In 2016, the Centers for Disease Control (CDC), in reaction to public concern over the growing opioid crisis in the United States – released a report called CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016. The publication was meant to reframe the way policymakers and medical professionals approach the prescription of opioid pain medication. The CDC had a compelling reason to enter the discussion on opioids and use the power of their organization to help stem the crisis. The data that drove them to create new guidelines is the same data that drove the media, the public, and members of the medical establishment to describe the trend in opioid use and misuse with words like crisis and epidemic:
- Opioid prescriptions rose dramatically from 1999 – 2014.
- Overdose deaths and the misuse of prescription opioids increased as the number of prescriptions increased.
- Heroin use and heroin overdose deaths increased between 2007 and 2016.
- Instances of fentanyl overdose increased between 2009 and 2016.
When the CDC published their guidelines, they explained their goals for reframing and resetting the use of opioids for chronic pain. To summarize, they intended to:
- Ensure clinicians and patients consider safer and more effective treatment
- Improve patient outcomes such as reduced pain and improved function
- Limit the number of people who develop opioid use disorder
- Decrease the number of people who overdose
- Reduce the number of people who experience adverse events related to opioids
Within a year, state lawmakers around the country wrote, signed, and implemented laws governing the prescription of opioid medication based on the guidelines suggested in the CDC report.
Unfortunately, some of these laws – while well-intentioned – created significant challenges for prescribing doctors, and, by extension, the patients they treat.
A Consensus Review Panel Forms
Before we go on, we suggest reading our article From Oxy to Heroin: The Unintended Consequences of CDC Opioid Prescription Guidelines. It will give you an idea of how public policy – especially health policy – can have real consequences for individuals in a short time.
Now, back to the subject at hand: the problems physicians face in implementing these guidelines, and the consequences those challenges create for patients.
In December 2017, the American Academy of Pain Medicine (AAPM) created an expert panel of physicians and hosted a meeting in order to:
- Review the core recommendations of the CDC guidelines
- Discuss any relevant literature
- Identify challenges related to guideline implementation
Physicians with a wide range of research, academic, and clinical experience made up the panel. Upon review, they first identified the positive components of the guidelines, and commended the CDC for reminding clinicians to:
- Understand opioids should not be the first-choice therapy for chronic pain
- Review the risks and benefits of nonopioid treatment
- Prescribe opioids only in needed quantities and durations
- Ensure opioids, if prescribed, are part of a comprehensive treatment plan, and not the only element
- Discontinue, reduce, or taper opioid use in patients for who the risks outweigh the rewards
- Arrange treatment for opioid use disorder if needed
However, as they dug deeper, they identified several areas in which lawmakers, physicians, insurers, and pharmacies misinterpreted the intent of the CDC guidelines. The primary issue, they discovered, was that the CDC never intended their guidelines to be used word-for-word as a new set of best practices for prescribing opioids, nor did they intend to create a new standard of care for patients receiving opioids for the long-term management of chronic pain – but that’s exactly what happened.
CDC Guidelines: Misinterpretations and Problems
Here’s how the CDC qualified their guidelines:
“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context. The recommendations in the guideline are voluntary, rather than prescriptive standards.”
After voicing their support for the spirit of the guidelines and commending the CDC for the points mentioned above, the panel identified the areas in which the implementation of the guidelines created significant issues that had a negative impact on both patients and prescribing physicians. We’ll review and summarize the misinterpretations and problem areas the panel identified, then include their recommendations for resolving the misinterpretations and problems moving forward.
The inflexible application of recommended ceiling doses or prescription duration.
When lawmakers, physicians, insurers, and pharmacists began implementing CDC guidelines as hard and fast rules, rather than displaying “an understanding of the patient’s clinical situation, functioning, and life context,” some patients experienced “…extremely adverse outcomes, including depression, loss of function, quality of life, and suicide.”
The panel concluded that “…any legislative regulatory, or payer policies enacted should make provisions for appropriately selected and monitored patients who need and benefit from longer duration or higher dosage.”
Abrupt opioid taper or cessation in physically dependent patients without empathetically reviewing benefits and risks in collaboration with patients.
