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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.   Abstract （285）      PDF（pc） （796KB）（511）       Knowledge map    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. Related Articles | Metrics

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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.   Abstract （355）      PDF（pc） （935KB）（503）       Knowledge map    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. Related Articles | Metrics

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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.   Abstract （270）      PDF（pc） （801KB）（427）       Knowledge map    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. Related Articles | Metrics

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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.   Abstract （349）      PDF（pc） （1965KB）（391）       Knowledge map    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. Related Articles | Metrics

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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.   Abstract （307）      PDF（pc） （923KB）（343）       Knowledge map    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. Related Articles | Metrics

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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.   Abstract （313）      PDF（pc） （1810KB）（315）       Knowledge map    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. Related Articles | Metrics

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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.   Abstract （299）      PDF（pc） （1103KB）（303）       Knowledge map    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. Related Articles | Metrics

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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.   Abstract （306）      PDF（pc） （447KB）（302）       Knowledge map    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. Related Articles | Metrics

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Drug Regulatory Science in EU and Its Enlightenment to China Li Yanying , Huang Zhe, Lian Guiyu Asian Journal of Social Pharmacy    2022, 17 (2): 115-119.   Abstract （221）      PDF（pc） （799KB）（284）       Knowledge map    Objective To analyze the current situation of research and application of drug regulatory science in EU, and provide suggestions for policy-making of drug regulatory in China. Methods The policy guidelines issued by European Medicines Agency (EMA) and domestic and foreign literature were retrieved to summarize how to carry out drug regulation science in Europe. Results and Conclusion A strategic plan was formulated by the EMA for the implementation of drug regulatory science, and the construction of academic system and discourse system of regulatory science were improved, which played a role in promoting the progress of European drug regulatory science. It is suggested that a phased strategic plan of regulatory science should be established to clarify strategic objectives and main tasks in China as soon as possible. Besides, the construction of discipline system and discourse system should be strengthened to realize the scientific supervision of drugs. Related Articles | Metrics

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Strategic Planning for Drug Regulatory Science in the United States and Its Enlightenments to China Chang Yingnan, Gong Jingran, Chang Senhao, Chen Yuwen Asian Journal of Social Pharmacy    2023, 18 (2): 91-97.   Abstract （487）      PDF（pc） （805KB）（244）       Knowledge map    Objective To study the strategic planning of drug regulatory science, the effectiveness and role of policy implementation in the United States so as to gain insights and make suggestions for further improving the strategic planning of drug regulatory science in China. Methods Literature research method and comparative research method were used to compare and analyze the strategic planning of regulatory science in China and the United States. Results and Conclusion Drawing on the US experience, China should set goals based on mission and vision and identify problems, knowledge gaps, and key areas, then concrete measures can be taken to advance regulatory science. Related Articles | Metrics

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Research on the Status of Patent Protection of Prostaglandin Analogues for Glaucoma in China Zhou Sheng’an, Dong Li Asian Journal of Social Pharmacy    2022, 17 (2): 178-185.   Abstract （198）      PDF（pc） （3779KB）（237）       Knowledge map    Objective To study and analyze the status of patent protection of prostaglandin analogues for glaucoma in China. Methods Patent literatures published up to April 7, 2020 were retrieved by the keywords “PG” and “prostaglandin” on such patent information service platforms as SIPO, SooPat, and IncoPat. And then they were statistically analyzed by qualitative and quantitative means. Results and Conclusion A total of 300 patent literature related to prostaglandin analogues for glaucoma were obtained, and most of them were invention patents, including patents for composition and dosage form, indications and uses, related synthesis, the compound, and composition preparations. Prostaglandin analogues play an important role in the treatment of glaucoma. At present, China has a large number of patents applications, and the patent protection covers a wide range of technical fields, but the number of patents with valid legal status is relatively small. Therefore, China’s pharmaceutical enterprises and R&D institutions have more options in topic selection and project approval and patent protection strategies. Related Articles | Metrics

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Present Situation and Enlightenment of Post-Approval Change Management of Drugs in China, USA and EU Lv Xiaowen, Huang Zhe Asian Journal of Social Pharmacy    2023, 18 (1): 17-23.   Abstract （292）      PDF（pc） （358KB）（229）       Knowledge map    Objective To provide suggestions for further improvement of China’s drug post-approval change management system. Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA, EU and China were compared and analyzed. Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs. However, there are still some problems in China’s current post-approval change management systems. According to the model and requirements of the post-approval change management systems of the USA and EU, this paper proposes the following suggestions for the improvement of China’s post-approval change management system. Firstly, electronic files for licensed products should be created. Then, regulatory standards at the national level must be unified. Lastly, the concept of product life cycle management should be implemented. Related Articles | Metrics

