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4,000원
Objective: This study aimed to comparatively analyze selected countries’ telepharmacy guidelines and propose directions for improving domestic guidelines. Methods: This was a multi-country comparative study analyzing 8 guidelines from 7 countries including South Korea, Australia, Canada, Singapore, Spain, UK and US. The analytical framework, based on WHO and International Pharmaceutical Federation reports, comprised eight core items and was applied to analyze the guidelines. Guidelines’ completeness was assessed using a three-tiered scale by two independent researchers. Results: Guidelines generally defined telepharmacy as qualified pharmacists using Information and Communication Technology for remote medication supervision and is emphasized as a supplement to face-to-face services. The primary difference between the Korean and international systems lies in the strictness versus maturity of regulations. International guidelines, often produced by professional organizations, ensure service quality while allowing broader pharmacist autonomy. Five countries, except South Korea and the UK, offered expanded services such as Comprehensive Medication Management (USA) and chronic disease management (Singapore). Korea showed the strictest procedural controls (e.g., volume limits) but lacked explicit standards for service quality or quality management. In contrast, Australia, Canada, Singapore, and the USA required tele-counseling quality to be equivalent to or higher than face-to-face care. Among the countries analyzed, only Korea specified details of the service reimbursement system. Conclusion: To enhance domestic service quality, it is necessary to establish an institutional framework for standardizing counseling criteria, broadening specialized services through social consensus, and systematizing education to strengthen pharmacists' digital competencies, along with the active and voluntary participation of pharmacist associations.
약학대학 신입생의 진로 선택 과정과 의미화에 대한 질적 연구
한국임상약학회 한국임상약학회지 제35권 제4호 2025.12 pp.217-225
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4,000원
Background: Professional identity among novice health professions students is fluid and context-dependent, constructed through narratives that integrate personal experience and social expectations. Following Korea’s transition to a six-year pharmacy program directly admitting high school graduates, little is known about how new entrants construct and interpret their career choices. Objective: This study explored how first- and second-year pharmacy students narrate their choice of pharmacy and how early collegiate experiences shape career reflection. Methods: Semi-structured interviews were conducted with 15 first- and second-year students at a pharmacy school. Transcripts were thematically analyzed using category aggregation, with credibility enhanced through triangulation and participant feedback. Results: Students’ narratives revealed four main drivers of career choice: strong family influence, personal interests and dispositions, admissions and institutional structures, and selective preference for pharmacy over medicine. Career values centered on stability, economic security, and social prestige, though some emphasized intrinsic interest and growth. Early curricular activities and peer interactions broadened perspectives toward research, industry, and regulatory roles. A minority reported lack of direction and motivation, showing that secure admission alone did not ensure sustained purpose. Conclusion: Findings align with prior research in health professions, underscoring the powerful role of family expectations and sociocultural context. Students demonstrated nascent career narratives strongly influenced by external factors, highlighting the importance of educational opportunities that promote narrative reflection. Structured interventions such as seminars, mentoring, and diverse career role models may foster intentional exploration and the formation of a mature professional identity.
말라리아 환자에서 아르테수네이트 치료 중 임상 악화 예측을 위한 위험점수 개발
한국임상약학회 한국임상약학회지 제35권 제4호 2025.12 pp.226-233
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4,000원
Background: Intravenous artesunate is the first-line treatment for severe malaria; however, clinical deterioration may occur during treatment. This study aimed to identify risk factors associated with clinical deterioration and to construct a risk-scoring system. Methods: We retrospectively reviewed medical records of adult patients who received at least one dose of intravenous artesunate for malaria at the National Medical Center between January 2014 and December 2023. Clinical deterioration was defined as the new onset of any severe malaria symptom after artesunate administration. Multivariable logistic regression analysis was conducted to identify independent predictors. Results: Among 98 patients included in the final analysis, 29 (29.6%) experienced clinical deterioration. Multivariable analysis revealed that female sex (adjusted odds ratio (aOR) 4.3, 95% confidence interval (CI) 1.0-19.0), age ≥60 years (aOR 3.4, 95% CI 0.8-14.3), presence of jaundice at admission (aOR 4.3, 95% CI 1.1-16.5), and elevated alanine aminotransferase (ALT) level (aOR 2.6, 95% CI 1.0-6.8) were independently associated with increased risk of clinical deterioration. Based on these factors, a risk scoring system (range: 0-5 points) was constructed and showed a stepwise increase in deterioration risk by score. Conclusions: Female sex, advanced age, jaundice, and elevated ALT were independent predictors of clinical deterioration in malaria patients treated with artesunate. The proposed risk score may aid in early identification of high-risk patients and guide clinical decision- making.
