Opioid-Related Disorders Among Pregnant Women with Sickle Cell Disease and Adverse Pregnancy Outcomes.

OBJECTIVE: Opioid use during pregnancy has increased in recent years, parallel with the opioid epidemic in the general population. Opioids are commonly used as an analgesic for pain crisis, a hallmark symptom of sickle cell disease (SCD). With the amplified frequency and severity of SCD pain crisis during pregnancy, the use of opioids may increase concurrently. The aim of this study was to examine trends in opioid-related disorders (ORDs) among pregnant women with and without SCD, as well as assess the risk for preterm labor, maternal sepsis, and poor fetal growth among patients with SCD and ORD. METHODS: We conducted a retrospective analysis of inpatient pregnancy- and childbirth-related hospital discharge data from the 2002-2014 National (Nationwide) Inpatient Sample database. The primary outcome was the risk of ORD in pregnant women with SCD and its impact on threatened preterm labor, fetal growth, and maternal sepsis. RESULTS: Among the >57 million pregnancy-related hospitalizations examined, 9.6 per 10,000 had SCD. ORD in mothers with SCD was four times as prevalent as in those without SCD (2% vs 0.5%). A significant rise in ORD occurred throughout the study period and was associated with an increased risk of maternal sepsis, threatened preterm labor, and poor fetal growth. CONCLUSIONS: Pregnant women with SCD have a fourfold increased risk of ORD compared with their non-SCD counterparts. The current opioid epidemic continues to worsen in both groups, warranting a tailored and effective public health response to reduce the resulting adverse pregnancy outcomes.

Cancer Disparities and Black American Representation in Clinical Trials Leading to the Approval of Oral Chemotherapy Drugs in the United States Between 2009 and 2019.

PURPOSE: Over the past 10 years, oral chemotherapy made up about half (45.6%) of all US Food and Drug Administration (FDA)-approved oncolytic and hematologic medications. Given the disparity in incidence and mortality rate because of certain cancers among Black Americans (BAs) in the United States, a review of BA's representation in the clinical trials that lead to the development and FDA approval of oral chemotherapy drugs becomes imperative. The objective of this study was to evaluate the reporting of race and inclusion of BA in clinical trials that led to the approval of oral chemotherapy medications by the FDA from 2009 to 2019 in the United States. Additionally, we evaluated the inclusion of BAs in clinical trials of three cancer types with the highest disparity rates among BAs (lung, breast, and prostate). METHODS: A retrospective review of all FDA-approved oral chemotherapy drug from 2009-2019 was obtained using the FDA's Hematology/Oncology Approvals & Safety Notifications website. Reports of racial and demographics inclusion were obtained from the clinical trials registry. RESULTS: Primary outcome: 142 clinical trials led to FDA approval of 81 oral chemotherapy agents between 2009 and 2019, among which 74 (52%) reported on at least one race and were included in our analysis. 35,933 participants were enrolled in these 74 clinical trials, among which 25,684 (71.47%), 6,061 (16.87%), 889 (2.47%), and 826 (2.30%) were White, Asian, Black, and Hispanic, respectively. BAs were also under-represented in the clinical trials of three cancer types with the highest disparity rates among this population. CONCLUSION: BAs were under-represented in clinical trials leading to FDA approval of oral chemotherapy drugs. There should be more BAs in cancer clinical trials to increase the generalizability of the results, improve outcomes, and eventually close the health disparity gap among this patient population.

Oral Endocrine Therapy Agent, Race/Ethnicity, and Time on Therapy Predict Adherence in Breast Cancer Patients in a Large Academic Institution.

INTRODUCTION: Adherence to oral endocrine therapy (OET) reduces recurrence risk for hormone receptor (HR)-positive breast cancer (BC). Refill data accessed through electronic health records may provide objective assessment of OET adherence. Our goal was to (1) determine the feasibility of reviewing electronic health records for assessing OET adherence, (2) evaluate 6 months' OET adherence in HR-positive BC patients, and (3) identify predictors of low adherence. PATIENTS AND METHODS: A single-center, retrospective study from May through December 2018 was conducted. Primary end point was adherance rate at 6 months. Chi-square and Student t tests were used to compare adherent and nonadherent groups. Multivariable logistic regression models were used to assess predictors of adherence. RESULTS: Of 492 patients, 338 patients were included in adherence analysis. Of 338 patients identified, 82% (n = 277) were adherent at 6 months. In the multivariable logistic model, race/ethnicity, type of endocrine therapy, and time on therapy were found to be significantly associated with adherence. Asian/non-Hispanic and white/Hispanic patients were less likely to be adherent compared to white/non-Hispanics (Asian/non-Hispanic: odds ratio [OR], 0.3; 95% confidence interval [CI], 0.11-0.82; white/Hispanic: OR, 0.27; 95% CI, 0.11-0.64). Patients prescribed aromatase inhibitors were more likely to be adherent compared to patients prescribed tamoxifen (OR, 2.06; 95% CI, 1.02-4.14). Last, patients prescribed OET for 3 to 5 years had lower adherence compared to patients given OET for 2 years or less (OR, 0.29; 95% CI, 0.09-0.91). CONCLUSION: Accessing refill data through electronic health records was found to be feasible. Tamoxifen therapy, Asian/non-Hispanic and white/Hispanic origin, and longer time on therapy predicted nonadherence in our patients.