Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy.

While many pregnant individuals use prescription medications, evidence supporting product safety during pregnancy is often inadequate. Existing electronic healthcare data sources provide large, diverse samples of health plan members to allow for the study of medical product utilization during pregnancy, as well as pregnancy, maternal, and infant outcomes. The Sentinel System is a national medical product surveillance system that includes administrative claims and electronic health record databases from large national and regional health insurers. In addition to these data sources, Sentinel develops and maintains a sizeable selection of analytic tools to facilitate epidemiologic analyses in a way that protects patient privacy and health system autonomy. In this article, we provide an overview of Sentinel System infrastructure, including the Mother-Infant Linkage Table, parameterizable analytic tools, and algorithms to estimate gestational age and identify pregnancy outcomes. We also describe past and future Sentinel work that contributes to our understanding of the way medical products are used and the safety of these products during pregnancy.

Triple challenges - Small sample size in both exposure and control groups to scan rare maternal outcomes in a signal identification approach: A simulation study.

There is a dearth of safety data on maternal outcomes after perinatal medication exposure. Data-mining for unexpected adverse event occurrence in existing datasets is a potentially useful approach. One method, the Poisson tree-based scan statistic (TBSS), assumes that the expected outcome counts, based on incidence of outcomes in the control group, are estimated without error. This assumption may be difficult to satisfy with a small control group. Our simulation study evaluated the effect of imprecise incidence proportions from the control group on TBSS' ability to identify maternal outcomes in pregnancy research. We simulated base case analyses with "true" expected incidence proportions and compared these to imprecise incidence proportions derived from sparse control samples. We varied parameters impacting Type I error and statistical power (exposure group size, outcome's incidence proportion, and effect size). We found that imprecise incidence proportions generated by a small control group resulted in inaccurate alerting, inflation of Type I error, and removal of very rare outcomes for TBSS analysis due to "zero" background counts. Ideally, the control size should be at least several times larger than the exposure size to limit the number of false positive alerts and retain statistical power for true alerts.

A Principled Approach to Characterize and Analyze Partially Observed Confounder Data from Electronic Health Records.

Objective: Partially observed confounder data pose challenges to the statistical analysis of electronic health records (EHR) and systematic assessments of potentially underlying missingness mechanisms are lacking. We aimed to provide a principled approach to empirically characterize missing data processes and investigate performance of analytic methods. Methods: Three empirical sub-cohorts of diabetic SGLT2 or DPP4-inhibitor initiators with complete information on HbA1c, BMI and smoking as confounders of interest (COI) formed the basis of data simulation under a plasmode framework. A true null treatment effect, including the COI in the outcome generation model, and four missingness mechanisms for the COI were simulated: completely at random (MCAR), at random (MAR), and two not at random (MNAR) mechanisms, where missingness was dependent on an unmeasured confounder and on the value of the COI itself. We evaluated the ability of three groups of diagnostics to differentiate between mechanisms: 1)-differences in characteristics between patients with or without the observed COI (using averaged standardized mean differences [ASMD]), 2)-predictive ability of the missingness indicator based on observed covariates, and 3)-association of the missingness indicator with the outcome. We then compared analytic methods including "complete case", inverse probability weighting, single and multiple imputation in their ability to recover true treatment effects. Results: The diagnostics successfully identified characteristic patterns of simulated missingness mechanisms. For MAR, but not MCAR, the patient characteristics showed substantial differences (median ASMD 0.20 vs 0.05) and consequently, discrimination of the prediction models for missingness was also higher (0.59 vs 0.50). For MNAR, but not MAR or MCAR, missingness was significantly associated with the outcome even in models adjusting for other observed covariates. Comparing analytic methods, multiple imputation using a random forest algorithm resulted in the lowest root-mean-squared-error. Conclusion: Principled diagnostics provided reliable insights into missingness mechanisms. When assumptions allow, multiple imputation with nonparametric models could help reduce bias.

smdi: an R package to perform structural missing data investigations on partially observed confounders in real-world evidence studies.

