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.

Themes, Rates, and Risk of Adverse Events of the Artificial Pancreas in the United States Using MAUDE.

Three manufacturers sell artificial pancreas systems in the United States for management of Type 1 Diabetes. Given the life-saving task required of an artificial pancreas there needs to be a high level of trust and safety in the devices. This evaluation sought to find the adjusted safety event reporting rate and themes along with device-associated risk in events reported utilizing the MAUDE database. We searched device names in the MAUDE database over the period from 2016 until August 2023 (the date of retrieval). Thematic analysis was performed using dual-reviewer examination with a 96% concurrence. Relative risk (RR) was calculated for injury, malfunction, and overall, for each manufacturer, as well as adjusted event rate per manufacturer. Most events reported related to defects in the manufacturing of the casing materials which resulted in non-delivery of therapy. Tandem Diabetes Care, Inc. had an adjusted event rate of 50 per 100,000 units and RR of 0.0225. Insulet had an adjusted event rate of 300 per 100,000 units and RR of 0.1684. Medtronic has an adjusted event rate of 2771.43 per 100,000 units and RR of 20.7857. The newer Medtronic devices show improvements in likely event rate. While the artificial pancreas is still in its infancy, these event rates are not at an acceptable level for a device which can precipitate death from malfunctions. Further exploration into safety events and much more research and development is needed for devices to reduce the event rates. Improved manufacturing practices, especially the casing materials, are highly recommended. The artificial pancreas holds promise for millions but must be improved before it becomes a true life-saving device that it has the potential to become.

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.

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.

Application of Pharmacogenomics Testing in a Community-based Facility.

This study was designed to examine the use of pharmacogenomics (PGx) testing in a community-based facility, the adoption of the PGx recommendations by providers, and assess challenges and opportunities for pharmacists in using PGx testing in a real-world setting. This was a retrospective study involving chart reviews of 137 patients with mood disorders who underwent PGx testing between September 2017 and December 2017. Eighty-seven patients who met inclusion and exclusion criteria were analyzed to evaluate the impact of PGx testing on psychotropic medication treatment and to evaluate the PGx test process. PGx test results were used by providers to guide their therapeutic modifications based on the gene-drug interactions identified. Patient medication use increased from 125 to 190 (P < .001) prescriptions. Patient medication belonging to no gene-drug interaction significantly increased from 46.4% to 87.4% (P < .001), medications belonging to moderate and significant gene-drug interaction decreased from 32.8% to 7.9% (P < .001) and 11.2% to 2.1% (P = .012), respectively. 88.5% of patients' psychotropic medication treatment after PGx testing was consistent with the PGx test report recommendations. The PGx test lengths of time analysis indicated that patient follow-up exceeded the standard time set by guidelines at multiple steps in the test process. There are multiple opportunities for pharmacists to become involved in the PGx testing process to improve patient care.

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.

Developing an Integrated Electronic Medication Reconciliation Platform and Evaluating its Effects on Preventing Potential Duplicated Medications and Reducing 30-Day Medication-Related Hospital Revisits for Inpatients.

The aims were to develop an integrated electronic medication reconciliation (ieMR) platform, evaluate its effects on preventing potential duplicated medications, analyze the distribution of the potential duplicated medications by the Anatomical Therapeutic and Chemical (ATC) code for all inpatients, and determine the rate of 30-day medication-related hospital revisits for a geriatric unit. The study was conducted in a tertiary medical center in Taiwan and involved a retrospective quasi pre-intervention (July 1-November 30, 2015) and post-intervention (October 1-December 31, 2016) study design. A multidisciplinary team developed the ieMR platform covering the process from admission to discharge. The ieMR platform included six modules of an enhanced computer physician order entry system (eCPOE), Pharmaceutical-care, Holistic Care, Bedside Display, Personalized Best Possible Medication Discharge Plan, and Pharmaceutical Care Registration System. The ieMR platform prevented the number of potential duplicated medications from pre (25,196 medications, 2.3%) to post (23,413 medications, 3.8%) phases (OR 1.71, 95% CI, 1.68-1.74; p < .001). The most common potential duplicated medications classified by the ATC codes were cardiovascular system (28.4%), alimentary tract and metabolism (26.4%), and nervous system (14.9%), and by chemical substances were sennoside (12.5%), amlodipine (7.5%), and alprazolam (7.4%). The rate of medication-related 30-day hospital revisits for the geriatric unit was significantly decreased in post-intervention compared with that in pre-intervention (OR = 0.12; 95% CI, 0.03-0.53; p < .01). This study indicated that the ieMR platform significantly prevented the number of potential duplicated medications for inpatients and reduced the rate of 30-day medication-related hospital revisits for the patients on the geriatric unit.

