Racial/Ethnic and Socioeconomic Disparities and Self-Reported Work Productivity in Urinary Incontinence Females Using the National Institute of Diabetes and Digestive and Kidney Diseases Data.

OBJECTIVE: To explore the relationship between racial/ethnic and socioeconomic disparities and self-reported work productivity in urinary incontinence females. METHOD: This was a retrospective observational and secondary analysis of the National Institute of Diabetes and Digestive and Kidney Diseases database trials. We included females with stress urinary incontinence and ≥ 21 years old. The primary outcome was self-reported work productivity evaluated using a proportional-odds regression model. A backward elimination method was utilized to create a final reduced model. The socioeconomic predictors were age, race/ethnicity, education, marital status, personal income, and language. RESULTS: We included 1252 participants with a median age of 52 years old. Whites accounted for 76.2% of total participants, while Hispanics constituted 11.4% only. Work productivity of Hispanic or non-Hispanic other group was greatly affected compared to whites (OR: 1.771, p value: 0.0008 and OR:1.592, p value= 0.0231 respectively). Work productivity of patients with higher education was less affected compared to less educated patients. Married females were less likely to report being greatly affected in work productivity than non-married females (OR 0.663, p-value 0.0005). Age, income, and language were not predictive of the outcome variable in the final model. CONCLUSION: Our finding showed that racial/ethnic and socioeconomic disparities play an important role in individuals' work productivity. Future research is needed to the influence of social determinants of health not captured by racial and socioeconomic factors.

Updates to a pharmacy-technician driven centralized medication refill service in a large community health system.

sIn 2020 we published a description of the newly implemented centralized medication refill service (CRS) led by pharmacy technicians in our large community health system. Since that time, the CRS has been refined, updated, and expanded. We have also received many inquiries with common questions about the process from those who seek to implement a similar process. The purpose of this commentary is to 1) provide updates to the process in the five years since its implementation, and 2) provide additional insights on specific topics from inquiries to the organization.

A risk stratification analysis of ASCVD events post-statin discontinuation in patients who underwent sleeve gastrectomy or Roux-en-Y gastric bypass bariatric/metabolic surgeries.

BACKGROUND: Cardiovascular disease remains a leading cause of mortality globally, and its prevalence is notably elevated in individuals with obesity. Bariatric surgery is an effective intervention to reduce obesity-related health risks. However, the implications of discontinuing statin therapy, particularly post-bariatric surgery, among those with a history of atherosclerotic cardiovascular disease have yet to be clarified. We aimed to ascertain the risk of atherosclerotic cardiovascular disease events following statin cessation after bariatric surgery and to delineate the variance in outcomes between primary and secondary prevention cohorts. METHODS: The TriNetX database, encompassing electronic medical records from 69 United States healthcare institutions, spanning 2012 to 2021. Using a retrospective cohort design, patients aged ≥18 years who underwent bariatric surgery and were concurrently on statin therapy were selected. Discontinuation was defined as a 90-day lapse after the last statin prescription. Patients were categorized as "primary" or "secondary" prevention based on their atherosclerotic cardiovascular disease history. The primary outcome was the occurrence of an atherosclerotic cardiovascular disease event post-statin cessation. Multivariable Cox proportional hazards models discerned factors influencing this outcome. RESULTS: Of the 453 statin users who underwent bariatric surgery, 332 (73.1%) were in the primary prevention group and 121 (26.7%) in the secondary prevention group. At 1-year post-surgery, atherosclerotic cardiovascular disease event-free rates were 93% for primary and 68% for secondary prevention groups. Primary prevention patients showed an 82% reduced risk of post-statin cessation atherosclerotic cardiovascular disease events than secondary prevention patients (hazard ratio, 0.181; 95% confidence interval, 0.119-0.274). Additionally, Hispanic/Latino patients had heightened post-statin cessation atherosclerotic cardiovascular disease risks compared to non-Hispanic/Latino peers. CONCLUSION: Post-bariatric surgery statin discontinuation can pose significant risks, especially for those with atherosclerotic cardiovascular disease history and certain demographic groups, such as those over age 40 with diabetes. Ethnic disparities in outcomes necessitate individualized, equitable healthcare strategies. Optimal decisions about statin cessation necessitate comprehensive evaluations of cardiovascular determinants, with future research crucial to refine therapeutic approaches based on these insights.