Objectives: Partially observed confounder data pose a major challenge in statistical analyses aimed to inform causal inference using electronic health records (EHRs). While analytic approaches such as imputation are available, assumptions on underlying missingness patterns and mechanisms must be verified. We aimed to develop a toolkit to streamline missing data diagnostics to guide choice of analytic approaches based on meeting necessary assumptions. Materials and methods: We developed the smdi (structural missing data investigations) R package based on results of a previous simulation study which considered structural assumptions of common missing data mechanisms in EHR. Results: smdi enables users to run principled missing data investigations on partially observed confounders and implement functions to visualize, describe, and infer potential missingness patterns and mechanisms based on observed data. Conclusions: The smdi R package is freely available on CRAN and can provide valuable insights into underlying missingness patterns and mechanisms and thereby help improve the robustness of real-world evidence studies.

Risk of Arterial and Venous Thrombotic Events Among Patients with COVID-19: A Multi-National Collaboration of Regulatory Agencies from Canada, Europe, and United States.

Purpose: Few studies have examined how the absolute risk of thromboembolism with COVID-19 has evolved over time across different countries. Researchers from the European Medicines Agency, Health Canada, and the United States (US) Food and Drug Administration established a collaboration to evaluate the absolute risk of arterial (ATE) and venous thromboembolism (VTE) in the 90 days after diagnosis of COVID-19 in the ambulatory (eg, outpatient, emergency department, nursing facility) setting from seven countries across North America (Canada, US) and Europe (England, Germany, Italy, Netherlands, and Spain) within periods before and during COVID-19 vaccine availability. Patients and Methods: We conducted cohort studies of patients initially diagnosed with COVID-19 in the ambulatory setting from the seven specified countries. Patients were followed for 90 days after COVID-19 diagnosis. The primary outcomes were ATE and VTE over 90 days from diagnosis date. We measured country-level estimates of 90-day absolute risk (with 95% confidence intervals) of ATE and VTE. Results: The seven cohorts included 1,061,565 patients initially diagnosed with COVID-19 in the ambulatory setting before COVID-19 vaccines were available (through November 2020). The 90-day absolute risk of ATE during this period ranged from 0.11% (0.09-0.13%) in Canada to 1.01% (0.97-1.05%) in the US, and the 90-day absolute risk of VTE ranged from 0.23% (0.21-0.26%) in Canada to 0.84% (0.80-0.89%) in England. The seven cohorts included 3,544,062 patients with COVID-19 during vaccine availability (beginning December 2020). The 90-day absolute risk of ATE during this period ranged from 0.06% (0.06-0.07%) in England to 1.04% (1.01-1.06%) in the US, and the 90-day absolute risk of VTE ranged from 0.25% (0.24-0.26%) in England to 1.02% (0.99-1.04%) in the US. Conclusion: There was heterogeneity by country in 90-day absolute risk of ATE and VTE after ambulatory COVID-19 diagnosis both before and during COVID-19 vaccine availability.

Improving data capture of race and ethnicity for the Food and Drug Administration Sentinel database: a narrative review.

PURPOSE: The U.S. Food and Drug Administration's Sentinel System is a national medical product safety surveillance system consisting of a large multisite distributed database of administrative claims supplemented by electronic health-care record data. The program seeks to improve data capture of race and ethnicity for pharmacoepidemiology studies. METHODS: We conducted a narrative literature review of published research on data augmentation and imputation methods to improve race and ethnicity capture in U.S. health-care systems databases. We focused on methods with limited (five-digit ZIP codes only) or full patient identifiers available to link to external sources of self-reported data. We organized the literature by themes: (1) variation in data capture of self-reported data, (2) data augmentation from external sources of self-reported data, and (3) imputation methods, including Bayesian analysis and multiple regression. RESULTS: Researchers reduced data missingness with high validity for Asian, Black, White, and Pacific Islander racial groups and Hispanic ethnicity. Native American and multiracial groups were difficult to validate due to relatively small sample sizes. CONCLUSIONS: Limitations on accessible self-reported data for validation will dictate methods to improve race and ethnicity data capture. We recommend methods leveraging multiple sources that account for variations in geography, age, and sex.

