Real-World Treatment Patterns Among Patients with Type 2 Diabetes Mellitus Initiating Treatment with Oral Semaglutide.

INTRODUCTION: The treatment landscape for type 2 diabetes mellitus (T2DM) is complex and constantly evolving, and real-world evidence of prescribing patterns is limited. The objectives of this study were to characterize lines of therapy (LOTs), calculate the length of time spent on each LOT, and identify the reasons for the LOT end among patients who initiated oral semaglutide for T2DM. METHODS: This retrospective, claims-based study included commercial and Medicare Advantage adults with T2DM. Data from November 1, 2019, and June 30, 2020, were obtained from Optum Research Database. Patients with ≥ 1 claim for oral semaglutide and continuous health plan enrollment for ≥ 12 months prior to (baseline period) and ≥ 6 months following (follow-up period) the date of the first oral semaglutide claim were included. LOT 1 began on the date of the first oral semaglutide claim. The start date of any subsequent LOTs was the date of the first claim for an additional non-insulin anti-diabetic drug class or a reduction in drug class with use of commitment medications. The LOT ended at the first instance of medication class discontinuation, change in regimen or end of follow-up. RESULTS: Of the 1937 patients who initiated oral semaglutide, 950 (49.0%) remained on their initial regimen over the 6-month follow-up period, 844 (43.6%) had at least one subsequent LOT, and 89 (4.6%) had at least two subsequent LOTs. Among patients with more than one LOT, approximately 20%-25% used oral semaglutide as monotherapy or combination therapy during LOTs 2 and 3. Metformin was frequently used during treatment across all LOTs. CONCLUSION: This study provides insight for physicians and payers into the real-world prescribing practices within the first 6 months following oral semaglutide initiation and fills the gap in understanding the frequency of regimen changes in the constantly evolving and complex environment of T2DM care.

Type 2 diabetes mellitus is a disease which, over time, can cause higher than normal levels of sugar in the blood (hyperglycemia) which can be harmful if not treated. Treatment for type 2 diabetes mellitus can be complex, and how doctors prescribe medications is always changing. For some people with type 2 diabetes mellitus who are overweight or obese, it is recommended for patients to use certain medications that can help with weight management such as semaglutide and metformin. This study aims to fill gaps in current treatment knowledge about type 2 diabetes mellitus patients and their treatment of oral semaglutide. Researchers in this study explored how patients treated with oral semaglutide differentiated among line of therapies, how long patients stuck to them and why they stopped. The study found that those patients who started with oral semaglutide, almost half of those patients stuck to their initial treatment plan for the entire 6 months. When it came to the top ten treatment plans, about 20% of patients used oral semaglutide alone and about 25% of patients used oral semaglutide plus an additional treatment option. Metformin was frequently used during treatment across all line of therapies. There is little information on the real-life setting of treatment after the start of therapy for type 2 diabetes mellitus. The results from this study show what happens when patients start using oral semaglutide and helps healthcare providers understand how often treatment plans can change in type 2 diabetes mellitus care.

Real-world glycated haemoglobin changes among type 2 diabetes mellitus patients treated with a maintenance dose of 7 mg or 14 mg of oral semaglutide.

AIM: To describe the change in glycated haemoglobin (HbA1c) among patients with type 2 diabetes following treatment with a 7 or 14 mg maintenance dose of oral semaglutide. MATERIALS AND METHODS: This retrospective, claims-based study included adult patients with type 2 diabetes with a pre-index HbA1c of ≥7%, initiating treatment with oral semaglutide between 1 November 2019 and 30 June 2020; the patients had continuous health plan enrolment for ≥12 months before (pre-index) and ≥6 months following (post-index) the date of the first oral semaglutide claim (index). Patients were required to have a maintenance dose of 7 or 14 mg. Pre-index demographic and clinical characteristics were captured, as were doses at initiation and prescriber specialty. The change in HbA1c between the latest post-index and pre-index HbA1c measurements was calculated among all patients and among those with ≥90 days of continuous treatment (persistent patients). RESULTS: This study included 520 patients, most of whom had a complex medical history, experienced a range of comorbidities and received an average of 11.5 different classes of medications during the pre-index period. The mean HbA1c reduction during the 6-month post-initiation period was 1.2% (p < .001) for all patients and 1.4% (p < .001) for persistent patients. CONCLUSIONS: In this real-world study, patients with a pre-index HbA1c ≥7% who initiated treatment with oral semaglutide with a 7 or 14 mg maintenance dose had significantly lower HbA1c levels following treatment.

