Unintended Consequences of the CDC’s 2016 Opioid Guideline on Individuals With Sickle Cell Disease

Objective Because the Centers for Disease Control (CDC) Guideline for Prescribing Opioids for Chronic Pain released in March 2016 was not intended to restrict opioid therapy to patients with sickle cell disease (SCD), we assessed whether the guideline resulted in a shift in prescribing level and negative health outcomes among this population. Methods This retrospective cohort study employed an interrupted time series analysis using the IBM® MarketScan® Commercial Database from January 1, 2011 to December 31, 2019. Patients who were ≥ 1 year old, had ≥3SCD diagnoses within 5 years, and no cancer diagnoses were included. Monthly-measured opioid use outcomes included: opioid prescription rate, mean total morphine milligram equivalents (MME) per patient, mean daily MME per opioid prescription, and mean number of days supplied per opioid prescription. Monthly rates of vaso-occlusive crisis (VOC)-related emergency department (ED) visits and hospitalizations were measured as health outcomes. Segmented regressions (breakpoint: March 2016) were conducted for all outcomes and the regression coefficients were used to estimate the changes of trends before and after the guideline release. Results The cohort included 14,979 SCD patients with a mean age of 25.9±16.9 years and 56.9% female. Compared to the pre-guideline trend, the following changes were observed after the guideline release: a significant decrease in the opioid prescription rate (-0.29 prescriptions/100person-month, P< 0.001), amount of opioid prescribed (-141.0 MME/person-month, P=0.001; -10.1 MME/prescription-month, P< 0.001), and number of days supplied per prescription (-0.05 days/month, P< 0.001), while a significant increase in the VOC-related hospitalization rate (+0.16 hospitalizations/100person-month, p=0.001). Conclusions The release of the CDC guideline was associated with a decrease in opioid prescribing practices and unfavorable health outcomes in patients with SCD. The guideline may have an unintended negative impact on this population. Because the Centers for Disease Control (CDC) Guideline for Prescribing Opioids for Chronic Pain released in March 2016 was not intended to restrict opioid therapy to patients with sickle cell disease (SCD), we assessed whether the guideline resulted in a shift in prescribing level and negative health outcomes among this population. This retrospective cohort study employed an interrupted time series analysis using the IBM® MarketScan® Commercial Database from January 1, 2011 to December 31, 2019. Patients who were ≥ 1 year old, had ≥3SCD diagnoses within 5 years, and no cancer diagnoses were included. Monthly-measured opioid use outcomes included: opioid prescription rate, mean total morphine milligram equivalents (MME) per patient, mean daily MME per opioid prescription, and mean number of days supplied per opioid prescription. Monthly rates of vaso-occlusive crisis (VOC)-related emergency department (ED) visits and hospitalizations were measured as health outcomes. Segmented regressions (breakpoint: March 2016) were conducted for all outcomes and the regression coefficients were used to estimate the changes of trends before and after the guideline release. The cohort included 14,979 SCD patients with a mean age of 25.9±16.9 years and 56.9% female. Compared to the pre-guideline trend, the following changes were observed after the guideline release: a significant decrease in the opioid prescription rate (-0.29 prescriptions/100person-month, P< 0.001), amount of opioid prescribed (-141.0 MME/person-month, P=0.001; -10.1 MME/prescription-month, P< 0.001), and number of days supplied per prescription (-0.05 days/month, P< 0.001), while a significant increase in the VOC-related hospitalization rate (+0.16 hospitalizations/100person-month, p=0.001). The release of the CDC guideline was associated with a decrease in opioid prescribing practices and unfavorable health outcomes in patients with SCD. The guideline may have an unintended negative impact on this population.