Use of Electronic Health Record Data for Drug Safety Signal Identification: A Scoping Review.

INTRODUCTION: Pharmacovigilance programs protect patient health and safety by identifying adverse event signals through postmarketing surveillance of claims data and spontaneous reports. Electronic health records (EHRs) provide new opportunities to address limitations of traditional approaches and promote discovery-oriented pharmacovigilance. METHODS: To evaluate the current state of EHR-based medication safety signal identification, we conducted a scoping literature review of studies aimed at identifying safety signals from routinely collected patient-level EHR data. We extracted information on study design, EHR data elements utilized, analytic methods employed, drugs and outcomes evaluated, and key statistical and data analysis choices. RESULTS: We identified 81 eligible studies. Disproportionality methods were the predominant analytic approach, followed by data mining and regression. Variability in study design makes direct comparisons difficult. Studies varied widely in terms of data, confounding adjustment, and statistical considerations. CONCLUSION: Despite broad interest in utilizing EHRs for safety signal identification, current efforts fail to leverage the full breadth and depth of available data or to rigorously control for confounding. The development of best practices and application of common data models would promote the expansion of EHR-based pharmacovigilance.

Early Real-World Data to Assess Benefits and Risks of COVID-19 Vaccines: A Systematic Review of Methods.

Since the authorization of the first COVID-19 vaccines in December 2020, multiple studies using real-world data (RWD) have been published to assess their effectiveness/safety profile. This systematic review aimed to characterize the methods and outcomes of studies using RWD for assessment of COVID-19 vaccines, four months after vaccine approval. MEDLINE and EMBASE were searched to identify published studies until 6 May 2021. Two independent researchers selected relevant publications and extracted data from included studies. The risk of bias was assessed using New-Castle Ottawa tools. After screening 1086 studies, 15 were included. Out of the 15 studies, 12 (80%) followed a cohort design, 8 (53%) were based on USA data, 7 (47%) assessed health care professionals, and 14 articles (93%) assessed the BNT162b2 vaccine. Data sources included institutional databases, electronic health records, and patient-generated data. The primary endpoint mainly described was SARS-CoV-2-infection. Hospitalization and mortality were assessed in 2 studies. For the comparability domain, six studies (40%) had a high risk of bias. A few months after the beginning of COVID-19 vaccination, Real-world Evidence (RWE) provided timely safety surveillance and comparative effectiveness with findings that showed similar findings to Randomized control trial (RCT). Most of the initiatives assessed BNT162b2 and were conducted in the USA and used healthcare workers' data.

TV Advertising, Corporate Power, and Latino Health Disparities.

INTRODUCTION: This study identifies mental health, tobacco prevention, alcohol/beer, food/beverage, pharmaceutical, and other health-related advertisements across Spanish- and English-language TV networks owned by the same parent media company in the U.S. as commercial determinants of health disparities for Latino populations and/or viewers of Spanish-language TV. METHODS: A 3-week composite sample of Telemundo and National Broadcasting Company prime-time TV owned by the same parent media company was randomly drawn from March 31, 2021 to June 12, 2021 in Houston, Texas. A total of 1,593 health-related advertisements were yielded for systematic content analysis. Analyses included intercoder reliability, descriptive and bivariate analysis, and rate ratio and rate difference calculations. RESULTS: Telemundo had significantly more health-adverse and fewer health-beneficial advertisements than National Broadcasting Company. Telemundo broadcasted about 11 more alcohol (95% CI=9.1, 12.5) and 5 more unhealthy/noncore food/beverages (95% CI=2.0, 7.2) advertisements per hour of TV advertisement programming than the National Broadcasting Company. Telemundo also broadcasted about 1 fewer mental health/tobacco prevention (95% CI= -0.9, -0.2), 3 fewer healthy/core food/beverages (95% CI= -1.5, -4.3), and 4 fewer pharmaceutical (95% CI= -2.4, -5.7) advertisements per hour of advertisement programming than the National Broadcasting Company. CONCLUSIONS: Overall greater health-adverse and fewer health-beneficial advertisements are broadcasted on Spanish-language than on English-language TV. Unchecked corporate marketing strategies may serve as a commercial determinant of health disparities for Latino populations by Spanish-language TV.

