亚洲社会药学

Select

1. Strategic Planning for Drug Regulatory Science in the United States and Its Enlightenments to China

Chang Yingnan, Gong Jingran, Chang Senhao, Chen Yuwen

亚洲社会药学 2023, 18 (2): 91-97.

摘要（488）

PDF（pc）（805KB）（246）

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.

相关文章 | 多维度评价

Select

2. Research on the Regulatory Framework of Advanced Therapies in the European Union and the United States

Wulan Qiqige, Yang Yue, Huang Zhe

亚洲社会药学 2023, 18 (2): 98-106.

摘要（438）

PDF（pc）（914KB）（124）

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.

相关文章 | 多维度评价

Select

3. Study on Problems and Countermeasures in the Management of Spot Check of Chinese Herbal Pieces

Cui Yihang, Chen Binbin, Sun Lihua

亚洲社会药学 2023, 18 (2): 107-115.

摘要（434）

PDF（pc）（899KB）（119）

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.

相关文章 | 多维度评价

Select

4. Study on the Management of Chronic Diseases in American and British Community Pharmacy

Chen Qianqian, Tian Lijuan

亚洲社会药学 2023, 18 (2): 157-164.

摘要（411）

PDF（pc）（773KB）（96）

Objective To provide a reference for promoting the construction of chronic disease management in community pharmacies in China. Methods Literature research and comparative research methods were used to analyze the management of chronic disease carried out by community pharmacies in the United States and the United Kingdom. Results and Conclusion The management of chronic diseases in American and British community pharmacies has formed retail health clinic and online chronic disease mode. It is recommended that Chinese government should issue measures and supporting guidelines for the management of chronic diseases in community pharmacies as soon as possible. Community pharmacies should be encouraged to carry out chronic disease management with the concept of prudent inclusion and gradual progression. Meanwhile, the concentration of drug retail industry should be improved to carry out the systematic construction of chronic disease management and build a standardized chronic disease service process. Besides, community pharmacies should make full use of new technologies such as the Internet, cloud computing and big data, smart wearable devices, and chronic disease management Apps to explore and carry out online professional chronic disease management mode.

相关文章 | 多维度评价

Select

5.

Research and Enlightenment of Accelerated Approval Pathway in China

Li He, Huang Zhe

亚洲社会药学 2023, 18 (1): 1-7.

摘要（373）

PDF（pc）（323KB）（209）

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.

相关文章 | 多维度评价

Select

6. 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

亚洲社会药学 2023, 18 (2): 116-127.

摘要（364）

PDF（pc）（1099KB）（124）

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.

相关文章 | 多维度评价

Select

7. The Investigation and Research of the Performance Appraisal of R&D Personnel in R Company

Cui Yuxue, Chen Jing, Chen Jing

亚洲社会药学 2022, 17 (2): 132-143.

摘要（362）

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.

相关文章 | 多维度评价

Select

8. Enlightenment of COVID-19 Treated by Botanical Drugs on the Development of Drugs for Rare Diseases in China

Li Qiao, Wang Su, Wang Aili, Wu Di, Chen Yuwen

亚洲社会药学 2023, 18 (2): 137-148.

摘要（361）

PDF（pc）（908KB）（92）

Objective To study the feasibility of developing botanical drugs to treat intractable diseases and play an important role in dealing with major public health crises. Methods From January 1990 to May 2021, a bibliographic search was carried out on the use of botanical drugs, rare disease drugs, related registration management policies and regulations in PubMed and CNKI. The following keywords were searched in the database: Rare disease policies and regulations, orphan drugs, botanical drugs for intractable diseases, botanical drugs for the treatment of new coronary pneumonia, traditional Chinese medicine, and emergency guidelines for major public health crisis. Other data were obtained from “Chinese Pharmacopoeia” and relevant Chinese government websites for sorting and analysis. Results and Conclusion Based on 39 Chinese corresponding policies and regulations, challenges and opportunities of developing and researching drugs for treating rare diseases were found out after the analysis and comparison. Based on the study of national policies on drugs for rare diseases, the priority review and approval procedures in the drug registration, as well as China’s emergency guidelines and policies for major public health events, some problems in the use of drugs for rare diseases are found out. Therefore, it is recommended to actively adopt the property rights protection system, explore the folk prescriptions of traditional Chinese medicine and the potential of hospital preparations, and the registration review strategy of giving priority to the use of botanical drugs for rare diseases. Thus, the international status of botanical drugs for rare disease and the influence of responding to major public health events can be enhanced.