Factors Associated with Statin Discontinuation Following Metabolic and Bariatric Surgery: A Retrospective Analysis of 2012-2021 Electronic Medical Records Network Data.

BACKGROUND: Bariatric surgery has been shown to improve hyperlipidemia, decreasing the need for statin medications. Although maintaining statin therapy post-surgery for those with a history of atherosclerotic cardiovascular disease (ASCVD) is advised, it is uncertain if discontinuation risks differ between those with and without ASCVD history. AIM: The study aims to analyze the rate and reasons for statin cessation post-bariatric surgery in the US using real-world data. METHODS: Using the TriNetX electronic medical records network from 2012 to 2021, the study involved patients aged 18 or older on statins at the time of bariatric surgery. They were categorized into primary and secondary prevention groups based on prior ASCVD. Statin discontinuation was defined as a 90-day gap post the last statin dosage. The Cox model assessed factors influencing statin cessation. RESULTS: Seven hundred and thirty-three statin users undergoing bariatric surgery were identified, with 564 (77%) in primary prevention. Six months post-surgery, 48% of primary prevention patients and 34.5% of secondary ones stopped statins. Primary prevention patients had a 30% higher likelihood of cessation compared to secondary prevention (hazard ratio, 1.30; 95% CI, 1.06-1.60) as shown by multivariable analysis. CONCLUSIONS: Post-bariatric surgery, primary prevention patients are more likely to discontinue statins than secondary prevention patients.

The roles of type 2 diabetes and obesity in disease activity and progression of non-alcoholic fatty liver disease/non-alcoholic steatohepatitis.

OBJECTIVE: We examined the roles of type 2 diabetes (T2D) and obesity in disease activity and fibrosis progression/regression in patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH). METHODS: This multi-center, retrospective study included patients with suspected or histologically proven NAFLD/NASH from the NASH Clinical Research Network. Outcomes included disease activity and rate of fibrosis, assessed using liver-biopsy driven measures (NAFLD activity score [NAS] and fibrosis score [FS]). Logistic regression and doubly robu estimation of causal effects tested relationships among T2D, obesity, and NAFLD/NASH. RESULTS: The analytical sample included 870 adult patients with baseline biopsy data and 157 patients with multiple biopsy data. Patients with NAFLD/NASH and T2D had significantly higher baseline average NAS (4.52 vs. 4.13; p = 0.009) and FS (2.17 vs. 1.56; p < 0.0001); those with T2D had a significantly greater reduction in average NAS over time (-0.77/year vs. -0.17/year; p = 0.0008). Change in FS over time did not differ significantly by T2D status (-0.23/year vs. -0.04/year; p = 0.34). Baseline NAS, baseline FS, and change in average NAS over time did not differ significantly by obesity status (4.17 vs. 4.47; p = 0.16; 1.73 vs.1.92; p = 0.31; -0.40/year vs. -0.59/year; p = 0.62, respectively). Patients with obesity had a slight increase in FS but those without obesity had a reduction in average FS over time (0.07/year vs. -0.27/year; p = 0.008). CONCLUSIONS: Patients with NAFLD/NASH and T2D had greater baseline disease activity versus those without T2D, but there was greater regression of disease activity over time among those with T2D. Patients with NAFLD/NASH and obesity had worsening of fibrosis versus those without obesity. NCT00063622.

Metabolic and Bariatric Surgery Utilization Trends in the United States: Evidence From 2012 to 2021 National Electronic Medical Records Network.

