By Dr. Reema Hammoud, AVP, clinical pharmacy
While the COVID-19 pandemic forced its way into every aspect of our lives for the past 18 months, it is not the only major ongoing health crisis.
The opioid epidemic is still a real threat to our population despite being somewhat overshadowed in the past year. In the most recent CDC data report on the opioid crisis, drug overdose deaths were up 30.9% year-over-year during 2020 — an estimated 94,134 people, with a significant portion attributed to opioids.
In the clinical field, opioids play a helpful role in acute pain management and end-of-life care, but long term use of opioids is not recommended for patients experiencing chronic pain. As a solution, healthcare practitioners often treat patients by opioid tapering – slowly weaning patients either off opioids or to a lower dose of opioids in a medically-supervised manner.
A new study published in JAMA from researchers at University of California, Davis has made headlines this month for its new – and somewhat controversial – insights about the efficacy of opioid tapering and its effects on mental health and patient well-being. According to the researchers, patients who tapered experienced a 68% increase in overdoses and twice the number of mental health crises compared with patients who stayed on their normal dose of medication. Those risks were even more pronounced among patients whose original doses were higher and who reduced their doses more quickly.
I’ve been asked about this new data quite a few times in recent weeks. While its insights raise interesting points to consider, the study raises just as many questions and shows limitations in how the researchers may have fallen short in their approach.
Limitations in patient population
Group health and Medicare patients aren’t the only types of patients who receive opioid tapering treatments. At Sedgwick, we see a major population of chronic pain patients start as workers’ compensation cases, and these patients are qualitatively very different than others. The design of the study may have unintentionally ended up with biased results in this population. Patients used opioids for 12 months as a baseline, then the researchers followed the patients for 60 days to see if the dose was tapered or not. Researchers did not conduct long-term follow-up on whether the patients continued tapering or if they went back to their full, original dose. This suggests a potential for skewed results in this study population. It’s very possible that some overdoses were caused when patients returned to their much higher original opioid dose. This is why appropriate tapering at the right pace with expert medical supervision and psychosocial support is so important. When we see this in real life it is very successful. The overdose causes were not explained in this study and would warrant further investigation.
Additionally, the comorbidities of the population were not reviewed and considered. This is an important factor to consider when one of the main takeaways from the study surrounds mental health conditions. In this study, the participants receiving tapering treatment had higher morphine equivalent dose (MED) and higher incidence of mental health conditions as a baseline condition. The authors do acknowledge that these patients are prone to experience more side effects and aberrant behavior, but it also adds a bias to the results of the study. It’s not surprising that mental health conditions were a common thread among patients who overdosed – a tapered population is high-risk to begin with, so you can’t imply that one condition caused the other.
In our experience at Sedgwick, comorbidities are one of the most important factors to consider in recommending treatment. There is no one-size-fits-all approach for pain management or addressing substance use disorder. All cases (especially workers’ compensation cases) are different and environmental factors such as family support or professional counseling impact outcomes. Our clinical pharmacists work with providers to provide a slow taper, one medication at a time and recommend psychosocial support, per CDC guidelines. This study acknowledges these guidelines, but it does not appear the study was designed in line with guideline expectations.
Sample size is key
In the UC Davis study, it’s important to note that the population sizes in the tapered group and the medicated group were not the same. The non-tapered (medicated) group was a much larger sample size. This may have introduced further bias into the resulting datapoints. In hypothetical studies where one in 10 subjects are affected, versus one in 1,000, the two yield very different results. This is an exaggerated example but shows how a sample size can affect study results. Oftentimes, reports in the media, however well-intentioned, overlook these discrepancies in medical studies.
Due to these limitations, it’s hard to say whether clinicians can really apply the statistics in the UC Davis study in practice. Statistically, it is incorrect to conclude that tapering causes overdoses – retrospective observational studies cannot imply causation. This study raises good points about individualized care, the role of mental health in opioid addiction and substance abuse disorder more generally, and how risky tapering could be for different kinds of patients.
While the risk of opioid use is very high for many patients, we believe tapering is an effective way to decrease opioid use if healthcare providers follow the right guidelines. Medication should never be removed abruptly, and clinicians should recommend that patients get support from others, such as family, a doctor, a pain coach, a mentor, or a therapist as part of the tapering process.