相关文章 | 多维度评价

Select

9.

Reflections on the Participation of Social Organizations in the Prevention of COVID-19

Liao Wenjing, Lin Xiangpeng, Liu Liang, Dou Lele, Wang Shuling

亚洲社会药学 2022, 17 (4): 376-382.

摘要（357）

PDF（pc）（450KB）（81）

Objective To study the problems of Chinese social organizations in participating in the prevention and control of the COVID-19 pandemic so that we can standardize the participation mechanism, improve the collaborative management mechanism, and promote the development of social organizations. Methods Through the analysis of CNKI, news reports, industry conferences and other data, combined with the current situation, the participation of social organizations in public health emergencies were investigated. Results and Conclusion The coordination between government and social organizations is not good. Social organizations in the field of public health are unable to stand out in a timely manner. The public do not have self-management ability. Some of the media spread rumors. Besides, most social organizations are highly dependent on the government and they are ack supervision. Social organizations should be incorporated into the emergency management system and national hub-based social organizations must be established. In addition, supervision should be strengthened to increase the credibility of social organizations. The responsibilities of community and emergency management at the grassroots level should be enhanced. The public opinion response and disposal system should be improved. Lastly, the responsibility of social organizations in the field of public health must be fulfilled.

相关文章 | 多维度评价

Select

10. Research on Liposomal Irinotecan in Combination with 5-FU/LV for Metastatic Pancreatic Ductal Adenocarcinoma

Wang Wenjun, Wang Yaoling, Huang Zhe

亚洲社会药学 2023, 18 (2): 128-136.

摘要（349）

PDF（pc）（1587KB）（113）

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.

相关文章 | 多维度评价

Select

11. Investigation on the Current Situation of China’s DTP Pharmacy and Suggestions for Its Development

Wen Dong, Dou Lele, Sun Yuyuan, Wang Shuling

亚洲社会药学 2023, 18 (2): 165-176.

摘要（349）

PDF（pc）（1965KB）（393）

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.

相关文章 | 多维度评价

Select

12.

Current Situation and Suggestions on the Development of Diagnosis Related Group (DRG) Policy in China

Dong Yujiao, Wang Shuling

亚洲社会药学 2022, 17 (4): 367-375.

摘要（345）

PDF（pc）（571KB）（210）

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.

相关文章 | 多维度评价

Select

13. Influence and Suggestions on Trial Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes

Li Wanying, Zhang Weiwei, Jia Siyao, Dong Li

亚洲社会药学 2023, 18 (2): 149-156.

摘要（342）

PDF（pc）（871KB）（99）

Objective To study the core contents of the “Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes (Trial)” in China, and to clarify the concerns for enterprises in future work. Methods A comprehensive review of the literature was used to find out the key regulations for detailed decomposition and analysis. Results and Conclusion By analyzing the key clauses of China’s “Implementation Measures for Early Settlement Mechanism of Drug Patent Disputes (Trial)”, some practical countermeasures and suggestions are put forward for related research and development (R&D) innovation and drug declaration of enterprises.

相关文章 | 多维度评价

Select

14.

Economic Evaluation of Gastroscopy for Detecting Gastric Cancer in Chinese Natural Population

Liu Yuhan, Sun Lihua

亚洲社会药学 2022, 17 (4): 343-350.

摘要（338）

PDF（pc）（535KB）（77）

Objective To evaluate the economy of detecting gastric cancer by electronic gastroscope in Chinese natural population of different ages and genders. Methods A Markov model was constructed for the population, including both men and women of different ages. The model cycle was one year and the simulation time was 60 years. The cost-effectiveness of electronic gastroscopy in detecting gastric cancer of general population in China was analyzed from the perspective of the whole society, and the stability of the results was verified by sensitivity analysis. Results and Conclusion For the general population, the incremental cost-effectiveness ratio (ICER) of gastric cancer screening from the age of 50 is 50 143 yuan/QALY (quality-adjusted life-year), which is less than two times of per capita gross domestic product (GDP) compared with the screening from the age of 55. For men who start gastric cancer screening at the age of 50, the ICER is 38 525 yuan/QALY, which is less than two times of per capita GDP, and it is economical. For women who start the screening from the age of 55, the ICER is 47 814 yuan/QALY, which is less than two times of per capita GDP, so it is economical. The results of sensitivity analysis are consistent with the conclusions of basic analysis, and the results of basic analysis are stable. For the general population, it is more economical to start gastric cancer screening from the age of 50, while for men and women, it is more economical to start gastric cancer screening from the age of 50 and 55, respectively.