The impact of using an intravenous workflow management system (IVWMS) on cost and patient safety.

PURPOSE: The aim of this study was to determine the financial costs associated with wasted and missing doses before and after the implementation of an intravenous workflow management system (IVWMS) and to quantify the number and the rate of detected intravenous (IV) preparation errors. METHOD: A retrospective analysis of the sample hospital information system database was conducted using three months of data before and after the implementation of an IVWMS System (DoseEdge®) which uses barcode scanning and photographic technologies to track and verify each step of the preparation process. The financial impact associated with wasted and missing >IV doses was determined by combining drug acquisition, labor, accessory, and disposal costs. The intercepted error reports and pharmacist detected error reports were drawn from the IVWMS to quantify the number of errors by defined error categories. RESULTS: The total number of IV doses prepared before and after the implementation of the IVWMS system were 110,963 and 101,765 doses, respectively. The adoption of the IVWMS significantly reduced the amount of wasted and missing IV doses by 14,176 and 2268 doses, respectively (p < 0.001). The overall cost savings of using the system was $144,019 over 3 months. The total number of errors detected was 1160 (1.14%) after using the IVWMS. CONCLUSION: The implementation of the IVWMS facilitated workflow changes that led to a positive impact on cost and patient safety. The implementation of the IVWMS increased patient safety by enforcing standard operating procedures and bar code verifications.

Applying Lean Techniques to Reduce Intravenous Waste Through Premixed Solutions and Increasing Production Frequency.

BACKGROUND: This study aims to use lean techniques and evaluate the impact of increasing the use of premixed IV solutions and increased IV production frequency on IV waste. METHODS: Study was conducted at a tertiary hospital pharmacy department in three phases. Phase I included evaluation of IV waste when IV production occurred three times a day and eight premixed IV products were used. Phase II increased the number of premixed IV products to 16. Phase III then increased IV production to five times a day. RESULTS: During Phase I, an estimate of 2,673 IV doses were wasted monthly, accounting for 6.14% of overall IV doses. This accounted for 688 L that cost $60,135. During Phase II, the average monthly IV wastage reduced significantly to 1,069 doses (2.84%), accounting for 447 L and $34,003. During Phase III, the average monthly IV wastage was further decreased to 675 doses (1.69%), accounting for 78 L and $3,431. Hence, a potential annual saving of $449,208 could result from these changes. CONCLUSION: IV waste was reduced through the increased use of premixed solutions and increasing IV production frequency.

Risk factors for i.v. compounding errors when using an automated workflow management system.

PURPOSE: Results of a study to determine the frequency of and risk factors for errors in automated compounding of i.v. medication doses at a pediatric hospital are presented. METHODS: Data compiled by the hospital's automated i.v. compounding workflow management system over a 12-month period were analyzed. A descriptive analysis was conducted to characterize intercepted errors by frequency and type. Multivariate regression analysis via a backward stepwise procedure was performed to identify notable risk factors for i.v. compounding errors. RESULTS: Among the 421,730 i.v. doses evaluated, there were 3,101 documented errors (an overall error rate of 0.74%). The automated system intercepted 72.27% of the errors, mainly those containing an incorrect drug or diluent. The remaining 27.73% of i.v. compounding errors, primarily dose preparation in the wrong volume (21.51%) or damage to the final product (0.93%), were identified during final inspection by a pharmacist. The logistic regression model showed that four factors were significantly (p < 0.05) associated with an increased risk of compounding errors: dose preparation during the morning shift (relative risk [RR], 1.84; 95% CI, 1.68-2.02) or on a Sunday (RR, 1.28; 95% CI, 1.11-1.47), preparation of doses for use in critical care units (RR, 1.17; 95% CI, 1.07-1.28), and technician versus pharmacist compounding (RR, 1.17; 95% CI, 1.04-1.32). CONCLUSION: Analysis of error reports generated by an i.v. compounding workflow management system at a large pediatric hospital over one year found an overall rate of detected errors of 0.74%. Four factors were identified as significant predictors of increased error risk.

Does the Elderly's Number of Prescribed Medications across Months Matter? National Cohort versus Single-Center Cohort.

