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    Suggestions on Foreign Pharmaceutical Enterprises Dealing with China’s Drug Centralized Procurement – Taking the First Batch of Implementation Results as an Example
    Li Yunlong, Ning Bowen, Yuan Hongmei
    Asian Journal of Social Pharmacy    2022, 17 (1): 23-33.  
    Abstract328)      PDF(pc) (1394KB)(606)      
    Objective To analyze the impact of the first batch of centralized drug procurement on foreign pharmaceutical enterprises since the national centralized drug procurement policy has brought great impact on pharmaceutical market, and put forward some suggestions on their marketing transformation in China. Methods Firstly, the documents of the drug centralized procurement were studied, and then the sales figures before and after the implementation of the policy were retrieved from MiNET. At the same time, the relevant business adjustment information of foreign pharmaceutical enterprises was collected for analysis. Results and Conclusion The sales of related products of foreign pharmaceutical enterprises have dropped sharply, so they have stripped off these products and reduced their staff. It is suggested that foreign pharmaceutical enterprises should adjust the structure of sales team, strengthen the layout of the market in the county, and accelerate the introduction of innovative drugs to cope with centralized drug procurement.
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    The Impact of Generic Drug Consistency Evaluation Policy on Pharmaceutical Enterprises
    Li Siwen , Yang Yue
    Asian Journal of Social Pharmacy    2022, 17 (2): 104-114.  
    Abstract285)      PDF(pc) (796KB)(511)      
    Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects: reference preparations, evaluation methods, input costs, and market competitions, and government incentives for generic drug manufacturers, so as to put forward relevant suggestions. Methods Literature research method and statistical analysis method were used to provide data support for paper writing, making suggestions, and enhancing the predictability of policy. Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations, high input costs for exploring evaluation methods, and greater market competition. Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs. However, difficulties in obtaining reference preparations, high input costs and complex evaluation methods all affect the enthusiasm of companies. Therefore, national and local regulatory agencies have issued some supporting policies, which should be improved to assist enterprises in conducting consistency evaluations.
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    The Investigation and Research of the Performance Appraisal of R&D Personnel in R Company
    Cui Yuxue, Chen Jing, Chen Jing
    Asian Journal of Social Pharmacy    2022, 17 (2): 132-143.  
    Abstract355)      PDF(pc) (935KB)(503)      
    Objective To improve the creativity and enthusiasm of R&D personnel in R Company. Methods The status quo of the performance assessment of R&D personnel in R Company was studied through questionnaire and interview survey. Factor analysis and multiple linear regression method were used to find out the core factors affecting the expectation of employee performance optimization, and the regression equation of employee performance optimization was established. Results and Conclusion R&D personnel in R Company have low satisfaction with the current performance appraisal and strong self-actualization needs, so they expect to optimize the performance appraisal. The objectives and key results (OKR), a management goal-setting system, can make up the deficiencies of R&D personnel’s current performance assessment in R Company, which meets their self-realization needs to a greater extent, thus stimulating their productivity.
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    Design of Pharmaceutical Care Process for Retail Pharmacies Based on Pareto Analysis
    An Lianyu, Liu Linchuan, Wang Shuling
    Asian Journal of Social Pharmacy    2022, 17 (1): 50-60.  
    Abstract355)      PDF(pc) (1555KB)(470)      
    Objective To study the problems of pharmaceutical care in retail pharmacies and provide reference for the standardized development of pharmaceutical care in China. Methods Based on the literature of CNKI database, Pareto analysis was used to study the present situation of pharmaceutical care in retail pharmacies. Then the following problems in pharmaceutical care were found such as low personnel professional quality, inadequate attention, imperfect laws and regulations, and lack of standard service process. As to the first three problems, there were more research references. But there was less literature on the standard care process. Results and Conclusion Focusing on the customer demand, taking drug sales process as the basic framework of pharmaceutical care standardized process, and combining with the collaboration, the service process including prescription drugs review and OTC drugs purchase consultation is established. This process elaborates the division of staff services as well as the service standards in pre-sale, on-sale, and after-sale stages. Besides, it also puts forward some advice for the previous three problems, which will ensure the smooth implementation of pharmaceutical care in drugstores.
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    Study on the Application of Quality Risk Management on Drug Collinear Production
    Xu Wenxiu, Ma Hui, Yang Dianzheng, Wei Jing
    Asian Journal of Social Pharmacy    2022, 17 (1): 39-49.  
