the entire rest of the industrialized world “combined” & more than 80% of those imprisoned are drug offenders. It’s far far past time to abolish the war on drugs & the DEA at least as we know it know. The DEA and the war on drugs were BOTH created in the 1970’s by president Richard Nixon & if that’s not reason enough to put an end to this failed debacle then there are plenty of other reasons. The war on drugs has failed every single year for more than 45 years yet we keep throwing money in the coffer. It destroys lives & family’s and is the “direct cause” for the issue at hand. Not to mention that I for one think it’s far past time that we Americans start taking back some of our rights & freedoms especially when the people on decades long campaigns to erode those freedoms are the very people we elect to protect us from that. The constitution & our rights & freedoms are what so many many of our soldiers have died or been maimed to protect. We send them to far away countries around the world, supposedly to protect us from the forces that fight against freedom yet at least in my adult lifetime the biggest threat to those freedoms is right here at home, in our state capitols & in Washington DC

    • “We hold these truths to be sacred & undeniable; that all men are created equal & independent, that from that equal creation they derive rights inherent & inalienable, among which are the preservation of life, & liberty, & the pursuit of happiness.” – draft of our Bill of Rights as written by Thomas Jefferson

      But that is no longer true for chronic pain patients, is it?

  • Just recently what is the victim oh patient abandonment had the same doctor for many years senior physician add pain clinic retired Junior Dr replaced abandon me searching new pain clinic or Dr responsible patient many years thanks

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