• Title/Summary/Keyword: Pharmaceutical policy

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Requirements for Reusable Infection Prevention and Control Measures for COVID-19 Response (코로나19 감염병 대응모델의 국제표준화 요건)

  • Ahn, Sun-Ju
    • Health Policy and Management
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    • v.31 no.3
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    • pp.244-254
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    • 2021
  • The management of emerging infectious diseases cannot help but completely depend on non-pharmaceutical interventions in the early stages of the outbreak. Consequently, South Korea has developed and implemented the 3T (test-trace-treat) models, non-pharmaceutical infection prevention and control (IPC) measures, in response to the coronavirus disease 2019 (COVID-19) pandemic. The IPC measures have gained global attention, rendering them to be essential in the development of a shareable, reusable, and applicable protocol for future pandemics. This study was conducted to identify the requirements necessary for standardizing the IPC measures. Three new work items of the 18 3T models were proposed to ISO/TC 304 (International Organization for Standardization/Technical Committee 304; healthcare organization management). Requirements for each IPC measure, identified by participating members (P-members) countries during the ISO ballots, were analyzed in this study. The three new work items were approved by the P-members countries after a 3-month ballot. There was a consensus that the three IPC measure models should be International Standards (IS). Other comments include (1) the models should include not only COVID-19 but also any respiratory pandemic; and (2) keep donning of level D protection at screening sites as an optional protocol, in consideration for the lack of personal protective equipment. Standardization is a systematic process of developing internationally agreed-upon wisdom and knowledge that consider and respect the diversity and universality of each country. It is expected that such standardized applicable IPC measure models contribute to global efforts to rapidly respond to a public health emergency of international concern during its early stages.

A Study on Role and Function of the Medical Representatives (의약정보담당자(MR)의 기능 및 역할에 관한 연구)

  • Lee, Dong-Il;Je, Hae-Kwan;Yoon, Seok-Jun;Ahn, Hyeong-Sik;Mun, Yeoung-Bae
    • Quality Improvement in Health Care
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    • v.10 no.1
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    • pp.58-76
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    • 2003
  • Background : Aim of this study is focused on the analysis of the needed abilities of medical representatives resulting in building up the market and increasing sales. It is to propose methods to increase this ability ensuring continuous growth in market share and profit. Methods : A survey was conducted between January 6 and May 31, 2003. Using SPSS(Version 10.0), the collected data was analyzed by Hotelling T2, factor analysis. Some hypotheses were selected to include the conclusion. Some questionnaires for physicians working in hospitals or clinics and the medical representatives working in a pharmaceutical company were created and asked to them to either prove or reject those hypotheses. The results were analyzed to find the primary factors that effect the interactions between physician and the medical representatives. These factors were also studied along with the theoretical research based on published references. Results : The results were as follows. The main reasons for the physician to meet with a medical representatives were collection of product informations needed for patient treatment and collection of informations on current medical issue and as well as personal interests. The main parameters by which physicians evaluate the medical representatives are human relationship including sincerity and manners and supply of accurate and unbiased information on products. Overall, the medical representatives' perception on the importance of medical knowledge and ability to deliver it are lower than that expected by physicians. Conclusion : Medical and pharmaceutical companies' environment are changed rapidly. And those changes forced medical representatives to set new roles and competency. In order to drive away from the past 'rule of thumb' and 'adaptation to circumstance', optimal method and systemic development to train and support the medical representatives should be quipped. They will help medical representatives to be specialists in medical knowledge and to understand the exact need of health care professions. Product competitiveness will be increased and eventually successful business can be achieved through it.

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Associations Between Compliance With Non-pharmaceutical Interventions and Social-distancing Policies in Korea During the COVID-19 Pandemic

  • Hwang, Yu Seong;Jo, Heui Sug
    • Journal of Preventive Medicine and Public Health
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    • v.54 no.4
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    • pp.230-237
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    • 2021
  • Objectives: This study explored changes in individuals' behavior in response to social distancing (SD) levels and the "no gatherings of more than 5 people" (NGM5) rule in Korea during the coronavirus disease 2019 (COVID-19) pandemic. Methods: Using survey data from the COVID-19 Behavior Tracker, exploratory factor analysis extracted 3 preventive factors: maintenance of personal hygiene, avoiding going out, and avoiding meeting people. Each factor was used as a dependent variable. The chisquare test was used to compare differences in distributions between categorical variables, while binary logistic regression was performed to identify factors associated with high compliance with measures to prevent transmission. Results: In men, all 3 factors were significantly associated with lower compliance. Younger age groups were associated with lower compliance with maintenance of personal hygiene and avoiding meeting people. Employment status was significantly associated with avoiding going out and avoiding meeting people. Residence in the capital area was significantly associated with higher compliance with personal hygiene and avoiding venturing out. Increasing SD levels were associated with personal hygiene, avoiding going out, and avoiding meeting people. The NGM5 policy was not significantly associated with compliance. Conclusions: SD levels, gender, age, employment status, and region had explanatory power for compliance with non-pharmaceutical interventions (NPIs). Strengthening social campaigns to inspire voluntary compliance with NPIs, especially focused on men, younger people, full-time workers, and residents of the capital area is recommended. Simultaneously, efforts need to be made to segment SD measures into substrategies with detailed guidance at each level.

