CDC Emphasizes Opioid Guideline is Voluntary and Should Support, Not Supplant, Patient Care

On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline.  Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R.,  CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1–95. (“2022 Guideline”).   DOI: http://dx.doi.org/10.15585/mmwr.rr7103a1.  CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February.  2022 Guideline at 15.  (We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th).

An important part of the 2022 Guideline includes CDC’s pronouncement that some laws, regulations and policies have misapplied the 2016 guidelines and likely contributed to patient harm.  2022 Guideline at 3.

CDC notes that even though “the recommendations are voluntary and intended to be flexible to support, not supplant, individualized, patient-centered care,” in response to the guideline about half of the states enacted legislation limiting initial opioid dosage for acute pain to less than 7-days, and that “many insurers, pharmacy benefit managers, and pharmacies have enacted similar policies.”  Id. at 3.  In addition, the guideline has been misapplied to cancer and palliative care patients, and there have been rapid opioid tapers without patient collaboration, rigid application of opioid dosage thresholds, application of opioid use for pain to opioid use disorder treatment, insurer and pharmacy duration limits, patient dismissals and abandonment.  Id.  Such actions have resulted in “untreated and undertreated pain, serious withdrawal symptoms, worsening pain outcomes, psychological distress, overdose, and suicidal ideation and behavior.”  Id. at 3-4.

The 2022 guideline, intended to improve communication between clinicians and patients about the benefits and risks of opioid therapy, expands and updates the 2016 guideline by providing evidence-based recommendations to clinicians (primary care, physicians, nurse practitioners, physician assistants, and oral health practitioners) for prescribing opioids for acute pain (lasting less than a month), subacute pain (lasting 1-3 months), and chronic pain (lasting longer than 3 months) to outpatients 18 years of age and older.  Id. at 1, 4.  The recommendations do not apply to inpatient hospital care, in the emergency department or other observed settings.  They do apply, however, to prescribing for pain management upon discharge.  Id. at 7.  The 2022 guideline, as with the 2016 guideline, reiterates that it does not apply to pain management related to sickle cell disease or cancer-related pain treatment, palliative care and end-of-life care.  Id. at 1.

Recommendations

The 2022 guideline recommendations address four general areas: (1) whether to initiate opioids for pain; (2) opioid selection and dosage; (3) initial opioid duration and follow-up; and (4) assessing risk and addressing potential harms of opioid use.

We again quote each recommendation verbatim in bold text and include significant “implementation considerations” though not verbatim.  We strongly suggest that clinicians and others read recommendations and implementation considerations in their entirety to obtain the fullest understanding of the guideline.

a.  Determining Whether to Initiate Opioids for Pain

Recommendation 1.

Nonopioid therapies are at least as effective as opioids for many common types of acute pain.  Clinicians should maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate for the specific condition and patient and only consider opioid therapy for acute pain if benefits are anticipated to outweigh risks to the patient.  Before prescribing opioid therapy for acute pain, clinicians should discuss with patients the realistic benefits and known risks of opioid therapy.  Id. at 17.

• Non-opioid therapy is at least as effective as opioids for many acute pain conditions such as low back and neck pain; musculoskeletal pain from sprains, strains, tendonitis and bursitis; pain related to minor surgeries with minimal tissue injury, and mild postoperative pain; dental pain, kidney stones, and headaches including migraines.
• Opioid therapy plays an important role in treating acute pain related to severe traumatic injuries when non-steroidal anti-inflammatory drugs (“NSAIDs”) and other therapies are contraindicated or ineffective.
• When acute pain warrants the use of opioids, clinicians should prescribe immediate-release opioids at the lowest effective dose for the expected duration of pain requiring opioids.
• Clinicians should prescribe opioids only as needed (for example, one hydrocodone 5 mg./acetaminophen 325 mg. tablet not more frequently than every four hours as needed for moderate to severe pain) rather than on a scheduled basis. Clinicians should encourage tapering if patients take opioids around the clock for more than a few days.
• Patients should be aware of expected benefits, risks and alternatives before beginning or continuing opioid therapy and should participate in therapy decisions. Id. at 17-18.

Recommendation 2.  

