药品不良反应损害救济机制探讨

药品不良反应损害是否应当救济,或在多大范围内救济,采用何种方式救济?这一系列问题都需由法律予以判断和裁决。而我国现行法律制度对药品不良反应的法律责任规定缺位,亦无相应的损害救济制度,受到药品不良反应损害的消费者或其他相关人员因而难以得到补偿或赔偿。文章通过比较药品不良反应各类救济制度,认为采用保险基金制度来建立药品不良反应救济制度是一项有效的途径,同时对我国药品不良反应救济制度的建立提供了初步意见。     

药品不良反应损害救济制度探讨

药品不良反应是在正常使用合格药品时产生的有害或意外反应。药品发生不良反应会给患者及其家庭带来严重的伤害,受害者理应得到补偿救济。而我国现行法律对药品不良反应损害的规定缺位。我国应及早建立和完善药品不良反应救济机制,实行药品不良反应救济基金制度。     

药品不良反应损害救济机制研究

探讨建立药品不良反应损害救济机制法律依据及模式,在产品责任理论基础上提出了我国应从行政主体、法律框架、保险体系等三方面建立药品不良反应救济制度。     

论我国药品不良反应的归责原则

药品不良反应的归责原则一直广受关注,直接影响药品不良反应受害者的救济可能性.文章在对德国、日本、美国药品不良反应归责原则发展轨迹进行考察的同时,也总结出了由合同责任到侵权责任,由过错责任到无过错责任的趋势.同时在考察了我国药品不良反应归责现状的基础上,提出了我国在药品不良反应救济方面宜采用无过错责任原则,并建立相应的配套制度.     

再论药品不良反应救济的保险模式

目的:探索适合现状的药品不良反应损害救济模式.方法:阐述药品不良反应相关理论依据及当前探索中的ADR救济模式,分析ADR责任险构建的可行性.结果:提出保险形式构建ADR救济机制的具体措施.结论:建立ADR保险救济机制有利于解决当前ADR补偿问题,有利于构建和谐社会.     

德日两国药品不良反应救济制度的运行模式对我国的启示

药品不良反应损害已日益发展成为一个社会问题，各国政府都在尝试建立完善的救济制度，而目前我国在这方面仍属空白。文章在比较分析德、日两种类型救济模式的基础上，提出了构建我国药品不良反应损害救济基金会的设想和具体运作形式。     

药品不良反应保险救济机制研究

通过对药品不良反应定义的分析,探析我国建立药品不良反应保险救济机制的可行性,结合近期＂严重药品不良反应综合保险＂的失败经验,提出了完善法律法规、累积数据、建立鉴定中心、政府补贴并强制购买等政策建议。     

建立医疗器械不良事件补偿机制的构想

在分析了我国目前医疗器械不良事件现状的基础上,提出了建立医疗器械不良事件补偿机制的构想。我国医疗器械不良事件的补偿机制可以借鉴国外药品不良反应救济制度的做法,引入保险机制的方式运作补偿救济金。本文着重阐述了建立医疗器械不良事件损害补偿机制,对保障病人的权益、保证医疗机构正常运行,促进医疗器械产业的健康发展都有着非常重要的意义。     

当前药品不良反应损害救济立法刍议

药品不良反应的损害救济在我国是个尚未解决的难题。文章通过我国当前药品不良反应立法现状的分析,对立法提出一些建议并有助于我国医药企业的立法和谐的发展。     

药品不良反应补偿救济制度运行机制研究——基金运作模式研究

药品发生不良反应会给患者及其家庭带来严重的伤害，受害者理应得到补偿救济．但我国在此项制度建立方面仍是空白。通过研究已经建立药品不良反应救济制度国家的制度运行机制，结合我国的实际情况分析不同运作模式的利弊．探讨基金运作模式的可行性，并在此基础上提出建议。     