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Exploration on the Implementation of the Integration of Medical and Preventive Model in China’s Primary Health Care Institutions Chen Hui, Wang Shuling Asian Journal of Social Pharmacy    2022, 17 (2): 167-177.   Abstract （305）      PDF（pc） （3599KB）（214）       Knowledge map    Objective To explore the different modes and approaches of medical and preventive integration in current primary health care institutions in China. Methods Through literature analysis, field research, telephone interviews, and other methods the implementation status was evaluated to systematically study the main experience and effect of implementing medical and preventive integration services in pilot areas. Results and Conclusion At present, there are three implementation modes of medical-prevention integration, namely, vertical mode based on the medical community, internal mode with optimized service process, and internal mode with great service capabilities. The three medical-prevention integration modes have their respective focuses, but they need to be further improved in terms of policy support, technical staffing, information system construction, and drug use. Related Articles | Metrics

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Research and Enlightenment of Accelerated Approval Pathway in China Li He, Huang Zhe Asian Journal of Social Pharmacy    2023, 18 (1): 1-7.   Abstract （369）      PDF（pc） （323KB）（208）       Knowledge map    Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs. Methods A comparative analysis was made to study the accelerated review, conditional approval and breakthrough therapy between China and the United States. Combined with the implementation of accelerated pathway in China, some suggestions were put forward. Results and Conclusion The implementation of accelerated drug review and approval system can significantly speed up the process of new drug development, which will improve the accessibility of innovative drugs. However, there are some problems in the review procedures and the implementation of supportive documents in China. In view of the above problems and combined with the experiences of US FDA, we should strengthen the construction of institutional system and reviewer team, and improve the efficiency of drug research and development. Related Articles | Metrics

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A systematic Review of the Safety and Effectiveness of Epidural Analgesia for Labor Analgesia Wang Dan , Liu Chunping , Zhang Fang, Gao jinglei Asian Journal of Social Pharmacy    2022, 17 (2): 186-197.   Abstract （332）      PDF（pc） （1597KB）（205）       Knowledge map    Objective To re-evaluate the systematic review of the safety and effectiveness of epidural analgesia (EA) for labor analgesia. Methods The Cochrane database, PubMed, EMBASE, EBSCO, Web of Science, ScienceDirect, China Biomedical Literature database, CNKI, Wanfang and VIP databases were searched, and the search time was limited to August 2020. Two researchers screened the literature and extracted data according to the inclusion criteria. AMSTAR was used to evaluate the methodological quality of the included studies. Pain intensity and pain relief satisfaction were used as the main indicators for re-evaluation of the effectiveness. Midwifery rate, cesarean section rate, back pain, fever, nausea and vomiting, umbilical artery pH value, and newborn Apgar score were used as the main indicators to re-evaluate the safety. Results and Conclusion A total of 9 meta-analyses were included. The safety and effectiveness of EA and opioid intravenous analgesia, acupuncture stimulation, inhalation analgesia, no analgesia, and continuous delivery were evaluated separately. The included systematic reviews showed that EA could increase the rate of device-assisted delivery, causing maternal fever, and prolonging the first and second stages of labor. But the incidence of back pain, nausea, and vomiting was lower. Therefore, analgesia had a good effect with better satisfactory degree. Current evidence shows that EA is safe and effective for labor analgesia, but the quality of the reports of current studies is not high. Related Articles | Metrics

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Current Situation and Suggestions on the Development of Diagnosis Related Group (DRG) Policy in China Dong Yujiao, Wang Shuling Asian Journal of Social Pharmacy    2022, 17 (4): 367-375.   Abstract （341）      PDF（pc） （571KB）（205）       Knowledge map    Objective To implement the national diagnosis related group (DRG) policy smoothly, and gradually move towards value medicine and fine management, some suggestions are put forward for improving medical service efficiency, saving medical insurance fund, and reducing the burden of patients, so as to realize the win-win situation of medical insurance and patients. Methods Based on the experience of the United States, Australia, and Germany, the policy implementation background and development process in China were summarized. The advantages and disadvantages of single disease payment method, disease score payment method, and diagnosis related groups - prospective payment system (DRG-PPS) method were compared, and then the problems were found out. Results and Conclusion In view of the imperfect information system, lack of professional talents, and uneven progress of each pilot, it is proposed that relevant departments should pay more attention to the construction and improvement of coding and other information systems, cultivate professional talents, promote the reform of DRG payment technology specification and grouping technology combined with national pilot project, thus enhancing the application and in-depth development of DRG policy in China. Related Articles | Metrics

