Objective To provide information for the establishment of a medical risk monitoring and precaution system in China, by reviewing and analyzing the current status of medical risk management system and preventative measures in New Zealand, Methods We searched EI (1969-2006), SCI and SSCI (1975-2006), EMBASE (1966-2006), SCOPUS (included 100% MEDLINE) (1960-2006), VIP (1989-2006), CNKI (1979-2006) and relevant official and governmental websites. This search was conducted in January 2006 and articles about medical risk management and prevention were collected. Results We included 10 articles involving medical adverse events, patient safety and medical litigation. New Zealand took many measures in order to prevent medical error and improve medical quality, including strengthening medical practice standards, doctor-patient communication, safety awareness and promoting informationization of hospitals. New Zealand also revised “The Health Practitioners Competence Assurance Act” and improved medical litigation to form an appropriate law environment. Conclusions New Zealand has taken many measures and established a medical risk management system to prevent medical risk. Some issues of particular relevance to China include building corresponding medical litigation and relevant laws and regulations.
【摘要】 目的 探讨优质护理活动中应用风险管理措施提高住院老年患者安全的作用和意义。 方法 对2010年2月-2011年3月开展优质护理活动实施风险管理后，其老年住院患者安全事件预防控制情况进行回顾分析。 结果 应用风险管理措施后老年住院患者的护理不良事件发生减少，患者对护理工作的满意度提高。 结论 加强风险管理有助于保障患者安全，提高患者满意度，构建和谐护患关系。【Abstract】 Objective To investigate the role and the effect of risk management in good care service on the safety of elder in-patients. Methods From February 2010 to March 2011, the risk management was carried out during applying good care service. The prevention and control of the poor nursing events for the elder in-patients were retrospectively analyzed. Results The poor nursing events for the elder in-patients decreased obviously after the application of risk management, and the patients were pleased with the service of nurses. Conclusion Risk management is conducive to prove the safety of the in-patients, improve the degree of satisfaction of the patients, and make the harmonious relations between the nurses and the patients.
目的 探讨风险管理在医院感染管理中的应用与效果。 方法 以风险管理知识为指导，通过分析医院感染管理工作中存在或潜在的医院感染风险制订风险管理预防，指导临床规避和化解感染风险，确保医疗安全。 结果 风险管理的实施提高了医院感染管理质量，减少了医院感染的发生。 结论 风险管理在医院感染管理中的应用不仅可以降低医院感染的风险，也提高了医疗质量。Objective To investigate the application of risk management in hospital infection control and its effect. Methods Guided by risk-management knowledge, we analyzed the potential infection risks in hospital infection control work and regulated risk management policies, in order to avoid and defuse the risk of infection and ensure medical safety. Result The implementation of risk management improved the quality of hospital infection control, and reduced the incidence of hospital infections. Conclusion Risk management in hospital infection control can not only reduce the risk of infection, but also improve the quality of care.
Objective To investigate the regulations and implementation effect for high-risk drugs of the FDA and MHRA on the basis of natalizumab, and to provide references for the risk regulation of the innovative drugs and high-risk drugs of China. Methods We searched MEDLINE, EMBASE.com, the official website of Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for the marketing/withdrawal and risk regulation information of natalizumab as well as the relevant information of drug marketing/withdrawal and approval track. Results (1) Natalizumab was initially approved by the FDA through accelerated approval in November, 2004 with the phase three clinical trial still being conducted. But in February 2005, it was withdrawn after 3 patients developed PML. FDA resumed its marketing under a specially restricted distribution program called the Touch Prescribing Program in March, 2006. (2) Natalizumab was marketed in the European Union in April 2006. No cases of PML have been reported in the UK for this drug. (3) To speed the development of drugs that treat serious diseases, the FDA developed 3 distinct and successful approaches to make such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. The proportion of new molecular entity and new biologic approved by fast tract were 45% and 74%, respectively between 2002 and 2009. (4) Drug regulation of MHRA contained: Yellow Card Scheme, Black Triangle products, Download Drug Analysis Prints (DAPs), and Defective Medicines Report Centre (DMRC). Self-reporting and monitoring system were fairly perfect, thus they can fulfill the close monitoring for high-risk drugs under the existing conditions and then realize the risk-minimization. Conclusion (1) The risk-minimization program of FDA for high-risk drugs is effective, and plays a role in the policy support for the researching and marketing of irreplaceable innovative drugs. (2) The risk regulation for high-risk drugs of MHRA is integrated into drug regulation program and enforces hierarchical management, and acquires risk-minimization effect. (3) We should learn from the policy and operational experience for the international new molecular entity and new biologic on the re-evaluation for innovative drugs and high-risk drugs. Combined with drug specific characteristics, evaluation indicators and criteria are developed base on evidence, risk management system and mechanism for innovative drugs are established and improved, and policy and administration security for the safety application of innovative drugs and high-risk drugs are provided.
Objective To analyze the policy and guideline, the institutional management and the operation mechanism of ICU medical risk management in the United Kingdom, the United States, Australia, Canada and Taiwan, so as to provide evidence and recommendations for health care risk management policy in China. Methods Such databases as PubMed, EMBASE, The Cochrane Library were searched to include the literatures such as the guideline documents and the research reports on ICU medical risk management in the United Kingdom, the United States, Australia, Canada and Taiwan; the institutional management and the operation mechanism of the risk management in the above four countries and one area were comprehensively analyzed, and especially the UK model was highly emphasized. Results A total of 31 literatures were included, including 1 guideline, 5 reviews, 2 investigative reports and 23 research documents. The United Kingdom guided the ICU risk management in forms of the standard and the guideline, formulated a clear tool of event classification and corresponding response mechanism. The United States learned from Australia’s experience and established the ICU safety reporting system; both of them regarded ICU as one part of the medical risk management and set up a special management column. Conclusion The ICU risk management with the independent report system in the United Kingdom is brought into the scope of national patient safety management, and is regarded as the relative complete system at present. In Australia and the USA, the national institutions are in charge of setting up the research projects of ICU risk management; the industry associations and the non-governmental organizations lead the risk research; and the experimental units popularize gradually after self-application.
Objective To provide some theoretical reference and practical guidance for the medical risk management and early warning of private medical institutions, and to improve the service level and social reputation of private medical institutions. Methods China National Knowledge Infrastructure, Wanfang, VIP, and Web of Science database were searched for literature on medical risk management of private medical institutions published from the dates of establishment of databases to July 31, 2023. CiteSpace software was used for analysis. The aspects of literature number, literature source, author-institution cooperation, keyword co-occurrence, keyword clustering and burst were analyzed. Results A total of 2 635 literature were detected. Among them, there were 1446 articles in Chinese and 1189 articles in English. Although domestic research started late, it covered a wide range of disciplines and research fields. The Chinese literature showed a growth trend in the medium term, but the growth trend was slower than that of foreign literature. At the same time, the cooperation network of foreign authors and institutions was closer than that of domestic ones, and the overall development was relatively insufficient. There were differences between domestic and foreign research hotspots in terms of disciplines and research contents. Conclusions It is necessary to strengthen the theoretical and practical research on medical risk management of private medical institutions, and accelerate the construction of risk management and early warning models suitable for the characteristics of private medical institutions in China. In the future, the emerging research fields such as moral hazard, emergency and internal control need to be deepened and expanded.