OBJECTIVES: To investigate the monthly number of prescribed medication (NPM) patterns among different elderly populations and the factors associated with monthly NPM changes. METHODS: This retrospective cohort study was conducted using the databases obtained from National Health Insurance Research Databases and a 2000-bed academic medical center in Taiwan (i.e., single-center cohort). We compared the monthly NPMs, demographic characteristics, disease states, and health care contacts among the National Health Insurance elderly cohorts in 2006 and 2007, and for those elderly in the national and single-center cohorts who had outpatient visits from November to October in 2006 to 2007 and 2007 to 2008, respectively. Generalized estimating equation analyses of repeated measures were performed for monthly NPMs. RESULTS: The average monthly NPMs among the National Health Insurance elderly cohort was 2.33 in 2006 and 4.39 in 2007, respectively. After controlling for other factors, the increment in the proportion of monthly NPMs among the older elderly patients, in certain months and for those patients with hypertension and dyslipidemia, was statistically significant among the single-center cohort but was not observed in the national elderly cohort. The proportional changes decreased significantly among patients who made visits to emergency rooms and who were hospitalized during a 1-year period. CONCLUSIONS: There was an incremental trend of monthly NPMs among the national cohort from 2006 to 2007. Although acute exacerbations and hospitalization might be the protecting factors of increasing monthly NPMs, more attention should be paid toward high-utilization patients with specific diseases during certain months for different elderly cohorts.

Utilization, spending, and price trends for short- and long-acting Beta-agonists and inhaled corticosteroids in the medicaid program, 1991-2010.

BACKGROUND: Asthma is a chronic respiratory disease that afflicts millions of people and accounts for substantial utilization of healthcare resources in most industrialized countries, including in the United States. However, the exact cost and utilization of anti-asthma medications in Medicaid in the past 2 decades have not been well studied. Considering the safety issues surrounding the long-acting beta-agonists, guideline updates, and the increase in asthma prevalence, understanding anti-asthma medication prescribing trends is important to payers and patients. GOAL: The purpose of this study was to analyze the utilization and spending trends for anti-asthmatic agents in the US Medicaid program over the past 2 decades. METHODS: This study was based on a retrospective, descriptive analysis of trends in utilization of and spending on anti-asthma medications, including short-acting beta-agonists, inhaled corticosteroids, long-acting beta-agonists, and inhaled corticosteroid/long-acting beta-agonist combinations. Quarterly utilization and expenditure data were obtained from the national Medicaid pharmacy files provided by the Centers for Medicare & Medicaid Services from quarter 1 of 1991 through quarter 2 of 2010. Average reimbursement per prescription was calculated each quarter as a proxy for drug price. RESULTS: The total number of prescriptions for the studied anti-asthma medications rose from 8.9 million in 1991 to 15.6 million in 2009, peaking at 20.8 million in 2005, the year before Medicare and Medicaid dual-eligible beneficiaries were moved to Medicare Part D. From 1991 to 2009, Medicaid spending on anti-asthma medications overall rose from $180.7 million to $1.3 billion, and spending on inhaled corticosteroid/long-acting beta-agonist combinations rose from $52.8 million in 2001-their first year on the market-to $411.7 million in 2009. The average price per prescription has risen in all the anti-asthma drug classes: overall, spending per prescription has increased 4-fold between 1991 and 2009, significantly faster than the consumer price index (57.5%) over the same period. In quarter 2 of 2010, Medicaid spent more on the combination medication fluticasone-salmeterol-$60 million-than on any other anti-asthma medication. CONCLUSION: Anti-asthma medications are a major and growing expense for state Medicaid programs and can be expected to be the same for Medicare Part D in the future. Increased disease prevalence has in part contributed to the rise in pharmacotherapy cost. Nevertheless, drug therapy is crucial for managing asthma and asthma exacerbations.

Effect of a robotic prescription-filling system on pharmacy staff activities and prescription-filling time.

PURPOSE: The effects of using an automated prescription-filling system, the ScriptPro SP-200, in an independent pharmacy were evaluated. METHODS: The study was conducted at Punches Pharmacy Plus, an independent pharmacy located in Clare, Michigan. The study design was a preinstallation and postinstallation assessment of the ScriptPro SP-200 automated prescription-filling system. Videotaping and work sampling techniques were used to collect the preinstallation and postinstallation data of the ScriptPro SP-200. The use of the pharmacy staff and the time spent in direct and indirect prescription- filling activities, such as receiving, order entry, filling, inspecting, packaging, dispensing, phone calls, and inventory management, were measured and compared preinstallation and postinstallation. RESULTS: With the installation of automation, the percentage of time spent by the pharmacy staff significantly changed (p < 0.001). Meanwhile, there was a statistically significant difference in terms of the percentages of time spent on various activities between the preinstallation and postinstallation of automation (p < 0.001). Before installation of automation, the direct and indirect prescription-filling times used were 6.07 and 2.11 minutes, respectively, to fill one prescription. Analyses of the average time spent per prescription showed that the installation of automation could save nearly 0.22 minute per prescription, especially filling time per prescription-which was significantly decreased from 2.63 to 2.07 minutes with an average of 0.56 minute saved (p < 0.05). CONCLUSION: An automated system reduced prescription-filling time but required staffing adjustments to optimize the efficiency gained.