임상시험 지정병원의 "의약품 임상시험 관리기준(KGCP)" 수행 가능성 평가에 관한 연구

장선미,이의경,박병주,허순임,Jang, Sun-Mee,Lee, Eui-Kyung,Park, Byung-Joo,Huh, Soon-Im 한국의료질향상학회 1995 한국의료질향상학회지 Vol.2 No.1

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

급성상기도질환에서 일차의료의사의 항생제 처방에 영향을 주는 요인

김남순,장선미,장숙랑,Kim, Nam-Soon,Jang, Sun-Mee,Jang, Soong-Nang 대한예방의학회 2005 예방의학회지 Vol.38 No.1

Objectives : To explore the factors influencing antibiotics prescription by primary health physicians for acute upper respiratory infections(URI). Methods : We performed a survey of 370 primary health physicians randomly sampled in April, 2003. The questionnaire consisted of a prescription on the scenario of acute bronchitis case, along with opinions and reasons for prescribing antibiotics on URI. Results : We found that 54.7% of the physicians prescribed antibiotics on the example case of acute bronchitis which is known as not needing antibiotics. Female physicians and ENT physicians had a greater tendency to prescribe antibiotics. The factors influencing antibiotics prescription on URI were the belief about the effectiveness of antibiotics, preference for their own experiences rather than clinical guidelines, perception of patients' expectations, and perception of competitive environment. The prescription of antibiotics in the example case was affected by how much they usually prescribe antibiotics (OR=2.400, 95% CI=1.470-3.917) and the physicians who thought that antibiotics were helpful for their income prescribed antibiotics more than others (OR=6.773, 95% CI=1.816-25.254). Conclusion : These findings demonstrated that the false belief on the effectiveness of antibiotics, patient's expectation of medication and fast relief of symptoms, and perception of competitive environment all affected the physicians prescription of antibiotics on URI. It may help to find barriers to accommodate scientific evidence and clinical guidelines among physicians and to specify subgroups for education about appropriate prescription behaviors.

제약기업 연구개발투자규모 결정요인

김동환 ( Dong Hwan Kim ),장선미 ( Sun Mee Jang ),송현종 ( Hyun Jong Song ) 한국보건경제정책학회 2010 보건경제와 정책연구 Vol.16 No.2

제약산업에서의 연구개발은 물질개발 단계에서부터 시장출시까지 오랜 시간이 소요되고 실패할 확률이 매우 높아 고액의 투자가 지속적으로 이루어져야 하는 특징을 가진다. 본 연구에서는 우리나라 제약기업을 대상으로 연구개발 투자규모를 결정하는 요인을 파악하고자 하였다. 유가증권 및 코스닥 상장 제약관련 기업을 대상으로 금융감독원 전자공시시스템에 2003년부터 2008년까지 6년간 공시된 자료를 이용하여 3개년(2006년~2008년) 패널자료를 구축하였다. 분석모형은 기업의 내부금융(현금흐름) 및 외부금융(부채비율), 건강보험 청구금액, 연구개발 성과경험을 고려하였고 직전년도까지의 누적연구개발투자규모가 당해연도 연구개발투자규모에 미치는 영향력을 추가하여 연구개발의 지속성을 고려하였다. 분석 결과, 유가증권상장기업과 코스닥상장기업에서의 연구개발투자규모 결정 요인이 다르게 나타났다. 유가증권상장 제약기업의 경우 신약이나 개량신약을 개발한 경험이 있는 기업 직전년도의 기업의 내부현금흐름과 당해연도 부채비율이 높은 기업, 직전년도의 건강보험청구금액이 많은 기업 직전년도까지의 누적연구개발투자규모가 큰 기업이 당해연도에 연구개발 투자규모가 큰 것으로 분석되었다. 반면, 코스닥상장 제약기업의 경우에는 당해연도 부채비율이 높을수록 연구개발 투자규모가 큰 것으로 나타났다. The purpose of this study was to analyze the determinants of pharmaceutical firm`s R&D investment expenditures in the Korean pharmaceutical industry. We analyzed 3 years` panel data(2006-2008) of 38 pharmaceutical firms listed on KOSPI and 42 on KOSDAQ using database m DART of Financial Supervisory Service, the Annual Report of Pharmaceutical R&D, and the drug claims data of Health Insurance Review & Assessment Service. For companies listed on KOSPI, experience success development of new drug, cash flow in t-1 year, t year external funding and cumulative R&D investment were positive effect on t year R&D investment. For companies listed on KOSDAQ t year external funding was positive effect on t year R&D investment.

