Earticle

Background: World Health Organization (WHO) Defined Daily Dose (DDD) often mismatches Korean clinical practice for anticancer (L01) and antihypertensive (C02-C09) drugs, causing statistical distortion in drug utilization research (DUR). This study aimed to establish Korean DDD (KDDD) for these agents. Methods: A modified Delphi method was employed. An expert panel (n=13) of clinicians and pharmacists reviewed 26 anticancer and 16 antihypertensive ingredients lacking a WHO DDD or showing significant discrepancies. KDDD proposals were drafted based on WHO guidelines, domestic approvals, and Health Insurance Review and Assessment Service (HIRA) claim data on prescribed daily dose (PDD) distributions. Two survey rounds were conducted to achieve consensus. Consensus-based KDDDs were determined for all 42 ingredients. Results: For anticancer drugs, KDDDs were assigned based on single approved doses (n=16), most frequent doses (e.g., imatinib), indication-specific average doses (e.g., axitinib), or doses adjusted for drug-holiday cycles (e.g., palbociclib). For antihypertensives, KDDDs were based on single doses (n=5), average range doses (n=6), or doses for major domestic indications (n=5). These KDDDs enabled, for the first time, standardized consumption measurement (DDD/1,000 inhabitants/day, DID) for 26 anticancer agents previously unquantifiable under WHO DDD. The 26 newly assigned anticancer KDDDs accounted for 36.4% of total anticancer expenditure (USD 430.8 million) in 2019, highlighting their substantial fiscal impact and the urgency of accurate utilization monitoring. Conclusion: This study established robust, evidence- based KDDDs reflecting Korean clinical reality through a systematic Delphi consensus. These KDDDs provide an essential tool for accurate DUR and rational health policy, particularly for monitoring high-cost oncology drugs.

Background: Sedative withdrawal syndrome (SWS) in the pediatric intensive care unit (PICU) can lead to vital sign instability and adversely affect clinical outcomes. In pediatric patients, the diagnosis of SWS is particularly challenging due to immature metabolic and neurological development. This study aimed to determine the incidence and risk factors of SWS and to describe current pharmacologic management practices in a tertiary PICU. Methods: From March 2022 to February 2025, we retrospectively reviewed the electronic medical records of pediatric patients admitted to the PICU who required mechanical ventilation and received a continuous intravenous infusion of midazolam or ketamine for sedation lasting more than 24 hours. Results: Among the 197 patients included, 44 patients (22.3%) developed SWS. Compared with the non-SWS group, the SWS group had longer PICU length of stay and sedative administration duration. For midazolam, sufentanil, and dexmedetomidine, the SWS group showed longer total infusion duration, higher maximum doses, and greater cumulative doses before tapering. Tapering for midazolam and sufentanil was initiated later in the SWS group. In contrast, ketamine-related variables did not differ between the two groups. In multivariable analysis, the cumulative dose of midazolam before tapering was the only independent risk factor for SWS. Clonidine and dexmedetomidine combination therapy was the most frequently used pharmacologic intervention for controlling SWS (22.7%). Conclusions: The cumulative midazolam dose before tapering initiation was the only independent risk factor for SWS. In PICU patients receiving prolonged or high cumulative doses of midazolam, monitoring for the occurrence of SWS should be considered.

Objective: The incidence of nontuberculous mycobacteria pulmonary disease (NTM-PD) has been increasing worldwide. However, treatment options for NTM-PD have been limited by the multidrug-resistant nature of these organisms and toxicities of antibiotics. Due to the lack of clinical safety studies related to NTM-PD treatment in Korea, the objectives of this study were to analyze NTM-PD treatment medication-related adverse events (AEs) and to identify clinical characteristics of various AEs and serious adverse events (SAEs) in medication treatments for NTM-PD patients. Methods: This study was conducted to analyze the current status of adverse event occurrences during drug treatment in domestic NTM-PD patients using the Korea adverse event reporting system database (KAERS DB) from 2017 to 2021. Results: According to the analysis of 2017-2021 KAERS DB in this study, 1,034 AEs were reported in the process of NTM-PD treatments, and the most common causative agents of AEs were ethambutol (19.2%), followed by rifampin (17.2%), azithromycin (12.6%), moxifloxacin (7.0%), clarithromycin (6.0%), levofloxacin (5.1%), amikacin (4.7%), cefoxitin (3.9%), imipenem (3.1%), linezolid (2.1%), and ciprofloxacin (0.8%). SAEs were approximately 5% of the total AEs and the most frequently reported drugs for SAEs were rifampin, ethambutol, clarithromycin, amikacin, and levofloxacin in order. AEs during NTM-PD treatments were the major causes of treatment discontinuation. Conclusion: Therefore, careful monitoring of AEs is required for safer medication treatments in patients with NTM-PD. Further related studies are needed to confirm this study.

