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.

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.

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.

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.

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.

Drug Expenditure, Price, and Utilization in the U.S. Medicaid: A Trend Analysis for SSRI and SNRI Antidepressants from 1991 to 2018.

BACKGROUND: SSRIs and SNRIs are antidepressants that have largely substituted old antidepressants like Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs). They have been widely used since 1987 when the FDA approved the first SSRI Fluoxetine and the first SNRI Venlafaxine in 1993. Since then, several new SSRIs and SNRIs have been approved and entered the market. Utilization, pricing, and spending trends of SSRIs and SNRIs have not been analyzed yet in Medicaid. AIM: To assess the trends of drug expenditure, utilization, and price of SSRI and SNRI antidepressants in the US Medicaid program, and to highlight the market share of SSRIs and SNRIs and the effect of generic drug entry on Medicaid drug expenditure. METHODS: A retrospective descriptive data analysis was conducted for this study. National pharmacy summary data for study brand and generic drugs were retrieved from the Medicaid State Outpatient Drug Utilization Data. These data were collected by the US Centers for Medicare and Medicaid Services (CMS). The study period was between 1991 and 2018. Study drugs include 12 different SSRI and SNRI brands and their generics available in the market, such as citalopram, escitalopram, paroxetine, fluoxetine, sertraline, venlafaxine, desvenlafaxine, duloxetine, and levomilnacipran. Data were analyzed annually and categorized by total prescriptions (utilization), total reimbursement (spending), and cost per prescription as the proxy of the price for each drug. RESULTS: From 1991 to 2018, total prescriptions of SSRI and SNRI drugs rose by 3001%. Total Medicaid spending on SSRIs and SNRIs increased from USD 64.5 million to USD 2 billion in 2004, then decreased steadily until it reached USD 755 million in 2018. The SSRIs average utilization market share was 87% compared to 13% of the SNRIs utilization market share. About 72% of total Medicaid spending on the two groups goes to SSRIs, while the remaining 28% goes to SNRIs. Brand SSRIs and SNRIs prices increased over time. On the contrary, generic drugs prices steadily decreased over time. DISCUSSION: An increase in utilization and spending for both SSRI and SNRI drugs was observed. After each generic drug entered the market, utilization shifted from the brand name to the respective generic due to their lower price. These generic substitutions demonstrate a meaningful cost-containment policy for Medicaid programs. IMPLICATIONS FOR HEALTH POLICIES: Our findings show the overall view of Medicaid expenditure on one of the most commonly prescribed drug classes in the US. They also provide an important insight toward the antidepressant market and the importance of monitoring different drugs and their alternatives.

Continuous quality improvement regulations for community pharmacy practice in the United States.

OBJECTIVES: In the United States, medication errors are considered to be the cause of 7000 deaths annually. Continuous quality improvement (CQI) is a management process that focuses on continually and systematically evaluating the organization's work process. In community pharmacy, CQI leads to enhanced patient safety through a reduction in medication errors and quality-related events (QREs). There is limited information about the variations in CQI regulations required by State Boards of Pharmacy (SBPs) for community pharmacy across the country. The objective of this study is to comprehensively describe CQI regulations required by SBPs for community pharmacy practice in the United States. METHODS: This was a cross-sectional study. Information regarding SBPs community pharmacy CQI regulations was collected electronically by surveying a representative of each SBP. In addition, a review of State Pharmacy Laws published online complemented the survey data. The percentage of states with CQI regulations for community pharmacy was estimated. RESULTS: Of the 50 Boards, 16 require pharmacies to maintain CQI programs to monitor and prevent QREs in community pharmacy. The most common elements of CQI programs include the management of known, alleged, and suspected medication errors that reach the patient (73%) and regular reviews of the pharmacy's aggregate data of medication errors or incidents (73%). The North Dakota SBP regulation is the most comprehensive, followed by that of Iowa, Maryland, Massachusetts, and Montana. CONCLUSION: There is wide variation among SBP CQI regulations for community pharmacy practice. Standardization of CQI programs across Boards, including a national database for reporting medication errors and QREs would enhance patient safety.

Healthcare services expenditures among prostate cancer patients with and without mood disorders in the United States: A propensity score-matched cross-sectional study.