건강보험데이타베이스를 이용한 골다공증성 고관절 골절 식별 및 타당도

박찬미 ( Chan Mi Park ),장선미 ( Sun Mee Jang ),장수현 ( Su Hyun Jang ),하용찬 ( Yong Chan Ha ),이영균 ( Young Kyun Lee ),윤현구 ( Hyun Koo Yoon ),신찬수 ( Chan Soo Shin ),김덕윤 ( Deog Yoon Kim ),이성수 ( Seong Su Lee ),최형진 ( 대한고관절학회 2010 Hip and Pelvis Vol.22 No.4

Purpose: The aim of this study was to develop and validate identification criteria for the cases of osteoporotic hip fracture using the National Health Insurance Database, and we calculated the incidence rate of osteoporotic hip fracture in the Korean population using these criteria. Materials and Methods: The criteria to identify osteoporotic hip fracture using a diagnosis code, a procedure code, the type and number of medical service usages and the patients` ages were developed via discussions among experts. These criteria were validated by using a hip fracture cohort in which all the genuine osteoporotic hip fracture patients in the Jeju area were identified by reviewing the registered medical records and radiographs. By applying the identification criteria to the National Health Insurance Database that was accumulated until June 2009, we calculated the incidence rate of osteoporotic hip fracture in patients between 50 and 100 years of age in 2008. Results: The identification criteria had a sensitivity of 93.1% and a positive predictive value of 77.4%. A total of 20,432 osteoporotic hip fracture cases were identified in 2008, and the incidence rate was 15.7 cases per 10,000 persons. The osteoporotic hip fracture incidence rate for females was 20.7 (per 10,000persons), and this was 2.1 times higher than that for the males (9.8case per 10,000persons), and the rates were increased with age. Conclusion: The incidence of osteoporotic hip fracture that occurred on a nationwide scale can be more precisely estimated by using the National Health Insurance Database with its comprehensive information on the overall details of treatment as well as the diagnosis codes, and so the incidence of osteoporotic hip fracture can be reliably calculated for each year. The results from this research could be used as evidence in a hip fracture management plan for establishing Korean Health policy.

주요국의 제네릭 의약품 활성화 정책 고찰과 시사점

김동숙 ( Dong Sook Kim ),배승진 ( Seung Jin Bae ),장선미 ( Sun Mee Jang ) 한국보건행정학회 2013 보건행정학회지 Vol.23 No.3

병원 약제행위의 원가구조 및 수가체계 개선방향

황인경(In Kyoung Hwang),이의경(Eui Kyoung Lee),이진이(Jin Nie Rhe),장선미(Sun Mee Jang) 한국병원경영학회 2000 병원경영학회지 Vol.5 No.1

The price systems of the hospital drug services play key roles in the provision of quality services and the development of pharmacy service technologies. Under the premises, this study attempted to determine the costs of hospital drug service, to compare the costs calculated with the fees publicly fixed by the Government, and based on the results of the analysis, to propose directions for the improvement of the price systems. A Costing model for the study was developed based on the cost-fee relationship analysed of the Korean fee-for-service systems. Data on costs and workloads of the 25 hospitals were collected through survey forms designed for the costing and analysis for the duration of 12 months of 1998. The results of the analysis show that a tremendous unbalance between cost and price levels of the drug services, and that overally the price level of the services is extremely low when compared to the costs of services. Based on these findings, this study suggests that unfairly high or low price level be corrected, and that service items newly developed and being practiced at tertiary hospitals, such as TDM and TPN consultation services, be compensated by fixing a proper level of price.