Perceived value of self-monitoring blood glucose by primary care physicians and endocrinologists.

The value of self-monitoring blood glucose (SMBG) in patients with non-insulin-treated type 2 diabetes (NITT2DM) has been debated; however, the practice remains common. Patient perception of SMBG has been documented in several qualitative studies. However, the literature is lacking on the perceived value of SMBG by providers. This study used a structured questionnaire to evaluate and compare the perceived value, recommended frequency, and utility of SMBG in patients with NITT2DM by primary care providers (PCPs) and endocrinologists. A total of 70 PCPs and 14 endocrinologists completed the questionnaire. The results suggest that PCPs and endocrinologists find the practice of SMBG valuable in NITT2DM and believe it promotes behavioral changes in their patients. However, endocrinologists tend to recommend more frequent SMBG and find SMBG values more useful in making medication decisions. Conversely, PCPs tend to find the hemoglobin A1c more valuable than SMBG in making medication adjustments.

Faculty Self- and Needs Assessment of Preparedness for Integrating Active Learning Based on Medina's Conceptual Framework.

BACKGROUND: Active learning (AL) is recognized as a valuable learning strategy. OBJECTIVE: Using a conceptual framework, the objective of this study was to conduct a faculty self- and needs assessment to determine the extent to which the faculty at one college of pharmacy perceived they already carried out AL, describe faculty challenges, and evaluate faculty examples of AL techniques. METHODS: A 19-question survey was administered in July 2017 to all 50 college faculty. Survey question types included multiple-choice single- or multiple-answer questions and open-ended questions. For validity, Medina's conceptual framework of 4 key elements for the effective administration of AL was used. For reliability, the draft survey questions were reviewed multiple times and revised accordingly. RESULTS: Thirty-five faculty members, 70%, completed the survey in full. The majority of the faculty perceived that they carried out 3 of the 4 key elements during lectures: activate prior knowledge (74%), involve the majority of students (89%), and provide feedback (91%). However, only 37% stated they promoted metacognition, another key element. Our qualitative analysis identified (1) faculty had misconceptions about most of Medina's conceptual framework elements, (2) challenges to AL implementation included: need for more technology training, perception that AL requires cutting course material, beliefs that AL does not work, and fear of poor evaluations with AL implementation, and (3) suggestions to improve AL included: faculty development, training students on the importance of AL, and integrating AL throughout the curriculum. CONCLUSIONS: Although most faculties indicated they integrated AL in their teaching, faculty misconceptions, and beliefs suggest the need for long-term faculty and organizational development using strategies aligned with or seeking to change the beliefs of the faculty and college system.

Student perceptions of non-technical skills development during advanced pharmacy practice experiences.

INTRODUCTION: In today's workforce, non-technical skills (NTS) are essential in determining an employee's ability to fit into an organization. However, it is unknown whether pharmacy students consider these skills essential to their future work or believe they are sufficiently trained. Therefore, this study evaluated student perceptions of the value of NTS as a pharmacist and their satisfaction with NTS training. METHODS: A 45-item survey was distributed to 111 fourth-year pharmacy students at Texas A&M College of Pharmacy in March 2019. Given the diverse nature of NTS, this study collected student perceptions about the 2016 Accreditation Council for Pharmacy Education Standard 4 Key Elements: self-awareness, leadership, innovation, and professionalism. Results were analyzed utilizing descriptive statistics. RESULTS: Approximately 84% (n = 93) of students completed the survey. More students perceived professionalism as an important skill to have, followed by leadership, self-awareness, and innovation. Similar results were shown with students' satisfaction with NTS training. Also, results highlighted that students' satisfaction level with their NTS training and their belief regarding their strengths relied on two factors: the number of advanced pharmacy practice experiences (APPEs) where NTS training occurred and the amount of time spent practicing the NTS. CONCLUSION: These data add to the existing literature to support NTS training in experiential pharmacy education. While APPEs should not be the only setting where these skills are practiced in the curriculum, our study's findings may further guide curricular priorities and assessment strategies for NTS in the experiential setting.

