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14 Articles in Volume 21, Issue #5
Analgesics of the Future: Interleukin-17 Inhibitors for Treating Psoriatic Arthritis
Ask the PharmD: What evidence exists for metformin in treating rheumatoid arthritis pain?
Case Chat: Spasms vs. Spasticity and Muscle Relaxant Options
CDC Opioid Prescribing Guideline Updates Are in the Works: Will the Changes be Enough?
Chronic Pain Management in Marginalized Populations: How to Rebalance the Provider-Patient Relationship
Dantrolene: The Forgotten Molecule for Outpatient Spasticity
Forgotten Analgesics: The Drugs Pain Practitioners Need to Reconsider
Machine Learning Predicts Patient Response to Rheumatoid Arthritis Therapy
Perspective: Where Have All the Rheumatologists Gone?
Rheumatoid Arthritis and Bridge Therapy: Primary Care Considerations
Root Cause of Plantar Fasciitis: Three-Step Exercise Protocol
Shoulder Pain and Rotator Cuff Injuries: Emerging Treatments
Special Report: The Evolution of Rheumatoid Arthritis Treatment, from Gold to Gene Therapy
Transfer of Care: Barriers and Solutions in Chronic Pain Management

CDC Opioid Prescribing Guideline Updates Are in the Works: Will the Changes be Enough?

August 3, 2021
A look at initial feedback from the Opioid Workgroup on the updated CDC guideline and how some states are making their own opioid prescribing rules.

Even before it was released five years ago, the CDC Guideline for Prescribing Opioids for Chronic Pain1 was at the center of controversy, with pain advocates and practitioners fearing that the recommendations would be misconstrued by policymakers as black and white rules with no room for individualized care and professional judgment. In the years since, these fears have often proven to be valid.2 Countless states legislatures and licensing boards have adopted portions of the guideline as law, as opposed to recommendations, and have typically done so in ways that ignore the nuance and flexibility of the underlying guideline in favor of strict dosage ceilings and duration limits never intended by the CDC.

While the CDC has not yet released its updated draft guideline on prescribing opioids for chronic pain, the Opioid Workgroup has released its observations, expressing deep concerns with the proposed changes. (Image: iStock)

Opioid Workgroup and Advocates Warn CDC Guideline Updates are Insufficient

In preparation for making updates to the highly contested CDC guideline, and in response to the significant number of reports of guideline misapplication after its initial release, an Opioid Workgroup was established in December 2019 by the Board of Scientific Counselors of the National Center for Injury Prevention and Control (which is responsible for advising the CDC on certain matters) to review an early draft of the updated guideline and offer findings and observations.3 This workgroup, made up of 23 clinicians and subject matter experts in the areas of pain medicine, primary care, public health, pharmacy, emergency medicine, and more have now had a chance to review the CDC’s proposed updates to the guideline – and they are not pleased.

While the CDC has not yet released the updated draft guideline to the public, the Opioid Workgroup has released its observations, expressing deep concerns with the proposed updates.4 The 12-page document highlights many problem areas, including that much of the supporting text of the proposed guideline is not balanced, is missing key studies, and focuses heavily on the risks of opioids, while less attention is focused on the potential benefits of opioids, or the risk of not taking opioids or undertreating pain. Further, the workgroup notes concerns that a sense of exceptionalism run throughout the guideline, as pain related to cancer, palliative care, and sickle cell disease is exempted from the guideline as though those conditions are more “real” or “worthy” of treatment than other chronic pain conditions. However, at the absolute core of their observations is that none of the provisions from the 2016 guideline that have been misunderstood and misapplied in the past five years have been sufficiently changed to prevent future harm.5

Advocacy groups and professional associations, who have been anxiously awaiting the release of the draft CDC guideline, are highly concerned with the lack of substantial updates. To illustrate how little the CDC has updated the guideline, US Pain Foundation released a side-by-side comparison of the 12 recommendations that appear in the 2016 guideline and the 2021 draft. The American Medical Association (AMA) is also speaking up, urging the CDC to remove arbitrary thresholds, restore balance and support comprehensive, compassionate care as it revises the guideline.6

Misapplication of the CDC Opioid Prescribing Guideline: State Actions

North Dakota Workers’ Comp Will Not Cover Opioid Therapy Beyond 90 MME/Day

In a nearly textbook example of the exact sort of misapplication of the CDC guideline warned of by advocacy groups, North Dakota recently passed House Bill 1139 (2021), legislation pertaining to opioid dosage and duration limits.7 Under the newly adopted policy, which applies to the workers’ compensation system in North Dakota, opioid therapy will not be covered if it exceeds 90 morphine milligram equivalents (MME) of opioid medication per day, or more than a seven-day supply of an opioid medication, within any single outpatient transaction during the initial 30-day period of opioid therapy.

