Nam Kyung Choi

Backgrounds: Real-world data (RWD) are drawing ever-increasing attention in the pharmaceutical industry. We survey to understand the current status of RWD utilization and gather opinions on improving its usage. Methods: We surveyed RWD utilization related to pharmaceutical companies' conducting and planning RWD studies. A survey was distributed to 181 members of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association and 47 members of the Korean Research-based Pharma Industry Associati

2019년 12월 중국 우한시에서 최초 보고된 코로나바이러스감염증-19(코로나19)는 전 세계적으로 대유행을 일 으켰다. 한국은 코로나19 백신이 개발되지 않았던 초반에 사회적 거리두기 정책을 실시하며 코로나19 확산을 억제하 려고 노력하였다. 하지만 다양한 방역 정책을 추진함에도 불구하고 코로나19 확진자가 지속적으로 증가하였고, 이에 코로나19 바이러스의 감염 및 전파를 예방하는 효과적인 수단인 코로나19 예방접종의 중요성이 강조되었다. 2020년 하반기에 코로나19 백신이 개발 및 생산되면서 2021년 2월 26일에 국내에서 첫 코로나19 예방접종이 시작되었다. 국 내 코로나19 대응 과정과 예방접종 전략은 미래의 신종감염병을 대비하는 중요한 수단으로써 주요 사항들을 파악하 는 것이 필요하다. 이에 본 연구는 국내에 도입된 코로나19 백신 종류, 예방접종기관, 예방접종 일정, 코로나19 대유 행 및 사회적 거리두기 정책에 대해 살펴보고자 한다. 한국은 바이러스벡터 백신 2종(아

Vaccines require stricter safety standards than most other medicinal products because they are given to healthy individuals. Despite various activities by national agencies, public concern about the vaccine safety often arises. Post-marketing activities for vaccine safety can be broadly classified into passive surveillance and active surveillance. Many countries as well as Korea, operate passive drug safety surveillance systems that report adverse events related to medications, including vaccine

Since the outbreak of the Covid-19 pandemic, multinational pharmaceutical companies have accelerated vaccine development at an unprecedentedly rapid pace. The safety concerns about Covid-19 vaccines may lead to the increasing number of people with vaccine distrust, making it difficult to maintain the vaccination rate for obtaining herd immunity. Therefore, some countries, including the United States (US) and Europe, have selected adverse event of special interests(AESIs) and planned to conduct v

-연구목적:본 연구는 국내외 보건 성차 연구 관련 기관의 현황과 사업을 살펴봄으로써 국내 성차 연구 활성화 방안을 모색하고자 한다. -연구방법:성차 연구가 활발히 이루어지고 있는 캐나다, 미국, 유럽을 중심으로, 성차 연구를 지원하고 수행하는 기관과 성차의학에 관한 전문학술지를 발간하는 주요 기관을 조사하였다. 각국 주요 기관의 공식 홈페이지를 통해 설립 배경, 주요 사업 및 성과, 추진 전략 등 핵심 정보를 종합적으로 정리하였다. -연구결과:캐나다는 캐나다 국립보건원(Canadian Institutes of Health Research, CIHR), 미국은 국립보건원(National Institutes of Health, NIH), 여성 건강 연구 협회(Society for Women’s Health Research, SWHR), 성 차이 연구 기구(Organization for the Study of Sex Differences, OSSD)가 성차 연구를 주도하고 있다. CIHR

Safety issues have arisen as vaccines have been rapidly vaccinated following a relatively short clinical trial period to prevent COVID-19 infection. In signal detection, based on disproportionality analysis, it is necessary to select an appropriate comparator because the results vary depending on the comparison group. To detect meaningful signals, we compared COVID-19 vaccines with Influenza vaccines, which targets respiratory diseases similarly and has well-known safety profile. We used adverse

