Declarations from two federal agencies offer hope — and possible action — for people in pain who have lost access to prescribed opioids. These declarations come not a moment too soon for those who have been abandoned by their health care providers or denied appropriate treatment and are suffering in real time.

In 2016, the Centers for Disease Control and Prevention released guidelines for prescribing opioids for chronic pain. Although these guidelines have been useful for many clinicians, they have been misapplied by individual prescribers, institutions, and agencies, too often causing the kind of pain they were meant to address. Writing in this week’s New England Journal of Medicine, the authors of the guidelines admitted that they have been misapplied by those seeking “shortcuts” to safer prescribing.

The authors, Dr. Deborah Dowell and Tamara Haegerich from the CDC and Dr. Roger Chou from Oregon Health and Science University, noted that ranges given in the guidelines related to opioid dosages and the number of days for which an opioid should be prescribed were often translated to “inflexible” limits that have been pushed, mandated and incentivized by countless insurers, state agencies, and regulators in ways that exceed or even contravene the guidelines.

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This misapplication of a few select provisions in otherwise useful guidelines, which wisely urge caution in starting and escalating opioids, has occurred at a breakneck pace since they were published, with real human consequences. Patients in serious pain face delays and denials when they attempt to fill their prescriptions, sometimes with tragic results. Some doctors have felt compelled by the guidelines to put patients who have relied on opioids to safely and effectively manage pain — often for decades — on lower doses or to take them off opioids altogether, even when they believe patients are benefiting from the medication, because they fear oversight and liability.

According to the authors, the guidelines have also been incorrectly applied to people they were never meant to cover, such as those with pain associated with cancer, surgery, or acute sickle cell crises.

This helpful perspective from the authors of the opioid prescribing guidelines comes on the heels of a related April 9 announcement from the Food and Drug Administration warning that abruptly stopping opioids or reducing doses too rapidly could cause uncontrolled pain, psychological distress, and even suicide in patients. The next day, CDC Director Robert Redfield issued a letter clearly stating that the opioid prescribing guidelines do not support abrupt or mandated tapering — reducing the daily dose of opioids in ways that are not undertaken in a carefully negotiated, patient-centered way.

The vigor of these warnings from the CDC and the FDA should discomfit those who have turned the guidelines’ cautionary thresholds into a shield from institutional risk, and what can feel like a sword to the patients who find themselves treated as liabilities by the clinicians and institutions charged with their care.

For us, the declarations are a welcome first step toward ending the trauma that we have observed and advocated against. One of us is a physician-researcher in primary care and addiction who has reported on patients’ fears, medical deterioration, and sometimes even death after opioid reduction. The other is a civil rights attorney who publicly described her own past experience with opioids and severe pain and who now receives daily emails and phone calls from desperate patients. Some are suicidal. Others who were once able to work or care for children are now bound to bed or home and unable to support their families because the opioids that had kept their chronic pain at bay were withdrawn. We have raised these concerns in published articles in STAT and elsewhere, as well as with policymakers and, by letter and in-person meeting, with the CDC itself. Indeed, the April 10 letter from the CDC director responded to efforts organized by one of us and his colleagues.

While we wish the statements from the CDC and FDA had come earlier, they required courage at a time of collective tragedy due in part to excess prescribing and are a critical first step. They also reflect the recognition that harms to patients with pain are a reality that can no longer be ignored.

But can these statements from the CDC and the FDA counter across-the-board reductions in opioid doses and patient abandonment when doctors work in fear of professional jeopardy? What about patients who have already been tapered and have lost the ability to work and function — will their medication be restored? What will happen to patients whose clinicians are willing to prescribe opioids for them but who then face delays and denials from insurers or pharmacists? Will law enforcement agencies and medical boards stop using dosage thresholds as surveillance for physician prescribing practices, or will quality assurance agencies stop imposing a dose threshold as the standard for quality which, when taken in isolation without consideration for the health or safety of the patient, may incentivize forced tapering and patient abandonment?

As the American Medical Association has stated, the opioid prescribing guidelines have been misapplied so widely that it will be challenging to undo the damage. Limits are in place throughout the health care system — where precise day and dosage cutoffs have become common. One-size-fits-all provisions have found their way into law in at least 32 states and two recently announced federal bills, and countless policies from insurers as well as major pharmacies like CVS, Walmart, Walgreens, and Express Scripts. Many invoke the CDC’s guidelines while, as the authors of the guidelines point out, contravening it.

