Adverse events associated with SARS-CoV-2 neutralizing monoclonal antibodies using the FDA adverse event reporting system database.

The purpose of this study was to analyze the important medical events (IMEs) of anti-severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) monoclonal antibodies using the reports from the United States Food and Drug Administration (US FDA) adverse event reporting system (FAERS) and to detect safety signals. In this study, data from the FAERS from January 2020 to December 2022 were used to investigate signals associated with five monoclonal antibody products (bamlanivimab, bamlanivimab/etesevimab, bebtelovimab, casirivimab/imdevimab, sotrovimab) in coronavirus disease 2019 (COVID-19) patients and one monoclonal antibody product (tixagevimab/cilgavimab) in patients wherein COVID-19 vaccination was not recommended. Disproportionality analyses were conducted using the reporting odds ratio, and an information component to identify safety signals.

Comparison of active tuberculosis occurrence associated with Janus kinase inhibitors and biological DMARDs in rheumatoid arthritis.

Objectives: This study aimed to evaluate the risk of tuberculosis associated with the use of Janus kinase (JAK) inhibitors or biological disease-modifying antirheumatic drugs (bDMARDs) in patients diagnosed with rheumatoid arthritis (RA) in South Korea.

Methods: In this nationwide matched-cohort study, we retrospectively identified adult patients with new-onset RA from the National Health Insurance Service database who were prescribed bDMARDs or JAK inhibitors and recently underwent latent tuberculosis infection (LTBI) screening during 2012‒2021, and followed them up until the end of 2022 for the development of active tuberculosis. HRs were estimated using Cox proportional hazards regression in a propensity score-matched cohort.

Utilizing temporal pattern of adverse event reports to identify potential late-onset adverse events.

Objectives: Through the use of FDA adverse event reporting system (FAERS) dataset, this study analyzes the pattern of time-to-event (TTE) for drugs and adverse events, and suggest ways to identify candidate late-onset events for monitoring.

Methods: The duration between administration date of the drug and the onset of adverse events was explored with using FAERS data from 2012-2021. The fold change of proportional reporting ratios or reporting odds ratios were calculated to identify enriched events in the later period and to suggest the late-onset events for further monitoring.

Association of Tumor Necrosis Factor Inhibitors with the Risk of Nontuberculous Mycobacterial Infection in Patients with Rheumatoid Arthritis: A Nationwide Cohort Study.

Tumor necrosis factor inhibitors (TNFi) are proposed as a risk factor for nontuberculous mycobacteria (NTM) infection. Limited research investigates NTM infection risk in rheumatoid arthritis (RA) patients treated with TNFi compared to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), considering other concurrent or prior non-TNFi antirheumatic drugs. We aimed to evaluate the NTM infection risk associated with TNFi using a real-world database.

Performance of Cardiovascular Risk Prediction Models in Korean Patients With New-Onset Rheumatoid Arthritis: National Cohort Study.

Background: This study aimed to compare the performance of established cardiovascular risk algorithms in Korean patients with new-onset rheumatoid arthritis.

Methods And Results: This retrospective cohort study identified patients newly diagnosed with rheumatoid arthritis without a history of cardiovascular diseases between 2013 and 2019 using the National Health Insurance Service database. The cohort was followed up until 2020 for the development of the first major adverse cardiovascular event.

Cardiovascular risk of Janus kinase inhibitors compared with biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis without underlying cardiovascular diseases: a nationwide cohort study.

Despite the ethnic differences in cardiovascular (CV) risks and recent increase in the prescription of Janus kinase (JAK) inhibitors, limited evidence is available for their CV outcomes in Asian patients with rheumatoid arthritis (RA). We aimed to compare the major adverse CV events (MACEs) of JAK inhibitors to those of biologic disease-modifying antirheumatic drugs (bDMARDs) in Korean patients with RA without baseline CV disease (CVD). In a nationwide retrospective cohort study, patients newly diagnosed with RA without a history of CVD between 2013 and 2018 were identified using the National Health Insurance Service database.

Comparison of cutaneous adverse events between second-generation tyrosine kinase inhibitors and imatinib for chronic myeloid leukemia: a systematic review and meta-analysis.

Background: Patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors (TKIs) often experience cutaneous adverse events, such as rashes and pruritus. In this study, we aimed to compare the risks of cutaneous adverse events between imatinib- and second-generation TKI-treated patients with CML.