한국은 의약품 규제의사결정에서 실사용자료(Real world data, RWD) 및 실사용 증거(Real world evidence, RWE)를 활용하기 위해 노력하고 있지만 실현되기에 아직 해결되어야 할 과제들이 많다. 본 연구는 미국, 유럽 및 국제기관에서 개발된 RWD/RWE 가이드라인을 국내 현황과 비교하여 국내 RWD/RWE 가이드라인 개발 우선순위를 도출하고자 하였다. 우리는 총 미국의 11개, 유럽의 11개, 기타 국제기관의 9개, 한국의 3개 가이드라인을 조사하였으며 국내외 개발현황의 격차확인을 위해 조사한 가이드라인을 주제에 따라 다음과 같은 6가지 기준으로 분류하였다: 1) RWD/RWE 프레임워크, 2) RWD 활용 연구수행 방법, 3) RWD 품질 및 표준화, 4) RWD 활용 연구 관련 양식, 5) 특정 데이터 중심 및 6) 특정 대상자 중심 RWD 가이드라인. 연구결과, 고품질 RWE를 생성하기 위한 전반적인 프레임워크가 가장 우선적으로 제시되어야 하며 점차

This Study aimed to establish consensus on conceptual foundations, terminology, and methodological relationships among self-controlled “trigger” study designs, which inherently control for time-invariant confounding and assess associations between transient exposures (potential triggers) and acute outcomes. Supported by the International Society for Pharmacoepidemiology (ISPE), a working group developed standardized guidance comparable to the Strengthening the Reporting of Observational Studies

To determine the utilization of potassium-competitive acid blockers (P-CABs) and explore the impact of expanded insurance coverage for P-CABs on their usage. Methods: The utilization of revaprazan, tegoprazan, and fexuprazan was analyzed using claims data from the Health Insurance Review & Assessment Service spanning January 2016 to May 2023. Prescriptions were identified for cases with a diagnosis of acid-related conditions. Monthly drug utilization was calculated per 100,000 population using t

As the safety issues of medical products have been continuously generated, the need for long-term safetymanagement, such as long term follow-up (LTFU), has been emerged. Current laws and regulations in Korea, however,have limitations to implement LTFU and track medical products immediately. This review examines the current status ofsafety management of medical products in Korea to propose future plan for establishing medical products LTFU systemin Korea. We review the laws and regulations for sa

The increase in polypharmacy in elderly patients is recognized as a serious health, economic, and socialproblem. Warfarin and statins are commonly co-administered to cardiovascular disease patients. However, there is apotential risk of drug-drug interaction (DDI). The objective of this study was to detect signals of adverse events (AEs) forDDI after concomitant use of warfarin and statins using Korea adverse events reporting system (KAERS) database. KAERS database from January 2016 to December 2

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 researchers in utilizing claims data and discuss improvement strategies. We summarized practical difficulties encountered by researchers who have experience using claims data from the National Health Insurance Service and the Health Insurance Review and Assessment Service. Challenges en

To compare and evaluate pharmacological treatment recommendations for neuropsychiatric comorbidities, this study analyzed national clinical guidelines for Attention- Deficit/Hyperactivity Disorder (ADHD). Methods: A structured literature search identified national ADHD guidelines published between 2015 and 2024 from Organisation for Economic Co-operation and Development (OECD) countries. Guidelines were included if they provided pharmacological recommendations for neuropsychiatric comorbidities.

Objectives: This study aimed to estimate background incidence rates (IR) for adverse events of special interest (AESI) associated with COVID-19 vaccines in South Korea. Methods: We used data from the Korean National Health Insurance Service-National Sample Cohort from January 1, 2015 to December 31, 2019, with IR calculated annually. Eight AESIs including acute myocarditis, acute pericarditis, acute disseminated encephalomyelitis (ADEM), acute transverse myelitis (ATM), encephalitis, anaphylaxis

The 23-valent pneumococcal polysaccharide vaccine (PPSV23) was introduced as part of Korea's nationalimmunization program (NIP) in May 2013 for people aged 65 years and older. We aimed to describe the immunizationstatus of Korean elderly aged 65 years and older who had received a first dose of PPSV23 via the NIP and to analyzethe cumulative PPSV23 vaccination coverage rates. A descriptive study was conducted using the Korea ImmunizationRegistry Information System. The study included adults aged