亚洲社会药学

本期目录

2023年, 第18卷, 第3期　刊出日期：2023-09-25 上一期   

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Research Progress in FDA’s Focus Areas of Regulatory Science for Drugs and Suggestions for China Gong Jingran, Chang Senhao, Chang Yingnan, Chen Yuwen 2023 (3):  191-197.  摘要 ( 88 )   PDF(363KB) ( 87 )   Objective To sort out the focus areas of FDA’s scientific supervision and to achieve corresponding results, so as to provide some suggestions for the scientific research and innovation of drug supervision in China. Methods In-depth research was carried out in the fields of safety evaluation tools, clinical trial innovation, new methods ofproduct quality evaluation, information science and so on. Results and Conclusion The research foundation of drug supervision related technology in China is weak, and a systematic supervision system has not been formed. Learning from the scientific experience of drug supervision in the United States, we can promote the development of the focus areas of drug supervision in China. Besides, we should improve the standard management ability while perfecting the regulations and standards system. Lastly, we should establish a system for government and industry-university-research to realize the full-cycle supervision of drugs. 相关文章 | 计量指标

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Supervision of Public Opinion under the Background of Social Co-governance - Take the Changsheng Vaccine Incident as an Example Ma Xiaonan, Tian Lijuan 2023 (3):  198-205.  摘要 ( 64 )   PDF(465KB) ( 41 )   Objective To provide reference for the news media to give play to the role of public opinion supervision in time based on the background of drug safety and social co-governance. Methods The method of case analysis was used to make a retrospective study on the Changsheng vaccine incident in 2018. Then the role of mainstream media, pharmaceutical media, and self-media in the supervision of public opinion was investigated. Results and Conclusion Both mainstream and pharmaceutical media played an excellent role in supervising the Changchun Changsheng vaccine incident. However, the content published by some pharmaceutical media was hard to understand by ordinary people. Besides, the role of self-media in public opinion supervision was polarized. Some self-media closely kept pace with mainstream media in public opinion supervision. Other self-media unilaterally pursued the click rate, publishing false information to guide wrong public opinion. The news media should optimize the supervision efficiency of drug safety. On the one hand, pharmaceutical media should pay attention to the fact that readers may not understand the difficult terms because they are not professional. On the other hand, self-media practitioners should improve their professional quality so that they will not publish some fake news to mislead public opinion. 相关文章 | 计量指标

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Suggestions for Promoting China’s Drug Regulatory Agency to Join Pharmaceutical Inspection Co-operation Scheme - PIC/S Hu Shigao, Wu Zhiang 2023 (3):  206-212.  摘要 ( 70 )   PDF(673KB) ( 22 )   Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme (PIC/S) audit checklist, find out the key improvement items, and revise them pertinently, which will promote the process of China joining PIC/S. Methods The general situation of PIC/S organization and audit checklist were introduced first, and then the accession of several countries that joined the organization was analyzed. Meanwhile, the process of China’s participation in PIC/S was sorted out. After referring to the contents of PIC/S audit checklist, the problems of GMP inspection system in China were studied. Results and Conclusion There are still many problems in GMP inspection in China. Some suggestions are put forward for improvement and change, which can provide reference for the development of drug inspection agencies at all levels in China. 相关文章 | 计量指标

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Analysis and Enlightenment of Big Data Platform for Adverse Drug Reaction Supervision in China and the United States Chang Senhao, Chang Yingnan, Gong Jingran, Chen Yuwen 2023 (3):  213-220.  摘要 ( 52 )   PDF(1730KB) ( 31 )   Objective To introduce the relevant big data platforms of FDA regulatory sciences and to provide reference for the construction of big data platform for China’s regulatory science under the “14th five-year plan” to deepen the reform of medical and health system. Methods A comparative analysis was made on China’s big data for regulatory science after studying the development process, operation mode, practical significance and characteristics of the big data platform for FDA regulatory science, which would help China to establish a perfect big database. Results and Conclusion The construction of big data platform for China’s regulatory science is not comprehensive compared with that in the United States. It is necessary to build data platforms in line with China’s national conditions through efforts in law, talents, standards, and other aspects. 相关文章 | 计量指标