    Abstract473)      PDF(pc) (1895KB)(444)      
    Objective To study how to ensure the quality of listed drugs by using quality risk management to control the risks in the drug collinear production because some pharmaceutical companies produce drugs with multiple dosage forms and specifications on the same line to save costs in China. Methods The application status of quality risk management in the production of drugs was analyzed by consulting literature, field investigation and research related policies. Results and Conclusion When introducing co-line products, we should focus on combining product reality, establish a cross-professional team in comprehensive quality, R&D, equipment, and production. Then we can coordinate quality risk management to integrate with each other to avoid “shortcomings” in different links, which will affect the effectiveness of risk management. When a company conducts co-line production, it should rely on quality risk management theories to establish a scientific quality management system, reasonably use quality risk assessment tools to evaluate the types of co-line production, and control key risk factors effectively. These methods can ensure the risk of co-production within an acceptable range.
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    The Development of DTP Pharmacy and Its Impact on Pharmaceutical Enterprises
    Shen Manzhu, Zeng Yingying, Yuan Hongmei, Fu Shuyong
    Asian Journal of Social Pharmacy    2022, 17 (2): 159-166.  
    Abstract270)      PDF(pc) (801KB)(427)      
    Objective To summarize the development status of direct to patient (DTP) pharmacy and its impact on pharmaceutical enterprises in China and to provide a reference for the pharmaceutical industry. Methods Literature research method was used to research domestic and foreign journals and magazines. Then, all sorts of data were collected to make a comprehensive comparison. Combined with relevant national policies, the current situation and advantages of the DTP pharmacy were analyzed to study its impact on pharmaceutical enterprises. Results and Conclusion Although DTP pharmacies are in the exploratory stage in China, with the advancement of comprehensive medical and health reforms, several national policies have created a good environment for the development of DTP pharmacies. Therefore, DTP pharmacies are accelerating their construction with better market value. As DTP pharmacies gradually become mature, some pharmaceutical enterprises have deepened cooperation with DTP pharmacies to open new channels for drug management. However, from the perspective of some generic drug enterprises, DTP pharmacies have certain adverse effects on them.
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    Investigation on the Current Situation of China’s DTP Pharmacy and Suggestions for Its Development
    Wen Dong, Dou Lele, Sun Yuyuan, Wang Shuling
    Asian Journal of Social Pharmacy    2023, 18 (2): 165-176.  
    Abstract349)      PDF(pc) (1965KB)(391)      
    Objective To summarize the main characteristics and development approaches of direct-to-patient (DTP) pharmacies, and to explore its future development trend. Methods Firstly, relevant policies of DTP pharmacies were sorted out based on some documents on the government website, and related articles were studied. Secondly, 499 DTP pharmacies were investigated. Finally, the current status of the industry was summarized and analyzed. Results and Conclusion Policies on China’s DTP pharmacy have been constantly improved. According to industry standards, the current compliance rate of DTP pharmacies is about 46.09%. In terms of varieties, the market share concentration rate of biological products is higher than that of chemical drugs. The regional distribution of these drugs is mainly concentrated in the central and eastern provinces. However, 63.45% of DTP pharmacies have less than 50 product specifications. DTP pharmacies have an average of 7.3 pharmacy technicians and 2.3 licensed pharmacists, which is higher than that of ordinary pharmacies. Due to the policy promotion, DTP pharmacies will be paid more attention by the public and the government, and the market share will become larger than before. Patients shifting from hospitals to drug-to-pharmacies can make them better layout. Besides, pharmaceutical services will become more specialized, and disease division will be more detailed. With the deepening of medical reform and the continuous improvement of national medical security as well as drug procurement and medical insurance payment methods, DTP pharmacies can play an important role in the national basic medical security system.
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    Research on the Differences of Media Reports on COVID-19 Based on Agenda-Setting Theory
    Zhang Wei, Wei Fuqian, Yang Yue
    Asian Journal of Social Pharmacy    2021, 16 (4): 281-289.  
    Abstract581)      PDF(pc) (5847KB)(372)      
    Objective To study the news reports on COVID-19 through comparing the forwarding volume and posting time of microblogs from the government media and non-government media and exploring the advantages and disadvantages of the two in mastering discourse power in public health emergencies, so to provide a reference for the government department to cope with online public opinion. Methods The GooSeeker data mining tool was used to collect the data of the six microblog accounts that reported the COVID-19 from January 1 to June 15, 2020. Then the data were analyzed from two aspects of microblog forwarding volume and posting time. Results and Conclusion According to the analysis of the forwarding volume data, the government media had a greater influence on the public during the process of COVID-19. The analysis of the news release time showed that the government media and non-government media had similar ability in discourse power on public health emergencies. This paper proposes the following recommendations for government departments to enhance their abilities to cope with online public opinion on public health emergencies, such as releasing information promptly, cultivating opinion leaders, and reporting the fact to avoid public misunderstandings.