Material And Methods: Paired reviewers independently obtained studies from PubMed, Embase, and Cochrane Library published until 15 March 2022.

Objective structured clinical examination as a competency assessment tool of students' readiness for advanced pharmacy practice experiences in South Korea: a pilot study.

Background: The assessment of pharmacy students' readiness to begin the education of an advanced pharmacy practice experience (APPE) in clinical pharmacy settings continues to gain increasing attention. This study aimed to develop an objective structured clinical examination (OSCE) in the core domains acquired through an introductory pharmacy practice experience (IPPE), for evaluating its appropriateness as a tool of assessing clinical pharmacist competency for APPEs in Korean pharmacy students throughout a pilot study.

Methods: OSCE's core competency domains and case scenarios were developed through a literature review, ideation by researchers, and external experts' consensus by a Delphi method.

Prognostic Significance of the Severity of Immune-Related Adverse Events in Advanced Cancer Patients Treated with PD-1/PD-L1 Inhibitors: A Real-World Data Analysis.

Background: There is limited evidence regarding immune-related adverse events (irAEs) in Asian cancer patients treated with antibodies directed against programmed cell death-1 (PD-1) or programmed cell death-ligand 1 (PD-L1).

Objective: This study aimed to investigate the clinical patterns and prognostic significance of grade 1-2 and grade ≥ 3 irAEs by PD-1/PD-L1 inhibitors in cancer patients using real-world clinical data.

Patients And Methods: We conducted a retrospective study of cancer patients who received pembrolizumab, nivolumab, or atezolizumab at a tertiary hospital in South Korea.

The risk of newly diagnosed cancer in patients with rheumatoid arthritis by TNF inhibitor use: a nationwide cohort study.

Background: Tumor necrosis factor (TNF) inhibitors use in patients with rheumatoid arthritis (RA) has raised safety concerns about cancer risk, but study results remain controversial. This largest nationwide study to date compared cancer risk in TNF inhibitor users to non-biologic disease-modifying anti-rheumatic drug (nbDMARD) users in Korean patients with RA.

Methods: Data on all the eligible patients diagnosed with RA between 2005 and 2016 were retrieved from the Korean National Health Information Database.

Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial.

Introduction: Rheumatoid arthritis (RA) generally requires lifelong treatment; however, its medication complexity might affect non-adherence. Pharmacist-led telehealth services were as effective as face-to-face services and reduced potential side effects in outpatients with chronic diseases. This study aims to analyse the effect of a telepharmacy service with a customised mobile device in comparison with the usual pharmacist service on the humanistic and clinical outcomes in patients with RA.

Women's attitudes toward certification logos, labels, and advertisements for organic disposable sanitary pads: results from a multi-city cross-sectional survey.

Background: This cross-sectional study evaluated women's attitudes toward the certification logos, labels, and advertisements for organic disposable sanitary pads (OSPs) and investigated what could be the main reason for them. Additionally, the present study examined whether a relationship could be found between these attitudes and OSPs purchasing behavior.

Methods: This study was conducted using a self-reported online survey of Korean adult women who have purchased OSPs.

Employee Perspectives on Onsite Health Clinics in Semiconductor Company in South Korea.

(1) Background: Onsite clinics are increasingly common features of corporate health promotion programs. These clinics allow employers to offer convenient care to employees at their workplaces, which can lead to reduced healthcare expenditure and improved productivity. The objective of this study was to build basic data by qualitatively exploring employees' experiences and perspectives on onsite clinics in a semiconductor company, as one part of the project to examine and improve the health management system of a large semiconductor company in Korea.

Potential Adverse Events Reported With the Janus Kinase Inhibitors Approved for the Treatment of Rheumatoid Arthritis Using Spontaneous Reports and Online Patient Reviews.

The aim of this study was to analyze the potential adverse events (AEs) caused by Janus kinase (JAK) inhibitors, including tofacitinib, baricitinib, and upadacitinib, used to treat rheumatoid arthritis using spontaneous AE reports from the FDA (FAERS) and interpreting them in correlation with those from Korea (KAERS) and an online patient review (WebMD). Potential AEs were identified based on a disproportionality analysis using the proportional reporting ratio (PRR), reporting odds ratio (ROR), and the information component (IC). A total of 23,720 reports were analyzed from FAERS database, of which 91.

Comparison of Online Patient Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study.

Background: Tramadol is known to cause fewer adverse events (AEs) than other opioids. However, recent research has raised concerns about various safety issues.