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An Empirical Study on Organizational Efficiency of Drug Review Institutions Wu Dongming, Jia Zheng, Wang Lifei, Xing Hua 2023 (3):  221-231.  摘要 ( 58 )   PDF(624KB) ( 55 )   Objective To construct the influencing factor model of organizational efficiency by using structural equation model, and to put forward some suggestions for drug review institutions to their management mode. Methods The model hypothesis affecting organizational efficiency was proposed by literature analysis, and a questionnaire was designed. Then, the questionnaires returned were analyzed to investigate the relationship among the factors affecting organizational efficiency with the structural equation models. Results and Conclusion The direct effect of communication on organizational efficiency was 0.83, that of system construction was 0.60, talents cultivation was 0.25, and task management was 0.38. The model results basically fitting met the various statistical indicators, with statistical significance thresholds. Talents cultivation and task management have little effect on organizational efficiency, while system construction and communication have great effect on organizational efficiency. However, due to the correlation between organizational systems, the influencing factors should be considered in a balanced manner, so as to put forward reasonable suggestions. 相关文章 | 计量指标

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Research on the Countermeasures for the Development of Biopharmaceutical Industrial Parks in China Zhang Zongjie, Wu Zhiang 2023 (3):  232-238.  摘要 ( 51 )   PDF(352KB) ( 145 )   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. 相关文章 | 计量指标

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The Impact of Population Aging on the Expenditure of Medical Insurance Fund for Urban Workers in China Wang Shuling, Dou Lele, Shi Hui, Huang Zhe 2023 (3):  239-246.  摘要 ( 60 )   PDF(2653KB) ( 59 )   Objective To explore the impact of population aging on the expenditures of medical insurance funds against the background that great changes in population structure influences economic development. Methods Through analyzing the impact of the population aging, the income and accumulated balance of the medical insurance fund, and other related factors on the expenditure of the medical insurance fund, development status of the medical insurance fund for urban employees in China since 2003 was obtained. Stata 16.0 was used to perform multiple linear regression analysis on related factors to determine the correlation between population aging and the change in medical insurance expenditures. Results and Conclusion The factors that have a greater impact on the expenditure of the medical insurance fund are the amount of income from the medical insurance, followed by the number of people over the age of 65 in China and the urban retired employees participating in medical insurance. We should focus on the sustainable development of the urban employee medical insurance fund to deal with the threat of aging. 相关文章 | 计量指标

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Effect of the Policies to Prevent Drug Shortage and Stabilize Drug Prices in Medical Institutions Li Xiaoqi, Fan Jianing, Huang Jiaxin, Liu Xinying, Raela·Abduhilil, Sun Lihua 2023 (3):  247-251.  摘要 ( 70 )   PDF(329KB) ( 33 )   Objective To evaluate the effect of some policies to prevent drug shortage and stabilize drug prices, and to provide reference for improving relevant policies. Methods With a combination of random stratified sampling and quota sampling, 532 medical institutions in 20 provinces were selected to carry out questionnaire surveys. Then, a comparative analysis was made to study the changes of drugs on the shortage list and drugs on non-shortage list before and after the release of the policy of ensuring supply and stabilizing prices. Results and Conclusion The policy played an important role in curbing the growth of drug shortage in the medical institutions, but it did not curb the growth of drugs on non-shortage list. Besides, the drugs on non-shortage list showed an overall fluctuation and upward trend. Meanwhile, from the perspective of drug prices, the price stability problem of drugs on the shortage list and on the non-shortage list became more serious, and the average price increase was 256% and 239%, respectively. The implementation of policies related to the supply and price stability of drugs prevents the growth trend of drug shortages in the list of medical institutions, which has been recognized by most medical institutions. However, there is an increasing trend in the number of drugs on non-shortage list. In addition, the price increase of drugs on both the shortage list and non-shortage list is severe. Some medical institutions report that they have difficulties in using the information reporting system of drug shortage and the classification, grading and the alternative use of drug shortages. It is recommended to strengthen the management of price stabilization of drugs on the shortage list. Further attention should be paid to the supply and price stabilization of drugs on non-shortage list. At the same time, trainings in the classification and substitution of drug shortage and information reporting system should be actively organized, thus comprehensively improving the capabilities of medical institutions at all levels to deal with the problem of drug shortage. 相关文章 | 计量指标