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    Research and Suggestions on the Development of Smart Hospital – Taking Hospital A in Liaoning for Example
    Zhang Yuting, Liu Xiaoxi
    Asian Journal of Social Pharmacy    2022, 17 (1): 88-93.  
    Abstract334)      PDF(pc) (789KB)(370)      
    Objective To study the development of smart hospital to better carry out medical services in the context of the popularization and application of the Internet and the traditional medical model facing the challenge of COVID-19 in 2020. Methods Literature research method was used to analyze the Internet medical mode, and field investigation was made to explore the application of smart medical treatment in hospital A during the pandemic. Results and Conclusion The smart medical platform built by hospital A provides convenient and fast services for patients, but it also exposes the problems in the construction of smart hospitals in China. This paper proposes some suggestions such as hospitals’ participating in the independent review of smart systems and optimizing their information systems.
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    The Development Opportunities and Dilemmas of Telemedicine – Base on the Perspective of Medical Resource Distribution
    Liu Liang, Wang Shuling, Zhi Yuanyuan, An Lianyu
    Asian Journal of Social Pharmacy    2022, 17 (1): 76-87.  
    Abstract403)      PDF(pc) (1715KB)(368)      
    Objective To discuss issues related to telemedicine in the context of the “Internet plus” and the prevention of novel coronavirus in early 2020, so as to provide some reference for the rapid development of Internet plus telemedicine. Methods Literature analysis method was used to summarize the current status of telemedicine at home and abroad. Descriptive statistical analysis and comparative analysis were also conducted to analyze the data of population and health in the “China Health Statistical Yearbook” and “China Statistical Yearbook” from 2009 to 2018. Results and Conclusion The distribution of medical demand and medical resources is uneven in 31 provinces, municipalities and autonomous regions, such problems are more serious between urban and rural areas in different regions. The population’s demand for medical care and the allocation of medical resources have the characteristics of positive correlation, large urban-rural differences and regional imbalance. Confronted with the situation that the uneven distribution of medical resources provides potential development opportunities for telemedicine and the difficulties in the further development of telemedicine, the government should formulate policies to improve the publicity of telemedicine, setting up a full coverage of telemedicine service system. Besides, hospitals should ensure the information security monitoring.
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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
    Asian Journal of Social Pharmacy    2021, 16 (2): 145-153.  
    Abstract284)      PDF(pc) (1053KB)(362)      

    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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    Policy Comparison between Shenzhen GPO and Guangdong Medicine Exchange Center
    Xiang You, Tian Lijuan
    Asian Journal of Social Pharmacy    2021, 16 (4): 290-294.  
    Abstract357)      PDF(pc) (785KB)(358)      
    Objective To put forward some suggestions for improving the procurement policy of Shenzhen Pharmaceutical Group. Methods The literature research and comparative research were used to compare the policies between Guangdong’s centralized drug procurement and Shenzhen Pharmaceutical Group’s procurement so as to analyze their advantages and disadvantages. Results and Conclusion The purchasing model of Shenzhen group purchasing organization (GPO) can ensure the timely supply of medicines. Besides, the cross-regional alliance system helps to achieve a true price-for-quantity exchange, and a market-based price linkage mechanism can effectively reduce drug prices. However, the online drug catalogue of Shenzhen GPO cannot fully cover the actual needs of hospitals for procurement. The market-based price linkage may lead to problems of drug quality or shortage of drugs. Therefore, the number of batches of drugs should be increased online appropriately. Meanwhile, a mechanism must be established to guarantee the supply and quality of low-priced drugs.
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    Comparative Analysis of Social Forces Participating in Emergency Management of Public Health Events in China, Australia, Germany and the United States
    Wang Shuling, Dou Lele, Lin Xiangpeng, Liu Liang, Chen Hui
    Asian Journal of Social Pharmacy    2022, 17 (2): 144-158.  
    Abstract307)      PDF(pc) (923KB)(343)      
    Objective To provide a reference and suggestions for Chinese social forces to participate in the emergency management of public health events. Methods Through literature research method, comparative research method and SWOT matrix analysis, four aspects of prevention, early warning, response and recovery of the social forces in China, Germany, Australia and the United States participating in emergency management were studied comparatively. Results and Conclusion In the emergency management of public health events, China’s social forces play greater role in the response and recovery phase than that in the prevention and response phase. As to its shortcomings, the following suggestions are made, such as incorporating social forces into the national emergency management system, strengthening the construction and training of social forces, popularizing public health knowledge and awareness, clarifying property rights and using incentives and punishment together.
