Mark Lenihan / AP
Doctors will soon receive new guidelines from the Centers for Disease Control and Prevention on how and when to prescribe opioids for pain.
These guidelines – currently being reviewed as a draft – will serve as an update to the agency’s previous advice on opioids issued in 2016. This suggestion is widely blamed for the detrimental effects that chronic pain can have on patients.
Federal officials acknowledge that their original guidelines were often misapplied; It was supposed to serve as a roadmap for clinicians to navigate complex decisions about opioids and pain – not as a strict set of rules.
But the 2016 version was used as the basis for the sweeping policy decision, as lawmakers and health leaders fought to control the country’s overdose crisis. Many states have enacted laws and regulations that set limits and health insurers also formulate policies to that effect.
And physicians were wary of prescribing opioids at all, which often led to sudden interruptions in treatment, resulting in physical and emotional distress and even increased the high risk of suicide.
Cindy Steinberg, director of national policy and advocacy at the US Pain Foundation, says there is a limited climate around prescriptions..
“I hear from patients every week and doctors don’t even want to see pain patients,” he says. “It’s a really difficult situation out there.”
For this reason, the revised guidelines of the company are now under scrutiny. The public comment period ends on Monday and the agency will then consider its final recommendations.
Some experts see the proposed changes as a promising step towards resolving the damage suffered by pain patients in the light of previous guidelines. And many more, including patients with chronic pain, argue that the guidelines are still flawed – including the possibility of misinterpretation and misapplication.
A step in the right direction
The new proposed guidelines – a comprehensive, 200-page document – continue to advise against using opioids for possible pain and caution when it comes to the risk of opioid abuse and overdose.
But there are some significant changes from the old guidelines.
Top recommendations – often accepted by physicians and policy makers – no longer include the dose and duration of an opioid prescription that a patient can take.
“This is a significant change,” said Dr. Stefan Cartes, a professor of medicine at the University of Alabama in Birmingham.
Along with the original guidelines, “it has been proven that insurance companies and regulators have seized those numbers as general tools to force changes in care that are often not safe for patients,” he said.
The new guidelines further emphasize that physicians should use their own discretion in determining what would be a safe and effective dose for each patient. The authors have previously stated that this is “intended to be applied as an inflexible standard of care” or “a law, regulation or policy that refers to clinical practice.”
Kertesz believes this is a much-needed recognition of how the previous guidelines were misapplied, especially for patients who are already on a stable system of opioids for chronic pain.
“The changes to the CDC are actually an attempt to make these drugs widely used and sold over the decades,” he said.
In fact, the proposed guidelines discourage doctors from using opioids as a first-line therapy for many common acute pain conditions – among them, lower back pain, muscle injury, and minor surgery-related pain. It discourages opioid use for chronic pain, but acknowledges that opioid therapy may play a role in treatment, especially if other approaches are tried.
“We’re trying to be very clear about the fact that these are not for a difficult threshold,” said Dr. Roger Chow of the University of Oregon Health and Science and author of the 2016 guide and updated edition.
Chow noted that the evidence still shows an increased risk with opioid abuse and overdose, and the benefits seem small. However, he said their 2016 guidelines were often applied in a way that they warned against, for example, for those who had cancer.
“Sometimes it’s hard to see how you can blame the guidelines for that.” He said. “We’ve done our best to be clean – even cleaner than before. ”
‘Not far enough’
Some patients and physicians say that the updated version still fails to solve the problem of chronic pain patients.
“I don’t think these guidelines go far enough to protect patients from the serious inhumane harm they have caused in the last six years,” Steinberg said.
There is a lack of balance between the new proposed guidelines when discussing the decision to start and stop opioid therapy, he said, noting that most focus on “opioid harm, not the benefits of being under medical supervision, or the risk and harm of poorly managed pain.”
Steinberg wants to see stronger language against abandoning opioid-dependent patients for pain.
Dr. Sally Sattle, who has studied the effects of opioid prescription rules on pain patients, said she was concerned about patients’ dosing instructions, or taper. They usually advise not to reverse the tapper once in progress, which he believes could cause harm.
Also, the “horse accent” that opioids are not the preferred treatment for non-acute pain “undermines physician discretion and useful care that guidelines have already been confirmed,” said Sattle, a senior fellow at the American Enterprise Institute.
