Cost-effectiveness of Pharmaceutical Interventions to Prevent Osteoporotic Fractures in Postmenopausal Women with Osteopenia

권진원,박혜영,김예지,문성환,강혜영 대한골대사학회 2016 대한골대사학회지 Vol.23 No.2

Background: To assess the cost-effectiveness of drug therapy to prevent osteoporotic fractures in postmenopausal women with osteopenia in Korea. Methods: A Markov cohort simulation was conducted for lifetime with a hypothetical cohort of postmenopausal women with osteopenia and without prior fractures. They were assumed to receive calcium/vitamin D supplements only or drug therapy (i.e., raloxifene or risedronate) along with calcium/vitamin D for 5 years. The Markov model includes fracture-specific and non-fracture specific health states (i.e. breast cancer and venous thromboembolism), and all-cause death. Published literature was used to determine the model parameters. Local data were used to estimate the baseline incidence rates of fracture in those with osteopenia and the costs associated with each health state. Results: From a societal perspective, the estimated incremental cost-effectiveness ratios (ICERs) for the base cases that had T-scores between -2.0 and -2.4 and began drug therapy at the age of 55, 60, or 65 years were $16,472, $6,741, and -$13,982 per quality-adjusted life year (QALY) gained, respectively. Sensitivity analyses for medication compliance, risk of death following vertebral fracture, and relaxing definition of osteopenia resulted in ICERs reached to $24,227 per QALY gained. Conclusions: ICERs for the base case and sensitivity analyses remained within the World Health Organization’s willingness-to-pay threshold, which is less than per-capita gross domestic product in Korea (about $25,700). Thus, we conclude that drug therapy for osteopenia would be a cost-effective intervention, and we recommend that the Korean National Health Insurance expand its coverage to include drug therapy for osteopenia.

Proper Management of Posttraumatic Tension Pneumocephalus

권진원,나형균,박해관,조정기,주원일,조성훈,구원모,문원준,한재성 대한신경손상학회 2017 Korean Journal of Neurotrauma Vol.14 No.2

Pneumocephalus is commonly seen after craniofacial injury. The pathogenesis of pneumocephalus has been debated as towhether it was caused by ball valve effect or combined episodic increased pressure within the nasopharynx on coughing. Discontinuous exchange of air and cerebrospinal fluid due to “inverted bottle” effect is assumed to be the cause of it. Delayed tension pneumocephalus is not common, but it requires an active management in order to prevent serious complication. We represent a clinical case of a 57-year-old male patient who fell down from 3 m height, complicated by tensionpneumocephalus on 5 months after trauma. We recommend a surgical intervention, but the patient did not want that so weobserve the patient. The patient was underwent seizure and meningitis after 7 months after trauma, he came on emergencyroom on stupor mentality. Tension pneumocephalus may result in a neurologic disturbance due to continued air entrainment and it signifcantly the likelihood of intracranial infection caused by continued open channel. Tension pneumocephalus threat a life, so need a neurosurgical emergency surgical intervention

Proper Management of Posttraumatic Tension Pneumocephalus

권진원,나형균,박해관,조정기,주원일,조성훈,구원모,문원준,한재성 대한신경손상학회 2017 Korean Journal of Neurotrauma Vol.13 No.2

Pneumocephalus is commonly seen after craniofacial injury. The pathogenesis of pneumocephalus has been debated as towhether it was caused by ball valve effect or combined episodic increased pressure within the nasopharynx on coughing. Discontinuous exchange of air and cerebrospinal fluid due to “inverted bottle” effect is assumed to be the cause of it. Delayed tension pneumocephalus is not common, but it requires an active management in order to prevent serious complication. We represent a clinical case of a 57-year-old male patient who fell down from 3 m height, complicated by tensionpneumocephalus on 5 months after trauma. We recommend a surgical intervention, but the patient did not want that so weobserve the patient. The patient was underwent seizure and meningitis after 7 months after trauma, he came on emergencyroom on stupor mentality. Tension pneumocephalus may result in a neurologic disturbance due to continued air entrainment and it signifcantly the likelihood of intracranial infection caused by continued open channel. Tension pneumocephalus threat a life, so need a neurosurgical emergency surgical intervention

경제성평가

권진원 대한외과학회 2012 대한외과학회 학술대회 초록집 Vol.2012 No.11

Current Status of the National Liver Cancer Surveillance Program in Korea

권진원,최하진,서재경,신상진 한국보건의료기술평가학회 2017 보건의료기술평가 Vol.5 No.2

Objectives: Surveillance for liver cancer has been shown to improve survival via earlier cancer detection. Although liver cancer surveillance is conducted at national level in Korea, little is known of the diagnostic performance and adherence to this surveillance, especially in a real surveillance setting. The purpose of this study was to evaluate the adherence and diagnostic accuracy of the liver cancer surveillance in real practice setting in Korea. Methods: We used the National Health Insurance Service claims data linked with the National Liver Cancer Surveillance Program (NLCSP) from 2013 to 2015. We analyzed the surveillance adherence and diagnostic accuracy. Sensitivity, specificity, and positive predictability values were assessed based on patients diagnosed with liver cancer within 3, 6, or 12 months after undergoing surveillance during the study period. Results: The annual surveillance rate resulted that individuals undergoing the NLCSP was 41.2% in 2014. Female, the younger, and people with less comorbidity and more income received more surveillance. The sensitivity of the surveillance program was 37.0% and 40.4% for positive predictive value and it was varied depending on the criteria used to define the diagnosis of liver cancer. Conclusion: This study highlights the current status of the NLCSP and the needs for continues efforts to help improve the current surveillance practice in quantitative and qualitative to fulfil the goal of NLCSP.

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.

의약품 허가 규제 국제 협력에서의 허가참조제도

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.

유전자 치료에서의 병원약사의 역할: 문헌고찰 연구

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.

국산의약품의 해외 시장진출을 위한 인·허가제도 연구-태국

윤근영,권진원,이의경 한국에프디시규제과학회(구 한국에프디시법제학회) 2018 FDC법제연구 Vol.13 No.1

국산의약품의 해외 시장진출을 위한 인·허가제도 연구-베트남

민경록,권진원,이의경 한국에프디시규제과학회(구 한국에프디시법제학회) 2018 FDC법제연구 Vol.13 No.1