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A Case Analysis of the Influencing Factors of Job Satisfaction of Licensed Pharmacists in Retail Pharmacies Based on SEM - Taking R Retail Pharmacy for an Example Chen Jing, Cui Yuxue, Chen Jing Asian Journal of Social Pharmacy    2022, 17 (4): 317-332.   Abstract （205）      PDF（pc） （1122KB）（201）       Knowledge map    Objective To explore the influencing factors on job satisfaction of licensed pharmacists in R retail pharmacy, and to provide a reference for improving the job satisfaction of licensed pharmacists in China. Methods Through literature research and satisfaction questionnaire, 349 licensed pharmacists in R retail pharmacy were investigated. Then, the influencing factor equation model was constructed by factor analysis and structural equation method. Results and Conclusion The overall adaptation of the structural equation model was well established. The job satisfaction of licensed pharmacists in R retail pharmacy was closely related to interpersonal relationship, work characteristics, good management, salary and growth opportunity, and it was not significantly correlated with job environment. Therefore, work characteristics influenced most, followed by salary. Five key factors affecting the job satisfaction of licensed pharmacists in R retail pharmacy are summarized in this paper. It is suggested to adjust corresponding key factors such as work characteristics and salary, so as to improve job satisfaction of licensed pharmacists in the same industry. Related Articles | Metrics

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Study on the Changes of FDA Finished Pharmaceuticals Warning Letters between 2011 and 2021 Jiang Yang, Yang Yue Asian Journal of Social Pharmacy    2022, 17 (4): 291-299.   Abstract （196）      PDF（pc） （487KB）（192）       Knowledge map    Objective To explore the trends in the distribution of countries to which FDA warning letters for Finished Pharmaceuticals have been issued over the past 10 years, and whether there are changes in the number of GMP violations, and to study their possible causes. Methods Public data on FDA warning letters and inspections were retrieved and analyzed using statistical methods for different classifications. Results and Conclusion Asia was the continent that received the most GMP warning letters in the last 10 years. More inspections were conducted in developed countries than that in developing countries, but they received a small number of warning letters. Quality control unit responsibilities were the most variable within all violation codes. The number of warning letters issued by Center for Drug Evaluation and Research (CDER) for Finished Pharmaceuticals increases with the number of inspections, and the enforcement of GMP by domestic drug manufacturers is better than that of overseas drug manufacturers. In addition, drug manufacturers in developed countries are better at GMP implementation than developing countries. GMP compliance in China has become better in recent years, but it still receives more inspections and warning letters. FDA inspections of Finished Pharmaceuticals become more stringent in the last 10 years, and many quality unit issues are affected by both personnel qualifications and personnel numbers. Related Articles | Metrics

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Experimental Design of Observational Studies in Real-World Study Qu Yi, Wang Yuzhuo, Yuan Xiaoliang, Wang Chuang, Huang Zhe, Chen Yuwen Asian Journal of Social Pharmacy    2022, 17 (3): 222-228.   Abstract （148）      PDF（pc） （817KB）（185）       Knowledge map    Objective To introduce the design of observational trials under real-world study (RWS), and to provide guidance for clinical development of new research trials and reference for real-world researchers. Methods Relevant literature of RWS and observational experiments at home and abroad were reviewed and analyzed, and then the design of observational studies was summarized under RWS. Results and Conclusion The data and information provided in observational studies not only help to further verify the clinical study results obtained by randomized controlled trial (RCT) in clinical practice, but also objectively reflect the real situation in the process of clinical research and application. Related Articles | Metrics

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Analysis of Factors Affecting Online Drug Purchase – Based on Factor Analysis Wang Shuling, Liu Liang, Zhi Yuanyuan Asian Journal of Social Pharmacy    2022, 17 (3): 268-280.   Abstract （228）      PDF（pc） （2843KB）（162）       Knowledge map    Objective To explore the factors affecting consumers’ online drug purchases, and construct models of these factors to provide references for the development and popularization of online pharmacies. Methods Through searching, classifying, integrating, and extracting evaluation indexes of online pharmacies in literature, the indexes of factors affecting online drug purchases were initially established. Then SPSS24.0 was used for data analysis, and finally factor analysis was applied for screening and combining the indexes. Results and Conclusion A model of influencing factors for online drug purchases is set up with 4 factors and 14 indexes. Convenient service is the most important factor affecting online drug purchases. Highly educated young people prefer to buy drugs online. At present, online drug purchase is only a supplement to the purchase of drugs in offline pharmacies, and the penetration rate is not high. Online pharmacies should give full play to their advantages in terms of drug types, prices, logistics and after-sales services to make online drug purchases more mainstream. Related Articles | Metrics

