• 약학회지
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• 제54권4호
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• pp.309-315
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• 2010

The Positive List System was newly introduced in South Korea as of January 2007. This study aims to survey and compare perception of and attitudes toward the Positive List System in the process of new drug listing that health professionals and pharmaceutical companies have. 50 professionals and 52 companies answered the questionnaire regarding health policy environments, policy decision/enforcement process, policy effects and satisfaction related to introducing the Positive List System. SAS 9.1 was used for statistical analyses. The results showed that participants had the general sympathy with health policy environments for the introduction of the Positive List System into South Korea. However, the response rates of policy decision/enforcement process and effects were negative and these tendencies were more striking in pharmaceutical companies. As for policy satisfaction, participants marked positive responses more than negative ones. It is necessary to remedy and supplement problems with policy decision/enforcement policy and effects revealed in this study and to improve the Positive List System through gathering opinions among groups and organization concerned.

• 보건행정학회지
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• 제21권1호
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• pp.132-157
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• 2011

The purpose of this article is to examine the cause of policy non-compliance in the case of pharmaceutical rebates from the perspective of rational choice institutionalism. In Korea, there have been rebates practices between pharmaceutical companies and hospitals since the introduction of the Actual Remuneration System for insured medicine in 1999. The government has chosen the policy means of punishment to eliminate pharmaceutical rebates but the illegal practices are still widespread. Institution in rational choice institutionalism usually reflects the incentives and preferences of actors, and the Actual Remuneration System has resulted in a the lack of procedures to ensure savings on drug expenditures. Pharmaceutical rebates are the product of the institutions which reflect their incentives: the Actual Remuneration System, the current pricing policy for generic drugs, the drug distribution system, and so on. In the end, the problem of the rebates is the consequence of policy non-compliance as actors' rational choice because their incentives lead to opportunistic behaviors. We should therefore understand the incentive structure of policy stakeholders, which is derived from the view of new institutionalism; also, the newly designed Korean drug pricing policy reform must be compatible with the incentive structure.

• 한국임상약학회지
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• 제23권3호
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• pp.185-196
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• 2013

This study aims to explore the difficulties of evidence-based pharmaceutical policy-making in the Korean context where several pharmaceutical policies were introduced within a short period. Semi-structured in-depth interviews were performed with eight experts in the Korean pharmaceutical arena. The key challenge in Korean situation might be the apparent lack of available evidence caused by the limited resources, the lack of policy consistency and coordination ability in the authorities and distrust across stakeholders. To build an evidence-based tradition, it is essential to resolve the tangible lack. At once, more fundamental changes seem to be required in the intangible policy environments.

• 보건행정학회지
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• 제28권4호
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• pp.360-368
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• 2018

Background: The proportion of pharmaceutical expenditure out of total health-care expenditure in South Korea is high. In 2016, 25.7% of national health insurance (NHI) spending was for pharmaceuticals. Given the increasing demands for the access to newly introduced medicines and following increase in pharmaceutical spending, the management of NHI pharmaceutical expenditure is becoming more difficult. Methods: This study analyzed the data claimed to NHI for pharmaceutical reimbursement from 2010 to 2016. Results: The policy implications with respect to the trends and problems in spending by drug groups were elicited. First, the proportion of off-patent drugs spending which were treated to chronic disease was much higher than anti-cancer drug spending. Second, the spending to the newly introduced high-costed medicine increased, however, current price-reduction mechanism was not sufficient to manage their expenditure efficiently. Conclusion: Our system seems to need several revisions to improve the efficiency of pharmaceutical expenditure and to cope with high-costed medicines. This study suggested that the prices of off-patent drugs need to be regularly readjusted and the Price-Volume Agreement System should be operated more flexibly as well.

• 약학회지
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• 제52권6호
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• pp.507-513
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• 2008

The purpose of this study is to analyze the factors affecting financial performance of community pharmacies after the implementation of the new drug policy in Korea: separation of drug prescription and dispensing (SPD). The online survey questionnaires were sent to the active pharmacists of the total 20,633 community pharmacies in Korea and 1,147 pharmacists responded to the survey (the response rate was 5.5%). The questionnaire asked simple financial data in order to compare their financial performances before and after the policy. With the SPSS package (version 12.0), two levels of data analysis were used: 1) descriptive statistics to see the financial status of the pharmacies; and 2) multiple regression analysis to find the factors. {or A multiple regression method was used for the data analysis.} The finding illustrated that the average net benefit of the pharmacies was 4,870 thousand won in August 2006, and the major factors affecting the net benefit were the location of pharmacy (geographical proximity to medical institutions), number of prescriptions, drug management services for patients, chain pharmacy membership. The findings of this study suggest that service improvement for patients, revitalization of non-prescription drug sales, professional management will contribute to promote community based pharmacy business.