중국의 의약품 등재 및 약가 제도 고찰 -우리나라와의 비교를 중심으로-

이보람 ( Bo Ram Lee ),유수연 ( Soo Yeon You ),장선미 ( Sun Mee Jang ) 한국보건경제정책학회(구 한국보건경제학회) 2013 보건경제와 정책연구 Vol.19 No.2

급속한 경제성장과 세계에서 가장 많은 인구를 바탕으로 중국의 의약품 시장은 매년 커지고 있다. 본 연구는 우리나라와의 비교를 바탕으로 중국의 의약품 등재 및 가격 결정 제도에 대한 기초 자료를 제공하는 것을 목적으로 한다. 중국에서 의약품을 분류하는 가장 큰 기준은 서약(西藥)과 중의약(中醫藥)이며 중국 정부에서는 필수의약품에 해당하는 국가기본약물목록(國家基本藥物目錄)과 의료보험 급여 의약품인 국가기본의료보험약품목록(國家基本醫療保險藥品目錄)을 제정·관리하고 있다. 의약품 등재에 있어서 우리나라와 중국의 가장 큰 차이점은 개별 기업이 수시로 등재 여부를 신청할 수 있는 절차와 제도를 가지고 있지 않은 점과 등재 기준이나 절차가 자세히 공개되지 않는다는 것이다. 또한 등재 이후 약가를 결정할 때도 협상과정 없이 중국 정부에서 특정 가격을 명시하거나(통일 가격) 상한가를 정하는 방식으로 한다. 이처럼 중국의 의약품 등재 및 가격 정책에서 나타나는 높은 불확실성은 중국 진출을 염두에 두고 있는 개별 기업에게는 위험 요소(risk)가 될 수 있다. 따라서 객관적인 기준과 정보 공개를 바탕으로 하여 투명성을 제고시키는 것이 향후 중국이 개선해야 할 과제라 할 수 있다. 중국의 의료보험 확대 정책은 우리 제약 기업에게 큰 기회로 찾아올 것이며 이를 위해서는 지속적인 제도 고찰과 장기적인 예측이 필요하다. Pharmaceutical market in China is rapidly increasing with economic growth and large population. The purpose of this study is informing the pharmaceutical policy within the Chinese health insurance system. Basic drug classification of China is similar to Korea, but separation between TCM(Traditional Chinese Medicine) and Western Medicine is distinct feature. Chinese government establishes and administers National Basic Pharmaceutical Lists and The National Basic Medical Insurance Pharmaceutical Lists. However, the process or principle of registration is not transparent yet and companies have no chance to apply for registration. In the step of price determination after registration, the authority declares certain price or determines the maximum price, either. Such uncertainty of registration and price determination policy is a kind of risk for the pharmaceutical companies which are planning to set up business in China. Therefore, Chinese government`s priorities are the development of objective standard and enhancement of transparency with information disclosure before opening pharmaceutical market. Nevertheless, China`s health insurance expanding policy and market opening are becoming great opportunities to Korean pharmaceutical companies, so continuous examination on Chinese policy changes and long-term prospects are needed.

처방 총액 절감 인센티브 시범사업과 약품비 절감 노력: 질적 및 양적연구

채정미 ( Jung Mi Chae ),이수옥 ( Soo Ok Lee ),김동숙 ( Dong Sook Kim ),송현종 ( Hyun Jong Song ),장선미 ( Sun Mee Jang ) 한국보건경제정책학회(구 한국보건경제학회) 2013 보건경제와 정책연구 Vol.19 No.4