OBJECTIVES: To compare the averages of healthcare services utilization and of expenditures for men with prostate cancer with and without diagnoses of mood disorders applying propensity score matching (PSM), and to identify the potential predictors associated with increased healthcare expenditures. DESIGN: Cross-sectional study. SAMPLE AND METHODS: A total of 308,602 weighted patients with prostate cancer were identified after applying PSM. The datasets for men with prostate cancer were extracted from the Medical Expenditure Panel Survey (MEPS) from 2010 to 2015. For cohort formation, 1:1 PSM was applied. Healthcare utilization and expenditures analyzed included emergency room visits, length of stay for hospital inpatients, outpatient visits, office-based visits, and prescriptions. Generalized linear model with gamma distribution and log link was used to determine which covariates are associated with the increase in healthcare expenditures for each healthcare service. FINDINGS: The mean expenditures for emergency room visits between men with prostate cancer and mood disorders was $3,092.34, and it was $1,330.64 for patients without mood disorders (p = 0.038). The weighted total expenditures for emergency room visits in prostate cancer patients with mood disorders is 57% higher (p = 0.0109). Moreover, the weighted total expenditures for outpatient visits in prostate cancer patients with mood disorders is 93% higher (p = 0.0001). The potential predictor in total healthcare expenditures is perceived health status (fair/poor) (p = 0.0066). CONCLUSIONS AND IMPLICATIONS FOR PSYCHOSOCIAL PROVIDERS OR POLICY: Individuals with a diagnosis of mood disorders were found to have higher average healthcare expenditures in emergency room visits than those without mood disorders. Therefore, the implications of this study are to inform the patient care team that the assessment and management of mood disorders is a priority. Moreover, screening of mood- disorder symptoms should occur early to optimize care. Finally, policymakers should provide accessible care to minimize emergency room visits.

Development and validation of coding algorithms to identify patients with incident lung cancer in United States healthcare claims data.

PURPOSE: Our aim was to develop and validate a practical US healthcare claims algorithm for identifying incident lung cancer that improves on positive predictive value (PPV) and sensitivity observed in past studies. METHODS: Patients newly diagnosed with lung cancer in Surveillance, Epidemiology, and End Results (SEER) (gold standard) were linked with Medicare claims. A 5% Medicare "other cancer" sample and noncancer sample served as controls. A split-sample validation approach was used. Rules-based, regression, and machine learning models for developing algorithms were explored. Algorithms were developed in the model building subset. Rules-based algorithms and those with the highest F scores were evaluated in the validation subset. F scores were compared for 1000 bootstrap samples. Misclassification was evaluated by calculating the odds of selection by the algorithm among true positives and true negatives. RESULTS: A practical single-score algorithm derived from a logistic regression model had sensitivity = 78.22% and PPV = 78.50% (F score: 78.36). The algorithm was most likely to misclassify older patients (ages ≥80 years) or with missing data in the SEER registry, shorter follow-up time in Medicare (<3 months), insurance through Veterans Affairs, >1 cancer in SEER, or certain Charlson comorbidities (dementia, chronic pulmonary disease, liver disease, or myocardial infarction). CONCLUSION: In this dataset, a practical point-based algorithm for identifying incident lung cancer demonstrated significant and substantial improvement (7.9% and 23.9% absolute improvement in sensitivity and PPV, respectively) compared with a current standard.

Implementation of a protocol-driven pharmacy technician refill process at a large physician network.

OBJECTIVES: To describe the implementation of a centrally located certified pharmacy technician (CPhT) team to streamline the process of approving medication refills for chronic disease state management within a multisite physician network. SETTING: Primary care (PC) offices within a large physician network. PRACTICE DESCRIPTION: Incoming medication refill requests from patients and community pharmacies were typically received at each PC office and processed by medical assistants, nurses, or providers. PRACTICE INNOVATIONS: A centralized team of CPhTs managed medication refill requests for 9 PC offices. Standardized protocols for 14 drug classes were built into the electronic medical record (EMR) system. Incoming medication refills were shifted from PC offices to the centrally located CPhT team. EVALUATION: The implementation process was assessed through pharmacists' random audits and feedback from providers, office staff, and patients. Refill reports from January 2020 through March 2020 were obtained. Refill requests' characteristics were summarized and evaluated to determine the volume of refill requests, approved or denied requests, and requests requiring further PC staff analysis. RESULTS: Changes to the protocol process and EMR documentation included modifying or removing laboratory test value parameters, adjusting "grace period" refill quantity on the basis of the scheduled office visit date, and expanding the CPhT role to include communicating with patients and pharmacies regarding denied refills. Data showed that the CPhT team processed 81.7% of all refill requests. This averaged 215 requests per CPhT per day. Of the refill requests approved, 22.5% passed the protocol for the maximum quantity and refills permitted, and 17.3% were granted grace supplies until office visit protocol criteria were met. CONCLUSION: A CPhT team processed 81% of the medication refill requests for 9 PC offices with institution-approved EMR protocols and ambulatory pharmacist supervision. There were many barriers identified and addressed, but through continuous evaluation the workflow and protocol continue to improve.

