CDC Opioid Guidelines’ Impact on Misuse, Outcomes: Jim Lichauer, PharmD, and Kerry Schwarz, PharmD

The initial publication of the CDC’s Clinical Practice Guideline for Prescribing Opioids for Pain had immediate implications on patient care and pain management as the dosage recommendations were regarded as hard limitations as opposed to suggestions.¹

With the 10th anniversary of its initial publication this month, Jim Lichauer, PharmD, BCPS, FASHP, senior performance improvement program director of pharmacy at Vizient, and Kerry Schwarz, PharmD, MPH, senior clinical manager of evidence-based medicine at Vizient, address common misconceptions about the guideline.

In this Q&A with The American Journal of Managed Care^® (AJMC^®), Lichauer and Schwarz explain the initial consequences of the guideline and how it reduced prescription opioid overdoses since its publication in 2016 and update in 2022.

This transcript was lightly edited for clarity.

AJMC: How much did the guideline contribute to reductions in opioid prescribing, and did it meaningfully impact overdose trends?

Lichauer: It's very important to understand where we were at, because we're very much in a full-blown crisis here with, as we said, with a lot of overdose deaths. And when we talk about overdose deaths, we'll make sure we try to point out there's overdose deaths to commonly prescribed opiates, and then we'll get into some of this discussion of phase 3 of the illicit opiate overdose deaths. But for the general point, when you ask if the guidelines made a meaningful impact, I think the short answer is yes, but we have to take that within context too, because there's a lot of other things going on at the time. There were states implementing regulations and changes. There were other bodies putting out work. But overall, looking back from the time of 2016, we can say there was a reduction in opiate prescribing, although there was a trend starting to go down starting in 2012, but we saw a continued reduction in opiate prescriptions, following the guidelines.

We also look at the volume of opiates being prescribed. There was some guidance in there about high-dose prescribing, and I think we saw a reduction in high-dose prescriptions following the guidelines. I think the guidelines also put us in a position to better understand monitoring of those medications, and so there was a lot put in place to help improve that monitoring and infrastructure around appropriate pain management, and then opiate overdose deaths for prescription opiates—that excludes the fentanyl products—continue to go down following these guidelines.

There, it was in a bit of a plateau, with a little bit of reduction since 2012, but we did see a reduction for those for opiate overdose death due to prescription opiates, which is an important distinction.

Schwarz: In the guideline itself, it talked about how in 2012 health care providers wrote 259 million prescriptions for opioid pain medications. This is enough for every adult in the US to have a prescription bottle. Also, at that time, opioid prescribing rates were increasing more for family practice and general practice and internal medicine practitioners compared with other specialties—something we had never seen before.

What we're also seeing is mortality or death rates for the top leading causes of death, heart disease and cancer, were decreasing. Mortality associated with opioid pain medication had markedly increased over time, and we knew that opioid pain medication is associated with opioid overdose death as well as opioid use disorder, so that sort of sets the stage for where we were at that time.

AJMC: What unintended consequences have emerged for patients with chronic pain?

Lichauer: Immediately, there were some unintended consequences. As we describe where we were at with prescribing habits being very loose and opiate overdose deaths being very high, we needed action. And I think when these guidelines came into place, sometimes it was a little bit more of a misapplication of overreaching with the guidelines, putting in hard limits when maybe we shouldn’t have.

I do think initially there were patients that were probably stopped abruptly or not tapered appropriately, or possibly patients that were not started on therapy because we were in the settling out period from the guidelines. I think in the long term, the guidelines combined with several other factors out there really have helped us improve pain control. Even from the guidelines’ standpoint, when they refer to opiate limits to be cautious with the 50 and 90 morphine milligram equivalents (MME) a day, that really should have given us a point to have that conversation with each patient regarding the dose they were on, why they were receiving the medication, what other medications they have tried, and what nonpharmacologic therapies they tried.

Each one of those interactions should have been an opportunity to provide better, well-rounded pain control, which it eventually did. But there was this initial, I think looking back, unsettling kind of pendulum moving a little bit too far in one direction that probably had some negative consequences for patients, especially some patients who were on these medications for chronic pain, right or wrong, that needed therapy to take place and not just be stopped or tapered off their opiates at that time.

