亚洲社会药学

本期目录

2022年, 第17卷, 第2期　刊出日期：2022-06-15 上一期   

Select

The Latest Advance of the FDA Sentinel Initiative and Its Enlightenment to China Xie Xuerong, Tian Lijuan 2022 (2):  95-103.  摘要 ( 309 )   PDF(1103KB) ( 305 )   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 | 计量指标

Select

The Impact of Generic Drug Consistency Evaluation Policy on Pharmaceutical Enterprises Li Siwen , Yang Yue 2022 (2):  104-114.  摘要 ( 290 )   PDF(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 | 计量指标

Select

Drug Regulatory Science in EU and Its Enlightenment to China Li Yanying , Huang Zhe, Lian Guiyu 2022 (2):  115-119.  摘要 ( 225 )   PDF(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 | 计量指标

Select

Cause Analysis and Preventive Measures of Drug Shortage Zhou Ziyang, Ma Jia, Liu Fuyao, Liu Yuhan, Sun Lihua 2022 (2):  120-131.  摘要 ( 321 )   PDF(1810KB) ( 322 )   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 | 计量指标

Select

The Investigation and Research of the Performance Appraisal of R&D Personnel in R Company Cui Yuxue, Chen Jing, Chen Jing 2022 (2):  132-143.  摘要 ( 364 )   PDF(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 | 计量指标

Select

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 2022 (2):  144-158.  摘要 ( 310 )   PDF(923KB) ( 344 )   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 | 计量指标

Select

The Development of DTP Pharmacy and Its Impact on Pharmaceutical Enterprises Shen Manzhu, Zeng Yingying, Yuan Hongmei, Fu Shuyong 2022 (2):  159-166.  摘要 ( 271 )   PDF(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 | 计量指标

Select

Exploration on the Implementation of the Integration of Medical and Preventive Model in China’s Primary Health Care Institutions Chen Hui, Wang Shuling 2022 (2):  167-177.  摘要 ( 312 )   PDF(3599KB) ( 218 )   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 | 计量指标

Select

Research on the Status of Patent Protection of Prostaglandin Analogues for Glaucoma in China Zhou Sheng’an, Dong Li 2022 (2):  178-185.  摘要 ( 204 )   PDF(3779KB) ( 239 )   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 | 计量指标

Select

A systematic Review of the Safety and Effectiveness of Epidural Analgesia for Labor Analgesia Wang Dan, Liu Chunping, Zhang Fang, Gao jinglei 2022 (2):  186-197.  摘要 ( 337 )   PDF(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 | 计量指标