Comparison of Approval Process for Nonprescription Drugs in Different Countries (비처방의약품 허가 제도의 국가별 비교 연구 및 고찰)

  • Kim, Joo Hee;Yee, Jeong;Lee, Gwan Yung;Lee, Kyung Eun;Gwak, Hye Sun
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.4
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    • pp.263-272
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    • 2018
  • Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

The Health Impact of, and access to, New Drugs in Korea

  • Lichtenberg, Frank R.
    • East Asian Economic Review
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    • v.24 no.2
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    • pp.127-164
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    • 2020
  • We perform an econometric assessment of the role that pharmaceutical innovation-the introduction and use of new drugs-has played in improving the health of Koreans, by investigating whether diseases for which more new drugs were launched had larger subsequent increases in longevity and smaller subsequent increases in hospitalization. Drugs launched during 1993-2012 are estimated to have increased mean age at death from all diseases by 1.71 years between 1995 and 2015 and 1.09 years between 2005 and 2015. We also estimate that new drugs increased the five-year relative survival rate from all cancers combined by 23.2 percentage points-78.5% of the total increase-between 1993-1995 and 2011-2015, and that new drugs launched during 2008-2010 reduced the number of hospital days in 2017 by 13.0 million. If the drugs launched during 2003-2012 had had no effect on other medical expenditure in 2015, the cost per life-year gained would not have exceeded 6332 USD. Therefore, even if we ignore the effect of new drugs on hospital utilization, the drugs launched during 2003-2012 were very cost-effective, overall. When reduced hospital utilization is accounted for, the evidence indicates that, in the long run, pharmaceutical innovation was cost-saving as well as life-year saving.

An Analysis of the Changes in Community Pharmacy Operation after the Implementation of the Separation Policy of Drug Prescription and Dispensing (의약분업 이후 약국의 운영현황 분석)

  • Ryu, See-Won;Youn, Kyung-Il;Chung, Woo-Jin
    • Korea Journal of Hospital Management
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    • v.7 no.4
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    • pp.102-122
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    • 2002
  • It has been 2 years since the implementation of the separation policy of drug prescription and dispensing. This study analyzes the changes in community pharmacy operation after the implementation of the policy. The main purposes of the analysis are to determine whether the changes in community pharmacy operation have occurred and to evaluate that the changes are consistent with the intention of the policy, if the changes actually have occurred. For the study a survey on 961 pharmacies chosen by stratified sampling method has been performed. Of the 961 sample pharmacies, 438 pharmacies were responded resulting 45.6% response rate. The sample pharmacies are classified by the location that the pharmacy are operating: the pharmacies around large size hospitals, the pharmacies around clinics or medium to small size hospitals and the pharmacies with no hospitals or clinics around. Based on the classification, the number of pharmacies, number of prescriptions processed, the personnel structure, the changes in facility, and other operational characteristics are compared. The results showed that the pharmacies were tended to concentrate around hospitals and clinic since the implementation of the policy. The number of pharmacists per pharmacy was increased, the size of pharmacy was increased and the facilities were improved to accomodate the requirements of the policy. The work hours a pharmacist spent on dispensing drug have increased almost twice, however, there was no corresponding increase in the time spent on patient education and medication history management, indicating a problem in the provision of quality pharmaceutical services. Based on the results, suggestions to minimize the negative effects of the policy are provided.

