Medicine & Research

Chronic pain is one of the most common reasons patients seek medical attention. Approximately 20.4 percent of American adults report chronic pain, which is defined as pain lasting more than three months. The prevalence of pain in patients with multiple sclerosis is estimated to range from 29 to 86 percent based on clinical studies. There are a host of medications that can be used to treat chronic pain with each class carrying its own set of benefits and risks. When it comes time for clinicians to consider opioid treatment for chronic pain, there is a delicate balance that clinicians must tread lightly. The goal is to find the balance between helping and upholding the oath of “do no harm.” One of the most notable and public examples of this Catch 22 is the 2016 CDC Guidelines for Prescribing Opioids in Chronic Pain.

This guideline was developed to help clinicians navigate safe prescribing practices concerning opioids, but it led to a lot of controversy. Normally, clinical practice guidelines are meant to be used as recommendations. However, the 2016 guideline was misapplied as a legal requirement. Various healthcare stakeholders including payers, prescribers, pharmacies, and, most importantly, patients were faced with difficult circumstances as a result of misapplication.

A needed update

The CDC has recognized this issue and in the forthcoming revised Clinical Practice Guideline for Prescribing Opioids, the authors point out these previous misapplications and misinterpretations of the guidelines. In February 2022, the CDC called for public comments on the practice guideline draft before its final release.

Critics of the 2016 guideline argue that the guideline was misconstrued to act as a regulatory requirement. The previous guideline included recommendations for primary care and general practitioners to place maximum daily limits on opioid prescriptions to be of no more than 90 mg of morphine milliequivalents per day. Patients receiving daily opioid prescriptions higher than this threshold may have been perceived to be receiving “unnecessary,” “excessive,” or “improper” amounts of opioids.

Ramifications from the prescriptive limit recommendations were felt by patients at the pharmacy counter and through insurance plans. Patients in some cases were turned away from pharmacies and some pharmacies instilled policies requiring a call to the prescriber to alert them that a prescription was written for more than 90 MME per day. Some insurance plans also changed their formularies to require prior authorizations for opioid prescriptions that were greater than 90 MME per day.

These barriers to medication access did not take into account that some patients may benefit from opioid dosing greater than 90 MME per day. Prescribers who wrote prescriptions for opioids greater than this threshold could be mislabeled as a “bad doc” based on how firmly the 90 MME limit was being emphasized in the guideline.

When the 2016 guideline was first introduced, the country was on the heels of a widespread opioid epidemic. In 2016, opioid overdoses caused more than 42,000 deaths in the United States. The guideline became incorrectly viewed as a law and several prescribers became labeled as “excessively prescribing opioids” for venturing over the 90 MME per day mark on prescriptions. The American Medical Association originally was in full support of the guideline and later released statements that “call for restraining in implementing the CDC guideline – particularly as it applies to the agency’s maximum recommended dose of 90 MME per day.”

“To support, not supplant”

The 2022 draft guidance displays a more relaxed stance, moving away from hard MME daily dose limits and recognizing that some patients may benefit from greater than 90 MME per day of opioids. Language including dose limitations is avoided in the new guideline. The updated guideline also makes an effort to reduce the likelihood of misapplication by any healthcare stakeholder, specifically stating “the guideline should not be used by payers and health systems to set rigid standards related to dose or duration of opioid therapy.” The CDC notes an emphasis on the document being a “voluntary clinical practice guideline [that] provides recommendations and does not require mandatory compliance. It is intended to be flexible so as to support, not supplant, clinical judgment and individualized patient-centered decision making.”

The new perspective
 
The new guidelines include 12 recommendations focused on the four aspects of the clinical practice of pain management for outpatients with pain not related to sickle cell, cancer, or palliative care. These four aspects are 1) determining whether or not to initiate opioids for pain, 2) opioid selection and dosage, 3) opioid duration and follow-up, and 4) assessing risk and addressing harms of opioid use.

When determining whether or not to start opioids for pain, clinicians should consider the following:

1. Non-opioid 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 the risks to the patient.
2. Non-opioid 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.

Not all patients may be candidates for opioid treatment and it is important to consider the type of pain the patient is experiencing. Decisions to start treatment with opioids should be based on the best available evidence-based medicine and be patient-centered.

Opioid selection and dosage selection should be done with careful consideration and the guideline recommends:

1. Clinicians should prescribe immediate-release opioids, instead of extended-release, when starting opioid therapy for acute, subacute, or chronic pain.
2. When opioids are started for opioid-naive patients with acute, subacute, or chronic pain, clinicians should prescribe the lowest dosage to achieve expected effects.
3. For patients already receiving higher opioid dosages, clinicians should carefully weigh benefits and risks and exercise care when reducing or continuing opioid dosage.

Patients should not be discontinued on opioids abruptly in the event that risks do not outweigh the benefit unless there is an indication of a life-threatening issue. Tapers should be conducted under medical supervision and done carefully.

When it comes to duration of opioid use and follow-up, clinicians should:

1. Prescribe no greater quantity than needed for the expected duration of pain severe enough to warrant opioid use.
2. Evaluate benefits and risks with patients within one-to-four weeks of starting opioid therapy for subacute or chronic pain, or of dose escalation. This risk versus benefit evaluation should be done every three months or more frequently.

Risk assessment is also a major part of pain management and should include appropriate actions when clinicians and patients decide treatment plans. The following recommendations are included in the guidelines as well:

1. Risk for opioid-related harms should be evaluated and discussed with patients before and during opioid therapy. Strategies to mitigate risk, including offering naloxone, should be incorporated when factors that increase risk of opioid overdose are present.
2. Review the patient’s history of controlled substance prescriptions using the state prescription drug monitoring program data to screen for high risk opioids or combination of medications posing risk of overdose.
3. Perform toxicology testing to assess for prescribed medications as well as other prescribed and non-prescribed controlled substances.
4. Use extreme caution when prescribing opioid pain medications and benzodiazepines concurrently, assess the risk versus benefits.

In summary, the new guidelines should be considered just that: guidelines. The goal of the updated guidelines is to ensure patient safety when prescribing opioid pain medications. I encourage all to read the final draft of the CDC Clinical Practice Guideline for Prescribing Opioids once it is released later in 2022.