Background: Bariatric surgery has evolved over the past 2 decades yet assessing trends of bariatric surgery utilization in the growing eligible population is lacking. Aim: This study aimed to update the trends in bariatric surgery utilization, changes in types of procedures performed, and the characteristics of patients who underwent bariatric surgery in the United States, using real-world data. Method: This retrospective descriptive observational study was conducted using the TriNetX, a federated electronic medical records network from 2012 to 2021, for adult patients 18 years old or older who had bariatric surgery. Descriptive statistical analysis was conducted to assess patients' demographics and characteristics. Annual secular trend analyses were conducted for the annual rate of bariatric surgery, and the specific procedural types and proportions of laparoscopic surgeries. Results: A steady increase in the number of procedures performed in the United States over the first 6 years of the study, a plateau for the following 2 years, and then a decline in 2020 and 2021 (during the coronavirus disease 2019 pandemic). The annual rate of bariatric surgery was lowest in 2012 at 59.2 and highest in 2018 at 79.6 surgeries per 100,000 adults. During the study period, 96.2% to 98.8% of procedures performed annually were conducted laparoscopically as opposed to the open technique. Beginning in 2012, the Roux-en-Y gastric bypass (RYGB) procedure fell to represent only 17.1% of cases in 2018, along with a sharp decline in the adjustable gastric band (AGB) procedure, replaced by a sharp increase in the sleeve gastrectomy (SG) procedure to represent over 74% of cases in 2018. Conclusions: Bariatric surgery utilization in the United States showed a moderate decline in the number of RYGB procedures, which was offset by a substantial increase in the number of SG procedures and a precipitous drop in the annual number of AGB procedures.

Safety profile and signal detection of phosphodiesterase type 5 inhibitors for erectile dysfunction: a Food and Drug Administration Adverse Event Reporting System analysis.

Background: Phosphodiesterase type 5 inhibitors (PDE5Is) are generally well tolerated but have been associated with uncommon and significant adverse events (AEs). Aim: This study aims to investigate and compare the characteristics of AEs associated with PDE5Is used for erectile dysfunction and identify any safety signals in a postmarketing surveillance database between 2010 and 2021. Methods: A descriptive analysis was conducted for all AEs reported to the Food and Drug Administration Adverse Event Reporting System for 4 PDE5Is-avanafil, sildenafil, tadalafil, and vardenafil-indicated for erectile dysfunction between January 2010 and December 2021. The frequency of the most reported AEs and outcomes were identified. A disproportionality analysis based on proportional reporting ratio (PRR) and reporting odds ratio (ROR) was conducted for the most common and clinically important AEs to identify signals to gain insights into potential differences in safety profiles. Outcomes: The outcome measures of the study are frequency of reported AEs and outcomes following AE. Results: A total of 29 236 AEs were reported for PDE5Is during the study period. The most reported AE was "drug ineffective" with 7115 reports (24.3%). Eight safety signals were detected across the 4 drugs. Key signals were sexual disorders (PRR, 3.13 [95% CI, 2.69-3.65]; ROR, 3.24 [95% CI, 2.77-3.79]) and death (PRR, 3.17 [2.5-4.01]; ROR, 3.211 [2.52-4.06]) for sildenafil, priapism (PRR, 3.63 [2.11-6.24]; ROR, 3.64 [2.12-6.26]) for tadalafil, and drug administration error (PRR, 2.54 [1.84-3.52]; ROR, 2.6 [1.86-3.63]) for vardenafil. The most reported outcomes were other serious events with 6685 events (67.2%) and hospitalization with 1939 events (19.5%). Clinical Implications: The commonly reported AEs and detected signals may guide clinicians in treatment decision making for men with erectile dysfunction. Strengths and Limitations: This is the first comprehensive report and disproportionality analysis on all types of AEs associated with PDE5Is used for erectile dysfunction in the United States. The findings should be interpreted cautiously due to limitations in the Adverse Event Reporting System, which includes self-reports, duplicate and incomplete reports, and biases in reporting and selection. Therefore, establishing a causal relationship between the reported AEs and the use of PDE5Is is uncertain, and the data may be confounded by other medications and indications. Conclusion: PDE5Is demonstrate significantly increased risks of reporting certain clinically important AEs. While these events are not common, it is imperative to continually monitor PDE5I use at the levels of primary care to national surveillance to ensure safe utilization.

Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018.

Background: There have been numerous cases of adverse events since the introduction of Essure medical devices for sterilization in 2002. This study analyzed the safety event reports of the Essure reported in the Manufacturer and User Facility Device Experience (MAUDE). Methods: A retrospective analysis examined the MAUDE reports between Jan-1, 2018, and Oct-31, 2018 and focused on safety reports related to the Essure device. Safety reports were categorized and analyzed by their event type, device problem, patients' symptoms and the level of harm. Of this study cohort, 10% of samples were randomly selected for quantitative analyses. Thematic analysis was conducted for reports included death cases. Results: A total of 4,994 eligible reports were analyzed. There were ten reports associated with individuals' deaths, and the main themes of safety reports from qualitative analysis were pains, bleeding, surgery, migraine, and infection. Quantitative analysis of 500 randomly selected samples showed that 98% of adverse event reports were associated with different injuries such as surgery, pain, bleeding, hysterectomy, and menorrhagia. Additionally, more than 90% of reports were submitted by the manufacturer. Conclusion: These findings indicated several safety issues of Essure. More meaningful pre- and post-marketing surveillance and regulation are warranted in the medical device market to ensure safety and effectiveness, including investigating complaints, promptly sharing relevant information with regulators and users, and implementing corrective actions.

Pharmacists' facilitators and barriers to implementing and billing for patient care services: Interviews from the Ohio Medicaid Project.

BACKGROUND: In the past several decades, a growing body of literature is recognizing the benefits of pharmacist-led health care services in improving clinical and economic outcomes. Despite this evidence, pharmacists are not recognized on a federal level as health care providers in the United States. Ohio Medicaid managed care plans began partnering with local pharmacies in 2020 to launch initial programs for implementing pharmacist-provided clinical services. OBJECTIVES: This study aimed to identify barriers and facilitators to implementing and billing for pharmacist-provided services in Ohio Medicaid managed care plan programs. METHODS: This qualitative study interviewed pharmacists involved in the initial programs using a semistructured interview based on the Consolidated Framework for Implementation Research (CFIR). Interview transcripts were coded for thematic analysis. Identified themes were mapped to the CFIR domains. RESULTS: Four Medicaid payors partnered with 12 pharmacy organizations, representing 16 unique sites of care. Interviews were conducted with 11 participants. The thematic analysis found data fit within the 5 domains with 32 total themes. Pharmacists described the implementation process of their services. The primary themes for improvement of implementation process were system integration, payor rule clarity, and patient eligibility and access. The 3 themes that emerged as key facilitators were communication between payors and pharmacists, communication between pharmacist and care teams, and the perceived value of the service. CONCLUSIONS: Payors and pharmacists can work collaboratively to improve patient care opportunities by increasing access with sustainable reimbursement, clear guidelines, and open communication. Continued improvement is needed in system integration, payor rule clarity, and patient eligibility and access.

Development and Validation of Coding Algorithms to Identify Patients with Incident Non-Small Cell Lung Cancer in United States Healthcare Claims Data.

