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외래약국 복약이행도에 영향을 미치는 요인 연구 - 제3기(2005년) 국민건강영양조사자료를 근거로 -
권진원(Jin-Won Kwon),박은자(Eun Ja Park),손현순(Hyun Soon Sohn) 대한약학회 2011 약학회지 Vol.55 No.6
This study was to identify factors influencing drug compliance based on the subjects' interview regarding community pharmacy utilization for 2 weeks, in 2005 KNHANES. Good compliance was regarded as important factors in improving the effectiveness and minimizing adverse drug reaction, resulting in reducing the medical costs. 83% of total 11,208 pharmacy visits in 7,066 subjects showed good compliance. Good satisfaction for pharmacist's medication counseling (OR=2.23, 95% CI 1.92-2.58), higher out-of-pocket money (OR=1.32, 95% CI 1.14-1.54), and users of prescription drugs than non-prescription (OR=2.21, 95% CI 1.91-2.57) drugs were significant factors for better compliance. Disease of nervous system and mental and behavioral disorders showed lower drug compliance.
권진원(Jin-Won Kwon),송윤경(Yun-Kyoung Song),이승미(Seung-Mi Lee),박은혜(Eun-Hye Park),시아차린가린다(Siachalinga Linda),박희영(Hee Young Park),공수진(Su Jin Kong),이인향(Iyn-Hyang Lee) 대한약학회 2021 약학회지 Vol.65 No.2
This study sought to understand the current regulatory collaboration practices of reference country systems in selected countries. The study included eight countries, namely; Nigeria, South Africa, Malaysia, Vietnam, Singapore, Indonesia, Switzerland, Mexico, and two alliances;, namely European Union and ACCESS consortium. The latest data on the reference country systems in the selected countries were collected and analyzed. The reference regulatory authorities include (1) internationally recognized countries (e.g., Stringent Regulatory Authority, SRA), (2) internationally recognized collaborations (e.g. Pharmaceutical Inspection Co-operation Scheme), (3) internationally recognized programs (e.g., WHO Prequalification), and (4) mutual recognition between countries. The SRA is the most frequently mentioned reference in unilateral reference systems, which are not based on mutual recognition. A reference country system could affect regulatory processes in two ways; either by countries requiring market approval from a reference country as a condition for a new application or by reducing the period of review if an applicant submits an assessment report and relevant data reviewed by a reference country. The European Union Mutual Recognition has resulted into efficient work-flow among member states, and similar international alliances are emerging. Of these, the ACCESS consortium is seeking the possibility of a new collaboration not based on geographical region, in contrast to regional collaboration, which seems seclusive to worksharing among nonequivalent member states.
이유민(Yum-Min Lee), 권진원(Jin-Won Kwon) 한국보건사회약료경영학회 2023 한국보건사회약료경영학회지 Vol.11 No.1
Several gene therapies have market authorization in US FDA since 2017, and Zolgensma was approved in Korea and marketed under national health insurance program from 2022. Market approval of gene therapy drugs are expected to increase dramatically in the near future. Hospitals and pharmacists are required to prepare for the application of gene therapy because gene therapy is a high-tech biopharmaceutical that requires stringent standard operation procedure and has biological risks and high price. This study reviewed the existing literatures to understand the role of pharmacists in relation to gene therapy using pubmed, embase, and Korean literature database. A total of 7 literatures were selected in western society and there were no published articles in Korea. The roles of pharmacists are grouped into 16 categories. Important roles include control of viral shedding and seroconversion, prevention of immune responses, and pharmacovigilance and post-marketing surveillance. The active involvement of hospital pharmacists in the entire process of gene therapy would be essential factors for safe and effective treatment of patients.
의약품 인허가 과정에서 허가참조제도에 대한 전문가 심층 의견
이인향(Iyn-Hyang Lee),권진원(Jin-Won Kwon),송윤경(Yun-Kyoung Song),이승미(Seung-Mi Lee),박은혜(Eun-Hye Park) 한국보건사회약료경영학회 2022 한국보건사회약료경영학회지 Vol.10 No.2
Each country is trying to enhance the efficiency of pharmaceutical licensing procedure by designating their own reference countries that have extensive experience in pharmaceutical regulatory affairs. This study aimed to investigate how Korea can become a regulatory advanced country that other countries can refer to in the pharmaceutical licensing procedure. Focus group or in-depth interviews were conducted with 8 pharmaceutical regulatory experts. The collected data were analyzed using the framework analysis technique. The three themes that emerged from the interviews were; the effectiveness of reference country system, possibilities and obstacles for Korea to become a reference country for other countries, and the prospect for Korea to become a reference country. The positive and negative aspects of reference country system were discussed. The possibility of Korea becoming a reference country for other countries was discussed in two ways; mutual recognition and unilateral recognition. Lastly, it was discussed that it is necessary to enhance the international status of the Ministry of Food and Drug Safety and to change the paradigm of the domestic pharmaceutical market in order for Korea to become a reference country. Based on the above results, short-term and mid-to-long-term strategies were presented for Korea to become a reference country for pharmaceutical licensing procedure as a measure to promote overseas expansion of domestic pharmaceutical companies.
