Use of Hydrochlorothiazide in the United States Following Label Update About Skin Cancer Risk.

Purpose: On August 20, 2020, the United States (U.S.) Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) along with labeling updates to inform the public about a small increased risk of non-melanoma skin cancer (NMSC) associated with hydrochlorothiazide (HCTZ) use.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The economic burden of systemic sclerosis-A systematic review.

Aim: Systemic sclerosis (SSc) is a rare, chronic autoimmune disease associated with a substantial economic burden. This study aimed to assess the costs associated with SSc and to identify major cost drivers.

Methods: A systematic search was conducted in MEDLINE and Embase to identify relevant studies.

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.

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.

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.

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

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.

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.

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

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. 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.

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.

Impact of Pharmacist-Led Drug Therapy Management Services on HbA 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.

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.

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.

Knowledge and Perceptions of E-cigarettes and the Motivations for their Use: Talking to Smokers (E-cigarettes and/or Conventional Cigarettes) and Non-smokers in Puerto Rico.

Objective: The awareness and use of e-cigarettes have been increasing in recent years. The World Health Organization recently reported that regulations are needed to impede the promotion of e-cigarettes to young people, prohibit unproven health claims about them (including those regarding smoking-cessation efficacy), minimize potential health risks to e-cigarette users and non-users, and protect existing tobacco controls. The study described herein explored e-cigarette knowledge, perceptions, and usage motivations among a group of adults in Puerto Rico.