相关文章 | 多维度评价

Select

15. A systematic Review of the Safety and Effectiveness of Epidural Analgesia for Labor Analgesia

Wang Dan, Liu Chunping, Zhang Fang, Gao jinglei

亚洲社会药学 2022, 17 (2): 186-197.

摘要（332）

PDF（pc）（1597KB）（205）

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.

相关文章 | 多维度评价

Select

16. Cause Analysis and Preventive Measures of Drug Shortage

Zhou Ziyang, Ma Jia, Liu Fuyao, Liu Yuhan, Sun Lihua

亚洲社会药学 2022, 17 (2): 120-131.

摘要（317）

PDF（pc）（1810KB）（317）

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.

相关文章 | 多维度评价

Select

17.

A Systematic Review of Economic Evaluation of CDK4/6 Inhibitors in HR+/HER2- Advanced Breast Cancer

Wang Fang, Zhang Fang, Li Xue, Dong Li

亚洲社会药学 2022, 17 (4): 351-366.

摘要（317）

PDF（pc）（558KB）（89）

Objective To review the domestic and foreign economic studies on CDK4/6 inhibitors in first-line or second-line treatment of HR+/HER2- advanced breast cancer, and to analyze the main methodologies and research results. Methods Systematic literature review was used to search PubMed, EMBASE, Cochrane Library, CNKI, CBM, and Wanfang database. The incremental cost-effectiveness ratio was taken as the main outcome index, and all pharmacoeconomic evaluations with CDK4/6 inhibitors as intervention measures were included, such as Palbociclib, Ribociclib, and Abemaciclib. According to the Quality of Health Economic Studies Instrument, the quality of the included articles was evaluated, and then the included literature was analyzed. Results and Conclusion A total of 16 pharmacoeconomic evaluation studies were included, mainly from the perspective of national healthcare systems or third-party payers. Only 2 studies focused on second-line treatment, and the remaining treatment levels were first-line treatment. In terms of model structure, 7 studies adopted the Markov model, 6 studies adopted the PSM model, and 3 studies adopted the DES model. The basic analysis results showed that CDK4/6 inhibitor combined with endocrine regimen was not economical compared with endocrine alone regimen when the threshold was the conventional willingness to pay (WTP) value of each country. The uncertainty analysis included deterministic sensitivity analysis and probability sensitivity analysis. The included studies are all Cost-Utility Analysis with high-quality evaluation, which can provide evidence support for health-related decision-makers in decision-making. It can also provide methodological reference for the economic evaluation of other targeted drugs.

相关文章 | 多维度评价

Select

18.

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

亚洲社会药学 2022, 17 (4): 300-308.

摘要（311）

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.

相关文章 | 多维度评价

Select

19. The Latest Advance of the FDA Sentinel Initiative and Its Enlightenment to China

Xie Xuerong, Tian Lijuan

亚洲社会药学 2022, 17 (2): 95-103.

摘要（308）

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.

相关文章 | 多维度评价

Select

20. 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

亚洲社会药学 2022, 17 (2): 144-158.

摘要（307）

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.

相关文章 | 多维度评价

Select

21. Exploration on the Implementation of the Integration of Medical and Preventive Model in China’s Primary Health Care Institutions

Chen Hui, Wang Shuling

亚洲社会药学 2022, 17 (2): 167-177.

摘要（306）

PDF（pc）（3599KB）（214）

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.

相关文章 | 多维度评价

Select

22.

Present Situation and Enlightenment of Post-Approval Change Management of Drugs in China, USA and EU

Lv Xiaowen, Huang Zhe

亚洲社会药学 2023, 18 (1): 17-23.

摘要（299）

PDF（pc）（358KB）（238）

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.