Impact of Fall Risk and Direct Oral Anticoagulant Treatment on Quality-Adjusted Life-Years in Older Adults with Atrial Fibrillation: A Markov Decision Analysis.

BACKGROUND AND OBJECTIVE: The decision to initiate anticoagulation in older adults with atrial fibrillation is complicated by the benefit of ischemic stroke prevention vs the risk of falls resulting in major bleeds. The objective of this study was to assess the impact of different treatments including direct oral anticoagulants on quality-adjusted life-years (QALYs) in patients aged 75 years and older with atrial fibrillation in the context of falls. METHODS: A Markov decision process was constructed for older patients with atrial fibrillation taking no anti-thrombotic, aspirin, warfarin, rivaroxaban, and apixaban. Input probabilities for clinical events were estimated from the available literature. One-way and two-way sensitivity analyses were performed by measuring the impact of varying input probabilities of clinical events on QALY outcomes. RESULTS: The base-case scenario estimated that older adults treated with no anti-thrombotic, aspirin, warfarin, rivaroxaban, and apixaban had QALYs of 8.03, 8.69, 10.38, 11.02, and 11.56, respectively. The sensitivity analysis estimated that an older adult would need to fall over 45 (rivaroxaban) and 458 (apixaban) times per year for the QALY of a direct oral anticoagulant to be lower than that of aspirin. CONCLUSIONS: Older adults with atrial fibrillation benefit from stroke protection of anticoagulants, especially direct oral anticoagulants, even if they are at high risk of falls. Clinicians should not consider fall risk as a deciding factor for withholding anticoagulation in this population of patients.

Impact of a pharmaceutical care incentive program on the asthma medication ratio among pediatric patients with persistent asthma enrolled in a Medicaid program.

BACKGROUND: Asthma is one of the leading chronic disease states in pediatric patients in Texas. Pharmacy-led interventions such as targeted asthma education, scheduled consultations, and monitoring have shown success in improving asthma outcomes. However, no studies have evaluated the impact of the pharmaceutical care incentive (PCI) programs on Texas Medicaid pediatric beneficiaries. OBJECTIVES: To (1) describe the prevalence of asthma medication utilization and persistent asthma among Medicaid pediatric patients in Texas Health Service Region 11 (HSR 11) and (2) describe the prevalence and impact of PCI program interventions offered by pharmacists to Medicaid pediatric patients or their caregivers at the point-of-service in their medication utilization and asthma medication ratio (AMR). METHODS: This study used a 2-year longitudinal assessment of Medicaid pharmacy claims for beneficiaries aged between 0 and 18 years, with continuous enrollment, and at least 1 asthma medication claim during 2018 and 2019. The prevalence of asthma medication utilization during the study period was described. Also, the prevalence of PCI interventions among beneficiaries with at least 1 asthma medication was described. The prevalence of PCI interventions was also estimated for beneficiaries with persistent asthma. The AMR for beneficiaries with persistent asthma was calculated and compared for those with and without at least 1 PCI intervention. RESULTS: 22,051 beneficiaries with continuous enrollment between the ages of 0 and 18 years and with at least 1 pharmacy claim for an asthma medication during the study period were included. The overall prevalence of asthma medication utilization was 14.55%. 374 (1.70%) beneficiaries with at least 1 asthma medication received at least 1 asthma PCI intervention. Among beneficiaries that received at least 1 asthma PCI intervention, 158 (42.25%) were on rescue medication only; 4 (1.07%) were on maintenance medication only; and 212 (56.68%) were on rescue and maintenance medications. The overall prevalence of persistent asthma was 4.86%. 52 (0.76%) persistent asthma cases received at least 1 asthma PCI intervention after the index date. The overall unadjusted mean AMR (SD) for the 6,885 beneficiaries with persistent asthma was 0.50 (0.19). The adjusted AMR (SD) among beneficiaries with persistent asthma was reported at 0.530 (0.026) for beneficiaries who received at least 1 PCI intervention and 0.483 (0.002) for beneficiaries who did not receive a PCI intervention (P = 0.066). Beneficiaries with persistent asthma generated 64.35% of the total asthma pharmacy claims during 2019. CONCLUSIONS: Despite a high utilization of asthma medications among Medicaid pediatric beneficiaries, pharmacists servicing this group are underusing the PCI program interventions. An increase in the AMR among patients with persistent asthma receiving PCI interventions was observed when compared with those without PCI interventions. However, the difference was not statistically significant. Subsequent studies should include larger groups of beneficiaries receiving PCI interventions to establish the effect of PCI interventions on AMR before widespread implementation. DISCLOSURES: This research project was supported by the Global Institute for Hispanic Health (GIHH) through research grant M1803961. The authors have nothing to disclose. A part of this study was presented as a poster at the AMCP 2020 Virtual Annual Meeting and Exposition Meeting, April 21-24, 2020.