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Review of Economic Evaluation Studies for Drug Reimbursement Decision (의약품 보험급여 결정을 위한 경제성평가 연구의 평가)

  • Choi Sang-Eun;Sullivan Sean D.
    • Health Policy and Management
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    • v.15 no.4
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    • pp.1-25
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    • 2005
  • Legislation on pharmaceutical reimbursement decision using economic evaluation results was made in Korea in fm, but has yet to be fully implemented. We evaluated the quality of Korean economic evaluation studies of pharmaceuticals to understand gaps between legislation and implementation. From this evaluation, we propose policy options that might strengthen the research Infrastructure In order to support such studies. We reviewed 23 published studies for drugs conducted between 1996 and 2004. Evaluation criteria included methodological characteristics, healthcare system characteristics, population characteristics, and applicability of results. Large variation in study quality was observed, particularly with study design, outcome data, treatment patterns and interpretation. Korean clinical data used was mostly from observational studies of 1-2 hospitals. Foreign data was extracted from clinical trials that did not Include Asian population and their selection criterion was not clarified. With respect to treatment patterns, medical records and hospital bills were used without adjustment regarding area, hospital type, and others. And next frequent situation relied on expert opinion from academic physicians in specialty practice. preference measures, when used, were not elicited from the Korean population. $78.3\%$ of studies did not clarify the funding source. If the Korean economic evaluation policy is to provide meaningful data for decision makers, the quality of cost-effectiveness studies will need to improve dramatically. This may involve access to or creation of better data, more diverse funding, unproved training of researchers and evaluators, and partnerships with technology manufacturers.

Lessons from Generic Promotion Policies in Other Countries (주요국의 제네릭 의약품 활성화 정책 고찰과 시사점)

  • Kim, Dong-Sook;Bae, Seungjin;Jang, Sunmee
    • Health Policy and Management
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    • v.23 no.3
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    • pp.210-223
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    • 2013
  • Backgrounds: Escalating pharmaceutical expenditure has threatened the sustainability of National Health Insurance system in Korea. Generic medicines allow patients to access safe, effective, high-quality medicines at low cost, thus insurers could achieve significant financial savings by promotion of generics, if they are priced much lower than the originator. The purpose of this study was to review generic pricing as well as promotion policies in other countries and assess the implication of those policies. Methods: We reviewed the main measures adopted by the developed countries such as Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Sweden, United Kingdom, especially in countries where governments are the largest third-party payers or insurance finance resource is the national health insurance. Results: The foreign countries's experience with generic medicine policy shows that demand-side policies such as physician budgets, international nonproprietary name prescribing, generics substitution, patients co-payment as well as supply-side policies relating to pricing and reimbursement seems to play a critical role in developing the generic medicines market. Conclusion: Various strategy should be implemented to promote generic drug use.

Survey Analysis of the Perception on the Performance of Pharmaco-economic Studies in Korea (의약품 경제성평가 수행에 관한 인식도 조사 분석)

  • Lee, Eui-Kyung;Ko, Suk-Ja
    • YAKHAK HOEJI
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    • v.51 no.6
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    • pp.424-429
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    • 2007
  • The demand for pharmaco-economic data has increased since the introduction of positive list system for drug insurance. A survey was conducted for pharmaceutical companies, universities and hospitals to find the current states and barriers for pharmaco-economic studies in Korea. The results showed that even those who are in charge of pharmaco-economic studies at companies/universities had a limited technical expertise. Government should pay more attention to the education of the relevant manpower, and the production of national statistics needed for economic evaluation.

Long-term Outlook and Implications of the Marine Biotechnology Market in Korea and Abroad (국내외 해양생명공학 산업시장의 장기예측 및 함의)

  • Jang, Duckhee;Kang, Gilmo;Chae, Gi-Young;Kim, Soo-Ji;Jo, Min-Ju;Cha, Jeong-Mi;Ham, Hyun-Kyung
    • Ocean and Polar Research
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    • v.35 no.2
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    • pp.93-105
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    • 2013
  • The marine biotechnology industry is very significant as compared to other industries as one of the driving forces for economic growth in the next generation in Korea. However, the marine biotechnology market has been considered as a component of the biotechnology industry market which made difficult for creating separate research areas in relation to the scope of the relevant industry market as well as making it difficult to establish its own R&D policy strategies. Accordingly, this study was executed to estimate the future long-term market value of the marine biotechnology within the limit of industrial field and to verify the importance of national R&D investment in marine biotechnology on the basis of estimations within the industrial perspective. To this end, we classified the marine biotechnology industry into the four sub-sectors and estimated the domestic and global industrial market in 2010 and 2024. According to the results, the domestic and global market of the marine biotechnology industry will see a remarkable growth by 2024. In particular, the bio-energy, pharmaceutical and functional foods industry markets will achieve astonishing advances. On the basis of the analysis results, Korea has to establish more progressive and aggressive R&D investment strategies to strengthen national competitiveness through the marine biotechnology industry.