药物不良反应事件民事赔偿问题研究

在药物不良反应事件中，药品存在设计缺陷、制造缺陷或警示缺陷的，药品的生产者应当承担赔偿责任。医疗机构无视药物不良反应的警示说明导致不良反应发生的，应当承担医疗差错的赔偿责任。国家疏于药物监管导致不良反应发。生的，从法学理论上讲，也应当承担赔偿责任。     

我国医保药品支付标准建设的理论与现实分析

建立针对药品的医疗保险支付标准(参考价)是多国控制药品费用不合理增长的重要措施。医保药品支付标准通过药品价格竞争刺激患者需求和增强患者选择的权利来影响医生行为和药品企业定价。我国放开药品政府定价后也亟需建立适应药品市场发展的价格形成机制,建立医保药品支付标准需要从我国药品管理政策转变和现状出发,厘清控费的具体机制,根据当前我国实践中存在的问题,从药物经济学评价、药品分级分类管理、完善医保药品支付方式和补偿机制、合理分配补偿结余等方面入手,提升药品的可及性、费用的可控性和政策的激励性。     

基于成本核算的公立医院补偿机制改革——美国经验及对我国的启示

长期以来,我国公立医院财政补助不以成本核算为基础,主要按人员编制、床位数为标准进行补偿.本文介绍了美国结合成本核算进行公立医院补偿机制改革的主要历程：从以实际成本为基础获得适当补偿,发展为按标准临床项目诊疗分组预付费.我国公立医院补偿机制出现以下问题：财政补偿没有以医院成本核算为基础,医疗服务收费普遍低于成本,技术劳务价值在收费价格上未得到合理体现,存在“以药补医”现象.美国经验启示我国应当以成本为基础,理顺医疗服务比价关系,建立科学合理的医疗服务价格体系;借助全成本信息,合理制定财政补偿政策;依托病种成本核算和DRGs,参与定价和谈判,确定支付标准.     

非诉讼纠纷解决机制在医患纠纷处理中的应用与完善

为完善我国医患纠纷的非诉讼纠纷解决机制，促成其与诉讼的有机互补，分析了医患纠纷非诉讼纠纷解决机制的构成，探讨了和解、调解、仲裁与诉讼在解决医患纠纷中的分工与衔接。我国现行医患纠纷解决机制面临的最大问题在于司法资源的配置不合理，非诉讼纠纷解决机制与诉讼缺乏有机的衔接与分工，诉讼的成本过高。建立完善的非诉讼纠纷解决机制，实现医患纠纷诉讼与非诉讼解决机制的有机互补是法制社会多元化需求的结果。     

Work outcome in workers with occupational skin disease

We carried out a follow-up study of employment outcome for 230 workers with a diagnosis of occupational skin disease who were at least 2 years postdiagnosis. Seventy-eight percent of the workers were working, but 57% of those working had changed jobs, 67% because of their skin problem. Thirty-one percent had lost no time from work because of their skin disease, while 35% had lost at least 1 month. Forty-three percent had applied for workers' compensation benefits, and 87% of those who had applied were successful in their claims. Older workers were more likely to be unemployed and to have applied for workers' compensation benefits. Women were less likely to have lost time from work and to have applied for workers' compensation. Those who had changed their jobs tended to have a better outcome with respect to active dermatitis, though they had lost more time from work and had more often applied for workers' compensation benefits.     

健全我国药品不良反应管理制度的思考

通过对我国现阶段药品不良反应制度现状进行研究,参照美国、日本等发达国家的相关制度进行分析发现,我国药品不良反应的相关制度目前仍然存在空白,亟待完善。只有我国的药品不良反应体系更加健全,才能更好地保护患者的合法权益。     

Involvement of the PI3K/Akt/Nrf2 Signaling Pathway in Resveratrol-Mediated Reversal of Drug Resistance in HL-60/ADR Cells

