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本期目录

    2021年, 第16卷, 第2期 刊出日期:2021-06-20 上一期    下一期
    EU Real-World Evidence Supporting Drug Regulatory Decision and Its Enlightenment to China
    Fu Min, Huang Zhe, Xu Fengxiang
    2021 (2):  103-107. 
    摘要 ( 269 )   PDF(706KB) ( 302 )  

    Objective To provide references and suggestions for the application of real-world evidence in the decision-making of drug regulation in China. Methods The application of EU real-world evidence in drug regulatory decision support was analyzed through literature research and other methods, and the specific operation of its application was demonstrated by case studies. Results and Conclusion The application of EU real-world evidence in drug regulatory decision-making has achieved certain results and is in a stable development stage. The application of real-world evidence in China’s drug regulation is feasible. The successful application of EU real-world evidence can provide reference for China.


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    Analysis on Causes of Drug Shortages and Countermeasures
    Xiao Yao, Sun Lihua
    2021 (2):  108-113. 
    摘要 ( 343 )   PDF(725KB) ( 314 )  

    Objective To analyze the causes of drug shortages in China and put forward some countermeasures and suggestions accordingly. Methods Based on the relevant data of 14 provinces that issued the lists of drug shortages from 2018 to 2020, 377 kinds of drugs were sorted out first, and then the features of shortage were analyzed descriptively. Finally, the degree and causes of shortage were studied based on field investigation and literature summary. Results and Conclusion Among the drugs in short supply across the country, 69.2% of them were listed in the National Medical Insurance Catalogue, 37.1% were essential drugs and 26.5% were low-price drugs. They were used for different diseases, and most were for treating nervous system and blood system. There were many reasons for drug shortages. For instance, any problems in supply chain (production, circulation, use) could lead to drug shortages, of which the production accounted for the largest proportion. This paper puts forward targeted measures to solve drug shortages from the aspects of unwillingness and inability of manufacturing enterprises in their production.




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    Research of FDA Risk-Based Drug Inspection Program and Its Enlightenment
    Yang Luyao, Dong Jiangping, Yang Yue
    2021 (2):  114-119. 
    摘要 ( 407 )   PDF(900KB) ( 313 )  

    Objective To carry out an on-site inspection to promote the optimal allocation of inspection resources through the introduction of risk management theory in the process of inspection because inspection can prevent drug quality deterioration and ensure drug safety and efficacy. Methods The application of Food and Drug Administration (FDA) risk management plan in pre-registration and daily supervision was analyzed to study the construction of inspection model for production site based on risk management procedures. Results and Conclusion In order to improve regulatory efficiency, China can establish a risk-based drug inspection system from FDA risk management plan.


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    The Construction and Thinking of the National Sentinel Alliance for Adverse Drug Reaction Monitoring
    Hu Rongbo, Yang Yu, Shi Yu, Xiang You, Tian Lijuan
    2021 (2):  120-127. 
    摘要 ( 316 )   PDF(813KB) ( 333 )  

    Objective To briefly introduce the construction and operation of the National Sentinel Alliance for Adverse Drug Reaction (ADR) Monitoring, and provide reference for strengthening the safety monitoring of drugs after listing in China. Methods The literature research method was used to analyze the establishment and promotion measures of the National Sentinel Alliance for ADR Monitoring, and then some countermeasures and suggestions were put forward to enhance the construction of the alliance. Results and Conclusion The alliance based on Chinese hospital pharmacovigilance system (CHPS) has played an important role in ADR monitoring and reporting. Promoting the construction of the alliance can provide a new method for improving the scientific evaluation system and active supervision system of drug safety after listing. Therefore, the construction of alliances at the national and provincial levels should be strengthened. Besides, relevant laws and regulations must be improved to accelerate the research and development of information systems, which will deepen the active monitoring of the  alliance continuously.

