Glucagon fill rates and cost among children and adolescents with type 1 diabetes in the United States, 2011-2021.

AIMS: To characterize glucagon fill rates and costs among youth with type 1 diabetes mellitus (T1DM). METHODS: Claims-based analysis of commercially-insured youth with T1DM included in OptumLabs® Data Warehouse between 2011 and 2021. Glucagon fill rates and costs were calculated overall and by formulation (injectable, intranasal, autoinjector, and pre-filled syringe). Sociodemographic and clinical factors associated with glucagon fills were examined using Cox regression. RESULTS: We identified 13,267 children with T1DM (76.4% non-Hispanic White). Over mean follow-up of 2.81 years (SD 2.62), 70.0% filled glucagon, with stable fill rates from 2011 to 2021. Intranasal glucagon had rapid uptake following initial approval, and it accounted for almost half (46.6%) of all glucagon fills by 2021. Family income was positively associated with glucagon fills in a stepwise fashion (HR 1.39 [95% CI 1.27-1.52] for annual household income ≥$200,000 vs. <$40,000), while Black race was negatively associated with fills (HR 0.83 [95% CI 0.76-0.91]) compared to White race). Annual mean out-of-pocket costs ranged from $21-$68 (IQR $29-$44). CONCLUSION: Roughly 30% of commercially-insured youth with T1DM may lack access to unexpired glucagon, with significant disparities among Black and low-income patients. Health systems, clinicians, schools, and caregivers should work together to ensure children have reliable access to this critical medication.

Evolution of Clinical Complexity, Treatment Burden, Health Care Use, and Diabetes-Related Outcomes Among Commercial and Medicare Advantage Plan Beneficiaries With Diabetes in the U.S., 2006-2018.

OBJECTIVE: To characterize trends in clinical complexity, treatment burden, health care use, and diabetes-related outcomes among adults with diabetes. RESEARCH DESIGN AND METHODS: We used a nationwide claims database to identify enrollees in commercial and Medicare Advantage plans who met claims criteria for diabetes between 1 January 2006 and 31 March 2019 and to quantify annual trends in clinical complexity (e.g., active health conditions), treatment burden (e.g., medications), health care use (e.g., ambulatory, emergency department [ED], and hospital visits), and diabetes-related outcomes (e.g., hemoglobin A1c [HbA1c] levels) between 2006 and 2018. RESULTS: Among 1,470,799 commercially insured patients, the proportion with ≥10 active health conditions increased from 33.3% (95% CI 33.1-33.4) in 2006 to 38.9% (38.8-39.1) in 2018 (P = 0.001) and the proportion taking three or more glucose-lowering medications increased from 11.6% (11.5-11.7) to 23.1% (22.9-23.2) (P = 0.007). The proportion with HbA1c ≥8.0% (≥64 mmol/mol) increased from 28.0% (27.7-28.3) in 2006 to 30.5% (30.2-30.7) in 2015, decreasing to 27.8% (27.5-28.0) in 2018 (overall trend P = 0.04). Number of ambulatory visits per patient per year decreased from 6.86 (6.84-6.88) to 6.19 (6.17-6.21), (P = 0.001) while ED visits increased from 0.26 (0.257-0.263) to 0.29 (0.287-0.293) (P = 0.001). Among 1,311,903 Medicare Advantage enrollees, the proportion with ≥10 active conditions increased from 51.6% (51.2-52.0) to 65.1% (65.0-65.2) (P < 0.001); the proportion taking three or more glucose-lowering medications was stable at 16.6% (16.3-16.9) and 18.1% (18.0-18.2) (P = 0.98), and the proportion with HbA1c ≥8.0% increased from 17.4% (16.7-18.1) to 18.6% (18.4-18.7) (P = 0.008). Ambulatory visits per patient per year remained stable at 8.01 (7.96-8.06) and 8.17 (8.16-8.19) (P = 0.23), but ED visits increased from 0.41 (0.40-0.42) to 0.66 (0.66-0.66) (P < 0.001). CONCLUSIONS: Among patients with diabetes, clinical complexity and treatment burden have increased over time. ED utilization has also increased, and patients may be using ED services for low-acuity conditions.

