By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released a long-awaited draft revision of its 2016 opioid prescribing guideline, making significant changes to recommendations so that healthcare providers have more flexibility in how they manage pain.  

Although voluntary and only intended for primary care physicians treating chronic pain, the original guideline was widely misapplied as a rigid “standard of care” by many states, insurers, providers and law enforcement, causing millions of patients to be taken off opioids or forcibly tapered to lower doses. As result, many went into withdrawal, became bedridden and disabled, committed suicide or were abandoned by their doctors. And while opioid prescribing declined, drug overdoses soared to record levels.  

“We certainly have learned and recognized the harm that has resulted when aspects of the 2016 guideline have been applied as inflexible, rigid standards that really go beyond the intent of what we wanted to occur,” said Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control. “We wanted to be very clear in this guideline that this is a clinical tool. It’s intended to support individualized patient centered care.

“There is a role for opioids in pain management and if the decision between a provider and a patient is to use them, here’s how we think that can be done in a safe manner.”

The updated draft guideline has been published in the Federal Register, where it will be available for public comment for 60 days. A final revised document is not expected until late this year.

Perhaps the most significant change to the guideline is the elimination of dose thresholds. The original guideline strongly encouraged providers not to exceed daily opioid doses of 90 morphine milligram equivalents (MME).

The revised guideline still maintains that opioids should not be used as first-line or routine therapy for pain, but takes a more nuanced and flexible approach to dosing. Providers are urged to be careful about increasing doses above 50 MME and to weigh the individual needs of each patient.

The revised guideline also has a strong warning to providers not to abruptly taper patients. And it drops a previous recommendation that limits the initial supply of opioids to a few days for acute, short-term pain. Rather than a specific number of days, the guideline recommends that opioids be provided for the “expected duration of pain severe enough to require opioids” – essentially leaving it up to providers to determine how long that may be.  

“I think we want to avoid something being seen as a rigid standard of care.  We’re quite explicit that is not the goal here,” Jones told PNN in an exclusive interview. “I think we’ve tried to frame the recommendations with more nuance than what was done in 2016, based on the latest science and feedback from the clinical community and patients that when there are hard thresholds, it is very easy for those to be misapplied and go beyond the intent of why they were there.”

‘They Listened to People in Pain’

Patients advocates who have lobbied the CDC for years to withdraw or revise the 2016 guideline were generally pleased with the updated version.

“I feel like they listened to people in pain,” says Kate Nicholson, Executive Director of the National Pain Advocacy Center and a member of the “Opioid Workgroup” that advised the CDC as the guideline was being rewritten. “It’s better than I feared. It’s trying to be more balanced. And I do feel there’s some intent to listen to people with pain and their experience, and acknowledge the guideline’s flaws. You’ve got to be grateful to them for that, that they listened. It’s a pretty big change for a federal agency.”

“The wording of the recommendations themselves is much improved over the 2016 version. In particular, the elimination of specific dosage numbers is welcomed because those were very easy for policymakers and payers to latch onto in setting policies,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management.  

“While it's good that they are removing those, I fear that it's a bit like closing the barn door after the horse has escaped. There is a lot of work that needs to be done to modify or eliminate policies that were tied to the specific numbers in the 2016 guideline, and I'd like to see CDC play a role in that work.”  

Twillman, who was a stakeholder consulted by the CDC during the drafting of its original guideline, said he was pleased to see the agency caution against the use of “step therapy,” which requires insured patients to try non-opioid treatments first before moving on to stronger pain relievers. He believes treatments should be decided by patients and providers, not insurers.    

“I'm gratified to see that they did what I advised them (twice) to do with the 2016 guideline, in that they are calling for clinicians and patients to jointly determine the goals of care,” Twilllman said in an email. “That is absolutely vital, and it's really nice to see the emphasis on that. Developing some tools that help patients and clinicians do that seems to be a task that needs to be done.” 

The transparent rollout of the revised guideline is in marked contrast to how CDC handled the release of the original guideline in 2015, a process that was cloaked in secrecy and included little input from patients or pain management experts. The agency initially refused to disclose who they consulted with, which included several anti-opioid activists.

The CDC’s secrecy sparked distrust in the pain community, which only worsened when the agency ignored early complaints that the guideline was being misapplied. It wasn’t until 2019 the CDC admitted the guideline was harming patients and that revisions were needed.

Six years have now passed since the original guideline was released. More work remains and the CDC is hoping to get additional feedback from patients, providers and others on its revisions.

“It’s important to point out that the guideline is not final and the step that we’re at now is a real critical point in the process to wrestle with and get feedback on the issues that you’re raising,” said Jones. “And that’s why it’s important that we hear from readers of Pain News Network to get feedback, to get that experience, so as we move toward a final guideline, we can incorporate that feedback. We hope that insurers, medical community, law enforcement and others will also review the guideline and provide feedback.”

You can leaver an online comment in the Federal Register by clicking here. Comments must be received by April 11.