Appointment-based models: A comparison of three model designs in a large chain community pharmacy setting.

OBJECTIVES: To compare the effects of 3 different appointment-based model (ABM) designs on medication adherence and medication use outcomes controlling for patient and pharmacy characteristics. METHODS: This study was a retrospective cohort analysis in a large grocery store chain from January 1, 2012, to October 31, 2015. A total of 500 comparison and 613 intervention patients in 3 different model designs were analyzed. The outcome measures were proportion of days covered for selected medication classes, number of fills, administered vaccinations, number of trips, statin use in persons with diabetes, use of high-risk medications in older adults, and medication therapy for persons with asthma. RESULTS: After adjusting for relevant covariates, the authors found that all of the ABM designs significantly increased the number of fills after enrollment. Model designs 1 and 3 also significantly reduced the number of trips after enrollment: 4.5 fewer trips (95% CI -5.3 to -3.8; P < 0.05) for model 1 and 1.9 fewer trips (95% CI -3 to -0.9; P < 0.05) for model 3. Models 1 and 3 increased the percentage of patients considered to be adherent for diabetes medications and increased the number of vaccinations patients received. Models 1 and 2 significantly increased the percentage of patients considered to be adherent for statins. No model design was significantly associated with statin use in diabetes, high-risk medication use in older adults, nor percentage of patients considered to be adherent for the hypertension measure. CONCLUSION: All of the ABM designs were effective at increasing the number of fills after enrollment. This paralleled an increase in percentage of patients considered to be adherent to diabetes and statin therapies after enrollment. Models that included face-to-face delivery of the appointment and telephonic synchronization, or face-to-face delivery for all components, increased the number of vaccinations that patients received after enrollment and significantly reduced the number of trips a patient made to the pharmacy.

Patient perceptions of a pharmacy star rating model.

OBJECTIVES: To identify patients' understanding of what constitutes a "quality pharmacy" and to obtain their feedback regarding the development and use of the pharmacy star rating model, a pharmacy-specific aggregate performance score based on the Centers for Medicare and Medicaid Services' Medicare Star Rating. DESIGN: Prospective cross-sectional study. SETTING AND PARTICIPANTS: Focus groups were conducted in Arizona, California, Mississippi, Maryland, and the District of Columbia, and one-on-one interviews were conducted in Indiana. Eligible patients were required to routinely use a community pharmacy. MAIN OUTCOME MEASURES: Consumer insights on their experiences with their pharmacies and their input on the pharmacy star rating model were attained. Key themes from the focus groups and interviews were obtained through the use of qualitative data analyses. RESULTS: Forty-nine subjects from 5 states and DC participated in 6 focus groups and 4 one-on-one interviews. Eighty-eight percent of participants reported currently taking at least 1 medication, and 87% reported having at least 1 health condition. The 7 themes identified during qualitative analysis included patient care, relational factors for choosing a pharmacy, physical factors for choosing a pharmacy, factors related to use of the pharmacy star rating model, reliability of the pharmacy star rating model, trust in pharmacists, and measures of pharmacy quality. Most participants agreed that the ratings would be useful and could aid in selecting a pharmacy, especially if they were moving to a new place or if they were dissatisfied with their current pharmacy. CONCLUSION: Pharmacy quality measures are new to patients. Therefore, training and education will need to be provided to patients, as pharmacies begin to offer additional clinical services, such as medication therapy management and diabetes education. The use of the pharmacy star rating model was dependent on the participants' situation when choosing a pharmacy.

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.

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. METHODS: 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: .0008 and OR: 1.592, P value=.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 nonmarried females (OR 0.663, P-value .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.

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 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.

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.

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.