The infamous 2016 opioid prescribing guideline is finally getting a make-over. It has been a long time coming, but the Centers for Disease Control and Prevention (CDC) finally released a draft revised guideline last week and is seeking feedback from the public on its recommendations on prescribing opioids for the treatment of both chronic and acute pain.
The CDC has recognized for a while that the 2016 guideline needed to be revised—and it went through a long process just to get to this point. At the end of 2019, the CDC held a public meeting where the agency announced its intentions to update the guideline to include up-to-date clinical evidence and best practices. As I highlighted in a Regs and Eggs post from that time, during the meeting, there was a robust discussion from a clinical panel of physicians and other health care practitioners about how the current guideline had been misinterpreted—as well as numerous public comments from patients supporting that assertion. According to the first-hand, extremely personal accounts from patients with chronic pain, the guideline caused their physicians to stop refilling their prescriptions—exacerbating their pain and leading to other negative health outcomes. Even though the guideline clearly does not state that physicians should stop prescribing opioids cold turkey, according to many patients, that’s exactly what happened.
From that meeting, the CDC decided to form an expert working group, called the Opioid Work Group (OWG), to begin evaluating new clinical evidence and working with the agency to revise the recommendations included in the guideline. Instead of just focusing on opioid prescribing for chronic pain, as the 2016 guideline did, the CDC wanted to create a suite of recommendations targeted at the treatment of both chronic and acute pain. Since the guideline was to be expanded to include acute pain, ACEP knew that having an emergency medicine representative on the OWG would be critical. ACEP formally nominated Dr. Aimee Moulin, the former President of California ACEP, to serve on the OWG, and we were extremely pleased that CDC decided to place her on the workgroup.
The OWG met a few times in 2020 and then completed its work in the summer of 2021. By that time, the OWG had gone through the clinical evidence and provided input on preliminary revised recommendations that the CDC had drafted. You can download the OWG’s final report here. Based on the OWG’s input, the CDC spent the rest of 2021 revising the guideline and getting an official draft ready for publication.
Now that you are all caught up, you are probably wondering what the revised draft guideline actually recommends. In all, there are 12 recommendations, all routed in various levels of clinical evidence. Importantly, the CDC states up front that the recommendations do NOT apply to care received while in an emergency department—but DO apply to prescribing for pain management upon discharge from the emergency department. The CDC also acknowledges that some recommendations should apply broadly to all people, and some involve individual decision making by both clinicians and patients. Further, some recommendations are backed by overwhelming clinical evidence and randomized control trials, and others are supported by less concrete data. Therefore, CMS separates characterizes each recommendation is the following ways:
- Category A recommendation: Applies to all persons; most patients should receive the recommended course of action.
- Category B recommendation: Individual decision making needed; different choices will be appropriate for different patients. Clinicians help patients arrive at a decision consistent with patient values and preferences and specific clinical situations.
- Type 1 evidence: Randomized clinical trials or overwhelming evidence from observational studies.
- Type 2 evidence: Randomized clinical trials with important limitations, or exceptionally strong evidence from observational studies.
- Type 3 evidence: Observational studies or randomized clinical trials with notable limitations.
- Type 4 evidence: Clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations
Found below are the 12 recommendations in the draft guideline:
Determining Whether or Not to Initiate Opioids for Pain
- Nonopioid therapies are effective for many common types of acute pain. Clinicians should only consider opioid therapy for acute pain if benefits are anticipated to outweigh risks to the patient (recommendation category: B, evidence type: 3).
- Nonopioid therapies are preferred for subacute and chronic pain. Clinicians should only consider initiating opioid therapy if expected benefits for pain and function are anticipated to outweigh risks to the patient. Before starting opioid therapy for subacute or chronic pain, clinicians should discuss with patients the known risks and realistic benefits of opioid therapy, should work with patients to establish treatment goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks (recommendation category: A, evidence type: 2).
Opioid Selection and Dosage
- When starting opioid therapy for acute, subacute, or chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids (recommendation category: A, evidence type: 4).