In some cases, patients forced to taper off opioids quickly or denied prescription refills turned to illicit channels to procure opioid medication. Panel physicians also shared anecdotes and small series of cases describing suicidal ideation, self-directed violence, and medical deterioration in patients forced to taper off opioids – called nonconsensual taper.
The panel agreed that “abrupt cessation of opioids is medically risky and outside the intent of the CDC guideline.” They emphasized “gradual and supported taper with patient engagement and cautioned that clinicians should not…automatically and immediately reduce or stop long-term opioid therapy or dismiss patients with risk factors from care.”
Problem Area 1
Lack of availability and coverage for recommended comprehensive, multi-modal pain care.
The CDC guidelines indicated that if the benefits of opioids for pain management outweigh the risks, opioid prescriptions should be part of a “comprehensive, multi-modal treatment plan in which patients are assessed and closely monitored.” The problem is that programs that meet that description are not common and insurers don’t always reimburse them sufficiently. This creates obvious problems: the CDC recommended something that’s almost impossible to achieve, given the current treatment and reimbursement environment.
The panel urged insurers to create a coverage and reimbursement structure that includes access to psychosocial and physical treatment and “comprehensive pain management services when needed.” They encouraged enhanced physician training in “a full range of available pain treatments and a team-based approach to care.” In addition, they advocated for more funding for comprehensive pain care, increased dissemination of “programs to enhance prescriber competence in safer opioid prescribing.” Their last recommendation in this area was to suggest insurers “acknowledge and reimburse some forms of telemedicine and virtual visits for follow-up and reassessment.”
Problem Area 2
Difficulty in Diagnosing and Treating Opioid Use Disorder
While researching the issues surrounding the new CDC guidelines, panelists noted a difference between Opioid Use Disorder (OUD) and what they described as “complex persistent [opioid] dependence from continuing treatment.” They further noted the difficulty in distinguishing between dependence with an origin in pain treatment and disordered use that may have begun with treatment, but developed into a use disorder for a variety of reasons – including abrupt cessation or nonconsensual taper resulting from the CDC guidelines. This difficulty is compounded by the fact that some patients who are unable to tolerate an opioid taper would be well-served by an opioid replacement, such as buprenorphine, but cannot acquire buprenorphine without a physician diagnosed OUD.
The panel advised all relevant stakeholders to “support research and policy deliberation on how to best serve the patient who poorly tolerates an opioid taper but lacks a formal OUD diagnosis, including the role of possible buprenorphine administration.” The panel also advised all relevant stakeholders to “optimize both OUD and pain treatment.”
Problem Area 3
Naloxone Unavailability and Underutilization
The CDC guidelines emphasized making naloxone – a highly effective, life-saving drug that can prevent overdose death when administered in time – available for patients with any risk factors for opioid overdose. The panel noted that problems such as high cost and insufficient access due to competing interests of manufacturers, legislators, and insurers have prevented naloxone from being used to its full potential.
For the panel, this one was simple. They encouraged all stakeholders to immediately “address access and cost barriers to naloxone distribution.”
Toward a Comprehensive Effort to End the Opioid Crisis
The recommendations of the panel convened by the American Academy of Pain Medicine (AAPM) – summarized above – sought to “increase guideline clarity and usefulness” for those in a position to affect the implementation of the CDC guidelines regarding opioid prescriptions.
From our point of view, the panel recommendations serve an additional function: they urge everyone involved to move our society out of crisis mode and into healing mode. The misinterpretations, misapplications, and problems caused by legislation and regulations based on the CDC guidelines seem to have occurred because of a hasty rollout, which itself was caused by the urgent need for lawmakers to take action to address the opioid problem. While swift action is typically essential to mitigate the worst effects of any crisis, the opioid crisis is different: we’re talking about the pain and suffering of people we know and love.
We need timely, decisive action, yes.
However, experience teaches that the best policies and practices for the treatment of chronic disease are always evidence-based and data-driven. And make no mistake: the disease of addiction fuels the opioid crisis. That’s why, with regards to the CDC Guideline for Prescribing Opioids, we need to heed the advice of the CDC itself and place patient care at the center of any decision we make about opioid policy.
We’ll end by reiterating what the CDC makes clear in the introduction to their guidelines:
“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”
If we do that, we’ll meet and overcome these challenges, and create a logical plan that helps as many people as possible achieve overall health and well-being.