On December 18, 2020, the Centers for Disease Control and Prevention reported that drug overdose deaths, already accelerating in number after a brief pause in 2018, have been increasing at an alarming rate. There were more than 81,000 overdose deaths during the 12 months ending in May 2020—a new record. There were just over 71,000 deaths reported for the 12 months ending in December 2019. But the most important feature of the report from the CDC is the fact that illicit fentanyl, made in clandestine labs in Asia and Mexico, was responsible for roughly 57 percent of all overdose deaths. Cocaine was found in roughly 22 percent of overdoses. And methamphetamines were found in 23 percent of all overdose deaths. By 2017, the top four killers were, in order, fentanyl, heroin, cocaine, and methamphetamine. Oxycodone was in sixth place and hydrocodone was ninth. Benadryl, which can be purchased over the counter, was in tenth place.
These facts seem to have been missed by Senators Robert Portman (R-OH), Sheldon Whitehouse (D-RI), and Amy Klobuchar (D-MN), who appear fixated on the misguided idea that reducing the number of opioids prescribed to patients in pain will somehow alleviate the overdose crisis. Around the time the CDC announced the grim news, these senators introduced CARA 2.0, the Comprehensive Addiction and Recovery Act (CARA 1.0 was enacted in 2016).
That’s because, among other things, this act would impose a national 3‐day limit on initial opioid prescriptions for patients in acute pain. To date 36 states already impose prescription limits, and total opioid dispensing per 100 persons has decreased more than 57 percent since its peak year of 2012. Yet overdose deaths continue to mount, as they have done exponentially since at least the late 1970s, well‐before the invention of OxyContin in 1996. This should come as no surprise to anyone studying data provided by the CDC and the National Survey on Drug Use and Health that show no association between the number of prescriptions dispensed and the rate of non‐medical use of prescription opioids or of opioid use disorder.
A November 2019 study in the Annals of Emergency Medicine found:
Although 1 in 5 opioid‐naïve ED patients who received an opioid prescription for acute pain on ED discharge filled at least 2 opioid prescriptions in 6 months, only 1% had persistent opioid use. These patients with persistent opioid use were likely to report moderate or severe pain 6 months after the ED visit.
This study came one year after a larger study of more than 568,000 “opioid‐naïve” patients treated for acute postsurgical pain from 2008–2016 found a total “misuse” rate of 0.6 percent.
The press report on CARA 2.0 issued by Senator Portman’s office states the three‐day limit is recommended by the CDC in its 2016 Guideline for Prescribing Opioids for Chronic Pain (recommendation number 6). But these guidelines were aimed at treating chronic pain, and were based on what the CDC stipulated was very limited evidence. The CDC also emphasized the guidelines were meant to be suggestive, not prescriptive.
Aware of the misinterpretation and misapplication of its 2016 guidelines, the CDC issued an Advisory in April 2019. The Advisory stated:
In addition, 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.
The CDC announced in December 2019 that it plans to update its guidelines, which have come under much criticism from many pain management and addiction treatment specialists, along with the American Medical Association.
In a June 2020 letter to the CDC on behalf of the AMA, James L. Madara, MD, Executive Vice President and Chief Executive Officer of the AMA stated:
As a starting point, the AMA points to the well‐received recommendation from the U.S. Health and Human Services Pain Management Best Practices Interagency Task Force that patients experiencing pain need to be treated as individuals, not according to one‐size‐fits‐all algorithms and policies that do not take individual patient’s needs into account. A similar statement was made by the CDC in 2016 when it published the CDC Guideline, where the authors plainly stated that:
“The recommendations in the guideline are voluntary, rather than prescriptive standards. They are based on emerging evidence, including observational studies or randomized clinical trials with notable limitations. Clinicians should consider the circumstances and unique needs of each patient when providing care.” (emphasis added)
Yet, the CDC Guideline also included multiple arbitrary dosage and quantity recommendations that have been consistently misapplied by state legislatures, national pharmacy chains, pharmacy benefit management companies, health insurance companies, and federal agencies. Early on, the AMA feared that the arbitrary opioid analgesic dosage and quantity thresholds appearing in the CDC Guideline would cause unintended consequences when used to severely limit individual treatment decisions made by physicians…
…It is clear that the CDC Guideline has harmed many patients—so much so that in 2019, the CDC authors and HHS issued long‐overdue, but greatly appreciated, clarifications that states should not use the CDC Guideline to implement an arbitrary threshold…
The prescription restrictions already in effect in most states have had a devastating effect on patients in pain. Many are unable to find a doctor willing to treat them, as physicians fear reprisals from law enforcement agencies that scan prescription drug surveillance systems. Many pain patients, abruptly tapered off their chronic opioid regimen turn, in desperation, to the black market for relief—or worse, to suicide. And the COVID-19 pandemic has only made matters worse.
Not content to wait for the updated CDC guidelines for opioid prescribing, the bipartisan group of senators sponsoring CARA 2.0 are pressing ahead, apparently uninterested in reconsidering their long‐held views.