외국 약사 국가시험 문항관리 분석연구

권경희,임성실,손의동,Kwon, Kyenghee,Lim, Sung Cil,Sohn, Uy Dong 대한약학회 2015 약학회지 Vol.59 No.5

The goal of this study is to help for the utilization the national pharmacists test through the analysis of item development management to the foreign pharmacists examination. The United States is going to NABP (National Association of Boards of Pharmacy) initiative under the curriculum in question on the basis of this assessment and develop standards and unified, systematic system to conduct tests pharmacist. Practice oriented (patient scenario, the participation of a pharmacist or perform work, clinical practice) examination is doing in Canada, The UK is asking the for more than 70 percent and the prescription needed for actual calculation in practice prior to testing program, and by the including that allows references use. Our country may introduce the job as a clinical pharmacist, positively. Item management system is integrated into four regions based on the six-year curriculum should be done in harmony proportion of each region. Integration of fusion of each region in accordance with the duties should be come out. It has gradually been able to item management system developed by the United States or Canada. This item notice pharmacist judging the results of the work must be carried out for management upgrading to a form of management with an emphasis on clinical practice in developed countries. Foundation design, development, production and management and test after actively reviewing ways to improve management system for to management systems, a pharmacist to improve the quality of the national examination could be contributing are involved.

환자 안전 측면에서 살펴본 분할 불가 정제 의약품의 분할선 사용 현황

양진욱(Jinwook Yang),권경희(Kyenghee Kwon) 대한약학회 2020 약학회지 Vol.64 No.4

Scoring is marked by a groove on the tablet surface to facilitate easy division or splitting into two or more equal pieces. It allows easy swallowing in different populations and to maintain weight and dose uniformity among fractions. In Korea, however, an undividable tablet is scored, which confuses consumers about the splitting efficacy. This study aims to clarify the scoring status of an undividable tablet and propose a policy for improvement. Public data obtained from the Ministry of Food and Drug Safety (MFDS) were utilized for the frequency analysis according to the physical and pharmaceutical characteristics of the product. The results showed that 33 products, i.e., 2.5% of all 1,300 undividable medicines, were scored. It was estimated that either the general practice to engrave scoring to facilitate dose adjustment or to distinguish appearance leads to confusion, and interferes with the function of the scoring and dosage form. In Korea, due to ambiguous scoring standards and poor consensus regarding the function of scoring, the regulatory framework for tablet scoring is incomplete. In contrast, foreign regulatory bodies such as FDA and EMA prohibit scoring of undividable tablets and provide a legal basis to ensure the quality of the split portion of medicines. Efforts by doctors, pharmacists and consumers as well as pharmaceutical companies are needed for appropriate scoring. We expect a prompt regulatory mechanism to promote drug safety.

한국, 미국, 유럽의 국제공통기술문서 Module 1 제출양식 중 의약품 표시에 관한 자료 비교 연구

양진욱(Jinwook Yang),권경희(Kyenghee Kwon) 대한약학회 2023 약학회지 Vol.67 No.6

국가별 무광고 표준담뱃갑 정책의 비교 분석: 담뱃갑과 담배 개비의 디자인 요소를 중심으로

양진욱 ( Yang Jinwook ),권경희 ( Kwon Kyenghee ) 한국보건사회연구원 2021 保健社會硏究 Vol.41 No.3

보건복지부에서는 담뱃갑과 담배 개비의 색상과 디자인 등을 표준화하여 광고 및 판촉 효과를 억제하는 무광고 표준담뱃갑 정책의 도입 추진을 2019년에 발표하였다. 이에 본 연구에서는 무광고 표준담뱃갑 정책을 도입한 국가 중 호주, 영국, 뉴질랜드, 캐나다의 관련 법령 및 가이드라인을 토대로 국가별 규제 요소를 비교하였다. 연구 결과, 각 국가에서는 담뱃갑 포장의 색, 개폐 방식, 크기, 표시 정보의 기재 방법, 개비의 길이와 지름, 개비에 기재하는 정보의 유형 등을 서로 유사하게 규제하고 있다. 하지만, 일부 규제 요소의 경우 국가별 규제 수준에 분명한 차이가 있어 우리나라에 적용 시 면밀한 검토가 필요하다. 특히, 시간이 지남에 따라 정책의 효과를 높이기 위한 규제 요소들이 추가·변경되고 있어 정책 입안 과정에서 최신 규제 동향을 충분히 검토해야 한다. 본 연구의 결과는 향후 정책 도입 시 법령 제정의 기초자료로 활용될 수 있을 것으로 기대된다. In 2019, the Ministry of Health and Welfare introduced a plain packaging policy for standardizing the color and design of conventional cigarette packs to suppress the effects of advertisements and promotions. In this study, the relevant laws and guidelines of Australia, the United Kingdom, New Zealand and Canada were searched on the website of each country’s regulatory agency. The regulatory elements of these countries were then compared. The results showed that each country similarly regulates the color, structure, and size of conventional cigarette packs, labeling information, the length and diameter of conventional cigarette sticks, the type of information labeled on the stick, and so on. However, some regulatory elements showed clear differences in the level of regulation by country. Thus, a close review is required when applying such elements to Korea. In particular, over time, regulatory elements to increase the effectiveness of the policies are being added or changed. Therefore, the latest regulatory trends must be thoroughly reviewed in the policy-making process. The results of this study are expected to be used as basic data for the enactment of laws and regulations in Korea when introducing policies in the future.