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    A Review of the Development and Effect of Contraceptive Counseling After Abortion
    Qiu Yu, Zhang Fang
    Asian Journal of Social Pharmacy    2022, 17 (1): 61-69.  
    Abstract416)      PDF(pc) (853KB)(341)      
    Objective To introduce the background and development of post-abortion services such as contraceptive counseling at home and abroad, and its important role for women so as to provide a reference for the further popularization of this service in China. Methods Chinese and English databases such as CNKI, WanFang Database, VIP, PubMed, and Web of Science were searched to find relevant studies on the implementation of post-abortion service, including post-abortion family planning and post-abortion contraceptive counseling in China. And then the literature on the implementation effect of post-abortion contraceptive counseling and related services was reviewed in China. Results and Conclusion The post-abortion contraceptive counseling service can effectively improve the reproductive health of the patients with induced abortion and the level of knowledge about contraception and birth control, so as to change the contraceptive behavior and adverse psychological state of the patients. Besides. it can guide patients to use more long-term and effective contraceptive measures, thereby reducing the occurrence of unintended pregnancy and repeated abortion. Standardized contraceptive counseling and related services can also improve patient satisfaction. According to the development and implementation effect of post-abortion service and post-abortion contraceptive counseling at home and abroad, it is necessary to further promote post-abortion contraceptive counseling service in the future. Much consideration should be given to carrying out a health technical assessment of the standardized post-abortion contraceptive counseling service as well as its implementation costs. Therefore, medical institutions will have a reference to carry out standardized post-abortion contraceptive counseling service.
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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
    Asian Journal of Social Pharmacy    2021, 16 (2): 120-127.  
    Abstract312)      PDF(pc) (813KB)(329)      

    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
    Asian Journal of Social Pharmacy    2021, 16 (2): 128-138.  
    Abstract331)      PDF(pc) (2102KB)(323)      
    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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    EU Real-World Evidence Supports the Expansion Indications for Drugs and Its Enlightenment to China
    Wang JiaoJiao, Huang Zhe
    Asian Journal of Social Pharmacy    2021, 16 (3): 214-218.  
    Abstract266)      PDF(pc) (780KB)(322)      
    Objective To analyze the value of EU real-world evidence (RWE) in supporting the expanded indications for drugs and to provide reference for the decision-making of expanding drug indications supported by RWE in China. Methods By searching relevant domestic and foreign literature and case analysis, the practice of the RWE of EU to support the expansion indications for drugs was investigated. Results and Conclusion The EU uses RWE to
    carry out adaptive path research, which provides a new idea for drug R&D and approval. Besides, it also provides evidence in supporting the research of expanded indications for drugs. With the increasing cognition of RWE, it will play a key role in medical and regulatory decisions in China.
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    Empirical Analysis on Performance Evaluation of A Pharmaceutical Company Based on Economic Value Added
    Li Meng, Huang Zhe
    Asian Journal of Social Pharmacy    2021, 16 (2): 154-162.  
    Abstract375)      PDF(pc) (829KB)(321)      

    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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    The Enlightenment of FDA’s “Real-World Evidence Program Framework” to China
    Yu Xiuna, Li Wanying, Dong Li
    Asian Journal of Social Pharmacy    2021, 16 (3): 225-229.  
    Abstract265)      PDF(pc) (789KB)(319)      
    Objective To provide a reference for China to use real-world evidence (RWE) in drug approval and regulatory decision-making system. Methods The main content of “Real-World Evidence Program Framework” issued by the FDA was summarized by literature research method, and the related system construction in China was analyzed. Results and Conclusion To promote the use of real-world study (RWS) for drug regulatory decisions, China should issue guidelines on RWS. Besides, the construction of data standards and the shared database should be strengthened. Then, the demonstration projects should be introduced extensively and the guidance for RWS of enterprises must be enhanced. Meanwhile, close attention should be paid to dealing with the relationship between stakeholders.
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    Selection Method of Production Enterprises by Large Pharmaceutical Commercial Companies Based on AHP
    Wang Xinyue, Lin Xiangpeng, Sun Xiaohua, Wang Shuling
    Asian Journal of Social Pharmacy    2021, 16 (4): 334-342.  