Purpose: We sought to develop and validate an incident non-small cell lung cancer (NSCLC) algorithm for United States (US) healthcare claims data. Diagnoses and procedures, but not medications, were incorporated to support longer-term relevance and reliability. Methods: Patients with newly diagnosed NSCLC per Surveillance, Epidemiology, and End Results (SEER) served as cases. Controls included newly diagnosed small-cell lung cancer and other lung cancers, and two 5% random samples for other cancer and without cancer. Algorithms derived from logistic regression and machine learning methods used the entire sample (Approach A) or started with a previous algorithm for those with lung cancer (Approach B). Sensitivity, specificity, positive predictive values (PPV), negative predictive values, and F-scores (compared for 1000 bootstrap samples) were calculated. Misclassification was evaluated by calculating the odds of selection by the algorithm among true positives and true negatives. Results: The best performing algorithm utilized neural networks (Approach B). A 10-variable point-score algorithm was derived from logistic regression (Approach B); sensitivity was 77.69% and PPV = 67.61% (F-score = 72.30%). This algorithm was less sensitive for patients ≥80 years old, with Medicare follow-up time <3 months, or missing SEER data on stage, laterality, or site and less specific for patients with SEER primary site of main bronchus, SEER summary stage 2000 regional by direct extension only, or pre-index chronic pulmonary disease. Conclusion: Our study developed and validated a practical, 10-variable, point-based algorithm for identifying incident NSCLC cases in a US claims database based on a previously validated incident lung cancer algorithm.

Trends in utilization, reimbursement, and price for DOACs and warfarin in the US Medicaid population from 2000 to 2020.

The use of direct oral anticoagulants (DOACs) is widely increasing in the United States (US). Warfarin has been the conventional anticoagulant used in the past few decades, but it has been gradually replaced by DOACs. The objective of the study was to analyze trends in utilization, reimbursement, and price for those anticoagulants in the US Medicaid population. Retrospective data analysis was conducted using the National Summary Files for the Medicaid State Drug Utilization Data. Study drugs included dabigatran, rivaroxaban, apixaban, edoxaban and warfarin. The study assessed secular trends of utilization, reimbursement, and per-prescription price. The data was collected from the first quarter of 2000 through to the second quarter of 2020 restricted for outpatient prescriptions only. During the 21-year study period, a substantial rise in total expenditures on warfarin and DOACs was observed from $144 million in 2000 to $694 million in 2020. Moreover, the utilization of DOACs has increased significantly since the first approval of Xarelto in 2010 from 1079 in 2011 to 1.5 million in 2019. The per-prescription price of DOACs increased from an average of $200 in 2011 to $407 in 2020. Conversely, the total number of prescriptions of Warfarin and branded Coumadin decreased from 2.4 million to 1.4 million and from 3.9 million to less than a million, respectively. The present study demonstrated a change in the trends of US expenditure and utilization for warfarin and DOACs with DOACs representing the majority of market share of both spending per prescription and reimbursement.

Assessment of pharmacy technician job satisfaction and duties in ambulatory care pharmacy settings: A mixed-methods analysis.

PURPOSE: Expansion of pharmacy services into ambulatory care has prompted the integration of pharmacy technicians into this setting. Many models exist for technician practice in ambulatory care, and job satisfaction in these settings needs evaluation. This study assessed the job satisfaction of ambulatory care pharmacy technicians, obtained a deeper understanding of their varied roles, and examined commitment to the pharmacy technician career and their employing organization. METHODS: This study used a mixed-methods sequential explanatory design of quantitative followed by qualitative data analysis. The phases included a validated questionnaire on job satisfaction and semistructured interviews using a modified guide and findings from the quantitative data. Descriptive statistics and constant comparative analysis were used to analyze quantitative and qualitative data, and data were integrated in the discussion. RESULTS: The questionnaire was sent to 125 potential participants at 11 organizations in 8 unique states. Seventy-four technicians participated in the quantitative phase. Seventeen of these were interviewed in the qualitative phase. Interviewees represented 7 different institutions in 6 states in the Southeast, Midwest, and Western regions of the US. Both phases indicated that respondents felt a strong commitment to their organization, with 60% of respondents indicating this on the questionnaire. Reasons for this commitment were further elucidated in the qualitative phase, which indicated high satisfaction with technician autonomy, work schedules, and ability to provide important services to patients. It was also found in both phases that technician duties varied greatly among organizations, although most technicians were involved in facilitating medication access. CONCLUSION: Ambulatory care pharmacy technicians are highly satisfied with their positions and careers. Although technician roles vary within ambulatory care settings, the majority involve facilitating medication access in various ways. As these positions become more prevalent in pharmacy practice, it will be important to continue to capitalize on satisfiers and mitigate dissatisfiers to advance the profession and ultimately provide optimal patient care.