The relationship between medical marijuana use and prescription pain reliever use among U.S. adults: A retrospective analysis utilizing the 2015-2019 National Survey on Drug Use and Health (NSDUH).

Background: Despite a number of states in the U.S. enacting medical marijuana policies, there is currently a lack of research outlining the role that individual-level factors play in predicting medical marijuana use, especially regarding use and misuse of prescription pain relievers. The overall aim of this study was to assess the prevalence of medical marijuana use in the U.S. and to identify clinical, social, and demographic predictors. Methods: A retrospective secondary database analysis was conducted utilizing five years of the National Survey on Drug Use and Health (NSUDH). A multivariable logistic regression model assessed the association between prescription pain reliever use and medical marijuana in the adult U.S. population while adjusting for substance use factors, psychiatric factors, and demographic characteristics. Results: Within the U.S. adult population from 2015 to 2019, medical marijuana use increased from 1.6% to 2.4%, while appropriate prescription pain reliever use decreased from 33.4% to 27.5%, and prescription pain reliever misuse decreased from 4.7% to 3.7%. Of all marijuana users, 15.1% resided within non-medical marijuana states. Medical marijuana users are more likely to have a serious mental illness (14.0% vs. 4.4%) and a non-marijuana related substance dependence (5.3% vs. 1.2%). Past-year medical marijuana use was significantly more likely to be reported among appropriate users of prescription pain relievers (OR = 1.99, p < .001) and misusers (OR = 1.94, p < .001) (relative to nonusers). Conclusions: Prescription pain reliever appropriate use and misuse were associated with higher odds of medical marijuana use. This study identified a potential treatment gap among individuals residing in states with no medical marijuana availability. These study findings highlight the potential benefits of medical marijuana legalization that future research can build on to guide policy making decisions.

Real-World Hemoglobin A1c Changes, Prescribing Provider Types, and Medication Dose Among Patients with Type 2 Diabetes Mellitus Initiating Treatment with Oral Semaglutide.

INTRODUCTION: Given the lack of real-world data on oral semaglutide use outside clinical trials, the purpose of this study was to describe dose, prescriber specialty, and change in hemoglobin A1c (HbA1c) after 6 months of oral semaglutide treatment for patients with type 2 diabetes mellitus (T2DM). METHODS: This was a retrospective study among adult patients with T2DM with ≥ 1 claim for oral semaglutide between November 1, 2019`1-June 30, 2020. Patients had continuous health plan enrollment ≥ 12 months prior to (pre-index) and ≥ 6 months following (post-index) the date of the first oral semaglutide claim (index). Dose at initiation and specialty of the prescribing provider were captured. Change in HbA1c between the last post- and pre-index HbA1c measurement was calculated. Patients were stratified by pre-index HbA1c ≥ 9% (poorly controlled) and HbA1c < 9%. RESULTS: A total of 744 HbA1c < 9% and 268 poorly controlled patients were included in the study. Most patients had an initial oral semaglutide dose of 7 mg (49.3%) or 3 mg (42.9%), prescribed most frequently by a primary care provider (27.8%). Mean HbA1c reduction was 0.8% (p < 0.001). Patients with poorly controlled T2DM had greater HbA1c reductions than patients with HbA1c < 9% (2.0% versus 0.4%, p < 0.001). Patients persistent with oral semaglutide (≥ 90 days continuous treatment) had a mean HbA1c reduction of 0.9% (p < 0.001); persistent patients with poorly controlled T2DM had a mean reduction of 2.5%. CONCLUSIONS: Patients with T2DM in this study experienced significant reductions in HbA1c within 6 months following initiation of oral semaglutide. Patients with a higher starting HbA1c experienced greater HbA1c reductions. The initial dose of oral semaglutide was higher than prescribing instructions indicated for more than half of the study patients.

Overcoming defensive responding in the estimation of prevalence of non-medical use of prescription stimulants.