Chimeric Antigen Receptor T Cells (CAR-T) 세포 치료에서 병원약사의 역할
설정은(Jung-Een Sul),변지혜(Ji-Hye Byun),김동균(DongKyun Kim),권진원(Jin-Won Kwon) 한국보건사회약료경영학회 2022 한국보건사회약료경영학회지 Vol.10 No.2
Chimeric antigen receptor (CAR)-T cell therapy, a cell based gene therapy, has been covered as a condition of the performance- based refund under national health insurance system since April 2022. Accordingly, the effectiveness and adverse drug reaction of CAR-T cell therapy should be reported to the Health Insurance Review and Assessment. (HIRA). Hospital pharmacists are expected to be responsible for monitoring the CAR-T cell therapy. Thus, literature review was conducted to determine the role of hospital pharmacists in the CAR-T cell therapy. There were no related articles in searching the domestic database, and seven articles were selected from PubMED database. Most of them were review-type papers describing the role of pharmacists, and one of them developed practical guidelines for hospital pharmacies. The roles of pharmacists were summarized into nineteen categories. Critical roles include developing standard operating procedures, training staff and patients, managing T cell collection, preparing and storing CAR-T cell, and monitoring and managing adverse drug reaction. The participation of hospital pharmacists in the process of CAR-T cell therapy can improve the effectiveness and safety of patients, and the responsibilities of hospital pharmacists should be standardized within a multidisciplinary team.
박혜영(Hae-Young Park),안세나(Sena An),전수민(Soo Min Jeon),권진원(Jin-Won Kwon) 대한약학회 2020 약학회지 Vol.64 No.5
Studies on the burden of disease for the patients with non-Hodgkin’s lymphoma (NHL) which accounts for about 90 percent of lymphoma are still insufficient. Thus, this study was conducted to assess mortality and economic burden of NHL overall and subtypes. This analysis based on a sample cohort database from the National Health Insurance Sharing Service. ICD-10 codes were used to select NHL patients (C82-86, C96) and to classify subtype of NHL. A retrospective cohort design was applied and patients and their matching controls were compared on survival and medical expenditure using Cox hazard proportion model and generalized linear regression. The 5-year survival rates were 66.2% in NHL total patients (n=521) and 61.7% in diffuse large B-cell lymphoma and male and aged ≥80 showed higher risk for survival. The 5-year cumulative medical expenditure after first diagnosis of NHL was 37.1 million won, and about 44% of the expenses were spent during the first year. The 5-year costs were 4.09 times higher than those of controls, and comorbidity index, older age, and death increased the medical expenditure. In conclusion, NHL caused lower survival and higher medical costs compared to the non-cancer controls, and this study confirmed that subtype of NHL, gender, age, comorbidity and death had a significant impact on the burden of the disease.
박혜영,Sena An,박수잔,Dong-Ha Kim,Hye Ok Kim,Jeong-Mi Kwon,권진원 대한약학회 2019 약학회지 Vol.63 No.1
This study aimed to assess the cost-effectiveness of insulin glargine/lixisenatide (iGlarLixi) in comparison with premixed insulin for patients with basal insulin-uncontrolled type 2 diabetes in South Korea. The CORE Diabetes Model, a Markov model, was used with the following settings: a 30 year horizon, a payer perspective, and a 3% discount rate. Each treatment was assumed to be administered for the first 3 years, and then switched to rescue regimen. The baseline HbA1c and body mass index (BMI) were 8.6 ± 1.3%, and 24.4 ± 3.3 kg/m2 , respectively. Indirect treatment comparisons showed that iGlarLixi resulted in significantly greater reduction from baselines for HbA1c and BMI compared with premixed insulin; −0.50% (95% confidence interval (CI): −0.68, −0.32) for HbA1c and −0.80 kg/m2 (95% CI: −1.29, −0.31) for BMI. In the base analysis, iGlarLixi was found to be dominant (more effective and less costly) over premixed insulin with 0.079 additional quality-adjusted life-years and lowered cost by approximately 230 USD, and the incremental costutility ratios from sensitivity analyses also remained dominant or below 10,000 USD. This study demonstrated that iGlarLixi was cost effective for treating patients with type 2 diabetes with poor glucose control on basal insulin in comparison with premixed insulin in South Korea.