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Research on the Extraction Techniques of Ginseng Based on Patent Analysis Yu Huixian, Zhang Wenfeng, Yuan Hongmei Asian Journal of Social Pharmacy    2022, 17 (4): 333-342.   Abstract （103）      PDF（pc） （3385KB）（160）       Knowledge map    Objective To analyze the gaps between patents of ginseng extraction method in China and South Korea, and to provide research and development directions for Chinese companies. Methods By observing the changes in the amount of patent applications over time, the distribution of application countries and regions, the analysis of applicants, the extraction of technical topics, and the development and change of method, an in-depth discussion on the patent of ginseng extraction method in China and South Korea was conducted. Results and Conclusion China lacks the mastery of advanced technology and the exploration of popular fields, while South Korea is just the opposite of China. Therefore, Chinese enterprises should focus on extraction processes and actively explore new technical fields. Related Articles | Metrics

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Research on the Development of Drug Regulatory Science in China Wang Guanjie, Shao Mingli Asian Journal of Social Pharmacy    2022, 17 (4): 285-290.   Abstract （211）      PDF（pc） （427KB）（155）       Knowledge map    Objective To study the situation of the development of China’s drug regulatory science and to provide some suggestions for its future development. Methods Based on the origin of regulatory science in China, the methods of literature research and comparison were used to make a detailed analysis of China’s drug regulatory science plan and its implementation effect, the research direction, the number of key laboratories, regulatory science exchange conferences and professional papers published, so as to put forward the development trend of China’s regulatory science. Results and Conclusion According to China’s national conditions, the government should continue to promote the development of the regulatory science system from three aspects: basic theoretical research, discipline construction and action plan. China’s drug regulatory science can not only promote the rapid development of pharmaceutical industry, but also guarantee public health. Related Articles | Metrics

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Enlightenment and Suggestions on the Construction of Information Platform and Processing Mechanism of Drug Shortages in Developed Countries to China Cui Li, Xing Hua Asian Journal of Social Pharmacy    2023, 18 (2): 177-186.   Abstract （258）      PDF（pc） （817KB）（153）       Knowledge map    Objective To study how to improve and perfect the information platform and processing mechanism of drug shortages in China. Methods By searching the relevant policies from official websites of FDA, European Medicines Agency (EMA), Health Canada (HC) and National Health Commission, the good experience of the United States, the European Union and Canada in the construction of information platform and processing mechanism of drug shortages was summarized for reference in China. Results and Conclusion China has initially established the processing mechanism of drug shortages, but the platform construction should be improved, and the information disclosure of drug shortages varies from province to province. We should improve the information platform of drug shortages, strengthen the disclosure and communication of information, enrich the processing tools and measures after the drug shortages occurs, and strengthen the cooperation with relevant associations and other non-governmental departments. Related Articles | Metrics

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Study on Emergency Use Authorization and Risk Control of Pfizer-BioNTech Vaccine Wang Yiran, Yang Yue Asian Journal of Social Pharmacy    2023, 18 (1): 24-29.   Abstract （211）      PDF（pc） （408KB）（151）       Knowledge map    Objective To analyze the methods and policies for emergency use authorization (EUA) and risk control of COVID-19 vaccines. Methods The legal basis, safety, and effectiveness evaluation criteria for Pfizer-BioNTech vaccine under EUA, as well as the continuation of phase III clinical trials and pharmacovigilance plans were sorted out. And attention was paid to the safety surveillance actions and risk control measures of vaccines under EUA. Results and Conclusion The methods and policies for EUA and risk control of Pfizer-BioNTech vaccine were made clear and we could provide a reference for the pharmacovigilance action after the COVID-19 vaccines were put on the market in China. In the case of EUA, it is necessary to analyze the existing clinical safety data. Based on this, the risk control process should be confirmed at the time of formal marketing approval and after listing. Finally, the risk control should be adjusted at any time. Related Articles | Metrics

