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本期目录

    2021年, 第16卷, 第1期 刊出日期:2021-03-20 上一期    下一期
    Analysis of Drug Purchase and Pricing Decision under the Mode of Procurement with Target Quantity
    Qiao Zelin, Huang Zhe
    2021 (1):  1-10. 
    摘要 ( 536 )   PDF(1600KB) ( 620 )  
    Objective To study the reasonable pricing strategy to effectively reduce the risk of drug supply disruption. This paper studies the vertical competition between drug purchasers and pharmaceutical enterprises, and the horizontal competition between different pharmaceutical enterprises. Based on the wholesale price of drugs made by pharmaceutical enterprises, drug purchasers adopt different procurement strategies. Methods A multi-stage game model was used to analyze the collusion and competition between two drug procurement parties. Results and Conclusion (1) Enterprise B can choose the optimal game strategies according to the stability of enterprise A; (2) Two procurement parties should choose collusion when the risk of supply interruption is low; (3) Emergency dual sourcing strategy is better than single sourcing strategy; (4) The optimal procurement quantity is irrelevant to the monotonicity of the stability of enterprise A in Cournot game. Through numerical analysis, the optimal decisions of pharmaceutical enterprises and drug purchasers are obtained respectively.
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    Research and Reference of the Authorized Generic Drug System in the US
    Wang Hongwei, Yang Yue
    2021 (1):  11-22. 
    摘要 ( 409 )   PDF(827KB) ( 503 )  
    Objective To study the significance of authorized generic drugs due to the successive relevant documents issued by China’s government in recent years, which clearly stipulated that China should establish a drug patent linkage system. Methods The authorized generic drugs play an important role in keeping the balance between brandname drugs and generic drugs in the US. Therefore, this system was investigated, focusing on its difference from independent generics, marketing procedures, application in patent litigation and legitimacy analysis through case evidence. This analogy analysis could provide a reference for the research of authorized generic drug systems in China. Results and Conclusion As an important factor affecting the balance between brand-name drugs and generic drugs, authorized generic drugs should be comprehensively analyzed and discussed, and a suitable system for China’s national conditions should be established by referring to the experiences of the US.
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    Research and Enlightenment of EU Drug Risk Management Plan
    Yang Yu, Shi Yu, Hu Rongbo, Tian Lijuan
    2021 (1):  23-30. 
    摘要 ( 444 )   PDF(896KB) ( 387 )  
    Objective To study the origin and development, framework and content of the EU-RMP (European Drug Risk Management Plan) so as to provide a reference for China’s drug risk management plan (RMP). Methods Literature research and comparative research were used in this paper. Through searching Chinese and foreign literature, the website of European Medicines Agency (EMA) and the Guideline on Good Pharmacovigilance Practices (GVP), in-depth understanding of the EU-RMP content and requirements, some lessons were extracted for our reference. Results and Conclusion All departments should cooperate closely in the preparation of RMP in China. Then, the risk control measures should be further enriched to reduce the risks. Besides, the rules for implementing RMP should be clarified to promote the risk management of the whole life cycle of drugs and maintain the safety of patients’ medication.
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    Analysis on the Development Dilemma and Opportunity of Independent Clinical Laboratory Based on PEST-SWOT
    Wang Shuling, Shi Ping
    2021 (1):  31-40. 
    摘要 ( 615 )   PDF(925KB) ( 549 )  
    Objective To study the current status of independent clinical laboratory (ICL) in China to offer some suggestions for further development of the industry because independent clinical testing is gradually occupying an important position in the medical market with the change of medical service mode. Methods The PEST-SWOT matrix model was constructed to sort out the strength and weakness, opportunities and threats of ICL and medical institutions. Results and Conclusion ICLs should enhance their social recognition by improving testing technology and industry operating standards. At the same time, it is also necessary to enhance their position in the clinical diagnosis industry and promote diversified competition in the field of clinical diagnosis so as to better help the development of national grading diagnosis and precision medicine. From the perspectives of SO, ST, WO, and WT, the development strategies of ICL are proposed, including personalized clinical diagnosis services and the construction of a database, and the family doctor system with community + ICL services. The remote diagnostic services should be implemented to help national graded diagnosis and treatment, and different operation schemes should be made to conform to market development. Besides, the access standards for ICL must be strictly required. Then, differentiated operations of enterprises should be valued for establishing industry brands and social awareness. Lastly, enterprises must focus on talents construction and management.
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    SWOT Analysis and Countermeasures Study on TCM Industry in Hainan Free Trade Port
    Liu Tianchi, Zeng Yu
    2021 (1):  41-47. 
    摘要 ( 474 )   PDF(773KB) ( 551 )  
    Objective To study the status of the Hainan’s traditional Chinese medicine (TCM) industry and propose countermeasures to promote the construction of Hainan’s modern TCM industry against the background of Hainan Free Trade Port construction, thus transforming the TCM industry into a modern TCM industry. Methods Sociology method and SWOT model in strategic management were used to analyze the current situation of the Hainan TCM industry. Results and Conclusion By using sociological methods (field investigation, policy research, and exchange interviews) and adopting the SWOT model in strategic management, and the current situation of the Hainan TCM industry was clarified, such as strength and weakness, opportunities and threat, thus nine suggestions were put forward for the construction of Hainan modern TCM industry.
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    Research on the Relationship between Export Orientation and R&D Investment of China’s Pharmaceutical Industry in Different Regions
    Qiao Jiahui, Wang Su, Chen Yuwen
    2021 (1):  48-59. 