Appropriateness of Acetaminophen Dosing by Caregivers of Pediatric Patients Presenting to the Emergency Department at the University Pediatric Hospital in Puerto Rico.

OBJECTIVE: Evaluate the appropriateness of acetaminophen dosing by caregivers seeking care for their children/wards at the emergency department of a pediatric hospital. METHODS: Design: Cross-sectional descriptive study. Setting: The emergency department of the University Pediatric Hospital in San Juan, Puerto Rico. Participants: Eighty-eight caregivers who had, in the past 24 hours, administered a known quantity of acetaminophen to a pediatric patient under their care and were visiting the emergency room with that patient. Intervention: The caregivers were interviewed by the investigators, using a standardized questionnaire. Main outcome measures: The appropriateness of the acetaminophen doses administered by caregivers. The product's dosage form and strength, measurement device used (if any), and demographic data (of the caregiver and child) were also collected. Doses of 10 to 15 mg/kg of acetaminophen were considered appropriate. RESULTS: Overall, 45% of the caregivers had administered an inappropriate dose. Of these, 70% were subtherapeutic and 30% were supratherapeutic. Although 74% of the caregivers knew their child's/ward's weight, only 50% had used it to determine the dose. Caregivers with previous experience (as caregivers) were most likely to have administered an inappropriate dose (P = 0.03). Physicians were the source most consulted (40%) by caregivers, followed by the product's label (35%). Only 9% of the caregivers consulted a pharmacist for dosing recommendations. CONCLUSION: Nearly half of all the caregivers administered an incorrect acetaminophen dose, suggesting that there is a need for better caregiver education. Due to their accessibility at the point of sale of OTC medications and pharmacotherapy knowledge, pharmacists could have an active role in promoting the safe and effective use of acetaminophen.

Prevalence of statin utilization and adherence among privately insured subjects in the Commonwealth of Puerto Rico.