Objective: We aimed to explore these new AEs related to tramadol using social media and conventional pharmacovigilance data.

Factors Influencing Workplace Health Promotion Interventions for Workers in the Semiconductor Industry According to Risk Levels of Chronic Disease.

(1) Background: This study aimed to analyze the risk of chronic diseases including hypertension, diabetes, and dyslipidemia in workers of a semiconductor manufacturing company and the factors associated with their participation in workplace health promotion (WHP) programs. (2) Methods: Subjects were workers in a semiconductor and liquid crystal display company in South Korea who had undergone regular health checkups. Data from regular health checkups and WHP interventions were analyzed.

Effectiveness of Clinical Pharmacist Service on Drug-Related Problems and Patient Outcomes for Hospitalized Patients with Chronic Kidney Disease: A Randomized Controlled Trial.

(1) Background: The study aimed to analyze the effectiveness of clinical pharmacist services on drug-related problems (DRPs) and patient outcomes in inpatients with chronic kidney disease (CKD). (2) Methods: In a randomized controlled trial, the participants in the intervention group received pharmacist services, including medication reconciliation, medication evaluation and management, and discharge pharmaceutical care transition services. Participants in the control group received usual care.

Antidepressant Use and the Risk of Major Adverse Cardiovascular Events in Patients Without Known Cardiovascular Disease: A Retrospective Cohort Study.

Conflicting data exist on whether an association exists between antidepressants and the risk of major adverse cardiovascular events (MACEs) in patients with depression. This may be due to the use of various study designs and residual or unmeasured confounding. We aimed to assess the association between antidepressant use and the risk of MACEs while considering various covariates, including severity of depression and the cardiovascular disease (CVD) risk score.

Major Adverse Cardiovascular Events in Antidepressant Users Within Patients With Ischemic Heart Diseases: A Nationwide Cohort Study.

Background: To evaluate the effect of antidepressants on the development of major adverse cardiovascular events (MACEs) in patients with ischemic heart disease (IHD), we analyzed the association between antidepressant use and the risk of MACE development.

Methods: Patients with depression and a history of IHD between 2008 and 2012 were identified by using the National Health Insurance Service database. A cohort was followed up for the development of MACE until the end of 2015.

Nationwide prevalence of potential drug-drug interactions associated with non-anticancer agents in patients on oral anticancer agents in South Korea.

Purpose: We analyzed the prevalence and severity of potential drug-drug interactions (PDDIs) in Korean patients receiving oral anticancer agents (OAAs) during two different periods.

Methods: A cross-sectional study was conducted using the national insurance reimbursement database. The subjects were adult outpatients diagnosed with cancer and prescribed OAAs at least once in 2010 or 2014.

International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.

The objective of this study was to analyze information on pediatric use in Korean drug product labels and compare it with that in US Food and Drug Administration (FDA) labeling information. Prescription information on pediatric use contained in the commonly used drugs' product labels approved by Korean government was compared with that approved by the FDA. Among the top 50 commonly prescribed drugs, 20 drugs were deemed to have insufficient prescribing information in Korean drug labels.

Economic Impact of Pharmacist-Participated Medication Management for Elderly Patients in Nursing Homes: A Systematic Review.

This systematic review examined the varied studies that have assessed the economic impact of pharmacist-participated medication management for nursing home residents older than 65 years of age. The articles published during 1990-2017 were found through PubMed, EMBASE and Ovid Medline. After the selection process by independent reviewers, a total of 12 studies were included.

Development of a New Type of Recombinant Hyaluronidase Using a Hexahistidine; Possibilities and Challenges in Commercialization.

Hyaluronidases enhance therapeutic drug transport by breaking down the hyaluronan barrier to lymphatic and capillary vessels, facilitating their tissue absorption. Commercially available hyaluronidases are bovine in origin; however, they pose risks such as bovine spongiform encephalopathy. The present study aimed to develop a novel, highly active hyaluronidase and assess its function.

Antidepressants-related cardiovascular adverse events using the adverse event reporting system.

The aim of this study was to evaluate clinical manifestations and the age and sex distribution of cardiovascular adverse events (CVAEs) related to antidepressants. The FDA Adverse Event Reporting System (FAERS) and Korea Adverse Event Reporting System (KAERS) database records on patients prescribed antidepressants were used. The frequency of CVAEs was compared between adults (19-64 years) and an older (age ≥ 65 years) group.