    摘要 ( 462 )   PDF(819KB) ( 655 )  
    Objective To study the relationship between export orientation and research and development (R&D) investment so as to provide suggestions and references for improving the R&D investment level and innovation capabilities of pharmaceutical industry due to the progress of globalization and the continuous development of export trade of China’s pharmaceutical industry. Methods The relevant data of China’s pharmaceutical industry from 2001 to 2016 was selected to establish an error correction model based on the co-integration theory, and then the Granger causality test was conducted to determine the relationship between the export orientation and R&D investment of China’s pharmaceutical industry in different regions. Results and Conclusion It is found that the export orientation of the pharmaceutical industry in different regions has a significant negative impact on the investment of R&D. Among them, the middle region has the greatest impact, followed by the eastern and western regions. The export orientation of the pharmaceutical industry in the middle region has a lag effect on R&D investment, and the lag phase is two years.
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    Literature Review on the Development of New Drugs Based on TRIZ
    Bu Hemeng, Xue Aoming, Zhang Fang
    2021 (1):  60-67. 
    摘要 ( 569 )   PDF(1119KB) ( 428 )  
    Objective To promote the application of TRIZ theory in the new drug R&D and the innovative development of medical devices. Methods TRIZ can be literally translated as “theory of inventive problem resolving”, focusing on clarifying and solving contradictions in the system. This article introduces the TRIZ theory and the general process of new drug development. It collects literature in the field of new drug development and medical devices and refers to ideas for solving problems in some successful cases of applying TRIZ theory in other fields. Results and Conclusion After summarizing the general ideas of TRIZ to solve the problems, it is concluded that attention should be paid to applying TRIZ theory in the development of new drug and medical devices.
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    Enlightenment and Reference of Vaccine Clinical Trial Design Based on Immunological Surrogate Endpoints in the United States
    Gu Jinmeng, Yang Yue, Xing Hua
    2021 (1):  68-75. 
    摘要 ( 399 )   PDF(890KB) ( 364 )  
    Objectives To explore the optimization method of vaccine clinical trial design based on immunological surrogate endpoint to improve the quality and efficiency of vaccine clinical research and development. Methods As to the problems in the vaccine clinical research in China, the relevant guidelines and literatures of FDA and WHO were used to analyze and summarize the methods of optimizing the design of vaccine clinical trials. Results and Conclusion The adaptive design guidelines are established to guide clinical trial design, encourage the development and application of immunological surrogate endpoints, establish qualification process for drug development tools and information disclosure procedures to improve vaccine development efficiency.
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    Research on the World’s Most Valuable Antihypertensive Drugs Based on Patent Analysis
    Zhang Tianqi, Chen Yuwen
    2021 (1):  76-83. 
    摘要 ( 441 )   PDF(948KB) ( 376 )  
    Objective To find out several patented technologies of antihypertensive drugs with the most market value through analysis, and provide a reference for the research and development of enterprises. Methods The most valuable patented technologies of antihypertensive drugs from 2009 to 2019 were analyzed to explore the patent layout and technical characteristics of the main patent applicants, and then the key directions of their research and development were gotten. Results and Conclusion Based on the method of patent analysis, five patents with the most market value are extracted to provide important technical support and market value reference for the research and development of generic drugs or new drugs.
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    DRG Payment System in the United States and Its Enlightenment to China
    Han Xu, Sun Lihua
    2021 (1):  84-92. 
    摘要 ( 598 )   PDF(982KB) ( 522 )  
    Objective To study the successful experience of implementing diagnosis related group (DRG) payment system in the United States and provide a reference for China’s reform of health insurance payment. Since the United States is the first country to develop and apply the DRG in the world, its research and practice of DRG are always at the forefront. Methods Literature research method was used to investigate DRG payment system, the specific steps of the payment, the setting method of relevant indicators, and the quality supervision measures. Results and Conclusion There are mainly three aspects from the experience of DRG payment system in the United States. Firstly, the government’s responsibility for health insurance is clarified. Secondly, the relevant indexes are set reasonably. Thirdly, the DRG weight and base rate are adjusted dynamically to ensure the fairness of DRG payment. Therefore, China should pay attention to the following three aspects: clarifying the main responsibility of the government in the reform of health insurance payment, establishing the quality control system of the first page of medical records, and improving the supervision mechanism for medical quality.
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    Research on the Construction of Pharmacy Organization and the Development of Pharmaceutical Services in China’s Primary Medical and Health Institutions— Based on the Survey of 5 Provinces
    Cai Hongning, Sun Lihua
    2021 (1):  93-101. 
    摘要 ( 557 )   PDF(881KB) ( 439 )  
    Objective To explore the current situation and problems of the pharmacy organization and pharmaceutical services in primary medical and health institutions so as to provide a reference for improving relevant policies. Methods Multi-stage stratified random sampling was used to collect questionnaires from primary medical and health institutions in 5 provinces, and 102 questionnaires were distributed. Then Excel 2016 and IBM SPSS 21.0 software were applied for descriptive statistical analysis, chi-square test and multiple response analysis. Results and Conclusion A total of 92 primary medical and health institutions participated in the survey, and 92 valid questionnaires were recovered. The survey shows that 54.1% of the institutions have established more than 8 pharmaceutical administration regulations. 63.5% and 31.8% of the institutions have formulated pharmaceutical administration and pharmacotherapy team charters (or management systems). 29.7% of institutions have pharmacy personnel in accordance with relevant regulations. The higher proportion of pharmacy services are prescription review and adjustment, medication guidance, collecting and reporting adverse reactions, medication errors and medication hazard information. Primary medical and health institutions still need to further improve their pharmaceutical administration system, organizational structure, pharmacy professional training and clinical pharmacy service.
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