Satell sees some positive changes in the new document, but in the end he believes it has the same problems as the previous version – citing specific doses throughout the document that can give the impression of a “hard ceiling” when determining opioids.
“Any mixed message has a high probability of being interpreted in a harmful way,” he says.
Questions about the effect of the guide
Many of the problems caused by the old guidelines were related to interrupting treatment for those who were already on long-term opioids.
But Dr. Gary Franklin, a research professor at the University of Washington, says removing prescriptions for acute or operative postoperative pain and how long the prescription for a clear dose threshold can be can be “problematic.”
He defended the 2016 guidelines, saying they were effective because they gave clear parameters to doctors who could be uncomfortable prescribing opioids and were uncertain about how to navigate decisions about pain management.
“If you remove that help by removing the specific guide, it will make them uncomfortable again. They don’t know what to do, “said Franklin.
Instead of softening its guidelines, the CDC should issue two different sets of recommendations, one for those starting opioids and the other for those who are already on opioids.
Franklin, who was also the medical director of the Washington State Workers’ Compensation Program, was among the first to raise concerns about the growing use of opioids and its link to overdose deaths.
“This is the worst man-made epidemic in the history of modern medicine – and it was created by us, by doctors, by surrogates for drug companies,” he said. “We’re trying to figure out, how do you reverse it?”
Yet some argue that the prescribed guidelines may have little effect on the overdose crisis. Over the past decade, opioid prescriptions have dropped by more than 40% – a trend that began before the CDC issued its 2016 guidelines. Meanwhile, the death toll from the annual U.S. drug overdose rose to an all-time high last year, with more than 100,000 people dying.
It is now illegal street drugs like fentanyl that are the primary cause of the increase. Prescription opioids were involved in about 16,400 of the more than 91,000 fatal overdoses in 2020.
Although the CDC’s guidelines may have reduced prescriptions, “what they haven’t done in the long run is to reduce overdose mortality,” said Dr. Sebastian Tong, an addiction specialist in Washington, DC.
‘Unbearable pain’ for patients
Experts warn that with an update to the guidelines, it may be difficult to uncover the effects of prescription practice, an effect that some patients are forced to suffer severely.
Amanda Vota says her problem with prescribing any opioids to doctors is starting to “roughly match the CDC guidelines.”
Vota, 41, was diagnosed with rheumatoid arthritis, an autoimmune disease, when he was 10 years old. Its special form of the disease does not respond well to treatment.
“I’ve had a loss that causes constant pain from bone fractures,” said Votta, who had to take opioids to manage her pain throughout her life. “I’ve always taken them as directed, and never flagged as an abuse of my prescription.”
After the CDC guidelines came out, her primary care doctor did not feel comfortable prescribing oxycodone and it was difficult to find someone who would give her enough to manage her pain. She was a graduate student and had several jobs on campus.
“There were times when I would sit in a small cube in the library and just cry because I was in so much pain,” he recalls. “It was unbearable.”
Voter-like pain patients still struggle to get prescribed opioids. In many places, primary care physicians do not accept new patients who need medication.
Last year alone, about 20,000 patients in California were left without pain management after the clinic closed, and those who were on long-term opioid therapy were given only 30 days of supply, according to a recent article. New England Journal of Medicine.
“Many patients quickly see that their primary care physicians are reluctant to prescribe opioids. Patients without a current physician have learned that almost no one will prescribe opioids for new patients and some will never prescribe opioids at all,” the author wrote.
The reluctance among physicians is related to the increased monitoring of their prescribed practice in the state electronic database. The State Medical Board and federal law enforcement agencies may investigate those who have been prescribed more opioids than their peers.
Carthage said he found the Drug Enforcement Administration warrant explicitly specifying opioid prescription doses that were part of the CDC’s 2016 guidelines (although Carthage himself was never involved in any of the cases).
“You can imagine it would have a cooling effect,” he says.
However, he said the CDC guidelines could not be held responsible for all “chaotic abuse” of patients because doctors, policymakers, regulators and insurers all responded in a way that was better than what was stated in the document.
He hopes the new guidelines will make meaningful changes to applicable laws and policies but says it is difficult to predict.
“Of course, bureaucrats don’t think fast about what they’ve done,” he said.