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.
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 (CVS), Walmart, Walgreens (WBA), 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.