BACKGROUND: Puerto Ricans are the Hispanic subgroup with the highest adjusted prevalence of statin-eligible patients. However, no study has described statin utilization and adherence among subjects living on the island of Puerto Rico. OBJECTIVES: To (a) estimate the prevalence of beneficiaries with diabetes aged between 40 and 75 years; (b) estimate the prevalence of statin utilization among beneficiaries with diabetes; and (c) estimate secondary adherence to statins among beneficiaries with diabetes. METHODS: With pharmacy claims data from a commercial pharmacy benefit manager (PBM) in the Commonwealth of Puerto Rico, this study used a retrospective longitudinal design to analyze all pharmacy claims generated by 115,674 beneficiaries aged between 40 and 75 years with continuous enrollment during 2018. Beneficiaries with diabetes were defined by having ≥ 2 pharmacy claims for antidiabetic agents during 2018. Statin utilization was defined by having ≥ 1 pharmacy claim for statins among beneficiaries with diabetes. The proportion of days covered (PDC) was used to measure secondary adherence to statins. Parametric and nonparametric statistics were used to describe statin utilization and adherence. RESULTS: The prevalence of beneficiaries with diabetes was 7.8%. Of the 8,975 beneficiaries with diabetes, 5,129 (57.1%) received ≥ 1 prescription for a statin. Older males with diabetes were more likely to receive prescriptions for statins. The median PDC for the 4,553 beneficiaries with ≥ 2 prescriptions for statins was 63.4%; 3,306 (72.6%) beneficiaries filled their statin prescriptions for a 30-day supply only; and 1,252 (27.5%) beneficiaries had a PDC ≥ 80%. The highest PDC (92.3%) was observed for beneficiaries who received statins for a 90-day supply only. CONCLUSIONS: This is the first study that has measured statin utilization and adherence among patients with diabetes living in Puerto Rico. The utilization and adherence to statins among privately insured beneficiaries with diabetes in Puerto Rico are suboptimal. Future studies should focus on understanding the reasons for the suboptimal use of statins and on potential interventions at the beneficiary and provider level to increase statin utilization. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest or financial disclosures to disclose related to this study.

Impact of Pharmacist-Led Drug Therapy Management Services on HbA1c Values in a Predominantly Hispanic Population Visiting an Outpatient Endocrinology Clinic.

PURPOSE: To assess the impact pharmacists have on improving glycemic control among predominantly Hispanic diabetic patients visiting an endocrinology clinic in South Texas. Pharmacists were recently integrated into this clinic to be part of a collaborative team. METHODS: This study follows a retrospective cohort design. All patients received diabetic care from endocrinologists, and some received pharmacist-led drug therapy management (PDTM). Patients with ≥1 PDTM were categorized as the intervention group and those without PDTM as the standard of care (SOC) group. The outcome variables were the mean absolute change in glycosylated hemoglobin (HbA1c) from baseline and the proportion of patients at goal HbA1c (<7%) postintervention. RESULTS: Data were collected from 222 patients (n = 120 SOC patients, n = 102 PDTM patients). The mean age was 61 ± 14 years, 136 (61%) were female, and 197 (89%) were Hispanic. The mean absolute change in HbA1c was -1.3%. In the adjusted model, the mean absolute change in HbA1c in the PDTM compared to the SOC group was not significant (-0.1% ± 0.2%; P < .74), and concurrent interventions from registered dieticians (RDs) and licensed professional counselors (LPC) were identified as effect modifiers of the association. The stratum specific analysis identified the greatest decrease in HbA1c when the three interventions (ie, PDTM, RD, and LPC) coincided (-1.0% ± 0.3%; P < .01). Postintervention, 25% of those who received PDTM achieved an HbA1c<7% as compared to 19% in the SOC group. CONCLUSION: The clinical importance of pharmacists is enhanced when integrated with behavioral modifying programs to achieve additional improvement in HbA1c.

Prevalence of Rheumatoid Arthritis and Drug Dispensing Patterns Among Medicaid and Medicaid-Medicare Dually Eligible Beneficiaries in Puerto Rico.

OBJECTIVE: To estimate the prevalence of rheumatoid arthritis (RA) in Puerto Rico, to describe disease-modifying antirheumatic drug (DMARD) dispensing patterns by prescriber specialty, and to illustrate the impact of RA case definition on the estimated prevalence. METHODS: This study estimated the prevalence of RA in Puerto Rico during 2016 among Medicaid and Medicaid-Medicare dually eligible beneficiaries of the Mi Salud health care plan, a federally funded health insurance program. DMARD dispensing and cost patterns were described and stratified by provider specialty. A sensitivity analysis was conducted to evaluate the effect of RA case definition on estimated prevalence. RESULTS: The prevalence of RA in 2016 was estimated to be 2 cases per 1,000 beneficiaries, with 3 per 1,000 beneficiaries among females, 4.5 times that of males. In total, 44% of beneficiaries received conventional synthetic DMARDs (csDMARDs) only, 32% received biologic or targeted synthetic DMARDs (b/tsDMARDs) only, and 24% received a combination of csDMARDs and b/tsDMARDs. Rheumatologists and a combination of specialties accounted for the highest median number of dispensed DMARDs, with 14 each. A sensitivity analysis revealed that when RA cases with ≥3 medical claims were restricted to having ≥1 DMARD claim, the estimated prevalence changed from 6 to 3 cases per 1,000 beneficiaries. CONCLUSION: The prevalence of RA in Puerto Rico in this study is lower than reported in the mainland US, possibly due to more stringent criteria to define RA. DMARD dispensing and cost patterns are similar to those found in other studies. Claims algorithms that identify RA have higher validity when pharmacy data is included.