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Benefit-Risk Assessment for PD-1/PD-L1 Inhibitors in the Treatment of Non-Small Cell Lung Cancer Li Zhuangqi, Yang Yue Asian Journal of Social Pharmacy    2022, 17 (3): 253-259.   Abstract （239）      PDF（pc） （1808KB）（147）       Knowledge map    Objective To explore the benefits and risks of PD-1/PD-L1 inhibitors Atezolizumab and Nivolumab in the treatment of non-squamous non-small cell lung cancer and provide some references for clinicians. Methods Based on the data results of relevant studies published by ClinicalTrical.gov in the US clinical trial database and foreign peer-reviewed journals, the internationally recognized multi-criteria decision analysis (MCDA) model was used to assess the benefit and risk of PD-1/PD-L1 inhibitors for non-squamous non-small lung cancer comprehensively. Finally, a sensitivity analysis was performed to test the sensitivity of the weight to the evaluation. Results and Conclusion The benefit-risk evaluation result of Atezolizumab for the treatment of non-squamous non-small cell lung cancer is better than that of Nivolumab. Specifically, Atezolizumab has more benefits than Nivolumab with a lower risk. The results of MCDA model in drug benefit and risk evaluation are easy to understand. However, the selection of indicators in the model and the degree of data acquisition are limited. The evaluation results of the MCDA model should be comprehensively viewed with other evaluations to make decisions objectively. Related Articles | Metrics

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Development Strategy of Green Marketing of Pharmaceutical Enterprises against the Background of Building a Beautiful China Wang Shuling, Wang Mingzheng, Yu Chang Asian Journal of Social Pharmacy    2022, 17 (3): 260-267.   Abstract （202）      PDF（pc） （790KB）（145）       Knowledge map    Objective To study the key issues and links in the construction of green marketing for pharmaceutical enterprises combined with the law of scientific development, so as to make joint efforts for the construction of beautiful China. Methods The literature and interview methods were used to demonstrate that green civilization was to pursue the harmonious coexistence between environment and human beings. Besides, the responsibilities and problems that pharmaceutical enterprises faced in the context of building a beautiful China had to be solved urgently. Results and Conclusion China should summarize historical errors and face the current situation while building a beautiful country. In addition, pharmaceutical enterprises should clarify the key links of green marketing to solve the problem of “three wastes”. Meanwhile, they should bear other responsibilities to promote green civilization and social development. Related Articles | Metrics

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Research on the Relationship between Cooperation Innovation Expenditure and Economic Output of China’s Pharmaceutical Industry Wang Qiuli, Chen Yuwen Asian Journal of Social Pharmacy    2022, 17 (3): 204-213.   Abstract （207）      PDF（pc） （873KB）（144）       Knowledge map    Objective To empirically analyze the relationship between cooperation innovation expenditure and economic output of China’s pharmaceutical industry, and provide a reference for improving its economic benefits and the capability of cooperation innovation in the future. Methods The relevant data of China’s pharmaceutical industry from 2000 to 2016 was selected as a sample. Based on the co-integration theory, an error correction model was established to conduct Granger test of causality to study the relationship between cooperation innovation expenditure and economic output of China’s pharmaceutical industry. Results and Conclusion The cooperation innovation expenditure of China’s pharmaceutical industry has a significant positive impact on economic output. If cooperation innovation expenditure increases 1%, its economic output will go up by 1.7%. At the same time, the long-term promotion effect of cooperation innovation expenditure on economic output is more significant than the short-term effect. Related Articles | Metrics

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Research on the Countermeasures for the Development of Biopharmaceutical Industrial Parks in China Zhang Zongjie, Wu Zhiang Asian Journal of Social Pharmacy    2023, 18 (3): 232-238.   Abstract （51）      PDF（pc） （352KB）（141）       Knowledge map    Objective To systematically analyze the current development status of biopharmaceutical industrial park in China, sort out the problems and put forward some countermeasures and suggestions. Methods Relevant literature was searched and reviewed to find out the problems faced by the development of biopharmaceutical industrial parks in China. Results and Conclusion Biopharmaceutical industrial parks are developing rapidly due to their unique industrial clustering advantages, but there are problems such as lack of overall planning at the top level, insufficient government support, imperfect talent support services and weak innovation capacity of the parks. It is recommended to promote the rapid development of biopharmaceutical industrial parks and biopharmaceutical enterprises by strengthening top-level design, increasing government support, focusing on talent introduction, and enhancing the innovative strength of the parks. Related Articles | Metrics