Nonopioid therapies are preferred for subacute and chronic pain.  Clinicians should maximize use of nonpharmacologic and nonopioid pharmacologic therapies as appropriate for the specific condition and patient and 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 realistic benefits and known risks 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.  Id. at 21.

• When appropriate, clinicians should suggest noninvasive, nonpharmacologic approaches to manage chronic pain.
• Clinicians should review FDA-approved labeling and weigh benefits and risks before beginning pharmacologic therapy.
• NSAIDs should be used at the lowest effective dose for the shortest needed duration.
• Although nonpharmacologic and nonopioid pharmacologic therapy should have to fail before initiating opioid therapy for subacute or chronic pain, opioids should not be first-line or routine therapy. Expected clinical benefits should be weighed against risks before beginning therapy.
• Opioid therapy should not be initiated without clinician and patient considering “an exit strategy” should therapy be unsuccessful.
• Patient education and discussion are critical before initiating therapy.
• Patients should be aware of expected benefits and common risks of opioid therapy and alternatives before beginning or continuing opioid therapy. Patients should be involved in the decision of whether to begin therapy.  Id. at 21-23.

b.  Opioid Selection and Dosage

Recommendation 3.  

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.  Id. at 28.

• ER/LA opioids should be “reserved for severe, continuous pain.”
• Methadone should not be the first choice for an ER/LA opioid.
• Only clinicians familiar with dosing and absorption of ER/LA opioid transdermal fentanyl who educate their patients about it should consider prescribing it. Id.

Recommendation 4.  

When opioids are initiated for opioid-naïve patients with acute, subacute, or chronic pain, clinicians should prescribe the lowest effective dosage.  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.  Id. at 30.

• Guideline opioid use recommendations “are not intended to be used as an inflexible, rigid standard of care; rather, they are intended to be guideposts to help inform clinician-patient decision-making.” The recommendations apply to beginning opioids or to increasing opioid dosages.  Different benefits and risks apply to reducing opioid dosages.
• “[B]efore increasing total opioid dosage to ≥ 50 MME/day, clinicians should pause and carefully reassess evidence of individual benefits and risks. If a decision is made to increase dosage, clinicians should use caution and increase dosage by the smallest practical amount.”
• Dosage increases beyond 50 MME/day “are progressively more likely to yield diminishing returns in benefits for pain and function relative to risks.” Id.

Recommendation 5.

For patients already receiving opioid therapy, clinicians should carefully weigh benefits and risks and exercise care when changing opioid dosage.  If benefits outweigh risks of continued opioid therapy, clinicians should work closely with patients to optimize nonopioid therapies while continuing opioid therapy.  If benefits do not outweigh risks 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 circumstances of the patient, 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 rapidly reduce opioid dosages from higher dosages.  Id. at 32-33.

• Clinicians should carefully weigh the benefits and risks of continuing opioid therapy and of tapering opioids.
• When benefits do not outweigh risks of continuing opioid therapy, clinicians should optimize other therapies and work with patients to gradually reduce dosage or if warranted because of the patient’s individual clinical circumstances, “appropriately taper and discontinue opioid therapy.”
• Clinicians should follow up at least monthly with patients tapering opioid therapy.
• Payers, health systems, and state medical boards should not use the guideline to set rigid standards or performance incentives related to opioid dosage or opioid therapy duration. Rather, they should ensure their policies do not result in rapid tapering or abrupt opioid discontinuation.  They should also ensure that policies do not penalize clinicians for accepting chronic pain patients using prescribed opioids, including those receiving high opioid doses.  Id. at 33-34.

c.  Opioid Duration and Follow-Up

Recommendation 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.  Id. at 38.

• Clinicians can often manage nontraumatic, nonsurgical acute pain without opioids. When opioids are needed, a few days or less are often sufficient when opioids are needed for nontraumatic, nonsurgical pain.  Duration should be individualized based on the specific patient’s clinical circumstances.
• Clinicians should evaluate patients continuing to receive opioids for acute pain at least every 2 weeks.
• Clinicians should refer to recommendations on subacute and chronic pain for initiation (Recommendation 2 above), follow-up (Recommendation 7 just below) and tapering (Recommendation 5 above) for treating patients receiving opioids for a month or longer. Id. at 38-39.