Schwarz: I agree, and I really like the pendulum as a visual, right? We went from one extreme to, in certain populations, potentially another undesirable extreme. This resulted in decreased access to opioids, as patients could have been dismissed from practices, rapidly tapered, or even not engaged in treatment where clearly indicated.

What happens? There's an under treatment of pain or nontreatment of pain, and that potentially shifts people from prescription opioids managed by a health care professional to illicit opioids to manage their pain.

AJMC: How did the guideline affect physician decision-making and autonomy?

Lichauer: The thresholds that were set—the CDC put in their information about 50 and 90 MME per day—those were thresholds based on risk of opiate overdose, especially over 90 [MME, where] the risk of opiate overdose went up. And the misapplication of that, using those as hard limits, probably did hinder many physicians and/or impact patients, as we settled out and better understood what those guidelines meant. Then putting into place things that would have minimized risk of opiate overdose, such as dispensing a naloxone pen or naloxone vial to everyone who was receiving chronic opiates, and some states even went forward to mandating that.

Initially, those limits or those monitoring parameters created some barriers or obstacles and also hindered some physicians from prescribing. But I think we got to a point where we were able to understand how to best implement and provide the resources and structure to provide that care in those settings and really look at the risk vs benefit and do so. But the misapplication, I think, of some of those guidelines and making them firm or hard limits were really where our downfall was at least initially.

Schwarz: Let's talk a little bit about the guidelines and how they're developed. They're developed for primary care clinicians prescribing opioids to adults for chronic pain, except for pain due to cancer, or patients receiving palliative or end-of-life care. Development was driven by concerns for the potential for misuse, abuse, and addiction, as well as the need for additional education on opioid prescribing. Remember, at the time, everyone was looking for help.

I want to emphasize, and it's emphasized in the guidelines as well, these are voluntary recommendations based on evidence, including various types of studies, all of which have limitations. That's the nature of research as well as the data available at the time the guidelines were developed. The guidelines were developed using a standard methodology for assessing evidence, expert opinion was requested, outside organizations and stakeholders, including patients, were engaged in the process. There's a peer review, a public comment period, and an advisory committee review.

Also, at the time, there were recommendations from other organizations. Shared decision-making was mentioned in these guidelines, as well as with any guideline; the patient-clinician relationship is foundational in any decisions that the clinician makes regarding the patient's care, and it was emphasized in these guidelines to consider each patient's unique clinical scenario and circumstances when managing patients within the scope of the guideline.

AJMC: How has the guideline impacted vulnerable populations, such as patients with cancer or long-term opioid use?

Lichauer: The guidelines were never intended to cover, in fact, [patients with cancer] were excluded from this, and I think it probably had less effect on cancer patients, at least from my experience, because they tended to be a separate population. This was intended for primary care in a chronic pain setting, but it did have an impact, because we had to pause a bit and look at the guidelines, look at those dosage limits, and evaluate where we're at. And I do think that some of the misapplication and overreach and trying to apply these beyond what was intended, whether it was the dosing limits, if you will, or whether it's the patient population, that could have had an impact. But I think for cancer patients, it was never intended for palliative care to be included in this, and that was clearly stated. I think that they were less impacted, although I can't say looking back on it that they were not impacted at all.

Schwarz: I would agree with that—acute pain and other populations where these guidelines were extrapolated or applied to, and they were, as we say, out of the scope of these guidelines in terms of the evidence and opinion and experience that was included to develop them. Jim has mentioned the MME and the perceived rigidity around those; there was also rapid tapering off opioids, so declining someone's dose too quickly, and that could have shifted special and vulnerable populations in an undesirable direction, undertreating pain, or not treating pain.

Reference

1. McCrear S. The 10th anniversary of the CDC’s opioid prescribing guidelines: new evidence and patient-centered decisions. AJMC. March 24, 2026. Accessed March 25, 2026. https://www.ajmc.com/view/the-10th-anniversary-of-the-cdc-s-opioid-prescribing-guidelines-new-evidence-and-patient-centered-decisions