The Utilization, Expenditure, and Price of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers in the US Medicaid Programs: Trends Over a 31 Year Period.

BACKGROUND: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) are used for several indications including hypertension. Our aim is to evaluate the utilization, expenditure, and drug price of ACEIs and ARBs in the US Medicaid population. METHODS: A retrospective descriptive trend analysis was conducted using Medicaid State Drug Utilization outpatient pharmacy summary files managed by the Centers for Medicare and Medicaid Services from 1991 to 2021. Study drugs included ACEIs (e.g., captopril) and ARBs (e.g., losartan). Annual reimbursement and utilization were calculated for both classes. The average reimbursement per prescription was calculated as a proxy for drug prices. Market share competition between ACEIs and ARBs was analyzed over time. RESULTS: ACEI and ARB utilization rose by 25% from 1991 to 2021. Brand ACEIs utilization peaked in 2002 with 28 million prescriptions while brand ARBs utilization continued to increase until 2005 with over 23 million prescriptions. However, generic products took the lead and exceeded brand ACEI and ARB utilization in 2006 and 2012 respectively. Medicaid spent over $ 33.7 billion on ACEIs and ARBs over 31-year. Brand ACEIs and ARBs average prices increased sharply to $8,104 and $6,908 respectively in 2021. The total prescription market share for ACEIs was 68% compared to 32% of ARBs over the entire study. CONCLUSION: ACEIs and ARBs utilization increased over the last 31 years. Brand utilization switched over to generic resulting in less reimbursement. The average prices of brand ACEIs and ARBs continue to increase even after generics were introduced to the market.

Characterization of doctor of pharmacy/health informatics dual degrees in the United States.

INTRODUCTION: Health care is trending towards an increasing reliance on data management, technology, analytics, and automation which is also reflected in pharmacy education. This study aimed to identify and characterize doctor of pharmacy (PharmD)/master of science in health informatics (MSHI) dual-degree offerings at pharmacy institutions within the United States (US). METHODS: A list of PharmD/MSHI programs was obtained from the American Association of Colleges of Pharmacy and the Pharmacy College Application Service. Furthermore, websites of the 143 accredited schools and colleges of pharmacy in the US were inspected to identify additional PharmD/MSHI dual degrees not identified with the previous sources and to verify that the dual degree was being actively offered at each institution. A 26-item questionnaire focusing on program structure, admissions, and output was developed and administered to program representatives via phone interview. Descriptive statistics were calculated. RESULTS: Thirteen schools offering a PharmD/MSHI dual degree were identified, of which 10 participated (response rate = 77%). All programs were created within the last 10 years. Programs were similar in terms of admission requirements such as grade point average thresholds and standardized testing. Variances existed in program structure and output, such as accreditation status and number of enrollees/graduates. CONCLUSIONS: Although health informatics has become more prominent in health care, health informatics education is not yet as pervasive in the pharmacy field. The information collected may be useful for schools considering implementing or modifying their own dual degree program or for students who are interested in health informatics-specialized educational opportunities.