    Abstract403)      PDF(pc) (902KB)(318)      
    Objective To study the policies of integrating medical resources and centralized drug procurement in China from 2018 to 2020, and to provide a reference for large pharmaceutical commercial companies to select partners. Methods Analytic hierarchy process (AHP) and fuzzy synthesis evaluation method were used to establish the index evaluation system and assign values to each index. Results and Conclusion According to the questionnaire survey data, the weight of each evaluation index was determined, and the evaluation results were obtained by using the fuzzy synthesis evaluation method. The selection of production enterprises by large pharmaceutical commercial companies includes five first-level indicators and 11 second-level indicators. They can provide a favorable reference for the selection of production enterprises by large pharmaceutical commercial companies against the background of complex pharmaceutical industry.
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    Cause Analysis and Preventive Measures of Drug Shortage
    Zhou Ziyang, Ma Jia, Liu Fuyao, Liu Yuhan, Sun Lihua
    Asian Journal of Social Pharmacy    2022, 17 (2): 120-131.  
    Abstract313)      PDF(pc) (1810KB)(315)      
    Objective To study the current situation and the root cause of drug shortage in China, and put forward countermeasures and suggestions accordingly for relevant national policy decisions. Methods Based on literature research, questionnaire survey and expert consultation, the causes of drug shortage in China were comprehensively investigated, and fishbone diagram was used to further analyze the logical relationship among the causes. Results and Conclusion The main reasons for the shortage of drugs are the low profit of production enterprises and insufficient active pharmaceutical ingredients (APIs). The other reasons include uncertain demand, standard problem and few exclusive manufacturers. Besides, the monopoly of circulation enterprises also leads to the shortage of drugs to a certain extent. It is suggested that we should increase the punishment of monopoly, optimize the market environment, and establish a reasonable drug price mechanism. In addition, enterprises should participate in the information communication platform of medical institutions to solve the asymmetry between supply and demand. The research on clinical drugs to substitute drugs in need should be strengthened, and the reporting system of drug discontinuation should be improved.
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    Analysis on Causes of Drug Shortages and Countermeasures
    Xiao Yao, Sun Lihua
    Asian Journal of Social Pharmacy    2021, 16 (2): 108-113.  
    Abstract335)      PDF(pc) (725KB)(312)      

    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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    Survey of Shanghai Residents’ Perceptions of Buying Prescription Drugs Online
    Yan Weijie, Li Lingxi, Li Yanran, Min Jie, Zhang Zhixuan, Zhou Yuliang, Huang Jiaoling, Zhang Li
    Asian Journal of Social Pharmacy    2021, 16 (4): 329-333.  
    Abstract324)      PDF(pc) (846KB)(311)      
    Objective To investigate the willingness of Shanghai residents to buy prescription drugs online. Methods By using e-questionnaire, Shanghai residents’ perceptions of online prescription drugs were investigated, and 206 valid questionnaires were collected. Results and Conclusion 96.1% of the respondents knew the correct definition of prescription drugs. 46.6% knew they could buy prescription drugs online. 67.7%, through social media, knew they could buy prescription drugs online. 72.3% knew a medical prescription should be required when buying prescription drugs online. And 83.5% refused to buy prescription drugs online because they were concerned about the quality and safety of drugs. The publicity of online-pharmacies and prescription drugs should be increased in China. Besides, the government supervision should be strengthened in the whole process of service to protect consumers’ rights and benefits. Then, the channels of online purchase must be optimized for customers. Lastly, a medical insurance payment system should be set up for buying prescription drugs online.
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    Research of FDA Risk-Based Drug Inspection Program and Its Enlightenment
    Yang Luyao, Dong Jiangping, Yang Yue
    Asian Journal of Social Pharmacy    2021, 16 (2): 114-119.  
    Abstract402)      PDF(pc) (900KB)(310)      

    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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    Real-World Evidence Supporting New Drug Review and Approval in European Union and Its Enlightenment to China
    Lan Yipeng, Huang Zhe
    Asian Journal of Social Pharmacy    2021, 16 (3): 203-208.  
    Abstract343)      PDF(pc) (793KB)(310)      
    Objective To analyze the application of real-world evidence (RWE) in the field of medicine in European Union, and provide suggestions for RWE supporting the review and approval of new drugs in China. Methods The European Medicines Agency (EMA) and other databases were used to search relevant documents for analyzing the European Union’s new drug review and approval process with the support of RWE. Results and Conclusion The European Union carrying out new drug review and approval with the support of RWE has just begun. The decision-making process includes three stages such as new drug research and development, review, and approval. However, there are some challenges in data quality, research methods, evidence sufficiency, and research process of RWE supporting the European Union in reviewing and approving new drugs. At present, RWE can accurately grasp the clinical effects of drugs and improve the safety and effectiveness in the process of assisting the review and approval of new drugs. At the same time, RWE also can promote the development and application of Traditional Chinese Medicine (TCM) and help find out the potential value of TCM such as new indications.