相关文章 | 多维度评价

Select

23. The Impact of Generic Drug Consistency Evaluation Policy on Pharmaceutical Enterprises

Li Siwen , Yang Yue

亚洲社会药学 2022, 17 (2): 104-114.

摘要（286）

PDF（pc）（796KB）（512）

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.

相关文章 | 多维度评价

Select

24. The Development of DTP Pharmacy and Its Impact on Pharmaceutical Enterprises

Shen Manzhu, Zeng Yingying, Yuan Hongmei, Fu Shuyong

亚洲社会药学 2022, 17 (2): 159-166.

摘要（270）

PDF（pc）（801KB）（428）

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.

相关文章 | 多维度评价

Select

25. The Expanding Roles of Hospital Pharmacists in Clinical Drug Trials in China

Zhao Shanshan, Zhang Boquan, Wang Hongyun

亚洲社会药学 2022, 17 (3): 229-235.

摘要（265）

PDF（pc）（789KB）（139）

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.

相关文章 | 多维度评价

Select

26. Enlightenment and Suggestions on the Construction of Information Platform and Processing Mechanism of Drug Shortages in Developed Countries to China

Cui Li, Xing Hua

亚洲社会药学 2023, 18 (2): 177-186.

摘要（259）

PDF（pc）（817KB）（154）

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.

相关文章 | 多维度评价

Select

27. Comparative Study and Enlightenment on Innovation Achievements of Pharmaceutical Industry in Liaoning Province

Tao Na, Tian Lijuan

亚洲社会药学 2022, 17 (3): 214-221.

摘要（247）

PDF（pc）（1291KB）（111）

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.

相关文章 | 多维度评价

Select

28. Benefit-Risk Assessment for PD-1/PD-L1 Inhibitors in the Treatment of Non-Small Cell Lung Cancer

Li Zhuangqi, Yang Yue

亚洲社会药学 2022, 17 (3): 253-259.

摘要（239）

PDF（pc）（1808KB）（147）

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.

相关文章 | 多维度评价

Select

29.

Co-integration Analysis of the Relationship between New Product Output and R&D Investment in China’s Pharmaceutical Industry

Li Gan, Wang Su, Chen Yuwen

亚洲社会药学 2022, 17 (4): 309-316.

摘要（239）

PDF（pc）（500KB）（84）

Objective To study the possible relationship between the output of new products in China’s pharmaceutical industry and the investment in research and development (R&D), and to provide a theoretical basis for the decision-making of relevant enterprises and institutions. Methods The econometric software Stata 14 was used to perform unit root test on the relevant data. Then, a co-integration regression equation was established after stabilization, which was analyzed through co-integration test (E-G two-step method). Results and Conclusion There is a long-term equilibrium and short-term error correction relationship between the output of new products and the investment of R&D funds in China’s pharmaceutical industry. During the lagging periods from 1 to 6, R&D investment is the Granger reason for the output of new products. The investment of R&D funds has a positive effect on the output of new products and the effect is significant. Therefore, more investment should be made in R&D to enhance the output of new products.

相关文章 | 多维度评价

Select

30. Analysis of Factors Affecting Online Drug Purchase – Based on Factor Analysis

Wang Shuling, Liu Liang, Zhi Yuanyuan

亚洲社会药学 2022, 17 (3): 268-280.

摘要（232）

PDF（pc）（2843KB）（162）

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.

相关文章 | 多维度评价

Select

31.

Economic Evaluation of Cervical Cancer Prevention Strategies in China

Chen Chuhan, Sun Lihua

亚洲社会药学 2023, 18 (1): 57-63.

摘要（232）

PDF（pc）（1964KB）（86）

Objective To evaluate the economy of domestic bivalent human papilloma virus (HPV) vaccine, imported 9-valent HPV vaccine and 5 cervical cancer screening programs, and to provide a reference for relevant decision-making. Methods A Markov model of the natural disease development of cervical cancer was constructed to simulate the cumulative long-term cost and quality-adjusted life years (QALYs) of one hundred thousand healthy women after they received different interventions for cost-effectiveness analysis. Results and Conclusion Compared with the non-intervention group, the cost of per QALY obtained by two HPV vaccines and 5 screening programs ranged from 1 117.56 yuan to 71 660.48 yuan. Taking China’s GDP per capita in 2020 as the threshold, two HPV vaccines and 5 screening programs are cost-effective. Domestic bivalent vaccine is cost-effective and it should be introduced to the national immunization program in the future. Different screening programs are all cost-effective, too. Among them, careHPV test once every 5 years has the lowest ICER value and it can be used as the first choice for cervical cancer screening in rural areas or resource-limited areas in China.

