Analysis of regulatory review times of new drugs in Japan: association with characteristics of new drug applications,regulatory agency,and pharmaceutical companies

What is known and Objective: Various factors have been reported to be associated with the duration of regulatory review of new drug applications (NDAs). We investigated potential links between the review times in Japan and the attributes of NDAs, the regulatory agency and pharmaceutical companies. Methods: We analysed new drugs approved in 2000–2009 in Japan using a proprietary database collected through annual surveys to pharmaceutical companies. Regression models in which individual firms were treated as either a fixed effect or a random effect were applied to examine factors associated with the overall review time and the duration of each step of the review. Results and Discussion: The fixed effect model analysis using variations within each firm indicated that new molecular entities that were submitted to the Pharmaceuticals and Medical Devices Agency (PMDA), priority reviews and pre‐NDA consultations were associated with a shorter overall review time, whereas additional studies during the review resulted in a longer review. In the random effect model analysis using both within‐ and between‐firm variations, use of end‐of‐phase 2 consultations and foreign clinical data also had negative coefficients, suggesting the effect of these two vary among firms. Analysis of each step of the review process revealed NDAs reviewed by the Committee on Drugs under the Ministry of Health, Labour and Welfare, and the number of NDAs assigned to a review team were significantly linked with their duration, whereas consultation services and the number of reviewers had no relation. What is new and Conclusion: Factors associated with each step of the review process as well as the differences in attributes and strategies among pharmaceutical companies should be considered to further improve the speed, quality and efficiency of the regulatory review.     

提高胃肠外科医师的综合素质应对当前复杂的医疗环境

医师和患者之间的关系日趋紧张,社会对医师,尤其是外科医师的要求也越来越高.外科医师除了具备良好的专业技能,还应培养自己多方面的素质和能力,如与患者及家属沟通的能力、自我减压的能力与应对媒体和社会责难的公关意识等.病历的重要性日益明显,外科医师必须给予足够的重视.医患之间的怀疑和误解,必然会伤害医患双方.     

A multidisciplinary approach to designing and evaluating Electronic Medical Record portal messages that support patient self-care

We describe a project intended to improve the use of Electronic Medical Record (EMR) patient portal information by older adults with diverse numeracy and literacy abilities, so that portals can better support patient-centered care. Patient portals are intended to bridge patients and providers by ensuring patients have continuous access to their health information and services. However, they are underutilized, especially by older adults with low health literacy, because they often function more as information repositories than as tools to engage patients. We outline an interdisciplinary approach to designing and evaluating portal-based messages that convey clinical test results so as to support patient-centered care. We first describe a theory-based framework for designing effective messages for patients. This involves analyzing shortcomings of the standard portal message format (presenting numerical test results with little context to guide comprehension) and developing verbally, graphically, video- and computer agent-based formats that enhance context. The framework encompasses theories from cognitive and behavioral science (health literacy, fuzzy trace memory, behavior change) as well as computational/engineering approaches (e.g., image and speech processing models). We then describe an approach to evaluating whether the formats improve comprehension of and responses to the messages about test results, focusing on our methods. The approach combines quantitative (e.g., response accuracy, Likert scale responses) and qualitative (interview) measures, as well as experimental and individual difference methods in order to investigate which formats are more effective, and whether some formats benefit some types of patients more than others. We also report the results of two pilot studies conducted as part of developing the message formats.     

医院环境文化的本质解读

医院文化的本质就是人文环境和文化氛围的交融。通过其精神文化、物质文化、制度文化、宣传文化和行为文化等相互作用、不断循环、整合，从而构成了一个动态的文化有机复合体，即医院环境文化。医院环境文化发展创新的本质就是利用医院文化的五个组成部分的不断整合、相互影响，培育出具有业务精湛、职业道德高尚、综合素质高的医务人员，最终更人性、更有效地为解除患者病痛、解救患者生命服务。