The effect of polypharmacy on quality of life in adult patients with nonalcoholic fatty liver disease in the United States.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is a significant epidemiological problem with rising prevalence. Due to limited literature, the objective of this study is to examine the association between polypharmacy and health-related quality of life (QoL) in NAFLD adult patients. METHODS: A retrospective observational study design was conducted to analyze health data collected by Steatohepatitis Clinical Research Network (NASH CRN). Patients were classified as receiving a polypharmacy therapy with five or more medications in their first screening visit. QoL was measured using the Short Form 36 (SF-36) instrument. Each patient self-reported the SF-36 form during the screening visit was compared between polypharmacy and non-polypharmacy groups using Wilcoxon Rank Sum test. Multivariable generalized linear models and multinomial logistic regression were performed to examine each predictor and its effect on QoL. RESULTS: Data included 1067 NAFLD adult patients; 834 patients used polypharmacy. The mean age was 48.64 years, and most patients were female (62%). Comparing NAFLD patients without steatohepatitis, borderline NASH, and definite NASH, the non-polypharmacy group had a significantly higher QoL than the polypharmacy group in Physical Component Summary (PCS) (86.25 vs 66.88, 85 vs 67.5, and 79.375 vs 63.12, respectively, all p < 0.01) and Mental Component Summary (MCS) (83.5 vs 73.38, 78.75 vs 67.62, and 78.75 vs 70.65, respectively, all p < 0.01). DISCUSSION AND CONCLUSION: Adults with NAFLD and polypharmacy have lower QoL than adults with NAFLD and non-polypharmacy. Number of medications had a significant negative impact on PCS, MCS, and all SF-36 domains except mental health, role physical limitation and role emotional limitation domains. Other factors that affect QoL negatively in NAFLD adult patients are female gender, obesity, diabetes, depression, and unemployment. Higher income had favorable effect on QoL.

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020.

Background Obesity is a globally growing health problem, and its treatment has been challenging. The use of anti-obesity medications (AOMs) has been associated with severe adverse events (AEs). Several AOMs have been withdrawn from the market owing to documented AEs. Aim To describe, estimate and characterize the frequency of AEs attributable to the use of the AOMs, and investigate previously unreported potential AEs associated with AOMs. Method Using the US FDA Adverse Event Reporting System (FAERS) between January 2013 and June 2020, a retrospective, descriptive analysis was conducted to analyze all major reported AEs and outcomes including death, life-threatening, hospitalization, disability, and required intervention or congenital anomaly. The total numbers of AEs reports, cases, adverse reactions and outcomes were calculated for each medication. Results A total of 18,675 unique AEs reports associated with AOMs used for 15,143 patients. The mean age was 49.8 years [SD 1.83], while most patients were female adults (73.4%). The most frequently reported AEs were nausea and vomiting, followed by dizziness and headache, drug ineffectiveness, cardiovascular diseases, and kidney complications. There were 21,229 unique outcomes, including 1039 deaths (fatality ratio of 4.9% of all analyzed reports), 1613 (7.6%) life-threatening events, 7426 (35%) hospitalizations, and 1249 (5.9%) disability cases. Phentermine/topiramate fatal cases represent 6% of the overall medication's reported AEs. Cardiovascular AEs represented 31%, 23%, and 22% of phentermine, liraglutide, and phentermine/topiramate total AEs, respectively. Conclusion The analysis of FAERS database revealed numerous serious AEs associated with AOMs. These AEs can lead to serious cardiovascular and kidney complications. It is necessary to continue and systematically monitor safety of AOMs' to optimize patient anti-obesity therapy.

Physician-approved protocols increase naloxone dispensing rates.