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The Expanding Roles of Hospital Pharmacists in Clinical Drug Trials in China Zhao Shanshan, Zhang Boquan, Wang Hongyun Asian Journal of Social Pharmacy    2022, 17 (3): 229-235.   Abstract （264）      PDF（pc） （789KB）（139）       Knowledge map    Objective To aim at summarizing the role of hospital pharmacists in clinical drug trials in China against the background that hospital pharmacists have already involved in team-based patient care. Methods The roles and responsibilities of Chinese hospital pharmacists were listed and categorized. Results and Conclusion There has been an upsurge in clinical drug trials in China. Hospital pharmacists play increasingly important roles in all aspects of clinical trials, such as stakeholder liaisons, protocol developers, ethics committee members, research team members, study drug managers, and subject intervention agents. Hospital pharmacists are an integral part of a clinical drug trial multidisciplinary team. Their value is reflected in several pharmacist-led or pharmacist-participating clinical trials as well as the trial project management position within hospitals. Pharmacists should be the designers, researchers, managers and supervisors of clinical drug trials. We expect that all clinical trial projects will include hospital pharmacists in their research teams soon. Related Articles | Metrics

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Analysis of Adverse Reactions in the Treatment of COVID-19 with Three Chinese Patent Medicines and Three Herbal Formulas Li Qiao, Wang Aili, Wu Di, Chen Yuwen Asian Journal of Social Pharmacy    2023, 18 (1): 8-16.   Abstract （149）      PDF（pc） （398KB）（127）       Knowledge map    Objective To explore the rules and characteristics of the adverse drug reactions (ADRs) of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19, and to provide a reference for clinical safe medication. Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed, Web of Science, Springer Link, CNKI, Wanfang and VIP database were retrieved from December 2019 to May 2021. Then we extracted and analyzed the effective information included in the literature. Results and Conclusion According to the pre-developed retrieval plan, a total of 136 documents were obtained, and a total of 6 documents met the inclusion criteria finally. 553 patients used three Chinese patent medicines and three herbal formulas, and there were 133 cases of adverse reactions. The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine, and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine. Related Articles | Metrics

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Thoughts on the Innovative Design of the Integrated Service Mode of Pharmacies and Elderly Care Centers Yu Lina, Xing Miaomiao, Wang Shuling Asian Journal of Social Pharmacy    2023, 18 (1): 78-86.   Abstract （155）      PDF（pc） （380KB）（126）       Knowledge map    Objective To evaluate the service model that integrates medical treatment and elderly care to provide a reference for the development of pharmacies and elderly care centers. Methods Through the literature investigation and case analysis, the domestic integrated medical treatment and elderly care service model was analyzed, and new ideas for the integration of pharmacies and elderly care centers were provided. Results and Conclusion The integrated service model of pharmacies and elderly care centers is designed and the integration mode of pharmacies, hospitals and elderly care centers is proposed by analyzing their advantages. The “pharmacy + elderly care” mode and the “pharmacy + medical treatment + elderly care” mode that integrates pharmacies, hospitals, and elderly care centers are put forward to predict its new development opportunities in the future. Related Articles | Metrics

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Research on Patent Situation of Medical Devices in China Wu Chenxia, Yuan Hongmei Asian Journal of Social Pharmacy    2023, 18 (1): 30-39.   Abstract （141）      PDF（pc） （899KB）（126）       Knowledge map    Objective To study the patent situation of medical device industry in China based on patent data. Methods The analysis function of the patent search software incoPat was used to analyze the patent situation from two perspectives: The overall situation and the technical level. Results and Conclusion At present, China’s medical device industry is developing rapidly under the leadership of enterprises as the main body of innovation, but only 16% of patents are authorized. In addition, the technology distribution of medical device industry is mainly related to diagnostic, surgical and identification medical devices and implantable devices, accounting for 59% of the main technology distribution, and their technical effects are mainly related to improving convenience, reducing complexity, and improving safety. The quality of patents related to medical device industry in China is low, the technology distribution is not rich enough, and the level of technical efficacy is low. Related Articles | Metrics

