Updated CDC Prescription Opioid Guidelines Appear More Flexible And Patient-Centric, But Fall Short
Rochelle Walensky, Director of the US Centers for Disease Control and Prevention (CDC), … [+]
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Over the past quarter-century, the opioid epidemic has taken nearly 600,000 lives. Drug overdoses now kill more than 100,000 Americans a year, which is more than vehicle crash and gun deaths combined.
Most drug overdose deaths are opioid-related. And, among opioid-related deaths, the vast majority are from illegal substances, such as illicit fentanyl and heroin. A relatively small proportion of opioid-related fatalities is due to misuse, abuse, overuse, and diversion of prescription opioids.
The Centers for Disease Control and Prevention (CDC) has issued an updated set of prescription opioid guidelines that accounts to some degree for the changing landscape of the opioid crisis. The recommendations acknowledge the importance of a more patient-centric approach to pain management. Nonetheless, the guidelines fall short. They continue to underplay the outsized role of illicit opioids play, and don’t adequately tackle the multifaceted nature of the opioid problem, which goes beyond the prescription of the doctor, patient, and the pharmaceutical industry. The problem also includes payer coverage policies.
US clinical practice and prescription drug policy with regard to opioids “radically changed” in the 1990s and again in the 2010s, as the pendulum swing from one extreme to another. Beginning in the late 1990s, opioid prescribing was liberalized, in part as a response to what had been considered inadequate pain management in chronic pain sufferers, including diabetic neuropathy, spinal cord injury, sickle cell anemia, and cancer patients.
Marketing efforts by pharmaceutical companies have often been the focus of inquiries into the rise in opioid prescriptions from the late 1990s through the early 2010s. Some of this marketing was legitimate and in accordance with labeled indications approved by the Food and Drug Administration, as well as reference to the risks posed by prescription opioids. Other promotional campaigns, most notably those of Purdue, were illegitimate as they included off-label uses and failed to properly identify the risks attached to prescription opioids misuse and abuse.
Lost in the shuffle is the role that payers played in the growth of opioid prescriptions, particularly in the late 1990s and 2000s as they often facilitated easy access to pain medications, both for short- and long-term use. To insurers, prescription opioids – especially generics – offered low-cost ways to address pain.
Then came the crackdown in the 2010s. Initially, the obvious targets were the so-called pill mills. This is a term typically used to describe a doctor or clinic that is prescribing or dispensing controlled prescription drugs inappropriately and in excess. Furthermore, prescription limits were imposed by way of guidelines, regulations, and payer policies.
This culminated in the 2016 CDC guidelines on opioid prescribing. While the guidelines weren’t intended to be rigidly applied, they certainly gave the appearance of being proscriptive, which had negative unintended consequences for some legitimate pain patients, such as seemingly arbitrary limits on prescription quantities, withholding of pain medications, and forced tapering. In turn, this has led to accusations that the CDC guidelines were failed policy recommendations, for patients and society as a whole.
A New England Journal of Medicine piece suggests, for example, that pain patients who have been prescribed opioids for years for certain chronic conditions must be treated differently. The article adds that one-size-fits-all approaches to tapering or discontinuing opioids prescribed for chronic pain ought to be avoided.
It’s clear that since the mid 2010s opioid prescriptions have declined rather precipitously. Yet, the opioid crisis has gotten progressively worse. Most of the current opioid problem concerns illicit opioids, such as street fentanyl, heroin, and counterfeit opiates.
Several municipalities and even the Biden Administration are finally moving forward with systematic steps to address addiction treatment. In October 2021, without much fanfare, the Biden Administration proposed new measures to curb the rise in drug overdose deaths. Moreover, there’s a building consensus around expanding federal support and coordinating harm reduction strategies for people actively using illicit drugs; for instance, wider distribution of fentanyl test strips, which help users avoid street drugs contaminated with the deadly synthetic opioid.
Last month, the CDC released a draft revision of its “clinical practice guideline” for prescribing opioids. Oddly, however, the updated CDC document continues to focus almost exclusively on the role that prescription opioids play in the opioid problem facing America. In so doing, the CDC perpetuates the fallacy that restricting access to prescription opioid analgesics will mitigate the nation’s overdose problem, which was what the American Medical Association warned in a letter to the CDC in July 2021.
To be clear, the CDC has heavily revised its prescription opioid guidelines in constructive ways. As such, it accounts to some degree for the changing landscape of the opioid crisis. For example, the recommendations acknowledge the importance of pain management that is more tailored to the individual patient. The draft guidance largely avoids specific numbers on dosage and length of prescription and clearly warns against abruptly or rapidly discontinuing pain medications for certain patients, such as those suffering from cancer, sickle cell anemia, and a number of other long-term conditions. As a result, the guidelines incorporate some built-in flexibility and the document no longer has a one-size-fits-all approach feel to it.
One of the main points of advice to doctors contained in the guideline is limit new opioid prescriptions to treatment-naive patients and discuss alternative therapies.
Yet, there’s a problem which the CDC does not recognize, and that is that the non-pharmacologic and even some of the non-opioid pharmacologic alternatives presented in the guideline recommendations, aren’t paid for by many insurers.
At this juncture, it is important that the opioid treatment debate evolves from a discussion focused on “too little” or “too much,” to one focused on identification of best treatment practices for chronic pain patients. And, this necessitates a comprehensive discussion that involves all stakeholders, including insurers.
Also, the CDC’s talk of better risk stratification of patients implies the need for insurer support for the time physicians must invest in doing the appropriate thing for their patients. Treatment-naive patients who present at the physician’s office with chronic pain should be assessed for their need for opioids or non-opioid treatments, plus a proper evaluation of the risk of misuse, abuse, overuse, or diversion.
Undoubtedly, abuse and diversion of prescription analgesics – the transfer of a prescription drug from a lawful to an unlawful channel of distribution or use – are serious problems that have negative implications for public health. Accordingly, physicians should evaluate each patient individually, reviewing his or her tolerance for pain, risk profile, and treatment preferences. Such a case-by-case approach requires that payers institute appropriate financial incentives to address risk stratification and appropriate prescribing of opioids and non-opioid treatments.
Payers, in particular, have demonstrated a delayed response to the prescription opioid problem, in part due to their distorted incentives. Based on their formulary decisions over the years it is plausible to presume that payers have focused on short-term cost minimization. Furthermore, most payers did not have, and many still do not have, sufficiently comprehensive chronic pain care management, along with healthcare provider and patient education.
There is a massive illicit opioid crisis in the US, as well as continued issues with prescription opioid misuse, abuse, overuse, and diversion. Both problems are multifactorial and solving them will require a wide range of interventions. The updated CDC guidelines make an attempt to address these issues more constructively. Yet, they fall short by continuing to underplay the major role illicit opioids play, and not adequately tackling the multifaceted nature of the prescription opioid problem, which goes beyond the doctor, patient, and drug industry. The problem also includes payer coverage policies.