Drug labeling changes and pediatric hematology/oncology prescribing: Measuring the impact of U.S. legislation.

BACKGROUND/AIMS: The Pediatric Research Equity Act and Best Pharmaceuticals for Children Act are intended to promote the conduct of clinical trials that generate pediatric-specific evidence about drug safety and efficacy. This study assesses the quality of evidence generated through Pediatric Research Equity Act-mandated and Best Pharmaceuticals for Children Act-incentivized clinical trials of hematology/oncology drugs and characterizes subsequent changes in pediatric drug utilization rates. METHODS: Trial characteristics (blinding, randomization, and comparator group) were determined for clinical trials that supported pediatric label changes. Using data from OptumLabs® Data Warehouse, a de-identified administrative claims database, we calculated pediatric utilization rates for each drug. We calculated monthly utilization rates from January 2003 (or from the first month in which data were available) to December 2018. RESULTS: We identified 11 hematology/oncology drugs that underwent pediatric label changes under the Pediatric Research Equity Act Pediatric Research Equity Act and/or Best Pharmaceuticals for Children Act, and we identified 15 trials supporting these changes. Of these trials, 36% (5/14) were randomized, 31% (4/13) were blinded, and 36% (5/14) used a comparator group. A median of 49 children (interquartile range 29.5) received the drug under investigation across these trials. Pediatric label changes were not associated with subsequent changes in pediatric drug utilization. Although some drugs saw increased pediatric use after gaining new pediatric indications, this pattern was not consistently observed. In addition, there was no evidence to suggest that drugs were utilized less frequently after they failed to receive pediatric indications. CONCLUSIONS: Clinical trials of hematology/oncology drugs conducted under the Pediatric Research Equity Act Pediatric Research Equity Act and Best Pharmaceuticals for Children Act generally have low methodological rigor, and the resulting label changes are not consistently associated with changes in pediatric utilization. Alternative regulatory strategies and study designs may be necessary to maximize the impact of newly generated knowledge on drug utilization.

Development of a Taxonomy for Medication-Related Patient Safety Events Related to Health Information Technology in Pediatrics.

BACKGROUND: Although electronic health records (EHRs) are designed to improve patient safety, they have been associated with serious patient harm. An agreed-upon and standard taxonomy for classifying health information technology (HIT) related patient safety events does not exist. OBJECTIVES: We aimed to develop and evaluate a taxonomy for medication-related patient safety events associated with HIT and validate it using a set of events involving pediatric patients. METHODS: We performed a literature search to identify existing classifications for HIT-related safety events, which were assessed using real-world pediatric medication-related patient safety events extracted from two sources: patient safety event reporting system (ERS) reports and information technology help desk (HD) tickets. A team of clinical and patient safety experts used iterative tests of change and consensus building to converge on a single taxonomy. The final devised taxonomy was applied to pediatric medication-related events assess its characteristics, including interrater reliability and agreement. RESULTS: Literature review identified four existing classifications for HIT-related patient safety events, and one was iteratively adapted to converge on a singular taxonomy. Safety events relating to usability accounted for a greater proportion of ERS reports, compared with HD tickets (37 vs. 20%, p = 0.022). Conversely, events pertaining to incorrect configuration accounted for a greater proportion of HD tickets, compared with ERS reports (63 vs. 8%, p < 0.01). Interrater agreement (%) and reliability (kappa) were 87.8% and 0.688 for ERS reports and 73.6% and 0.556 for HD tickets, respectively. DISCUSSION: A standardized taxonomy for medication-related patient safety events related to HIT is presented. The taxonomy was validated using pediatric events. Further evaluation can assess whether the taxonomy is suitable for nonmedication-related events and those occurring in other patient populations. CONCLUSION: Wider application of standardized taxonomies will allow for peer benchmarking and facilitate collaborative interinstitutional patient safety improvement efforts.