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    Research on the Identification of Core Technologies of China’s Pharmaceutical Cold Chain Based on Patent Analysis
    Yuan Hongmei, Zhang Wenfeng, Ma Junhong, Zeng Yingying, Meng Lingquan
    2021 (2):  128-138. 
    摘要 ( 335 )   PDF(2102KB) ( 329 )  
    Objective To study the identification method that aims at the research and development target and makes the limited resources be optimized. With the frequent occurrence of potential drug safety hazards and the vigorous development of biomedicine, China’s pharmaceutical cold chain is facing huge opportunities and challenges. Under this background, it’s vital to promote the research and development of Chinese pharmaceutical cold chain technology. Methods First, China’s pharmaceutical cold chain patents were sorted out through the literature
    research method and patent analysis method, de-noises and cleans the data, uses the international patent classification (IPC) numbers as the pharmaceutical cold chain technology. Then, the IPC number co-occurrence matrix was constructed. Third, UCINET was used to visualize, draw the IPC number co-occurrence network. After that, K-cores analysis was applied to initially screen the core technology so as to build a comprehensive evaluation index system to evaluate the core technologies. Finally, Condorcet voting method was used to integrate the evaluation results to identify the core technologies. Results and Conclusion Based on this method, it can provide theoretical guidance for the development and decision-making of Chinese pharmaceutical cold chain enterprises, helping them break through technical barriers and improving the efficiency of Chinese pharmaceutical cold chain logistics.
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    Analysis on the Development Trend and Countermeasures of Clopidogrel
    Wu Tong, Dong Li
    2021 (2):  139-144. 
    摘要 ( 264 )   PDF(885KB) ( 231 )  

    Objective To analyze the development trend of clopidogrel bisulfate so as to provide suggestions for the research and development (R&D) of China’s pharmaceutical enterprises. Methods By studying the development process of thiophenic pyridine drugs, we found that clopidogrel bisulfate belongs to the second generation product. Then, the patent status of generic drugs of thiophene in the United States and China was analyzed to identify the key points and trends of its R&D. Results and Conclusion This paper analyzes the patent and important technology of clopidogrel to predict its development trend, and put forward countermeasures for Chinese pharmaceutical enterprises.

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    Research on the Status Quo and Countermeasures of Patent Application in Liaoning Biopharmaceutical Industry Based on Patent Map
    Ma Junhong, Zhang Wenfeng, Liu Yue, Yuan Hongmei, Zhang Dawei
    2021 (2):  145-153. 
    摘要 ( 288 )   PDF(1053KB) ( 368 )  

    Objective To study the patent map and the relevant theories of the patent development of biopharmaceutical industry for conducting a comprehensive and in-depth analysis of the problems in patent application in Liaoning biopharmaceutical industry. Methods Literature review, information visualization method, empirical analysis method and comparative analysis method were used to research the problems in the patent application. Results and Conclusion While developing biopharmaceutical industry, Liaoning provincial government should strengthen the protection of pharmaceutical patents, creating a new R&D mode of “university + research institutes + enterprises + individuals” to broaden the scope of technical fields. Then, its biopharmaceutical industry will be developed in an all-round way. Besides, it should closely follow the national development direction so that the biopharmaceutical industry in Liaoning Province will have a bright future.

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    Empirical Analysis on Performance Evaluation of A Pharmaceutical Company Based on Economic Value Added
    Li Meng, Huang Zhe
    2021 (2):  154-162. 
    摘要 ( 379 )   PDF(829KB) ( 322 )  

    Objective To establish an economic value added (EVA) performance evaluation system to maintain the competitiveness of pharmaceutical company A under the environment of fierce competition in the pharmaceutical industry. Methods An EVA performance evaluation model was established by adjusting the items of EVA performance evaluation index, such as after-tax profits, total invested capital and weighted average cost of capital rate. Results and Conclusion EVA values of pharmaceutical company A from 2014 to 2018 were calculated and compared with the traditional performance evaluation method, it was found that EVA performance evaluation model reflected the real performance of pharmaceutical company A. Therefore, pharmaceutical company A is doing well, but its growth rate is unstable.

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    Current Situation and Development Strategy of Residents’ Cognition and Use of TCM in Liaoning Province
    Wang Shuling, Ren Zhaoxia, He Yalan
    2021 (2):  163-173. 
    摘要 ( 385 )   PDF(4509KB) ( 289 )  

    Objective To investigate and analyze the residents’ cognition and use of traditional Chinese medicine (TCM) and put forward corresponding countermeasures for its existing problems. Methods A questionnaire survey was conducted to investigate the cognition and trust of TCM from 380 residents in Liaoning Province. Then, the differences of residents’ way of purchasing TCM and gaining the knowledge of TCM. Finally, Polygonum multiflorum was taken as an example to analyze the problems in residents’ cognition and use of Chinese medicinal materials, Chinese traditional decoction pieces, and Chinese patent medicine. Results and Conclusion A total of 402 questionnaires were collected, and 380 were valid. The effective rate was 94.53%. Residents’ understanding of the top three TCM processing techniques were simmering (58.95%), baking (56.84%), and parching (45.00%). The top three best-known TCM for them were chrysanthemum (72.63%), tangerine peel (63.16%), and hawthorn (62.11%). The main factors influencing residents’ willingness to purchase TCM were doctors’ advice (52.63%), and experts or experienced people’s suggestion (54.21%). The top three ways of residents’ gaining TCM knowledge were: TCM knowledge lecture (64.21%), health care knowledge (55.79%), and personal experience of Chinese medicine such as acupuncture and cupping (54.21%). However, due to the lack of professional knowledge of TCM, insufficient supervision and inconsistent standards, residents frequently took TCM by mistake. Residents have a high recognition of TCM, so its future development is optimistic. However, some residents’ insufficient knowledge of TCM often leads to the misapplication of the medicine. Therefore, to improve residents’ cognition of