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Research on the Regulatory Framework of Advanced Therapies in the European Union and the United States Wulan Qiqige, Yang Yue, Huang Zhe Asian Journal of Social Pharmacy    2023, 18 (2): 98-106.   Abstract （437）      PDF（pc） （914KB）（123）       Knowledge map    Objective To study the regulatory framework of advanced therapies in the European Union and the United States, and to provide reference for the regulation of cell- and gene-based therapeutic products in China. Methods The legal and regulatory documents, annual reports, work information and related literature published on the websites of the FDA and European Medicines Agency (EMA) were reviewed to analyze the regulatory models of advanced therapies in the European Union and the United States. Results and Conclusion the United States and the European Union have carried out a lot of work in the classification standards of advanced therapies, policy formulation and accelerated listing procedures. Therefore, they have established a relatively mature regulatory system. China can learn from their experience and continuously improve the regulatory system to help the sustainable development of gene and cell therapy industry. Related Articles | Metrics

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Present Situation and Thinking of the Evaluation and Management of Biomedical Projects in Shenzhen Industrial Park of Shenzhen-Hong Kong Cooperation Zone Zhao Xuanhe, Wang Shuling Asian Journal of Social Pharmacy    2023, 18 (2): 116-127.   Abstract （362）      PDF（pc） （1099KB）（122）       Knowledge map    Objective To put forward some suggestions for the improvement of the evaluation system of Shenzhen Industrial Park of Shenzhen-Hong Kong Innovation Cooperation Zone by studying the scientific research project evaluation and management system of Japan Agency for Medical Research and Development (AMED). Methods Through literature review, lessons were drawn from the review and management policies and methods of biomedical projects implemented by Japan AMED. Then some reference was provided to the review and management of the projects in Shenzhen Industrial Park. Results and Conclusion A basic review framework has been set up in Shenzhen Industrial Park, which consists of scientific research management institution of Shenzhen Industrial Park, Third-Party Review Institution and Science Committee. However, there are three problems in this system: unclear selection criteria of review experts, insufficient supervision and lack of project evaluation standards. These problems can be solved by establishing an expert think tank, setting up graded project supervisors to have the dynamic monitoring, and developing a general evaluation scale for evaluating scientific research projects in Shenzhen Industrial Park. Related Articles | Metrics

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The Problems and Countermeasures of Four Community Pharmacies on Drug Quality Management in Kangping County Zhang Jie, Tian lijuan Asian Journal of Social Pharmacy    2023, 18 (1): 64-70.   Abstract （88）      PDF（pc） （394KB）（119）       Knowledge map    Objective To study the drug quality management of four community pharmacies and provide countermeasures and suggestions for improving the drug management level in Kangping County. Methods Literature research and investigation research were adopted in this paper to analyze the current situation and problems of drug management in four community pharmacies in a town of Kangping County. Results and Conclusion The problems of four community pharmacies in a town of Kangping County are low level of drug quality management, insufficient quality and capability of the practitioners and physician’s illegal act such as some licensed pharmacists paid from the linked pharmacies. There are also problems in facilities and equipment, drug display and storage, and document management, which reflects the lack of local drug supervision. Based on the above problems, some countermeasures and suggestions are put forward to strengthen the drug quality management of four community pharmacies in Kangping County. Related Articles | Metrics

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Study on Problems and Countermeasures in the Management of Spot Check of Chinese Herbal Pieces Cui Yihang, Chen Binbin, Sun Lihua Asian Journal of Social Pharmacy    2023, 18 (2): 107-115.   Abstract （434）      PDF（pc） （899KB）（118）       Knowledge map    Objective To provide suggestions for optimizing the sampling management of Chinese herbal pieces and improving the quality Chinese herbal pieces. Methods Logical reasoning method was used to analyze the problems in the drug spot check of Chinese herbal pieces based on the data of drug quality published by the National Medical Products Administration from 2013 to 2021, combined with the current provisions and implementation of drug spot check management in China. Results and Conclusion At present, there are some problems in the drug spot check of Chinese herbal pieces, such as fewer varieties of Chinese herbal pieces in the national drug spot check, the unreasonable sampling links, the insufficient territorial management in some areas, and error-prone sample extraction. It is suggested that the actual quantity and overall quality of Chinese herbal pieces should be fully considered in the formulation of sampling plan. Besides, the variety coverage of drug spot check of traditional Chinese medicine should be strengthened. In the planning, the sampling links shall be made as a whole, and the credit rating and distribution of drug production, operation and use units within the jurisdiction shall be fully combined. While strengthening the sampling management at the production end in areas with concentrated industries, regional special drug spot check should be carried out or the administrative forces at the provincial, municipal and county levels should be fully mobilized to avoid local protection. In the assigned tasks, the name of Chinese herbal pieces should be accurately expressed to avoid the sampling errors of Chinese herbal pieces with the same original medicinal materials and different processing methods. Related Articles | Metrics