Background: Sarcomas are rare mesenchymal malignancies originating from connective tissues and are generally associated with poor prognosis. Previous bioinformatics studies have often relied on a single database, limiting generalizability. This study aimed to identify novel hub genes associated with sarcoma using integrative analysis of GEO (Gene Expression Omnibus) and TCGA (The Cancer Genome Atlas) datasets. Methods: Differential gene expression (DEG) analysis was performed using integrated data from TCGA and GEO. Functional enrichment analyses and protein–protein interaction (PPI) network construction were conducted, and hub genes were identified based on node connectivity. Survival analysis was performed using the Kaplan–Meier method. Results: After identifying 47 overlapping DEGs from the analysis of 261 TCGA samples and 149 GEO samples, the GO (Gene Ontology) enrichment analysis revealed associations with cell adhesion, plasma membrane components, and calcium ion binding. Moreover, the KEGG (Kyoto Encyclopedia of Genes and Genomes) pathway enrichment analysis showed that target genes were mainly involved in the chemical carcinogenesis-receptor activation. Then, 29 genes were screened through the PPI network. With calculating protein nodes, eight genes (BCL2, EMCN, CLDN5, LYVE1, CD36, CD93, VWF, and CDH5) were screened from TCGA and GEO datasets. Comparing survival analysis outcomes among these eight genes, highly expressed CD36 (HR=0.627, log-rank p value=0.0202) was identified as being associated with improved survival outcomes in sarcoma patients. Conclusions: CD36 may serve as a candidate prognostic biomarker or survival-associated hub gene in patients with sarcoma. However, further validation is required to clarify its clinical relevance.

Objective: This study aimed to identify structural differences in policy frameworks for digital therapeutics medical devices (DTx) and to derive policy implications for improving patient access in South Korea through cross-national comparison. Methods: A comparative analysis was conducted across three dimensions: regulatory definition and scope, market authorization pathways, and reimbursement mechanisms in South Korea, Germany, France, and Japan. Data were collected from official documents, policy reports, and peer-reviewed literature, and synthesized using comparative tables and narrative analysis. Results: All four countries regulate DTx within medical device frameworks but differ in the clarity of definitions and authorization structures. Germany has established a distinct framework through digital health applications, whereas other countries, including South Korea, rely on broader software as a medical device classifications. Greater variation was observed in reimbursement pathways. Germany provides a structured mechanism linking authorization to statutory health insurance coverage, while South Korea lacks a dedicated pathway and relies on prolonged provisional arrangements with high patient cost-sharing. France and Japan represent intermediate models. These differences are reflected in utilization, with cumulative prescriptions exceeding one million in Germany, approximately 200,000 in Japan, and only 31 in South Korea in the first half of 2024. Conclusion: An authorization–reimbursement disconnect persists in South Korea, limiting patient access despite regulatory approval. Aligning reimbursement with authorization through structured pathways may improve access and support evidence generation.

The Objective Structured Clinical Examination (OSCE) is a performance based assessment tool widely used to evaluate clinical competence in healthcare education. Although several pilot studies have examined the feasibility of pharmacy OSCEs in South Korea, reports describing the long term implementation and operation of institution-based OSCE programs remain limited. This study describes the development, implementation, and refinement of an in-house OSCE program conducted between 2023 and 2025 at a college of pharmacy. The program was initially developed for fifth-year students before advanced pharmacy practice experiences and was expanded to include sixth-year students following completion of externships. The OSCE program evolved from a five-station format with 10-minute stations in 2023 to a nine- to ten-station format with 5-minute stations in subsequent years. Assessment domains included prescription verification, prescription counseling, self-care counseling, drug information services, clinical pharmacy services, and patient assessment. A peer-assisted model utilizing pharmacy students as standardized patients and assistants was implemented. Continuous modifications of station structure, assessment domains, and operational procedures improved the feasibility and sustainability of the program. Challenges identified during implementation included assessment tool validation, evaluator standardization, and long-term sustainability of personnel and financial support. The study demonstrates the feasibility of implementing and maintaining a pharmacy OSCE program within a college of pharmacy using available institutional resources. The experience gained through this three-year program may provide practical guidance for other pharmacy schools seeking to develop competency-based clinical performance assessments. Further studies are needed to establish the validity, reliability, and educational impact of pharmacy OSCE programs.