• 한국산학기술학회논문지
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• 제19권8호
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• pp.360-369
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• 2018

국내 제약 산업에는 2012년부터 혁신형 제약기업 인증 지원 정책이 시행되고 있다. 이 연구는 이 정책의 형성과정 및 정책만족도에 대한 이해관계자와 관련 전문가의 인식을 파악하고, 정책만족도를 설명하는 요인을 파악하기 위해 수행하였다. 혁신형 제약기업을 포함하여 제약기업, 대학, 정부출연연구소 관계자를 대상으로 이메일, 팩스 등을 통해 설문조사하였으며, 유효 응답률은 38.4% (61/159) 였다. 연구결과 정책형성과정 중 정책필요성(정책문제설정 단계)에 대한 인식이 가장 긍정적이었으며, 다른 모든 단계와 정책만족도에 대한 인식은 보통 수준이었다. 응답자 개인 변인 및 정책형성과정에 대한 인식 변인 중 정책만족도와 관련이 있는 변인을 대상으로 다중회귀분석을 통해 영향 요인을 살펴본 결과, 정책결과 및 정책집행 단계의 일부 변인이 주요 요인으로 분석되었다. 구체적으로 정책만족도에 가장 큰 영향을 미치는 요인은 인증기업의 성과(정책결과 단계)에 대한 인식인 것을 확인하였다. 또한 적정성 및 사후관리 능력(정책집행 단계)에 대한 인식 역시 정책만족도에 미치는 영향력의 크기가 유사했다. 이는 수요자의 정책만족도에는 정책결과뿐만 아니라 정책집행과정에 대한 인식이 중요하다는 것을 시사한다. 다만 정책 시행 초기에 수행되는 등의 한계로 인해 향후 추가 연구를 통해 검증 및 보완이 필요하다.

• 약학회지
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• 제56권2호
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• pp.116-125
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• 2012

Local pharmaceutical companies in Korea, which have grown focusing on domestic markets, have recently faced difficulties such as market saturation, price control policies and market-opening pressures by FTA. It seems to be an urgent issue for them to export pharmaceuticals to developed countries comprising the greater part of the global pharmaceutical market. Hence, this research was conducted to investigate and benchmark the strategies employed by India industry for the successful access to the global pharmaceutical markets. Drug policies as well as their influences on pharmaceutical market changes between India and Korea for the last 40 years have been searched and the differences have been comparatively analyzed. The pharmaceutical industry of India has the following strengths: low costs; experienced labor pool; excellent reverse-engineering skills; powerful IT; marketing capability; and established distribution network. After 2000, consolidations, M&A and alliances with domestic and multinational companies have been sharply increased in the industry of India. Indian companies unfolding both competition and cooperation with multinational corporations currently move up the value-added chain, and this enthusiastic strategy should be learned by local pharmaceutical companies.

• 보건행정학회지
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• 제27권3호
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• pp.247-255
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• 2017

Background: South Korea has experienced problems with excessive pharmaceutical expenditures. In 2010, the South Korean government introduced an outpatient prescription incentive program to effectively manage pharmaceutical expenditures. Therefore, we examined the relationship between the outpatient prescription incentive program and pharmaceutical expenditures. Methods: We used data from the Korean National Health Insurance claims database, which included medical claims filed for 22,732 clinics from 2011-2014 to evaluate associated pharmaceutical expenditures. We performed multiple regression analysis and Poisson regression analysis using generalized estimating equation models to examine the associations between outpatient prescription incentives and the outcome variables. Results: The data used in this study consisted of 123,392 cases from 22,372 clinics (average 5.4 periods follow-up). Clinics that had received outpatient prescription incentives in the last period had better cost saving and Outpatient Prescribing Costliness Index (OPCI) (received: proportion of cost saving, ${\beta}=6.8179$; p-value < 0.0001; OPCI, ${\beta}=-0.0227$; p-value < 0.0001; reference = non-received). Moreover, these clinics had higher risk in the provision of outpatient prescription incentive (relative risk, 2.772; 95% confidence interval, 2.720 to 2.824). The associations were higher in clinics that had separate prescribing and dispensing programs, or had professional staff. Conclusion: The introduction of an outpatient prescription incentive program for clinics effectively managed problems with rapid increases of pharmaceutical expenditures in South Korea. However, the pharmaceutical expenditures still increased in spite of the positive impact of the outpatient prescription incentive program. Therefore, healthcare professionals and health policy makers should develop more effective alternatives (i.e., for clinics without separate prescribing and dispensing programs) based on our results.

• 보건행정학회지
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• 제22권4호
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• pp.561-578
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• 2012

This study was performed in order to compare a change in pharmaceutical expenditures per outpatient of clinic and to analyze factors relevant to a systems as part of evaluating policies for the incentive scheme to reduce total prescribed drug expenditure and for the drug utilization review system("DUR system" hereafter). For this, it had finally analytical subjects as 21,320 clinics nationwide without a change in location, clinics symbol and signed subject during both terms of the first half of 2010 and the first half of 2011. As a result, the odds ratio with reduction in pharmaceutical expenditures of clinic was statistically higher significantly in the shorter year number of opening clinic, in the larger number of doctors, when the classification of establishment is other, not individual, and when the signed subject is surgical division. Also, the odds ratio was significantly higher in the less patient number of clinic and in the lower ratio of patients aged over 65. Finally, the odds ratio was significantly high when a clinic had been located in DUR system demonstrative project area. Through this, a case of policy for improvement in doctor's autonomous prescription behavior like DUR system can be known to be effective for reduction in pharmaceutical expenditures. A future research on evaluation of policy for pharmaceutical expenditure management system will need to be performed in-depth analysis in consideration of diverse characteristics on the participatory entities.

• 한국시스템다이내믹스연구
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• 제13권4호
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• pp.57-80
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• 2012

This research studies effect of FDA regulations in pharmaceutical industry on new drug development. System dynamics is implemented to demonstrate dynamic relationship between FDA regulations and R&D costs, firm's profits, sales. This research is focused on clinical trials of new medical entity process 50~60% portion of total development cost. Simulation results say that firm's profit is more sensitive to increasing the regulation than alleviating the regulation and effect of regulation policy make different result depending on the intensity of regulation and policy direction. Our simulation model provides the instrumental means for the policy makers and strategic decision in pharmaceutical industry.