BACKGROUND: Prevalence of Non-Medical Use of Prescription Stimulants (NMUPS) is estimated to be high among young adults enrolled in college. However, precise estimation of the prevalence of NMUPS is challenging owing to biases affecting self-report of sensitive and potentially illegal behaviors. OBJECTIVE: This study aimed to estimate the prevalence and risk factors of NMUPS using the crosswise randomized response technique (CRRT) and compare findings to the traditionally-used direct self-report (DSR) method. METHODS: This study utilized a cross-sectional, randomized experimental design to survey adult undergraduate students at a major southeastern university in the United States. Eligible respondents were randomly assigned to a DSR group or a CRRT group. Those in the DSR group were presented a direct question about NMUPS, but those in the CRRT group were asked to indicate whether their response to the NMUPS question was the 'same' or 'different' compared to a random non-sensitive question. RESULTS: Prevalence of NMUPS was found to be 18.6% (95% CI:18.5%-18.7%) in the DSR group and 32.5% (95% CI:32.1%-32.9%; p = 0.003) in the CRRT group. Logistic regression analysis predicting NMUPS in the DSR group showed that it was significantly associated with positive expectancies (OR:3.50; 95% CI:2.44-5.02), negative expectancies (OR:0.49; 95% CI:0.35-0.68), perceived norms (OR:1.71; 95% CI:1.27-2.29), and religious beliefs (OR:0.69; 95% CI:0.52-0.92). CONCLUSIONS: The setting and mechanism of the survey is likely closely related to the validity of prevalence estimation of sensitive behaviors. This study found that prevalence of sensitive behaviors such as NMUPS is significantly higher when respondents are provided increased anonymity.

Impact of food affordability on diabetes-related preventable hospitalization.

OBJECTIVES: This study aims to estimate the burden of food affordability on diabetes-related preventable hospitalizations among Medicaid enrollees in the United States. STUDY DESIGN: This study used a retrospective observational design with Medicaid administrative claims data from 17 states from 2014. METHODS: Data were linked with county-level social determinants of health (SDOH) from the American Community Survey. The rate of diabetes-related preventable hospitalizations was measured using the Agency for Healthcare Research and Quality's Prevention Quality Diabetes Composite, which includes hospitalization for short-term complications, long-term complications, lower extremity amputations, and uncontrolled diabetes. Multivariable logistic regression was used to predict the occurrence of diabetes-related preventable hospitalization. RESULTS: Among the 16 million eligible individuals, diabetes-related preventable hospitalizations were identified at the rate of 1.91 per 1000 individuals and contributed to more than $160 million in charges. Rates were higher among men compared with women (0.25% vs 0.15%; P < .001) and among Black adults compared with White adults (0.29% vs 0.18%; P < .001). Compared with individuals residing in counties with low food affordability, those residing in counties with high (odds ratio [OR], 0.84; 95% CI, 0.78-0.91; P < .001) or medium (OR, 0.85; 95% CI, 0.81-0.90; P < .001) food affordability had lower odds of hospitalization. CONCLUSIONS: This study provides real-world evidence about the impact of SDOH on diabetes-related preventable hospitalizations. Federal and state policies that can help improve accessibility of healthy foods are needed to ameliorate the burden of diabetes on society.

Associations of job demands and patient safety event involvement on burnout among a multidisciplinary group of pediatric hematology/oncology clinicians.

BACKGROUND: Workplace burnout can result in negative consequences for clinicians and patients. We assessed burnout prevalence and sources among pediatric hematology/oncology inpatient nurses, ambulatory nurses, physicians (MDs), and advanced practice providers (APPs) by evaluating effects of job demands and involvement in patient safety events (PSEs). METHODS: A cross-sectional survey (Maslach Burnout Inventory) measured emotional exhaustion, depersonalization, and reduced personal accomplishment. The National Aeronautics and Space Administration Task Load Index measured mental demand, physical demand, temporal demand, effort, and frustration. Relative weights analyses estimated the unique contributions of tasks and PSEs on burnout. Post hoc analyses evaluated open-response comments for burnout factors. RESULTS: Burnout prevalence was 33%, 20%, 34%, and 33% in inpatient nurses, ambulatory nurses, and MD, and APPs, respectively (N = 481, response rate 69%). Reduced personal accomplishment was significantly higher in inpatient nurses than MDs and APPs. Job frustration was the most significant predictor of burnout across all four cohorts. Other significant predictors of burnout included temporal demand (nursing groups and MDs), effort (inpatient nurses and MDs), and PSE involvement (ambulatory nurses). Open-response comments identified time constraints, lack of administrator support, insufficient institutional support for self-care, and inadequate staffing and/or turnover as sources of frustration. CONCLUSIONS: All four clinician groups reported substantial levels of burnout, and job demands predicted burnout. The body of knowledge on job stress and workplace burnout supports targeting organizational-level sources versus individual-level factors as the most effective prevention and reduction strategy. This study elaborates on this evidence by identifying structural drivers of burnout within a multidisciplinary context of pediatric hematology/oncology clinicians.

Approaches to assessing the provider experience with clinical pharmacogenomic information: a scoping review.

