According to a recent publication in the Journal of the American Medical Association Network, researchers noted that the release of the CDC 2016 Guideline for Prescribing Opioids for Chronic Pain may have had unintended consequences for patients with sickle cell disease (SCD).

The authors wrote, “The purpose of this study is to determine if the 2016 CDC guideline has unintended consequences for patients with SCD and, if so, to what extent. To do this, we aimed to examine the association of the release of the CDC guideline with changes in opioid prescriptions filled and pain-related health outcomes among patients with SCD.”

The researchers conducted a retrospective cohort study involving 14,979 patients with SCD with an average age of 25.9 [16.9] years and included 8,520 [56.9%] females. Using data from the Merative MarketScan Commercial Database from January 1, 2011, to December 31, 2019, the researchers conducted interrupted time series analysis of claims data. In this population-based study in the United States, individuals with SCD who were aged at least 1 year with no cancer diagnosis and who had pharmacy coverage for the month of evaluation were included, and the data were evaluated from January 2021 to November 2023.

The primary variables assessed included the practice of opioid prescribing among patients with SCD (i.e., the rate of opioid prescriptions dispensed, the average number of days supplied, average total morphine milligram equivalents [MME] per patient, and average daily MME per opioid prescription). Additionally, pain-related health outcomes were defined as rates of emergency department visits and hospitalizations related to vaso-occlusive crises (VOC).

The authors noted that during the preguideline period, the rate of opioid prescriptions among patients with SCD was 0.81. After the release of the guideline, the rates diminished considerably (0.29 prescriptions per 100 person-month; 95% CI, 0.39-0.2).

By December 2019, the dispensing rate for patients with SCD was 13.1 percentage points lower than in the preguideline period.

Also, compared with preguideline releases, other noteworthy changes observed included a decline in the number of days supplied per prescription (–0.05 [95% CI, –0.06 to –0.04] days per prescription month; P <.001) and opioid dosage (–141.0 [95% CI, –219.5 to –62.5] MME per person-month; P = .001; –10.1 [95% CI, –14.6 to –5.6] MME/prescription-month; P <.001).

Additionally, the authors noted that, on the other hand, there was an increase in VOC-related hospitalizations following the guideline release (0.16 hospitalizations per 100 person-month; 95% CI, 0.07-0.25), resulting in a 7.05 percentage point increase in December 2019 versus periods without the guideline. Additionally, results revealed that these changes were observed to a greater degree among adult patients, but pediatric patients experienced comparable changes in numerous measures, even though the guideline focused solely on adult patients. The authors indicated that throughout the study period, compared with the adult patients, pediatric patients with SCD received fewer opioid prescription fills with lower dosages of opioids and had fewer VOC-related healthcare visits.

The authors wrote, “Decreases in prescription opioids among those with SCD imply that this population was susceptible to the guideline’s recommendations and subsequent changes in regulations by state legislatures and health insurance organizations.”

Based on their findings, the authors concluded that in this retrospective cohort study that investigated nationally representative commercial claims data, the 2016 CDC Guideline for Opioid Prescriptions for Chronic Pain was linked with adverse outcomes for patients with SCD, and these outcomes include a decline in opioid prescriptions and an increase in pain-related healthcare use.

Lastly, the authors concluded, “The federal guideline and policymakers should carefully consider the negative outcomes that their interventions may present in vulnerable populations, as well as clearly communicate the intention and scope of the interventions.”

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