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Exploration and Research on the Integrated Development of “Internet Plus Medical Treatment” Guo Jialin, Wang Shuling 2023 (3):  252-260.  摘要 ( 69 )   PDF(410KB) ( 37 )   Objective To analyze the development of “internet plus medical treatment” and to explore advantages. Methods The literature of “internet plus medical treatment” was systematically combed and analyzed. Results and Conclusion After exploring the status quo of “internet plus hospitals”, smart pharmacy and web-assisted health management in China, we find that there are some problems in the medical service at present, such as the imperfect laws and regulations, the hidden dangers of information security and the obstacles of medical insurance payment. Therefore, we propose that the development of web-assisted medical service should be led by the government and relevant policies must be improved. Then, self-regulation should be strengthened, and industry standards should be enhanced. Three suggestions are made to improve medical insurance payment and benefit both hospitals and patients, which can provide reference for promoting the development of “internet plus medical treatment” in China. 相关文章 | 计量指标

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A Systematic Review of Patient-Reported Outcome Measurement for Psoriasis in Chinese Population Li Kexin, Zhang Fang, Huang Zhe 2023 (3):  261-280.  摘要 ( 63 )   PDF(1758KB) ( 52 )   Objective To review the development of patient-reported outcome measurement (PROM) for patients with psoriasis in China, and to analyze the main results and methodology. Methods The systematic review method of COSMIN (consensus-based standards for the selection of health measurement instruments) was adopted, and the domestic and foreign databases were searched to find the patient-reported outcome scales based on Chinese psoriasis patients. Then, the included studies were evaluated by using COSMIN risk of bias checklist. Results and Conclusion A total of 3 studies were included, involving 3 scales. We found that the quality evaluation of the development process of the 3 scales was not high, and there were large methodological loopholes in the whole cycle of scale development and verification. The included studies have many problems such as low extrapolation, poor quality, and lack of validation, which can provide more insights for the quality control requirements of the whole cycle of scale development in the future. 相关文章 | 计量指标

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Cost-effectiveness Analysis of Insulin Degludec and Liraglutide Injection in the Treatment of Type 2 Diabetes Sun Quan, Zhang Fang, Dong Li 2023 (3):  281-295.  摘要 ( 70 )   PDF(699KB) ( 31 )   Objective To analyze the cost-effectiveness of insulin degludec and liraglutide injection (IDegLira) compared with insulin glargine plus insulin aspart (IGar plus IAsp) in the treatment of type 2 diabetes mellitus (T2DM) based on the price of IDegLira before and after it was successfully admitted to the National Reimbursable Drug List (NRDL). Methods Cost and effectiveness parameters were obtained through systematic retrieval from PubMed, ScienceDirect, CNKI, and Wanfang database. A cost-effectiveness analysis (CEA) model was established to analyze the economics using IDegLira for T2DM patients with 1 to 5 years of medication. Results and Conclusion Before IDegLira was admitted to NRDL, its economic advantages over the IGlar plus Iasp regimen became more significant as patients’ medication time prolonged. After being admitted to NRDL, with 1 year of medication, the medical cost of IDegLira decreased by 2 853.91 yuan and the quality adjusted life years (QALY) increased by 0.120 55 than IGar plus IAsp. The sensitivity analysis was highly consistent with the results of the baseline result. After being admitted to NRDL, for patients with T2DM who have poor blood glucose control, IDegLira is absolutely an economic advantage scheme compared with IGar plus IAsp. 相关文章 | 计量指标

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Hypersensitivity Reaction Caused by Intravenous Gadolinium-based MRI Contrast Agents Lai Jing, Qin Liangyi, Qin Yane, Lan Xiaobu, Zhang Qi 2023 (3):  296-298.  摘要 ( 67 )   PDF(769KB) ( 22 )   Objective To present a rare case of skin allergic reaction to gadobutrol, a magnetic resonance imaging (MRI) contrast agent, in a 37-year-old man. Methods The adverse reactions of gadobutrol were analyzed combined with the instructions and related literatures. Results and Conclusion The presence of this patient is consistent with the adverse reactions in the instructions of gadobutrol. The incidence of ADR in gadobutrol is considered to be low, although sometimes patients report a hypersensitivity reaction when undergoing MRI. There are only a few cases of immediate adverse reactions to gadobutrol. However, we should improve the ability of medical staff to use drugs safely and take preventive measures. 相关文章 | 计量指标