亚洲社会药学

本期目录

2017年, 第12卷, 第3期　刊出日期：2017-10-20 上一期    下一期

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Construction of Competency Model of Drug GMP Inspectors Zhao Zhenyu, Wu Zhi’ang 2017 (3):  89-97.  摘要 ( 412 )   PDF(646KB) ( 657 )   Objective To establish a competency model for drug good manufacturing practice (GMP) inspectors after studying the current status of drug GMP inspectors’ competency in a certain city and to provide references for the perfection of relevant systems for drug GMP inspectors. Methods Behavioral event interview and expert interview were used to survey competency characteristics of the elite group of drug GMP inspectors, and the competency model for drug GMP inspectors were constructed and verified. Next this competency model was used to investigate the status of drug GMP inspectors in a certain city and to compare the differences in competency between the normal group and elite group of drug GMP inspectors. Results and Conclusion The competency model was tested and proved to be reliable and valid. There were many differences in the competencies between the normal group and elite group of drug GMP inspectors regarding the following seven areas: knowledge of laws and regulations, attention to order and quality, organizational ability, achievement orientation, influence, responsibility, and team leadership. The drug GMP inspector management system should be reformed by the following measures: improving inspector selection and training system, enhancing the legal position of drug GMP inspectors, establishing a specialized drug GMP inspector team, improving the inspector performance evaluation system, grading and salary incentive mechanisms. 相关文章 | 计量指标

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Research on Administrative Accountability of Drug Safety Incidents from Incentive Management Perspectives in China Liu Zhiqiang, Yang Yue 2017 (3):  98-105.  摘要 ( 396 )   PDF(432KB) ( 426 )   Objective To study the effective measures so as to strengthen administrative accountability of drug safety. Methods The literature research method was adopted to discuss the principles of administrative accountability of drug safety from the incentive management perspectives. In addition, the problems and adverse consequences of drug safety incidents in China were analyzed. Results and Conclusion The problems of administrative accountability of drug safety included the following aspects: lack of foresight, excessive accountability, and low transparency. These problems led to the consequences, such as curbing the enthusiasm of regulators, concealing drug safety problems and hindering the development of pharmaceutical industry. At present, administrative accountability of drug safety should aim at improving the rationality, predictability and transparency. Therefore, it was suggested establishing a system for administrative accountability of drug safety, standardizing the process of accountability and promoting its transparency 相关文章 | 计量指标

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Research on Standardizing the Instructions of Acanthopanax Injection Liu Xiaochen, Tian Lijuan 2017 (3):  106-111.  摘要 ( 335 )   PDF(377KB) ( 471 )   Objective To study the problems in acanthopanax injection instructions from different manufacturers in China and to provide references for revising and perfecting the instructions. Methods Literature research and comparative research were adopted to find out some problems in acanthopanax injection instructions from six manufacturers in China. Results and Conclusion The problems in acanthopanax injection instructions were as follows: inadequate content, unclear and incorrect labels. These problems should be solved in time, thus some suggestions were put forward for standardizing the instructions of acanthopanax injection. 相关文章 | 计量指标

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Empirical Study of Influential Factors on Profitability of Pharmaceutical Manufacturing Enterprises in China Zhang Lirong, Chen Yuwen 2017 (3):  112-117.  摘要 ( 339 )   PDF(423KB) ( 596 )   Objective To study influential factors on profitability of pharmaceutical manufacturing enterprises in China so as to provide references for pharmaceutical enterprises. Methods Factor regression analysis method was used to analyze the influential factors of R&D capital investment, enterprise scale, and R&D knowledge output on the profitability of pharmaceutical manufacturing enterprises based on the data of pharmaceutical manufacturing enterprises in China Statistics Yearbook on High Technology Industry and Statistics Yearbook on Science and Technology Activities of Industrial Enterprises from 1995 to 2015. Results and Conclusion Factors, such as new product market demand (0.076), enterprise competition (0.070), research and development of human knowledge reserve level (0.036), exports (0.028), enterprise scale (0.023), government funding (0.019), R&D investment (0.017), and output of R&D (0.015) had significant positive correlation with profitability. Some suggestions were put forward for the improvement of profitability based on the empirical study results. 相关文章 | 计量指标

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Surviving in the Cracks: Lessons from China’s State-Owned Enterprise Affiliated Hospitals Wang Tao, Wu Zhi’ang, Li Shuchuen 2017 (3):  118-126.  摘要 ( 342 )   PDF(457KB) ( 480 )   Objective To analyze why the number of China’s state-owned enterprise affiliated hospitals (EAHs) decrease gradually and why EAHs are turning from prosperity to depression. Methods EAHs reform was divided into several periods. Each period had internal and external influential factors of reform, such as the way of reform, the effect of reform, the problems faced in each stage. Results and Conclusion There were several reasons leading to EAHs’ depression. EAHs reform was a process of “crossing a river by feeling the stones”, lack of reform blueprint, lagging behind the economic reform and health care reform. All of these factors made EAHs reform into a passive state. Accordingly, some suggestions were raised for health care reform in China. 相关文章 | 计量指标