Resistance to chemotherapy drugs, such as adriamycin (ADR), is a common problem in acute myeloid leukemia (AML) patients. We hypothesized that the natural compound resveratrol (Res) may reverse AML drug resistance through the PI3K/Akt/Nrf2 pathway. We investigated the in vitro effect of Res using human promyelocytic leukemia cells (HL-60) and the ADR-resistant cell line (HL-60/ADR) and treated with either Res or ADR?+?Res. Cellular proliferation inhibition rate, auto-fluorescence intensity of ADR in HL-60/ADR cells and HL-60 cells, mRNA expression of Nrf2 and the drug-resistant gene MRP1, and protein expression of PI3K, Akt, p-Akt, Nrf2, and MRP1 were measured. Results showed ADR?+?Res had a more significant inhibitory effect than ADR alone on HL-60/ADR cells. Auto-fluorescence intensity of ADR in HL-60/ADR cells treated with ADR?+?Res significantly increased. No difference of the auto-fluorescence intensity of ADR was observed in HL-60 cells treated with ADR and ADR?+?Res. mRNA expression of Nrf2 and MRP1 significantly decreased in HL-60/ADR cells treated with both Res and ADR?+?Res; protein expression of PI3K, p-Akt, Nrf2, and MRP1 significantly decreased in HL-60/ADR cells treated with PI3K inhibitor, Res and ADR?+?Res. In conclusion, Res reverses the drug resistance of AML HL-60/ADR cells through regulation of the PI3K/Akt/Nrf2 signaling pathway and MRP1 expression.     

223例药品不良反应分析

目的了解某院药品不良反应（ADR）的发生情况、探讨ADR发生的易感因素,为更好地预防ADR的发生、减少用药风险提供参考。方法收集该院2011年1月1日-12月31日临床上报的223例ADR报告,对患者年龄、引发ADR的药品种类及给药途径、ADR累及器官或系统等进行分析。结果223例 ADR患者,静脉滴注给药 211例（94.62%）,静脉注射3例,肌内注射2例,口服给药7例。74.44%的ADR发生在用药1~30 min内,其中39例（17.49%）发生在用药后1~4 min内,45例（20.18%）发生在用药后5~9 min内,80例（35.87%）发生在用药后15~29 min内。在ADR累及器官或系统损害中,以皮肤及附件损伤最为常见（93例）,其次为胃肠系统（62例）和全身性损害（45例）等;以累及单一器官或系统损害最为常见（184例,82.51%）。123例（55.16％）ADR是由抗菌药物引起,60例（26.91%）是由中药注射剂引起;ADR发生率居前10位的药物包括7种抗菌药物、3种中药注射剂,其中乳酸左氧氟沙星氯化钠注射液引起的ADR居各药物首位（23例,10.31%）。结论ADR的发生与多方面因素有关,临床应加强ADR报告与监测工作力度,促进抗菌药物和中药注射剂临床合理应用,从而降低ADR发生率。     

The mundane administration of worker bodies: From welfarism to neoliberalism

We are in the midst of a disjuncture between welfarist rationalities which assume collective insurance techniques such as workers' compensation, and neoliberal rationalities which assume a greater burden on individual responsibility to avoid risk. This study examines the mundane administration of the welfarist Canadian workers' compensation system through a qualitative study of how managers in four Ontario newspaper workplaces understand and respond to workers complaining of repetitive strain injury (RSI). Findings indicate that managers are informed by a pervasive neoliberal rationality and view RSI-prone workers as undisciplined and neglectful of their own bodies. Managers worked to reduce workers' claims for compensation through extensive surveillance of 'risky' worker bodies. The worker body emerges as a biopolitical terrain for the working out of tensions between welfarist and neoliberal rationalities as worker health becomes a locus for discourse on where to draw the line between rights and responsibilities and between civilian and the state. While others have targeted macrostructural reasons for the malfunctioning of workers' compensation, these data point to an alternative micropolitical explanation. This paper argues that the shift from a welfarist to a neoliberal rationality in workers' compensation consists in the mundane administration of worker bodies.