By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released a long-awaited final update to its controversial opioid prescribing guideline, expanding the recommendations to include patients suffering from short and long-term pain, while at the same time giving doctors more flexibility when prescribing opioids.

Although voluntary and only intended for primary care providers treating chronic pain, the original 2016 guideline was adopted as a mandatory opioid policy by many states, insurers, medical societies and even law enforcement agencies, resulting in millions of patients being reduced to lower ineffective doses or taken off opioids and forced into withdrawal. The newly revised guideline is intended to end the “one-size-fits-all” approach to pain care and a public health experiment gone wrong.

“Fundamentally, the framing of the guideline is that pain happens in many different ways, in different intensities, and patients respond to different treatments in different ways. And so it is paramount that clinical decisions are based on the individual needs of the patient,” said Christopher Jones, PharmD, Acting Director of CDC’s National Center for Injury Prevention and Control and a guideline co-author.

“In some cases opioids, even opioids at high doses, are the right thing to do for the patient. It’s more about working with the patient to set expectations and goals and look at the full range of treatments. And if opioids are the right thing or opioids plus non-pharmacological treatments, or opioids plus NSAIDs, if that’s the right thing and the patient is doing well and meeting their goals, this guideline supports that. It doesn’t dictate any particular type of care that any particular patient has to receive.”

Benefits vs Risks

To be clear, the revised guideline still takes a dim view of opioid pain medication and its potential to result in addiction and overdose. Doctors are advised to “maximize” the use of non-opioid drugs and non-pharmacological treatments, and should “only consider initiating opioid therapy if expected benefits for pain and function are anticipated to outweigh risks to the patient.” When opioids are prescribed, it should be at the “lowest possible effective dose.”   

Other notable changes in the guideline:

• A more cautious, slower approach to opioid tapering that strongly encourages patient buy-in before doses are reduced

• Drug testing only recommended when “appropriate.” Doctors should first “consider the benefits and risks of toxicology tests”

• Instead of “extreme” caution about taking opioids with benzodiazepines and other anti-anxiety drugs, “particular” caution is recommended

• Patients should not be dismissed for failing a drug test or because of information found in prescription drug databases (PDMPs)

Importantly, the revised guideline also removes a recommendation in the 2016 guideline that daily opioid doses not exceed 90 MME (morphine milligram equivalents), which was widely seen as a hard limit. It is replaced with cautionary language about doses above 50 MME being “more likely to yield diminishing returns.”  

“There are tweaks, but I think they are tweaks that are meaningful. That doesn’t mean its not still built on a rotten core,” says Kate Nicholson, Executive Director of the National Pain Advocacy Center (NPAC), who belonged to an independent advisory panel that advised the CDC to drop all references to MME.

Nicholson is concerned the 50 MME threshold – which is mentioned two dozen times in the revised guideline – will be misapplied as the new hard limit.

“They still overly focus on MME’s,” she told PNN. “They do qualify it whenever they mention it, but it’s still there, it’s there a lot, and it’s aligned strongly with risk. My concerns are misapplication, even though they say repeatedly ‘Do not apply this as a strict threshold.’”

Nicholson is also concerned about the guideline’s expansion beyond chronic pain (pain lasting three months or more) to include people with short-term acute pain from trauma or surgery, as well as “sub-acute” pain lasting one to three months.

“It’s good to cover all pain and not just single out chronic pain. So in theory I think it’s fine, but in practice, given that they acknowledge again and again the problems of the 2016 guideline. Usually, you check your safety features on the airplane before you expand the fleet. And they didn’t. They did it all at once,” she said. “I also have concerns that it’s a clinical practice guideline written mostly by non-clinicians and by people who are not experts in pain. And it’s now going to cover how all pain should be treated?”

For some patient advocates, no amount of revisions are acceptable. They want the CDC guideline revoked.

“False claims of one-size-fits-all dose thresholds are alive and well in this final draft. More than ever, I am convinced that the CDC must be restricted by law from issuing practice guidelines of this type,” says patient advocate Richard “Red” Lawhern. “It doubles down on lies and cherry-picked research intended to further suppress opioid prescribing at the expense of undertreating patients and driving clinicians out of pain management practice.”

Most of the mainstream media coverage of the revised guideline portrayed it as a weaker or softened version of the 2016 guideline. That is puzzling to Andrew Kolodny, MD, founder and president of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), who believes the new guideline is “much stronger” than the original.

“Press coverage of the CDC opioid guideline is wacky,” Kolodny wrote on Twitter. “CDC issued a guideline much stronger than the 2016 version (high dose defined as 50 MME/day instead of 90) but press headlines say CDC softened guideline.”

Reversing the Damage

Many patient advocates believe it will be hard to unwind the damage caused by the 2016 guideline to patients, pain management practices, and the healthcare system in general.

“Many laws, regulations, and policies were implemented from the rigid application of the 2016 opioid dosage thresholds. I believe this means many physicians may remain reluctant to prescribe opioids when indicated for chronic pain, and patients may continue to find access to treatment a challenge,” said Dr. Lynn Webster, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine

“To reverse the damage, the CDC could take an active and vocal public role in publicizing the statements about the guideline not being a law, regulation or policy. The agency should make sure that governmental and enforcement entities know there’s a new CDC statement on these matters.”

Chris Jones said the CDC would monitor how the revised guideline is implemented by states, insurers and others to prevent further misapplication. But he was vague about how it would be done, saying it needs to be handled on a case-by-case basis and while recognizing that “states do what states do.” The CDC has no legal authority to enforce its recommendations.

 “As with any clinical practice guideline, the work doesn’t stop today. It really starts as we engage with the clinical community, as we engage with patient organizations with educational opportunities. Certainly engaging with insurers and others to say, ‘Here’s the latest evidence about the range of treatment options that can be effective,’” he told PNN. “But we’re still working through, from a policy perspective when we see misapplication, how to respond to that.”

Jones said he would be speaking next month to the National Conference of State Legislatures about the revised guideline and to reinforce the need for individualized patient care. He and the other guideline co-authors also published an op/od in The New England Journal of Medicine that cautions providers about misapplying the CDC’s recommendations.

Webster thinks the CDC’s efforts to combat addiction and overdoses should be refocused on illicit fentanyl and other street drugs, which are involved in the vast majority of drugs deaths. In 2021, nearly 108,000 Americans died from overdoses, a record number.

“I think it is important to remember that the goal of the guideline was to reduce the number of overdose deaths by reducing the opioid supply or amount prescribed. It hasn’t worked out that way,” Webster said. “Over the past decade, opioid prescribing has plummeted, but the number of overdoses has skyrocketed. The CDC should now focus on the cause of most opioid-related overdose deaths, which is to bring attention to the social and economic factors that create the demand for so many Americans to escape the pain of living.”