의약품이상사례보고시스템 데이터베이스를 활용한 비스테로이드성 소염진통제 계열 간 약물이상반응 비교 분석
한국임상약학회 한국임상약학회지 제35권 제4호 2025.12 pp.234-242
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4,000원
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to manage pain and inflammation but are associated with adverse events (AEs) across various organ systems. However, organ-specific AE profiles among different NSAID classes remain underexplored. This study aimed to compare AE patterns across NSAID classes using national pharmacovigilance data. Methods: A total of 54,251 NSAID-related AE reports from 2017 to 2021 were extracted from the Korea Adverse Event Reporting System (KAERS). NSAIDs were classified into six groups: propionic acids, acetic acids, oxicams, fenamic acids, COX-2 inhibitors, and salicylic acids. AEs were categorized into nine System Organ Classes (SOCs) based on Medical Dictionary for Regulatory Activities (MedDRA) terminology. Disproportionality analysis was performed using Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) to identify class-specific AE signals. Results: The most frequently reported SOCs were skin disorders (30.1%) and gastrointestinal events (24.0%). Salicylic acids showed the highest disproportionality for musculoskeletal and connective tissue disorders [ROR (95% CI)=4.18 (3.56-4.90); PRR (95% CI)=4.11 (3.51-4.81)]. Fenamic acids were notably associated with skin-related AEs [ROR (95% CI)=1.86 (1.69-2.04); PRR (95% CI)=1.47 (1.40-1.55)], while COX-2 inhibitors were linked to endocrine [ROR (95% CI)=1.91 (1.47-2.47); PRR (95% CI=1.90 (1.47-2.46)] and genitourinary disorders [ROR (95% CI)=1.92 (1.59-2.31); PRR (95% CI)=1.90 (1.58-2.28)]. Conclusion: NSAID classes demonstrate distinct AE disproportionality patterns, suggesting class-specific organ susceptibilities. These findings emphasize the need for personalized NSAID selection and further research into predictive safety models.
미국, 유럽, 한국의 의약품 규제기관 자문기구 비교 연구
한국임상약학회 한국임상약학회지 제35권 제4호 2025.12 pp.243-256
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4,600원
Background: Regulatory agencies operate their own advisory committee with external experts to address complex scientific issues in the approval of pharmaceutical products. However, each advisory committee operates very differently. Hence, the authors performed a comprehensive gap analysis among the committees operated by Food and Drug Administration (FDA), European Medicines Agency (EMA) and Ministry of Food and Drug Safety (MFDS). Methods: The regulations, guidelines, minutes and reports on advisory committees were retrieved from the websites of FDA, EMA and MFDS. A gap analysis comparing the advisory committees of each regulatory authority was performed, including the disclosure of information and meeting procedures, and conflict-of-interest policies. Results: Substantial differences were found among the advisory committees in the strictness of conflict-of-interests and the transparency of meeting details. Whereas FDA and EMA disclose the detailed curriculum vitae of each committee member, MFDS does only names and majors. Whereas FDA live-streams each meeting and publishes the transcript of all dialogues by each member, EMA and MFDS release only anonymized summary minutes without live broadcasts. Whereas FDA and EMA require members to disclose their financial interests, MFDS merely requires signing a statement that confirms no conflict-of-interest. Conclusions: Compared with Advisory Committee of FDA and Scientific Committee of EMA, the Central Pharmaceutical Affairs Advisory Committee (CPAAC) of MFDS appears to require substantial improvements in the disclosure of conflict-of-interests and the transparency of meeting details. This gap analysis will likely serve as a basis for policy discussions to improve the credibility of CPAAC.
소아청소년 코로나바이러스감염증-19의 임상적 특성과 약물 요법
한국임상약학회 한국임상약학회지 제35권 제4호 2025.12 pp.257-266
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4,000원
Coronavirus disease 2019 (COVID-19) generally presents with milder illness in children and adolescents than in adults; however, infants and those with underlying chronic conditions, obesity, or immunocompromised states remain at increased risk for severe disease and death. Multisystem inflammatory syndrome in children (MIS-C) affects multiple organs, including the heart, gastrointestinal tract, and skin, and can result in severe illness requiring hospitalization or death. In children and adolescents, long COVID manifests with age-dependent, heterogeneous symptoms, leading not only to persistent physical complaints but also to neurologic manifestations and mental health problems. Therefore, evidence-based clinical guidelines and approved treatments for COVID-19 in children and adolescents remain limited, and research is needed to build a pediatric evidence base. Generating high-quality data is essential to develop optimized diagnostic and therapeutic strategies, establish standardized care pathways, and ultimately improve preparedness and outcomes for children and adolescents during future emerging infectious disease outbreaks. In this clinical information article, we review the epidemiology, clinical symptoms, complications, and drug treatment of COVID-19 in the pediatric population.
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