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인플릭시맵 바이오시밀러 도입 이후 TNF-α 억제제 사용 변화 및 지출 영향 분석
노윤하(Yunha Noh),윤동원(Dongwon Yoon),신주영(Ju-Young Shin) 대한약학회 2020 약학회지 Vol.64 No.1
Tumor necrosis factor α (TNF-α) inhibitor, biologics for immunosuppression, is widely used for various kinds of autoimmune disease and it has contributed to improving patients’ prognosis. With the expiration of its patent, biosimilars have emerged since September 2012 in South Korea. The competitive cost of biosimilars can lead to significant impact on national health insurance finance. Thus, we aimed to estimate budget impact of the introduction of infliximab biosimilar. Overall trends of utilization and expenditure among TNF-α inhibitors were presented using the National Health Insurance Service-National Sample Cohort database, between May 2011 and December 2013. We conducted segmented regression of interrupted time series analysis to evaluate impact of biosimilar introduction. Utilization and expenditure of TNF-α inhibitor had generally increased during study period. Both quantitative usage and drug expenditure of infliximab biosimilar have significantly increased, while those of etanercept have decreased, since the introduction of infliximab biosimilar. The estimated expenditure savings due to the introduction of infliximab biosimilar was about 52 billion won, which greatly contributed to the reduction of the price of the infliximab original rather than the reduction from the use of infliximab biosimilar. In conclusion, the introduction of biosimilar presented substantial savings of expenditure. Further study will be needed to assess comprehensive impact of other biosimilars introduction.
한국, 일본, 대만에서의 의약품 부작용 피해구제 제도 현황 조사
안상완(Sang-Wan An),노윤하(Yunha Noh),백연희(Yeon-Hee Baek),박한희(Han-Heui Park),박소희(So-Hee Park),박성민(Sungmin Park),신주영(Ju-Young Shin) 대한약학회 2019 약학회지 Vol.63 No.4
Abstract The adverse drug reaction relief system is no-fault compensation system which provides compensation for severe injuries that were caused by adverse reaction even after proper use of medicines. The purpose of this study is to evaluate current status of the adverse drug reaction relief system in Japan, Taiwan, and Korea. We investigated the relief system in above three countries through websites, literatures, reports, spot investigation and e-mail questionnaires. Although great similarities for the relief system were recognized among the three countries, the difference among the countries and the unique characteristics of each country’s relief system was also identified; for example, the relief for injuries by offlabel uses, details of relief benefits, the relief payment for the adverse drug reactions, and the compensation for medical expenses which is classified as non-reimbursement treatment. Therefore, it is possible to establish more valuable no-fault compensation system in Korea through application of advantage and experience for the relief system in Japan and Taiwan.
신주영(Ju-Young Shin),노윤하(Yunha Noh),박병주(Byung-Joo Park) 대한약학회 2020 약학회지 Vol.64 No.3
Patient-safety incidents consistently take place around the world, and the extent of the damage from the incidents is considerable. To improve safety of patients and prevent adverse events, a variety of activities and systems have been set up to report and manage patient safety at both international and national levels. This paper summarizes the type and cause of adverse drug reactions, as an important part of patient safety, and addresses the drug safety systems of Korea for monitoring and minimizing the occurrence of adverse drug reactions.
미국, 유럽, 일본의 레지스트리 구축 등 데이터기반 의료제품의 안전관리 동향
이정은(Jeong-Eun Lee),심다영(Da-Young Shim),윤동원(Dongwon Yoon),노윤하(Yunha Noh),신주영(Ju-Young Shin) 대한약학회 2020 약학회지 Vol.64 No.5
Over the past years regulatory agencies of Europe, the United States, and Japan have announced policies to facilitate the establishment and utility of registries at the national level in order to enhance post-marketing surveillance. With the recent increase in medical products safety issues, the Ministry of Food and Drug Safety (MFDS) is planning to build a patient registry system to monitor the safety of problematic products. The objective of this study is to examine the initiatives and the activities of health authorities in the US, Europe, and Japan and identify the essential features of well-operated registries. We collected information from official documents and postings on the health authority’s homepages about activities and efforts of the initiatives. We also surveyed and analyzed the official reports, the guide for each stakeholder of registries, and the information sheets for patients or doctors as case studies of well-designed registries. Therefore, this study suggests future directions on how to plan a long-term follow-up system and on how to design national level registries in Korea.
박고은 ( Goeun Park ),정윤현 ( Yunhyun Chung ),조다은 ( Daeun Cho ),김수현 ( Soohyun Kim ),노윤하 ( Yunha Noh ),박정규 ( Junggyu Park ),유견아 ( Kyeonah Yu ) 한국정보처리학회 2023 한국정보처리학회 학술대회논문집 Vol.30 No.2
학교상담은 학생들의 학업 및 심리적 건강을 촉진하는 핵심 구성 요소 중 하나로 자리 잡고 있으며, 코로나 19 로 인한 언택트 시대로의 전환은 비대면 상담 방식의 혁신을 촉발하였다. 본 연구는 AI 챗봇을 활용한 상담 서비스를 통해 학교상담의 효과를 높이고, 학생들의 학업 및 심리적 건강에 대한 지원을 강화하는 데 주력한다. 이러한 연구는 미래의 학교 상담 서비스 분야에 크게 이바지할 것으로 기대된다.