PURPOSE: Barriers to the implementation of pharmacogenomics in clinical practice have been thoroughly discussed over the past decade. METHODS: The objective of this scoping review was to characterize the peer-reviewed literature surrounding the experiences and actions of prescribers, pharmacists, or genetic counselors when using pharmacogenomic information in real-world or hypothetical research settings. RESULTS: A total of 33 studies were included in the scoping review. The majority of studies were conducted in the United States (70%), used quantitative or mixed methods (79%) with physician or pharmacist respondents (100%). The qualitative content analysis revealed five major methodological approaches: hypothetical clinical case scenarios, real-world studies evaluating prescriber response to recommendations or alerts, cross-sectional quantitative surveys, cross-sectional qualitative surveys/interviews, and a quasi-experimental real-world study. CONCLUSION: The findings of this scoping review can guide further research on the factors needed to successfully integrate pharmacogenomics into clinical care.

Never Enough Time: Mixed Methods Study Identifies Drivers of Temporal Demand That Contribute to Burnout Among Physicians Who Care for Pediatric Hematology-Oncology Patients.

PURPOSE: Burnout is a syndrome of emotional exhaustion, depersonalization, and reduced personal accomplishment because of chronic occupational stress. Approximately one third of pediatric hematology-oncology physicians experience burnout. The goal of this mixed methods study was to determine the prevalence and drivers of burnout among physicians caring for pediatric hematology-oncology patients at our institution. MATERIALS AND METHODS: This mixed methods, cross-sectional study was conducted at a large academic cancer center. Validated survey instruments were used to measure burnout, job demands, experience with patient safety events, and workplace culture. Quantitative data informed development of a semistructured interview guide, and physicians were randomly selected to participate in individual interviews. Interviews were transcribed and analyzed via content analysis based on a priori codes. RESULTS: The survey was distributed to 132 physicians, and 53 complete responses were received (response rate 40%). Of the 53 respondents, 15 (28%) met criteria for burnout. Experiencing burnout was associated with increased temporal demand. Twenty-six interviews were conducted. Qualitative themes revealed that frequent meetings, insufficient support staff, and workflow interruptions were key drivers of temporal demand and that temporal demand contributed to burnout through emotional exhaustion and reduced personal accomplishment. CONCLUSION: Nearly one-third of participating physicians met criteria for burnout, and burnout was associated with increased temporal demand. Qualitative interviews identified specific drivers of temporal demand and burnout, which can be targeted for intervention. This methodology can be easily adapted for broad use and may represent an effective strategy for identifying and mitigating institution-specific drivers of burnout.

Community pharmacists and mental illness: a survey of service provision, stigma, attitudes and beliefs.

Background Half of Americans experience mental illness during their lifetime. Significant opportunity exists for community pharmacists to deliver services to these patients; however, personal and practice-related barriers may prevent full engagement. Objective To assess the demographics, practice characteristics, service provision, stigma, attitudes and beliefs of a national sample of community pharmacists towards individuals with mental illness. Setting National random sample of 3008 community pharmacists in the USA. Method 101-item cross-sectional mailed survey questionnaire on: (1) demographics, (2) knowledge and practice characteristics, (3) provision of clinical pharmacy services, and (4) comparative opinions. Main outcome measure Scaled measures of service provision (comfort, confidence, willingness and interest) and comparative opinions (stigma, attitudes and beliefs) of mental illness, four linear regression models to predict service provision. Results A total of 239 responses were received (response rate 7.95%). Across pharmacy services, ratings for willingness/interest were higher than those for comfort/confidence. Pharmacists who reported providing medication therapy management (MTM) services for patients reported higher comfort (18.36 vs. 17.46, p < 0.05), confidence (17.73 vs. 16.01, p < 0.05), willingness (20.0 vs. 18.62, p < 0.05) and interest (19.13 vs. 17.66, p < 0.05). Pharmacists with personal experience with mental illness also resulted in higher scores across all four domains of service provision, lower levels of stigma (18.28 vs. 20.76, p < 0.05) and more positive attitudes (52.24 vs. 50.53, p < 0.01). Regression analyses demonstrated increased frequency of MTM service delivery and more positive attitudes as significantly predictive across all four models for comfort, confidence, willingness and interest. Increased delivery of pharmacy services was significantly associated with both willingness and interest to provide mental illness-specific services. Conclusion Despite willingness/interest to provide services to patients with mental illness, decreased levels of comfort/confidence remain service-related barriers for community pharmacists.