    TCM, it is not only to actively publicize the professional knowledge of TCM, but also to improve the professional skills of practitioners, and the supervision standards and intensity of TCM market, so as to make residents feel at ease to buy safe and high-quality TCM products.

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    Investigation and Analysis of the Current Situation of Online Drug Sellers
    Xu Guangwei, Wang Shuling
    2021 (2):  174-179. 
    摘要 ( 281 )   PDF(717KB) ( 286 )  

    Objective To provide reference for the relevant departments to train and manage online drug sellers. Methods A questionnaire was conducted among 124 grass-roots drug sellers from 13 online drug sales enterprises, including Tmall Medical Center and JD Home Health Channel and 265 teachers and students from 33 pharmaceutical colleges and universities. The problems were analyzed in this paper and some specific suggestions were made. Results and Conclusion 389 questionnaires were sent out and 371 effective questionnaires were recovered. The effective recovery rate was 95.37%. The universities surveyed mainly recruited undergraduates, accounting for 66.7% of the total. Most of the employees in the online drug sales enterprises surveyed graduated from secondary school or universities, accounting for 91.9%. The number of graduates surveyed who were willing to work in the online drug sales enterprises was low, accounting for only 8.67%. Besides, it was difficult for online drug sellers to be promoted, 71.7% of the respondents had no promotion opportunities. In view of the main problems such as the low professional quality of online drug sellers, their low willingness to engage in online drug sales, and few promotion opportunities, it is suggested the reform of licensed pharmacists should be deepened to improve the number and quality of online drug sellers. Meanwhile, we should learn the advanced experience from developed countries. In addition, the income and welfare of the online drug sellers should be improved. Lastly, a unified management platform must be set up for online drug sellers by technical means.

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    The Practice of Pharmacist-Driven Antimicrobial Stewardship Based on Value-Based Healthcare
    Sun Yinxiang, Xu Chunhua, Li Yong, Huang Sichao, Zhou Zhiling, Cui Min
    2021 (2):  180-186. 
    摘要 ( 306 )   PDF(942KB) ( 268 )  

    Objective To evaluate the effect of pharmacist-driven antimicrobial stewardship based on value-based healthcare in a tertiary hospital in China. Methods The application of plan-do-check-action (PDCA) cycle and antimicrobial stewardship (AMS) were respectively used to improve the rational use of antimicrobial agents in prophylactic and therapeutic. Data were collected and the effect was assessed during the management period (2016-2019). Results and Conclusion From 2016 (before implementation) to 2019 (after implementation), the rational use of antibiotics were obviously enhanced in outpatients, inpatients, and emergency department. For instance, the utilization rate in type I incision operation was decreased from 26.42 % to 14.60 % (P = 0.000), the daily doses of antibiotic per 100 patient-days decreased from 49.34 ± 2.97 to 35.89 ± 4.96 (P = 0.000), and the average antibiotic expenditures dropped from 948.53 yuan to 526.30 yuan (P = 0.000). There was no significant change in infection rate, nosocomial mortality rate, and the length of hospital stay. After the implementation of clinical pharmacistdriven antimicrobial stewardship based on value-based healthcare, the consumption and cost of antibacterial have been greatly reduced. Therefore, the pharmacist-driven antimicrobial stewardship increases its value.

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    Problems in China’s Licensed Pharmacists System and Suggestions for Improvement
    Wang Lili
    2021 (2):  187-192. 
    摘要 ( 329 )   PDF(753KB) ( 298 )  

    Objective To study the main problems existing in the current licensed pharmacists system in China. Methods The relevant literature was searched, and the differences of licensed pharmacists system at home and abroad were compared. Results and Conclusion By comparison, it is found that there are obvious differences in the management system, access system and continuing education of licensed pharmacists between China and foreign countries. In order to improve the system of licensed pharmacists in China, the supervision of licensed pharmacists should be strengthened by introducing relevant laws and regulations as soon as possible. Besides, the admittance criteria of licensed pharmacists should be enhanced, and the continuing education system of licensed pharmacists should be optimized as well.

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