Recommendation 7.  

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 regularly reevaluate benefits and risks of continued opioid therapy with patients.  Id. at 40.

d.  Assessing Risk and Addressing Potential Harms of Opioid Use

Recommendation 8.  

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.  Id. at 43.

• Clinicians should offer naloxone when prescribing opioids to patients who are at increased risk for overdose including those with a history of overdose, substance use disorder or sleep-disordered breathing. This includes patients who take higher opioid dosages, for example 50 MME/day or more, patients combining benzodiazepines with opioids and patients at risk for returning to a high dose who have lost tolerance.
• Clinicians should educate patients on preventing overdose and use of naloxone, and offer to educate patient’s households.
• Clinicians should review state Prescription Drug Monitoring Program (“PDMP”) data and toxicology screening to assess concurrent substance use disorder and overdose. Id. at 43-44.

Recommendation 9.  

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.  Id. at 48. 

• Clinicians ideally should review available and accessible PDMP data before issuing every opioid prescription for acute, subacute, or chronic pain.
• For long-term opioid therapy, clinicians should review PDMP data before issuing initial opioid prescriptions and at least every 3 months thereafter.
• Clinicians should not dismiss patients from treatment on the basis of PDMP information.
• Clinicians should strive to improve patient safety. Id.

Recommendation 10.

When prescribing opioids for subacute or chronic pain, clinicians should consider the benefits and risks of toxicology testing to assess for prescribed medications as well as other prescribed and non-prescribed controlled substances.  Id. at 50.

• Clinicians should not use toxicology test results punitively nor dismiss patients based on toxicology test results.
• Clinicians should consider toxicology results as “potentially useful data” along with other clinical information. Id.

Recommendation 11.

Clinicians should use particular 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.  Id. at 52-53.

• There are circumstances when it may be appropriate to prescribe opioids to a patient taking benzodiazepines, for example a patient in acute pain who is taking long-term, low-dose benzodiazepines. Clinicians should use caution and consider whether benefits outweigh risks of concurrent opioid use with other central nervous system depressants including muscle relaxants, non-benzodiazepine sedative hypnotics and potentially sedating anticonvulsant medications like gabapentin and pregabalin.
• Buprenorphine or methadone for opioid use disorder should not be withheld from patients who are also taking benzodiazepines and other medications that depress the central nervous system. Id. at 53.

Recommendation 12.

Clinicians should offer or arrange treatment with evidence-based medications to treat patients with opioid use disorder.  Detoxification on its own, without medications for opioid use disorder, is not recommended for opioid use disorder because of increased risks for resuming drug use, overdose, and overdose death.  Id. at 54. 

• Clinicians should not dismiss patients from their care due to opioid use disorder which can adversely impact patient safety. Id.

Conclusion

CDC concludes that “[a] central tenet of this clinical practice guideline is that acute, subacute, and chronic pain needs to be appropriately and effectively treated regardless of whether opioids are part of a treatment regimen.”  Id. at 59.  Clinicians achieve this through nonpharmacologic or pharmacologic treatments that “maximize patient safety and optimize outcomes in pain, function, and quality of life.”  Id.  Care must “be individualized and person centered.”  Id.  To avoid unintended consequences to patients, CDC warns that, neither the 2022 guideline nor policies derived from it should be misapplied and extended “beyond its intended use.”  Id. at 60. Misapplication can include inflexibility on opioid dosage and duration, discontinuing or dismissing patients, rapidly tapering patients without their collaboration who may be stable on higher doses, and application to cancer, sickle cell, or end receiving end-of-life patients.  Id.

The 2022 guideline comes at a critical time as more and more resources are being devoted to preventing opioid abuse and provide much needed addiction treatment.  In our opinion, the 2022 guideline provides necessary clarification and additional support for the recommendations related to appropriate prescribing of opioids for pain.  These should provide the healthcare industry with more useful guidance to be incorporated in patient treatment and care.  We also commend CDC for acknowledging the damage done to patient care by misapplication of the 2016 guideline and CDC’s emphasis on the appropriate use of the 2022 guideline.  We hope that CDC’s statements and recommendations will result in a more balanced approach by federal and state regulators to ensure that patients receive effective, appropriate medical care.