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Penicillin Allergy Delabeling

Song SJ, Kang HR, Lee JH

Penicillin allergy labels are associated with significant challenges, including antimicrobial resistance, restricted prescribing options, and negative outcomes for both patients and health care systems. However, only 10% of individuals labeled...
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Awareness of Drug Safety System in Local Clinics in Korea

Lee DY, Choi B, Moon SH, Choi EY, Kang DY

Objective: The importance of effective adverse drug reaction (ADR) management in local clinics is increasing. This study investigates the current status of ADR management and reporting system use in local...
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Gene Therapy Products in Advanced Therapy Medicinal Products: Comparative Mechanism and Safety Study by Product

Park J, Park D, Kim S, Jung SY, Shin JY

Globally, advanced therapy medicinal products (ATMP) such as stem cell therapies and gene therapies have become the focal point of the pharmaceutical market. In response to this trend, Korea, like the...
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Identifying Factors Associated with Spontaneous Reporting of Statin-Associated Muscle Symptoms Using Machine Learning-Based Cluster Analysis

Kim JY, Park S, Lee MT, You SH, Lee JW, Nam DR, Jung SY

Objective: We aimed to identify factors associated with adverse event (AE) reports in statin-associated muscle symptoms (SAMS) using hierarchical clustering of patients in the Korea Institute of Drug Safety and...
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Diabetes Medication Intensifications at Discharge in Older Adults: Prevalence and Impact on Short-Term Clinical Outcomes

Han JH, Jung AH, Kim M, Jung SH, Lee JY

Objective: This study aimed to assess diabetes medication intensification at discharge in older adults hospitalized for non-glycemic reasons, examining its shortterm benefits and risks. Methods: A retrospective review of electronic...
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Hepatotoxicity and Related Factors Induced by Sulfamethoxazole/ Trimethoprim in Pediatric Patients with Acute Lymphoblastic Leukemia

Park YB, Hong S, Jang HJ, Kim SH, Cho EJ, Cho YS, Kang HJ, Lee JY

Objective: This study aimed to examine the causality of hepatotoxicity related to sulfamethoxazole/trimethoprim (SMX/TMP) in pediatric patients with acute lymphoblastic leukemia (ALL). Methods: We retrospectively analyzed medical records of pediatric...
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Current Issues and Improvement Strategies for Promoting the Utilization of National Health Insurance Claims Data

Kim HJ, Kim DW, Kim MG, Kim MS, Kim YJ, Kim JA, Park S, Bae S, Shin A, Shin JY, Ahn SV, Ahn J, Yang BR, Won H, Lee SM, Lee J, Lee HE, Jung SY, Cho H, Choi NK

While health insurance claims data in Korea have the potential as evidence for drug regulatory decision-making, its effective utilization remains limited. This study aims to identify the challenges encountered by...
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Comparison of Drug-Induced Liver Injury in Fimasartan and Losartan Using Common Data Model and Clinical Data Warehouse: A Single Hospital Retrospective Cohort Study

Yoon J, Kim HJ, Ko YH, Yi S, Ahn KM, Jeong J, Lee JH, Kim K, Kang HR

Objective: Fimasartan, an angiotensin II receptor blocker (ARB) with superior potency and longer-lasting effects than losartan, demonstrates a good safety profile. However, recent case reports have emerged, linking fimasartan to...
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Safety Monitoring of Oral Antiviral COVID-19 Treatment Using Korea Adverse Event Reporting System (KAERS) Database

Choe Y, Park SJ, Kim JH, Yoon D, Kang DY, Jung JH, Shin JY

Objective: This study aimed to evaluate the association between nirmatrelvir/ritonavir, molnupiravir and adverse events and identify safety signals not previously known. Methods: To identify major adverse events and safety signals...
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