Recalibrating policy regarding opioids will require concerted efforts by multiple players in the health care system, including people living with chronic pain. The guidelines’ authors discuss the CDC’s considerable work with partners in the health care system to implement the guidelines shortly after they were issued in 2016. We hope it can now undertake a similar effort to help health care providers mitigate missteps in implementation that, despite good intentions, have gone well beyond what the guidelines supported.

When a public health measure designed for patient safety ends up doing harm to some, correction is needed. As problematic as opioids often are, they are sometimes the only viable option for serious pain where nothing else works. Careful opioid dose reduction can prove helpful in some patients, but there is no evidence to support reducing doses by fiat. The health care system’s failure to allow for nuance has put at risk the more than 10 million Americans who take opioids to manage pain.

The commendable engagement of the CDC and the FDA now gives us a chance to protect them.

Stefan G. Kertesz, M.D., is a physician at the Birmingham Veterans Affairs Medical Center and professor at the University of Alabama at Birmingham School of Medicine. His writing represents his own views and not those of any federal or state agency. Kate M. Nicholson, J.D., is co-chair of the Chronic Pain/Opioids Task Force for the National Centers on Independent Living and a civil rights attorney formerly with the U.S. Department of Justice.

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  • My wife and I were hit by a drunk driver 14 years ago.we have had multiple surgeries,therapy, ,spinal injection, to no avail, we were both doing ok on 4,30mg oxycodone per day for 10 years.we were able to live a normal life for age I’m 72 she is 69 we were left by our dr. of eight years along with 200 plus other patients.dumped on a dr. who cut our dose first visit.still going down on dose.not able to function anymore,we refuse to be driven to street stuff.we are having serious talks now.The media keeps talking about opioid crisis, after a lot of research I found it isn’t so much prescription meds it is Chinese fentenal heroin meth doing most of the damage,it turns out coroners can’t tell the difference in most cases. FYI in one year 1087 drug overdose deaths 1268 alcohol deaths 480,000 smoking death.they are taking our legal presciptions away,making China and street dealers richer.why isn’t this on the news.wake up media,Congress,is there some bad apples in medical field yes there everywhere every profession,a minor can find a place to buy booze and cigarettes you can bribe your kid into college.Somebody please fix this before it’s to late we are really tired of living this way.

  • I am a chronic pain suffering I have been to pain management, I have received numerous steroid injections so many the steroids were causing severe cramping and anxiety without success. I have had nerve ablations and no success. I have tried every non-opioid drug out there and they did not work or caused anything from to extreme blood pressure drops to swelling in my limbs face and lips. I took tramadol safely for 7 years and hydrocodone 5/500 mg safely for 3 years. My doctor has cut me off because of the laws and regulations out of fear. I had to cut my work from 40 hours and active life to now 20 hours a week where I can barely do. I can’t sleep because of the pain and I went from a functioning person to someone where it takes all my mental and physical effort just to work. I don’t sleep anymore from the pain and I am depressed all the time. I tell my doctors and they don’t offer me anything to help. I started as a chronic pain patient not by choice and I am treated like a drug seeker. I took my medication as prescribed and I passed every drug test and went through all the hoops. I was not addicted to these medications I got off both without any issues, no rehab etc. My quality of life and joy have been stripped from me what am I suppose to do?

  • As a retired nurse and chronic pain patient I am disgusted that humans are being treated with less compassion and respect than animals treated in veterinary clinics. I chose a pain management doctor associated with Vanderbilt Hospital, thinking that would ensure my quality of care. He then moved to a clinic outside the hospital, however I remained a patient of his in good standing for over 8 years. On May 8, 2019 two days following my last visit I was notified the clinic where he practiced was closed with no way of contacting the doctor. Although my primary doctor and other pain management clinics have tried on my behalf, I am unable to obtain a copy of my medical records. When I was accepted as patient in another pain clinic my medications were immediately lowered, regardless I had over 8 years of records from my pharmacy documenting a stable dose prescribed by the same doctor. I have gone from being stable, not pain free but tolerable to almost constant pain with the threat of having all medication taken away if I complain. What happened to my patient rights? How does my (and many others) pain and suffering benefit society or decrease the over dose and illegal drug trade? The bottom line is people are suffering needlessly.

    • The meeting of these advisory committees has already taken place, but the docket is open only until Sunday. About 1300 comments have been registered. The focus of the meeting was on risks and benefits of high-dose opioids. I’ve commented at length in both the docket and directly to members of the committees. Much of the medical evidence in the article above was included.

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