국내 의약품 규제업무(RA) 전문인력 양성에 필요한 역량과 지식에 대한 산업체의 교육요구도 분석

이대성(Daesung Lee),권경희(Kyenghee Kwon) 대한약학회 2023 약학회지 Vol.67 No.4

FDA와 EMA에서 시판허가된 AAV 기반 유전자치료제의 규제 및 임상시험 설계 측면에서의 사례 연구

안연희(Yoenhee Ahn),김종원(Jongwon Kim),권경희(Kyenghee Kwon) 대한약학회 2023 약학회지 Vol.67 No.6

미국 FDA 허가 심사자료를 토대로 본 마이크로바이옴 기반 치료제 개발의 전략적 접근

장수영(Sooyoung Jang),김종원(Jongwon Kim),권경희(Kyenghee Kwon) 대한약학회 2024 약학회지 Vol.68 No.3

The development of microbiome-based therapeutics has received considerable attention, as our understanding of the complex interactions between the microbiome and humans deepens. The potential of microbiome-based therapeutics has been proved by the US FDA’s approval of two fecal microbiota transplantation (FMT) products. This study analyzes FDA approval documents of two microbiome-based therapies, RebyotaTM and VowstTM, to identify regulatory science evidence, and to provide insights into the development and regulation direction of Live Biotherapeutic Products (LBPs). Strategic use of expedited review programs to reduce time and cost during the approval process, standardized manufacturing processes to ensure consistent quality and safety, preparation of nonclinical studies tailored to productspecific characteristics, and addressing changing unmet medical needs are essential for successful therapeutic development and rapid market entry. Strategic approaches are essential in the development of microbiome-based therapeutics, and we look forward to the continued application and evolution of these approaches in the future.

국가별 전자적 형태의 의약품 첨부문서(e-라벨) 제공 현황 분석: 한국, 미국, 유럽, 일본, 싱가포르를 중심으로

이재성(Jaesung Lee),양진욱(Jinwook Yang),권경희(Kyenghee Kwon) 대한약학회 2024 약학회지 Vol.68 No.4

Recent amendments to the Pharmaceutical Affairs Act permit certain prescription drugs in South Korea to provide packaging leaflets electronically, referred to as e-labels. As this system has been adopted internationally, variances in information delivery mechanisms necessitate a review to guarantee both readability and utility. This study compares elabel regulations in Korea, Japan, the U.S., Europe, and Singapore. In Korea, the Act does not distinguish between the targets of the drug package insert and allows the e-labels to replace the paper package insert. Japan similarly provides elabels based on the law, but only for prescription drug package inserts for HCPs. Singapore is running a pilot based on guidelines for e-labeling issued by the regulator. It started with the package inserts for HCPs for prescription medicines but has recently expanded its e-labeling to include non-prescription medicines. In Europe, electronically provided medicinal product information is known as ePI, and a pilot project is underway to establish core principles and utilization plans for providing it. In particular, the e-labels will not replace the paper inserts and will ensure maximum accessibility and use of the information by consumers. In the U.S., the proposal to make prescribing information for HCPs available only electronically failed to reach a consensus on the public health benefits, so drug information is still provided in the same way. As e-labeling is a global trend, Korea will adopt it, but institutional mechanisms are needed to reduce drug information blind spots that inevitably occur in the process. We hope that the e-labeling system will be established to ensure consumers’ right to know, reduce drug information blind spots, and ultimately contribute to improving public health.

과도한 의약품 시장독점 방지를 위한 연장된 특허권 존속기간의 비교

김소희(Sohee Kim),이대성(Daesung Lee),최형빈(Hyungbin Choi),권경희(Kyenghee Kwon) 대한약학회 2022 약학회지 Vol.66 No.6

The extended patent term or exclusivity period from pharmaceuticals’ approval date is limited to 14 years in the US or 15 years in the EU. However there are no such restrictions in Korea, so the market exclusivity can be excessively extended. Therefore, the status of extension of patent term in Korea was analyzed and the patent term from the product’s approval date in Korea, the US, Japan, the UK, France, and Germany were compared. For that, the following information from NEDRUG or KIPRIS were collected and analyzed: the filing date of the patent, whether the patent term has been extended, the expiration date of the patent term, approval date, the products’ name, and representative claims. Alecensa, Xalkori, Biktarvy, and Champix were selected for the comparison. Among 597 patents in Korea, 90.1% (538) were extended and 17.1% (102) of patents exceeded 14 years from the approval date. There were 81 and 60 products that have patents whose term exceeds 14 and 15 years from the approval date, respectively. In the comparative cases of 4 products, the patent term from products’ approval date in Korea is longer than 14 or 15 years, whereas the US, the UK, France, and Germany comply with the regulated limitation. The excessive patent protection delays the market entry of lower-cost generics and leads to an increase in financial burden on healthcare cost. To address such problems, a proper limitation on the extension of the patent term from the product’s approval date needs to be established.