- When opioids are started for opioid-naïve patients with acute, subacute, or chronic pain, clinicians should prescribe the lowest dosage to achieve expected effects. If opioids are continued for subacute or chronic pain, clinicians should use caution when prescribing opioids at any dosage, should carefully evaluate individual benefits and risks when considering increasing dosage, and should avoid increasing dosage above levels likely to yield diminishing returns in benefits relative to risks to patients (recommendation category: A, evidence type: 3).
- For patients already receiving higher opioid dosages, clinicians should carefully weigh benefits and risks and exercise care when reducing or continuing opioid dosage. If risks outweigh benefits of continued opioid therapy, clinicians should optimize other therapies and work closely with patients to gradually taper to lower dosages or, if warranted based on the individual clinical circumstances of the patient, to appropriately taper and discontinue opioids. Unless there are indications of a life-threatening issue, such as warning signs of impending overdose, e.g., confusion, sedation, or slurred speech, opioid therapy should not be discontinued abruptly, and clinicians should not abruptly or rapidly reduce opioid dosages from higher dosages (recommendation category: B, evidence type: 4).
Opioid Duration and Follow-up
- When opioids are needed for acute pain, clinicians should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids (recommendation category: A, evidence type: 4).
- Clinicians should evaluate benefits and risks with patients within 1 to 4 weeks of starting opioid therapy for subacute or chronic pain or of dose escalation. Clinicians should evaluate benefits and risks of continued therapy with patients every 3 months or more frequently (recommendation category: B, evidence type: 4).
Assessing Risk and Addressing Harms of Opioid Use
- Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk for opioid-related harms and discuss with patients. Clinicians should work with patients to incorporate into the management plan strategies to mitigate risk, including offering naloxone when factors that increase risk for opioid overdose are present (recommendation category: A, evidence type: 4).
- When prescribing initial opioid therapy for acute, subacute, or chronic pain, and periodically during opioid therapy for chronic pain, clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or combinations that put the patient at high risk for overdose (recommendation category: B, evidence type: 4).
- When prescribing opioids for subacute or chronic pain, clinicians should consider toxicology testing to assess for prescribed medications as well as other prescribed and non-prescribed controlled substances (recommendation category: B, evidence type: 4).
- Clinicians should use extreme caution when prescribing opioid pain medication and benzodiazepines concurrently and consider whether benefits outweigh risks of concurrent prescribing of opioids and other central nervous system depressants (recommendation category: B, evidence type: 3).
- Clinicians should offer or arrange treatment with medication for patients with opioid use disorder (recommendation category: A, evidence type: 1).
ACEP is still reviewing all these recommendations, their associated clinical evidence, and their potential impact on you as emergency physicians and the patients you serve. As we begin to respond to the guideline, we will be soliciting feedback from various experts across the College and will incorporate all that input into our official response.
While we have a critical opportunity now to comment on the draft guideline, as I mentioned earlier, we were already able to get the emergency medicine perspective incorporated early in the process through Dr. Moulin’s participation in the OWG. You can truly appreciate the significance of having the viewpoint of an emergency physician on the OWG by looking at the change the CDC made to one of the major recommendations impacting emergency medicine—number 6: “When opioids are needed for acute pain, clinicians should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids.” If you look at the OWG report, you will notice that when that recommendation was initially presented to the OWG for consideration, it included an additional sentence at the end: “One to three days or less will often be sufficient; more than seven days will rarely be needed.” ACEP has repeatedly argued against imposing day-limits on opioid prescriptions, and Dr. Moulin and others on the OWG commented in the OWG report that such a limit was not backed by clinical evidence. Dr. Moulin therefore requested that the CDC delete that sentence from recommendation number 6 before the draft guideline was published—and the CDC did just that!
I’m sure ACEP will have numerous other comments as we review the recommendations in more detail. Comments on the draft guideline are due on April 11. I will keep you updated on ACEP’s progress responding to the guideline, but in the meantime, please feel free to email me any questions or feedback you may have.
Until next week, this is Jeffrey saying, enjoy reading regs with your eggs!