Travel to Mexico and uropathogen-antibiotic susceptibility mismatch in the emergency department.

INTRODUCTION: International travel results in an increased risk of colonization and infection with multidrug-resistant organisms. This study aimed to determine if recent travel to Mexico affects the rate of uropathogen-antibiotic susceptibility mismatch (UASM) in outpatients treated for urinary tract infection (UTI) in a South Texas emergency department (ED). METHODS: A retrospective cohort of adult patients presenting to the ED and treated outpatient for UTI from October 1, 2014, to February 25, 2020, was conducted at a community hospital located within approximately 15 miles of the United States-Mexico border. Rates of UASM were compared between patients with a history of recent travel to Mexico and those who have not recently traveled. RESULTS: A total of 192 patients were included, with 64 in the travel to Mexico group and 128 in the no travel group. UASM was significantly higher in the recent travel to Mexico group when compared to the no travel group (RR 1.49, 95% CI 1.03-2.13). Antibiotics most commonly associated with UASM included fluoroquinolones, cephalexin, and sulfamethoxazole-trimethoprim. There was no significant difference between the rates of resistance to first-line agents for the treatment of UTI among the two groups. CONCLUSION: In addition to known antibiotic resistance risk factors, recent travel to Mexico may increase the risk of UASM for ED patients with UTI. Considering the potential consequences of UTI treatment failure, antimicrobial stewardship services in the ED should include screening for antibiotic resistance risk factors and urine culture follow-up to ensure appropriate outpatient antibiotic therapy, especially among patients with recent international travel.

Knowledge and beliefs, behaviors, and adherence among Latino parents or legal guardians related to antibiotic use for upper respiratory tract infections in children under 6 years of age.

OBJECTIVE: Evaluate parents or legal guardians' knowledge and beliefs, behaviors, and adherence regarding antibiotic use for upper respiratory tract infection (URTI) in their children who are younger than 6 years. DESIGN: A cross-sectional study from September 2016 to February 2017. SETTING: Emergency department with a pediatric unit. PARTICIPANTS: One hundred and one parents or legal guardians who visited one of the selected emergency departments during the study period. INTERVENTION: Administration of a validated questionnaire to assess knowledge and beliefs, behaviors, and adherence regarding antibiotic use for URTI. MAIN OUTCOME MEASURES: Knowledge and beliefs, behaviors, and adherence regarding antibiotic use for URTI. RESULTS: Items with the least desired scores were seen in the "knowledge and beliefs" domain. Higher number of antibiotics used for URTI during the last year (P < 0.01) and lower education level (P = 0.03) were associated with least desired knowledge and beliefs scores. The "behaviors" domain contained the items with the best scores: higher education level (P = 0.05), fewer antibiotics used for URTI during the last year (P = 0.05), and older age (P = 0.02) were the only variables associated with better behaviors. For the "adherence" domain, lower education level (P < 0.01) was associated with poor indicators of adherence. The Cronbach alpha for the "knowledge and beliefs" items was 0.875, the "behaviors" items 0.569, and the "adherence" items 0.798. CONCLUSION: Findings of our study support the need for proper antibiotic education among parents, especially in those with an increased risk of antibiotic misuse and overuse. Pharmacists and physicians need to establish a dialogue with parents or legal guardians to discuss how antibiotics work, what types of infection they treat, and how to prevent antibiotic resistance. Sociodemographic variables can be used to identify at-risk groups and to develop successful interventions.