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    Strategic Research on Pharmaceutical Enterprises’Participation in National Drug Centralized Procurement
    Yang Dianzheng, Xu Wenxiu, Qi Yun, Yang Yue
    Asian Journal of Social Pharmacy    2022, 17 (1): 15-22.  
    Abstract346)      PDF(pc) (958KB)(310)      
    Objective To study the influence of national drug centralized procurement policy on pharmaceutical enterprises manufacturing generic drugs and original drugs, so as to provide a reference for them to make different strategic choices. Methods Through the literature research on the related policies and the bidding data, the national drug centralized policies were studied systematically. Combined with the bid-winning price and price reduction range of the winning enterprises in the three rounds of centralized procurement, their difficulties, strategic choices and the winning factors were investigated. Besides, a model was established to clarify the optimal price of enterprises in the process of drug procurement. Results and Conclusion The strategic choices of enterprises in participating national drug centralized procurement are influenced by many factors such as the market share of the original varieties, active pharmaceutical ingredients (APIs) and cost. Therefore, corresponding strategies should be formulated according to the characteristics and interests of enterprises.
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    Management of Orphan Drug Reimbursement Abroad and Its Enlightenment to China
    Ma Jia, Li Xiaoqi, Raela·Abduhilil, Sun Lihua
    Asian Journal of Social Pharmacy    2021, 16 (4): 352-357.  
    Abstract334)      PDF(pc) (819KB)(307)      
    Objective To analyze relevant policies and measures on the management of orphan drug reimbursement in foreign countries to provide a reference for future reimbursement management in China. Methods According to the percentage of health care expenditure in GDP, the completeness of rare disease policies, and the total population, Russia, Australia, and India were selected as the reference. Based on the existing literature, the main content and characteristics of the reimbursement of rare disease drugs were analyzed. Results and Conclusion Russia manages rare diseases in the form of lists. Special rare diseases are reimbursed by federal or regional finances, and ordinary rare diseases are reimbursed by statutory medical insurance funds. Orphan drugs in Australia are included in the pharmaceutical benefits scheme (PBS) and the lifesaving drugs program (LSDP), LSDP provides fully reimbursed drugs for eligible rare disease patients. India’s proposal takes health system sustainability into consideration. China should carry out epidemiological research to legally determine the rare diseases, establish reasonable reimbursement standards, and improve the multi-level reimbursement system.
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    EU Real-World Evidence Supports New Drug Research and Development Decisions and Its Implications for China
    Yang Lingling, Xu Fengxiang
    Asian Journal of Social Pharmacy    2021, 16 (3): 197-202.  
    Abstract416)      PDF(pc) (927KB)(307)      
    Objective To analyze the application of EU real-world evidence in the decision-making of new drug research and development (R&D), and to provide policy recommendations for China’s government to make new drug R&D decisions. Methods The relevant policy documents of the EU on the development of new drugs and other domestic and foreign literature on the real-world evidence were analyzed to obtain the role and application of the current EU real-world evidence in the implementation of new drug development policies. Results and Conclusion At present, the EU is carrying out the national synchronous scientific advisory policy, urging the formation of a European innovation framework, and providing decision-making for new drug R&D selection and program design based on real-world evidence. It is recommended that China build a real-world medical database and design a new drug screening platform to help companies, scientific research institutions assess target drugs. In addition, a national scientific advisory platform should be set up to integrate scientific research strength and provide technical support for new drug R&D institutions.
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    The Latest Advance of the FDA Sentinel Initiative and Its Enlightenment to China
    Xie Xuerong, Tian Lijuan
    Asian Journal of Social Pharmacy    2022, 17 (2): 95-103.  
    Abstract299)      PDF(pc) (1103KB)(303)      
    Objective To study the useful experience of the FDA’s Sentinel initiative and provide a reference for the smooth implementation of China’s active drug safety surveillance after marketing. Methods By searching the official website of the FDA and relevant literature at home and abroad, the development history, framework, organizational system, data source and protection, monitoring tools and application of the FDA Sentinel initiative were sorted out. Results and Conclusion Sentinel initiative is an active surveillance method adopted by the US FDA to evaluate approved drugs and other medical products by using electronic health care data from various sources, which has formed a relatively mature management system in terms of data protection monitoring tools and other aspects. Drawing on the experience of FDA, China should integrate and utilize the existing health care database and expand the source of sentinel alliance database. Besides, the government should explore distributed database management mode to protect patients privacy effectively. Meanwhile, a public-private partnership platform can be established by formulating relevant regulations and policies to encourage academic institutions and pharmaceutical companies to make full use of sentinel data for mining data security signals and developing new monitoring tools.