While these provisions are largely in line with the 2016 CDC recommendations pertaining to initiating therapy at the lowest possible dose and timely follow-up visits within the initial weeks of treatment, the new law does not limit itself to care provided by primary care physicians, as was intended by the CDC guideline. Furthermore, while the CDC recommends that a provider avoid increasing a patient’s dosage to ≥90 MME/day, the CDC has explicitly emphasized that “…policies that mandate hard limits conflict with the Guideline’s emphasis on individualized assessment of the benefits and risks of opioids given the specific circumstances and unique needs of each patient.”8

By codifying these provisions, North Dakota has overtly defied the CDC’s intentions. The new law is scheduled to take effect on July 1, 2022.

Read more about reconciling federal opioid guidelines with state laws.

Other states, having already borne witness to the patient suffering that can take place when opioid guidelines are misapplied, are actively taking steps to ensure that each patient’s unique needs are taken into consideration in the course of pain management. However, even these well-intentioned pieces of legislation often illustrate underlying misunderstandings associated with the CDC guideline and potentially perpetuate misapplication.

Rhode Island Exempts Chronic Intractable Pain from CDC Opioid Prescribing Guidelines

Rhode Island recently passed legislation pertaining to “chronic intractable pain,” defining such pain as “excruciating; constant; incurable, and of such severity that it dominates virtually every conscious moment; and/or produces mental and physical debilitation.”9 The law goes on to say that a practitioner acting in good faith “may prescribe, administer, and dispense controlled substances without regard to the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain” when treating a patient with chronic intractable pain, a cancer diagnosis, or who is receiving palliative or nursing home care. The new law specifically requires practitioners to take into consideration the individualized needs of patients.

While the goals of Rhode Island’s legislation may be laudable, the need for such legislation in the first place speaks to the large-scale misunderstanding of the CDC guideline. Firstly, the guideline was never intended to apply to patients receiving active cancer treatment or palliative care in the first place, so an exemption shouldn’t have been required. Secondly, it is unclear why “chronic intractable pain” was exempted by Rhode Island, as it seems to be the exact type of pain contemplated by the CDC guideline (assuming it is being treated in a primary care setting). One might assume that this exemption is to ensure that these patients are able to receive opioid dosages of greater than 90 MME/day, if their circumstances demand; however, there are no hard limits found within the CDC guideline, so this exemption should have been unnecessary. Regardless, it seems that Rhode Island recognized that securing these exemptions through legislative action was needed in order to safeguard a practitioner’s ability to appropriately treat their patients, and the provisions were effective immediately upon the bill’s passage in June 2021.

Colorado Ups Clinical Education About Opioid Prescribing

Similarly responding to the current phenomena of undertreatment of pain and problems associated with rapid discontinuation of opioids, Colorado has adopted House Bill 1276 (2021), aimed at ensuring that people living with chronic pain are able to receive appropriate care. Unlike Rhode Island’s choice to carve out guideline exemptions for certain types of patients, Colorado’s new law takes aim at educating practitioners through updating their continuing education requirements pertaining to opiate prescribers.10 As a condition of renewing licensure on or after October 1, 2022, practitioners must receive education on the potential harm of inappropriately limiting prescriptions to chronic pain patients, which will ideally reduce the number of pain patients harmed by practitioner misunderstandings related to dosage, duration, and tapering guidelines.

The Colorado legislation, it should be noted, goes far beyond opioids in its efforts to secure appropriate treatment for people living with pain, adopting sweeping requirements pertaining to mandatory insurance coverage for nonpharmacological alternative treatment to opioids. Beginning in 2023, health benefit plans within the state will be required to align cost-sharing amounts for nonpharmacological treatments for pain in cases where an opioid might be prescribed, including for physical therapy, occupational therapy, chiropractic, and acupuncture visits. These new insurance mandates will make it easier for practitioners to follow the CDC’s recommendation of considering alternatives to opioids before starting or continuing opioid therapy, as patients will be able to access those alternatives more affordably.

CDC Opioid Prescribing Guideline Updates Expected in 2022: Will the Changes Be Enough?

Prior to the release of the 2016 guideline, advocates warned the CDC of their concerns related to potential misapplication and misunderstandings related to their guideline’s recommendations. At the time, the concerns were all abstract possibilities that had not come to fruition, and it was believed by the CDC that misunderstandings could be mitigated through education and awareness campaigns. However, now armed with five years of patient and practitioner anecdotes, as well as the proliferation of states laws and rules that clearly misapply and misconstrue the guideline, advocates are hopeful that the CDC will make significant updates to mitigate these issues going forward.

The updated CDC Guideline for Prescribing Opioids for Chronic Pain is not expected to be finalized until late 2022,11 well after a draft has been released for public review and comments, so there is still plenty of time for the agency to make substantial edits to the guideline. According to the Opioid Workgroup – the only group of stakeholders to have yet laid eyes upon the current draft – there is still much work to be done.

Editor's Note: This article was published in advance of the PPM September/October 2021 issue, on August 10, 2021.

 
Last updated on: September 13, 2021
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