국내에서는 약품비 지출 증가율을 감소시키기 위해, 2008년 7월 외래 처방 약품비 절감 인센티브 시범사업을 도입하였다. 이는 의원 자신의 전년도 지급된 비용에 기반해 기대약품비를 산출하고, 실제약품비와 비교하여 절감된 약품비의 20∼40%를 지급하는 사업이다. 본 연구에서는 외래 처방 약품비 인센티브 시범사업에 대한 개원의사가 어떻게 반응하는지를 파악하고자, 포커스 그룹 인터뷰를 실시하였고, 시범사업 전후로 특정 질환에서 환자당 약품비와 투약 일수의 변화를 살펴보았다. 포커스 그룹 인터뷰는 시범사업을 실시한 5개 지역의 개원의사 중무작위로 명단을 추출하였고 전화로 연락을 취해 모집하였고, 27명의 의사를 5개 그룹으로 나누어 토론을 진행하였다. 또한, 고혈압, 당뇨, 급성상기도감염에서 시범사업 전후로 차이가 있었는지 2007년 7월~2009년 6월 2개년의 건강보험청구자료를 이용하였다. 시범사업은 약품비 절감 노력에 일부 긍정적 영향을 미친 것으로 관찰되었으나, 인센티브에 대해 긍정적인 인식보다는 부정적인 인식이 더 많았고, 제도에 대한 이해와 공유가 부족하였다. 참여자들은 약품비를 절감하기 위해서는 의료계 내적 측면보다는 보건의료 체계 측면, 환자 측면의 정책을 수행할 것을 요구하였다. 또한 인센티브를 받은 의료기관에서 급성상기도감염 질환에 대해서만 환자당 약품비, 투약일수가 통계적으로 유의하게 감소하는 것으로 나타났다. 처방총액 절감 인센티브 시범사업은 의사의 약제비 절감노력과 처방행태에 영향을 주는지에 대해서는 일부 효과가 있으나, 그 영향력은 미미한 것으로 판단되므로, 지속적 홍보와 교육을 통해 효과를 증진시킬 필요가 있겠다. In an attempt to curb the rapidly rising expenditure of prescribing, the government introduced a financial incentive demonstration project in July 2008, to encourage clinicians to restrain their prescribing. This study undertook a qualitative and quantitative exploration of the attitude of doctors on Prescribing Incentive Scheme(thereafter PIS) demonstration project based on the pharmaceutical cost saving. In order to explore a plurality of perspectives, data were obtained from focus groups and a series of individual semi-structured interviews with doctors. To analyze PIS demonstration project, prescribing data in 2007.7~2009.6 were used. This study suggest that PIS demonstration has being expected to enhance a few efforts to reduce pharmaceutical expenditure. In the other hand, participants concerned negative attitude to demonstration project. To change the prescribing behavior, continuous training and giving public information should be made.

OECD 주요국의 약제비 증가 억제방안 고찰

장선미,박정영,김성옥 서울대학교 보건대학원 2001 서울大學校 保健環境硏究所論叢 Vol.11 No.1

During last 30 years, most developed countries have been experienced rapid increase of pharmaceutical expenditures. In 1996, pharmaceutical expenditures represent 0.7-2.2% (Mean 1.2%) of GDP and 8-29% (Mean 15.4%) of National Health Expenditures in OECD countries. Thus most developed countries have developed and implemented various type of drug policies to contain expansion of pharmaceutical expenditures, because the pharmaceutical expenditures may be increased with growth of old population and become budgetary burden of NHS of NHI States. In this study, we introduced and reviewed various type of pharmaceutical policy of OECD countries to contain the pharmaceutical expenditure as follows. They are grouped as three different strategies by targets; physician, patient and health industry. First, we reviewed strategy to control physicians' prescribing behavior. These are 1. Budgeting constraints of prescribing (DRG, Pharmaceutical fixed budget), 2. Direct limitations of volume and expenditure, and 3. Guidelines for physicians, Benchmarking and feedback. Second, we reviewed strategy to control patient. These are 1. Co-payments and 2. Reference pricing. Third, we reviewed strategy to control Health Industry, These are 1. Price control (pricing), Reference pricing system, 2. Profit control, 3. Listing and delisting from reimbursement and 4. Fostering the use of generic drugs. The strategies to control physicians' prescribing may be effective if economic incentive or disincentive as well as information (lists or guidelines) is given to physicians. The strategies to control patients' should be accompanied with advance preparations such as considerations including health effect, equity, and quality (bio-equivalence). The impacts and considerations of these strategies which are implemented in OECD countries give us valuable lessons in developing policies to reduce pharmaceutical expenditure of Korea.

DDD(the Defined Daily Dose) 방식에 의한 국내 항생제 사용량 산출 및 항생제 약제비 분석

이의경,장선미 大韓臨床藥理學會 2000 臨床藥理學會誌 Vol.8 No.1