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    Interviews on the Cooperation between Hainan and Macao in the TCM Industry to Promote Hainan’s TCM Industry
    Liu Tianchi, Zhang Xiaopo, Wang Yitao, Zeng Yu
    Asian Journal of Social Pharmacy    2022, 17 (4): 300-308.  
    Abstract306)      PDF(pc) (447KB)(302)      
    Objective To develop the internationalization and modernization of Hainan’s TCM industry, explore the development direction and fill in the research gap. Methods Design qualitative approaches, including fieldwork, semi-structured interviews, and policy analysis, were employed to identify development challenges for the cooperation between Hainan and Macao in TCM industry. Ten interviews with key TCM industry stakeholders in Hainan and Macao were conducted in 2020. These stakeholders are from schools, hospitals, companies, and governments. Hainan Province is the only free trade port with Chinese characteristics. Macao is an international free trade port that has special economic relations with European and Portuguese-speaking countries. Therefore, this study focuses on the cooperation in the traditional Chinese medicine (TCM) industry between Hainan and Macao. Besides, it investigates the traditional Chinese medicine industry in Hainan and Macau according to the SWOT model. Results and Conclusion The study revealed strengths, weaknesses, opportunities, and threats for cooperation between Hainan and Macao in TCM industry. Cooperation between Hainan and Macao can be taken as a priority outline and a standard for the internationalization and modernization of Hainan’s TCM industry.
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    Identification of Technology Catch-up Path from the Perspective of Technology Leapfrogging
    Huang Yufeng, Ning Bowen, Yuan Hongmei
    Asian Journal of Social Pharmacy    2021, 16 (4): 320-328.  
    Abstract346)      PDF(pc) (3540KB)(300)      
    Objective To propose a method to identify the shortest catch-up path by using patent data based on the perspective of technology leapfrogging so as to provide a reference for the catch-up strategy formulation by the governments of the developing countries. Methods Firstly, the international patent classification (IPC) co-occurrence network was used to screen key technologies, and the TOP 5 countries and China were located from the aspects of technology life cycle and technological innovation capabilities. Next, the technology development path based on the ordered clustering algorithm and the main IPC number was set up. Finally, the Dijkstra algorithm was applied to identify the shortest catch-up path. Results and Conclusion Applying this method to the current biopharmaceutical industry with the most potential for development, the shortest catch-up paths are found in the selected C12N15, C07K14 and C12Q1 technology fields, proving the feasibility of the method.
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    EU Real-World Evidence Supporting Drug Regulatory Decision and Its Enlightenment to China
    Fu Min, Huang Zhe, Xu Fengxiang
    Asian Journal of Social Pharmacy    2021, 16 (2): 103-107.  
    Abstract265)      PDF(pc) (706KB)(300)      

    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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    Problems in China’s Licensed Pharmacists System and Suggestions for Improvement
    Wang Lili
    Asian Journal of Social Pharmacy    2021, 16 (2): 187-192.  
    Abstract325)      PDF(pc) (753KB)(297)      

    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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    Research on the Relationship between Salary Incentives for R&D Personnel and R&D Investment in China’s Pharmaceutical Industry
    Wang Yuzhuo, Wang Su, Chen Yuwen
    Asian Journal of Social Pharmacy    2021, 16 (4): 295-304.  
    Abstract292)      PDF(pc) (901KB)(296)      
    Objective To explore the relationship between salary incentives for R&D personnel and R&D investment in China’s pharmaceutical industry through an empirical analysis so as to propose suggestions for increasing more R&D investment from the perspective of stimulating R&D personnel. Methods Based on the relevant data of the China’s pharmaceutical industry in the “China High-tech Industry Statistical Yearbook” and other data from the National Bureau of Statistics from 1995 to 2018, co-integration tests was used to construct error correction models and Granger causality tests to explore the relationship between R&D personnel salary incentives and R&D investment. Results and Conclusion There is a long-term balanced relationship between the salary level of R&D personnel in China’s pharmaceutical industry and the investment of R&D. For the per capita salary of R&D personnel increases by 1 unit, the internal expenditure of R&D investment will increase by 2.245 1 units. In the short term, the per capita salary of R&D personnel has a slight negative impact on the internal expenditure of R&D investment. In addition, the salary incentives for R&D personnel have the most significant role in promoting R&D investment after five years of implementation.