OBJECTIVE: To measure the impact of the implementation of a law that allows pharmacists to provide naloxone under a physician-approved protocol on naloxone dispensing rates in an all-payer population across the United States. METHODS: Prescription claims from a national grocery chain for 31 states and Area Heath Resource File were used for this retrospective study. The study sample included all patients who filled at least one naloxone prescription during the study period from July 16, 2014 to January 16, 2017. A stepwise autoregression was performed for 30 consecutive months to evaluate the change in naloxone prescription dispensing rate. The primary independent variable was "implementation of the physician-approved protocol." The primary outcome measure was the rate of naloxone prescriptions dispensed per month per state. Secondary outcome measures were naloxone dispensing rates by each payer. RESULTS: Number of patients who received naloxone prescriptions in the states with physician-approved protocol was 423% higher compared to states without the protocol. The overall model showed that the naloxone dispensing rate was 6 times higher in the states with a physician-approved protocol. In the payer-based models, comparing states with and without protocol, the dispensing rate was highest for Medicare (9.0 times) followed by Private (4.6 times), Medicaid (3.2 times), and Cash (3.1 times). The number of prescriptions dispensed in the low-employment states with the protocol was 17.59 times higher compared to states without the protocol. CONCLUSIONS: Implementation of physician-approved protocol was strongly associated with an increase in naloxone dispensing rates, especially in the low-employment states.

Safety and cost-effectiveness of ponatinib versus other tyrosine kinase inhibitors as second-line therapy in patients with chronic myeloid leukemia in the United States.

To evaluate the cost-effectiveness of ponatinib compared with second-line TKIs in the treatment of adult patients with CML who failed, or were intolerant to, first-line TKIs. A Markov state transition model was conducted. Model transition, adverse-effect probabilities, utility data and medical costs were obtained from clinical trials and literature. Measurements included medications, follow-ups, adverse events, allogeneic stem cell transplantation and quality-adjusted life years (QALYs). Univariable and Bayesian multivariable probabilistic sensitivity analyses were conducted using Monte Carlo simulations. Dasatinib resulted in an ICER of $79,086/QALY compared to nilotinib. Ponatinib yielded an ICER of $176,278/QALY and $141,563/QALY compared to dasatinib and nilotinib, respectively. Dasatinib was the optimal treatment at a $100,000/QALY threshold. The probability (36%-40%) for ponatinib or dasatinib optimal treatment was associated with thresholds of $160,000-$180,000/QALY. Dasatinib and ponatinib can be considered cost-effective options and provide clinical benefits compared to other second-line TKIs for CML in the US.

Comparative effectiveness and persistence of TNFi and non-TNFi in juvenile idiopathic arthritis: a large paediatric rheumatology centre in the USA.

OBJECTIVE: To evaluate the persistence and effectiveness of TNF inhibitors (TNFi) vs non-TNFi among newly diagnosed JIA patients after initiation of biologic DMARD (bDMARD). METHODS: Using longitudinal patient-level data extracted from electronic medical records in a large Midwestern paediatric hospital from 2009 to 2018, we identified JIA patients initiating TNFi and non-TNFi treatment. Treatment effectiveness was assessed based on disease activity. Inverse probability of treatment weighting of propensity score was used to estimate the treatment effectiveness and Kaplan-Meier analyses were conducted to assess persistence. RESULTS: Of 667 JIA patients, most (92.0%) were prescribed one of the class of TNFi as their initial biologic treatment. Etanercept was the most frequently prescribed (67.1%) treatment, followed by adalimumab (27.5%). Only around 5% of patients were prescribed off-label bDMARDs as their first-course treatment; however, >20% were prescribed off-label biologics as their second-course therapy. Some 7.2% of patients received four or more bDMARDs. The median persistence of the first-course bDMARD is 320 days, with TNFi being significantly longer than the non-TNFi (395 vs 320 days, P = 0.010). The clinical Juvenile Disease Activity Score (cJADAS) reduction of TNFi users (6.6, 95% CI 5.7, 7.5) was significant greater compared with non-TNFi users (3.0, 95% CI 1.5, 4.6, P < 0.0001) at 6-month follow-up visit. CONCLUSION: Persistence was significantly longer among patients initiating TNFi as their first biologic therapy than those receiving non-TNFi. Patients receiving TNF therapy had significant greater reduction of cJADAS at the 6-month follow-up visit compared with patients in the non-TNF cohort.