相关文章 | 多维度评价

Select

32. Drug Regulatory Science in EU and Its Enlightenment to China

Li Yanying , Huang Zhe, Lian Guiyu

亚洲社会药学 2022, 17 (2): 115-119.

摘要（223）

PDF（pc）（799KB）（284）

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.

相关文章 | 多维度评价

Select

33.

Study on Emergency Use Authorization and Risk Control of Pfizer-BioNTech Vaccine

Wang Yiran, Yang Yue

亚洲社会药学 2023, 18 (1): 24-29.

摘要（212）

PDF（pc）（408KB）（153）

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.

相关文章 | 多维度评价

Select

34.

Research on the Development of Drug Regulatory Science in China

Wang Guanjie, Shao Mingli

亚洲社会药学 2022, 17 (4): 285-290.

摘要（211）

PDF（pc）（427KB）（157）

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.

相关文章 | 多维度评价

Select

35.

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

亚洲社会药学 2022, 17 (4): 317-332.

摘要（208）

PDF（pc）（1122KB）（201）

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.

相关文章 | 多维度评价

Select

36. Research on the Relationship between Cooperation Innovation Expenditure and Economic Output of China’s Pharmaceutical Industry

Wang Qiuli, Chen Yuwen

亚洲社会药学 2022, 17 (3): 204-213.

摘要（207）

PDF（pc）（873KB）（145）

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.

相关文章 | 多维度评价

Select

37. Development Strategy of Green Marketing of Pharmaceutical Enterprises against the Background of Building a Beautiful China

Wang Shuling, Wang Mingzheng, Yu Chang

亚洲社会药学 2022, 17 (3): 260-267.

摘要（203）

PDF（pc）（790KB）（145）

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.

相关文章 | 多维度评价

Select

38. Research on the Status of Patent Protection of Prostaglandin Analogues for Glaucoma in China

Zhou Sheng’an, Dong Li

亚洲社会药学 2022, 17 (2): 178-185.

摘要（199）

PDF（pc）（3779KB）（238）

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.

相关文章 | 多维度评价

Select

39.

Study on the Changes of FDA Finished Pharmaceuticals Warning Letters between 2011 and 2021

Jiang Yang, Yang Yue

亚洲社会药学 2022, 17 (4): 291-299.

摘要（197）

PDF（pc）（487KB）（192）

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.

相关文章 | 多维度评价

Select

40. Research on the Price Level of Drugs in Short Supply in China

Liu Fuyao, Sun Lihua

亚洲社会药学 2022, 17 (3): 243-252.

摘要（187）

PDF（pc）（5382KB）（78）

Objective To determine the price level of drugs in short supply and conduct affordability evaluations, thus putting forward countermeasures and suggestions for the management of prices of these drugs. Methods Taking the national list of drugs in short supply and the national key monitoring list of clinically essential drugs in short supply as the research objects, the bid-winning prices were searched through various bidding websites across the country, and the price levels of the varieties in the list were evaluated through fixed base price index, median price ratio and other indicators. The per capita income evaluation method was used to evaluate the affordability of the drugs on the list. Results and Conclusion Among the 30 varieties with valid international reference prices, 25 are higher than the international reference prices. The prices of 14 kinds of drugs are 1-5 times higher than the international reference prices. The prices of 10 kinds of drugs are 6-35 times higher than the international reference prices. In rural and urban areas, 50% and 73% of the drugs in short supply cost more than two times of the daily income for each course of treatment. The current price levels of selected drugs in short supply are generally high. It is recommended that these drugs should be classified and managed. Besides, the shortage of drugs should be included in the centralized procurement organized by the state to solve the unstable supply in the market.

相关文章 | 多维度评价

亚洲社会药学

最多阅读

编辑部办公

编辑部公告

友情链接

Asian Journal of Pharmaceutical Sciences

Asian Journal of Traditional Medicines

Journal of Polyphenols