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目的为探索建立适合我国国情的药品不良反应救济制度提供参考。方法对德国药品不良反应救济制度的相关法规、机构、救济程序、救济内容及特点进行具体分析。结果德国药品不良反应救济制度为保障当地公众用药安全、平衡社会各方权益提供了有效措施。结论德国药品不良反应救济制度对建立我国药品不良反应救济制度具有借鉴意义。 相似文献
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阐述我国建立药品不良反应损害救济制度的必要性和可行性,分析我国现阶段开展药品不良反应损害救济工作面临的问题与挑战,为建立我国药品不良反应损害救济制度提供参考。 相似文献
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建立我国药品不良反应救济制度的调查分析 总被引:1,自引:0,他引:1
目的调查探索建立我国药品不良反应救济制度的必要性、可行性与可操作性。方法采用随机问卷调查方法,应用建立我国药品不良反应救济制度调查表,对全国各地的5 800名民众关于建立药品不良反应救济制度的必要性、可行性与实际操作性进行调查。结果 91.81%的被调查者认为药品不良反应引起的损害应该得到救济;89.32%的被调查者认为有必要建立我国的药品不良反应救济制度;77.72%的被调查者认为可以通过购买商业保险进行救济。结论建立我国药品不良反应救济制度是必要的;我国可建立以政府救济基金为主,商业保险为辅的救济模式对发生的严重药品不良反应进行救济。 相似文献
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日本药品不良反应被害救济制度的启示 总被引:9,自引:1,他引:9
目的:探索建立我国药品不良反应受害救济制度的方法。方法:介绍日本药品不良反应被害救济制度,分析药品不良反应被害救济制度在我国建立与实施的意义。结果与结论:我国应尽快建立药品不良反应受害救济制度,以保障患者的权益。 相似文献
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赵玮 《药物流行病学杂志》2013,(7):368-370
目的:为我国药品不良反应补偿救济制度的建立提供政策建议。方法:比较分析德国、瑞典、日本药品不良反应补偿救济制度中模式、对象及资金来源方面的特点。结果与结论:建立符合我国国情的救济基金模式,不断完善相关立法,制定配套实施方案,明确补偿救济的对象和范围,保障补偿救济资金的来源。 相似文献
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目的:建立药品不良反应损害救济基金制度,更好地推进我国药品上市许可持有人(MAH)制度试点工作。方法:对日本药品不良反应损害救济基金制度的具体内容进行分析,对其基金来源、支付标准、申请流程做了重点研究。结果:日本药品不良反应损害救济基金制度主要通过对MAH征收合理的缴纳金,来平衡民众的合法权益以及保证医药产业健康发展之间的关系。结论:结合具体国情,建议我国从法律层面明确建立药品不良反应损害救济基金制度,制定药品不良反应损害救济实施办法,从基金管理部门(行政主管部门、技术鉴定机构、基金管理运作机构)、筹资模式、救济范围、救济标准、运行程序、监督管理、制度宣传等各个方面做出详细规定,切实保证药品不良反应损害救济制度的可操作性。 相似文献
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Lan-Hui Chih Angela W.F. On Yi-Shin Huang 《Yao wu shi pin fen xi = Journal of food and drug analysis.》2014,22(3):356-362
Antituberculosis drug-related liver injury (ATLI) is the most prevalent hepatotoxicity in many countries. Whether monitoring liver tests is beneficial to prevent this potentially grave adverse drug reaction (ADR) is open to debate. The Taiwan Drug Relief Foundation (TDRF) was established by the Taiwan Food and Drug Administration to collect severe cases of ADR and carry out drug injury relief tasks. Our intention was to explore the role of monitoring liver tests in the susceptibility and severity of ATLI from the database of this foundation. All cases of suspected ATLI collected by the TDRF from 1999 to 2012 were reviewed. The basic demographic data, clinical course, and laboratory data of these patients were analyzed. A total of 57 cases with severe ATLI were verified and enrolled into this study. There was a high mortality (71.9%) in this cohort. Twenty-four cases (42.1%) were chronic viral hepatitis B carriers, who had higher baseline serum aminotransferase level than noncarriers. The patients without monitoring liver tests had higher peak serum alanine aminotransferase, bilirubin levels, and mortality (adjusted odds ratio, 8.87; 95% confidence interval = 1.32–59.41; p = 0.024) than those with monitoring liver tests. In conclusion, patients with severe ATLI whose records were collected by the TDRF have a high mortality. Patients without follow-up monitoring liver tests had more severe liver injuries and higher mortality than those with monitoring live tests. To alleviate this potentially grave ADR, checking of liver biochemical tests prior to antituberculosis treatment and periodic monitoring of these tests thereafter are highly suggested. 相似文献
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目的:促进大陆地区医院药学服务质量的持续改进。方法:介绍台湾地区医院药学的相关制度、药品管理(包括药品调剂和医院制剂配制)、临床用药管理(包括临床药学和用药疏失管理及循证医学信息服务)与大陆地区的差异,并提出对大陆地区医院药学工作的启示。结果与结论:台湾地区执行全民健康保险制度,引入总额支付制度;执行医院评鉴制度和药害救济制度。台湾地区医院门诊和住院药品调剂均采取拆零调配模式,调配流程合理且高效;医院制剂配制方面,一般均提供全静脉营养剂配制服务,中草药均为瓶装粉末,对于儿童用药品提供粉碎和分装服务;对于频繁使用且剂量较恒定的品种医院也会委托企业批量生产;单设化疗药房。台湾地区的临床药学工作内容与大陆地区基本相同,药事服务在院内网络上进行记录;医院药师(包括临床药师和药房药师)可随时将各类用药疏失填报至院内网络,填报者能获得院方奖励。台湾地区医疗品质策进会已将医院循证工作开展情况视为质量控制的一项指标,纳入医院的评鉴系统。启示大陆地区需要推动药学服务的信息化、注重临床药学人员的培养与考核、加强人性化服务。 相似文献
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摘要: 目的:探索完善我国药品不良反应损害救济风险分担机制的方法。方法:采用文献研究方法、比较研究方法,描述我国现行法律关于药品不良反应损害赔偿的问题,通过借鉴国外和我国台湾地区药品不良反应损害救济制度,提出完善我国药品不良反应损害救济风险分担机制的建议。结果与结论:侵权责任方面,我国产品缺陷界定存在不足,应加以完善;专门救济方面,我国应通过ADR损害责任保险和ADR损害救济基金分担ADR损害风险。 相似文献
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Jui Hsu Jii-Jun Lin Wen-Ing Tsay 《Yao wu shi pin fen xi = Journal of food and drug analysis.》2014,22(2):169-177
Drug abuse has become a global issue of concern. It affects not only individual users, but also their families and communities. Data were retrieved from the database of the Taiwan Surveillance System of Drug Abuse and Addiction Treatment (SSDAAT) from 2002 to 2011, and 147,660 cases reported by medical institutions in Taiwan were reviewed. This study showed that the top five reported abused drugs by medical institutions during the last decade were heroin, methamphetamine, benzodiazepines, ketamine, and zolpidem. Heroin and methamphetamine continued to be the first two abused drugs reported by medical institutions. Heroin abuse was significant, but has shown a downward trend. However, emerging abused drugs, such as ketamine and zolpidem, presented upward trends. 3,4-Methylenedioxy-N-methylamphetamine (MDMA) abuse seems to have re-emerged and has increased gradually since 2010. Injection without needle sharing has become the most common route of administration of abused drugs since 2002. The majority of causes for these reported drug abuses were drug dependence, followed by peer influence and stress relief. Hepatitis C was the most commonly reported infectious disease, followed by hepatitis B and AIDS in the drug abusers reported by medical institutions. It should be noted that access to drugs via the Internet increased year by year, and this is clearly an area needing constant monitoring. 相似文献