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Considerations on the Quality Standards Reflecting the Characteristics of Compound Preparations of Traditional Chinese Medicine Zhao Wei, Wu Zhi’ang Asian Journal of Social Pharmacy    2022, 17 (3): 199-203.   Abstract （177）      PDF（pc） （821KB）（117）       Knowledge map    Objective To study the current quality standard of traditional Chinese medicine (TCM) and its limitations in China, and encourage enterprises to take more responsibility to promote the development of this industry. Methods Based on the analysis of the status quo and problems of the quality standard system of TCM, the quality control mode, as well as the problems found in the reevaluation after marketing, some suggestions were put forward for adjusting the current quality standard of TCM. Results and Conclusion Through strengthening the quality control of the source, and under the premise of ensuring the safety, effectiveness and stability of TCM, the quality standards of TCM can be improved greatly. Related Articles | Metrics

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Comparative Study and Enlightenment on Innovation Achievements of Pharmaceutical Industry in Liaoning Province Tao Na, Tian Lijuan Asian Journal of Social Pharmacy    2022, 17 (3): 214-221.   Abstract （242）      PDF（pc） （1291KB）（111）       Knowledge map    Objective To promote the innovation and development of pharmaceutical industry in Liaoning Province. Methods Literature study and comparative study were used to investigate the current situation and problems of innovation driven development of pharmaceutical industry in Liaoning Province by comparing data of Heilongjiang, Jilin, Shandong, and Jiangsu from four aspects of priority review and approval, consistency evaluation of generic drugs, new drugs on the market, and scientific and technological innovation achievements. Results and Conclusion In terms of innovation-driven development, pharmaceutical industry in Liaoning Province has the following problems, such as small scale, weak transformation of scientific and technological achievements, tough business environment, and single platform module of scientific and technological achievements. Combined with the actual development of pharmaceutical industry in Liaoning province, the government should give full play to its leading role and guide “Benxi Pharmaceutical Capital” to establish characteristic industrial cluster and incubation park. After high quality enterprises and high-level innovative talents get together, enterprises can analyze their actual situation to plan R&D layout, focusing on the input-output ratio. Meanwhile, the benign development of the enterprises, universities and research institutes should be promoted to integrate technical innovation and product supply. This can enhance the cooperation among the government, enterprise, university, and research institute, and provide reference for further development of pharmaceutical industry in Liaoning province. Related Articles | Metrics

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Research on Liposomal Irinotecan in Combination with 5-FU/LV for Metastatic Pancreatic Ductal Adenocarcinoma Wang Wenjun, Wang Yaoling, Huang Zhe Asian Journal of Social Pharmacy    2023, 18 (2): 128-136.   Abstract （347）      PDF（pc） （1587KB）（110）       Knowledge map    Objective To systematically review the published clinical and economic research on liposomal irinotecan in combination with 5-FU/LV for metastatic pancreatic ductal adenocarcinoma (mPDAC) at home and abroad. Methods PubMed, Cochrane Library, Embase, CBM, CNKI, Wan Fang data, CRD database and health technology assessment official websites were searched to collect clinical and economic studies on liposomal irinotecan for mPDAC. Results and Conclusion Nine clinical studies and four economic studies were included. The result of clinical studies showed that liposomal irinotecan in combination with 5-FU/LV could extend survival with good drug compliance in patients with mPDAC who progressed on prior gemcitabine-based therapy. This agent represented a new treatment option for second-line chemotherapy in these patients. The results of the economic evaluations failed to reach a consistent conclusion due to different economic levels in various countries. Related Articles | Metrics

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Analysis on the Revenue Status of the “Fourth Terminal” Industry of Ali Health Sun Xiaohua, Gao Jingyi, Wang Shuling Asian Journal of Social Pharmacy    2023, 18 (1): 40-48.   Abstract （127）      PDF（pc） （383KB）（103）       Knowledge map    Objective To analyze the revenue status of the “fourth terminal” industry of Ali Health, and to explore the opportunities of the “internet and medical health” model and provide some suggestions for China’s medical e-commerce industry. Methods Through literature research and network collection methods, a large number of literature and network materials were studied in detail, and the revenue status of the “fourth terminal” of Ali Health in different fiscal years was compared and analyzed. Results and Conclusion According to the revenue of different fiscal years, the “fourth terminal” industry of Ali Health has developed rapidly, and the revenue gap between different business is large, so the “fourth terminal” industry should be improved. Related Articles | Metrics