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    The Enlightenment of EU Real-World Evidence Supporting the Inclusion of Rare Disease Drugs in Medical Insurance Decisions to China
    Yu Zhongyi, Xu Fengxiang
    Asian Journal of Social Pharmacy    2021, 16 (3): 209-213.  
    Abstract258)      PDF(pc) (728KB)(293)      
    Objective To study the use of real-world evidence by EU and its member states for establishing a strategy for rare diseases and provide references for the inclusion of orphan drugs in China’s medical insurance. Methods A case analysis method was used to introduce the EU’s decision to include rare disease drugs in medical insurance by using real-world evidence because clinical data of rare diseases were difficult to obtain. Results and Conclusion
    China can use real-world evidence to make medical insurance decisions based on the experience of the EU and continue to invest more in rare diseases, which can solve the problem of few drugs for patients with rare disease.
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    Application of Real-World Evidence in Regulatory Decision-Making for Medical Devices
    Huang Xianqin, Chen Chuhan, Dong Li
    Asian Journal of Social Pharmacy    2021, 16 (3): 230-237.  
    Abstract319)      PDF(pc) (776KB)(292)      
    Objective To understand the real-world study (RWS) and its application in domestic and foreign pharmaceutical device regulatory decision-making, so as to promote its further application in the decision-making of medical devices supervision in China. Methods Literature analysis and comparative analysis were used to compare the real-world evidence (RWE) and randomized controlled trials to obtain the development status of medical devices in China and the United States. Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages, which can make up for the deficiencies of traditional clinical data. In addition, the RWE has a wide range of applications in the field of medical devices in China. In recent years, the RWE has received extensive attention in the medical field in the United States. The FDA has issued related guidelines, and its applications have gradually formed a complete system. Research on RWE will become the development trend of clinical evaluation of medical devices in the future. While attaching importance to the development of the RWE, China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.
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    Evaluation of the Effect of China’s Health Care Reform Based on Prospect Theory
    Guan Yueyue, Huang Zhe
    Asian Journal of Social Pharmacy    2022, 17 (1): 1-10.  
    Abstract356)      PDF(pc) (1626KB)(292)      
    Objective To evaluate the effect of health care reform policy in China comprehensively and provide suggestions for its further implementation. Methods Data on the effect of health care reform were obtained from “China Health Statistics Yearbook” and National Bureau of Statistics of China and the indicators were selected by corrected item total correlation (CITC) and Cronbach’s α reliability coefficient. Then, the selected indicators were calculated through the prospect theory model. Meanwhile, the gray relation analysis method was introduced to enlarge the differences between the advantages and disadvantages to make the comprehensive evaluation result more obvious. Results and Conclusion The implementation of China’s health care reform has a significant impact on China’s medical and health system. However, the effect of the policy will become less with the increase of the total amount. An effective management can ensure that the policy continues to play its role.
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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
    Asian Journal of Social Pharmacy    2021, 16 (2): 163-173.  
    Abstract375)      PDF(pc) (4509KB)(287)      

    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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    Analysis of Drug Use in Outpatients with Hypertension Based on Real-World Study
    Wang Lili
    Asian Journal of Social Pharmacy    2021, 16 (3): 264-271.  
    Abstract362)      PDF(pc) (807KB)(285)      
    Objective To explore the situation and trend of drug use in the treatment of hypertension in outpatient department of a hospital, and to provide reference for clinical rational drug use. Methods The data of 833 outpatients with hypertension in a hospital from July to December in 2020 were retrospectively analyzed. Results and Conclusion Among the 833 cases, calcium channel blocker (CCB) was the most frequently used drug (38.54%), followed by angiotensin receptor blocker (ARB) (13.81%), β-receptor blockers (β-RB) (10.44%), angiotensin-converting enzyme inhibitor (ACEI) (5.52%), and diuretics (0.72%). The combination rate was 37.09% (including single-pill combination, SPC). The highest rate was the combination of two drugs (28.21%), followed by the combination of three drugs (8.64%) and four drugs (1.20%). The DDDs and DDC of SPC were the highest among the six kinds of drugs. The use of antihypertensive drugs in outpatient department of the hospital is in line with the medication guidelines, but a small number of drugs are used irrationally, which needs further supervision and management.
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    Investigation and Analysis of the Current Situation of Online Drug Sellers
    Xu Guangwei, Wang Shuling
    Asian Journal of Social Pharmacy    2021, 16 (2): 174-179.  
    Abstract274)      PDF(pc) (717KB)(284)      

    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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