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1.
2004年11月8日,武汉市的20家制药企业联合发出倡议:“承诺凡由本公司生产并已销售出厂的药品,一旦发现安全隐患问题,会主动联系经销商,尽最大努力在第一时间将该批药品全部召回。”这是全国首次制药企业联合发起实行问题药品召回制。时隔半年后,武汉再一次见证了中国探索建立药品召回制度历程。2005年5月21日,在“第二届中国(武汉)医药峰会”上,来自全国各地23家知名医药企业的代表在“医药召回倡议书”展板上郑重地签下了自己的名字,承诺实施药品公开召回制度。  相似文献   

2.
由“PPA”事件、“龙胆泻肝丸”事件、“齐二药”事件等连续引发的关于中国药品召回制度的讨论,在“欣弗”事件发生后被推向高潮。在社会各界的共同声讨下,华源公司主动向全国发文实施药品召回,并称按照成本价收回,全部运费由公司独自承担。相关人士早已指出,药品召回作为一种国际通行的制度,很多国家都将其写入了法律;我国也要以“欣弗”药品召回为契机,尽快建立健全统一的药品召回制度。[第一段]  相似文献   

3.
2010年10月底,国家食品药品监督管理局就西布曲明可能增加严重心血管风险,减肥治疗的风险大于效益,决定停止西布曲明制剂和原料药在我国的生产、销售和使用,已上市药品由生产企业负责召回销毁。此次被责令退市召回的含有西布曲明的减肥药品有曲美、澳曲轻、可秀、赛斯美、曲婷、浦秀、亭立、奥丽那、曲景、新芬美琳、希青、申之花、衡韵、苗乐、诺美亭等15个品牌的同类产品。  相似文献   

4.
《食品与健康》2008,(3):7-7
美国食品药品管理局(FDA)宣布,召回25微克剂型芬太尼止痛贴(其中包括已过期或2009年12月以前到期的产品),因这些产品存在严重缺陷。此次被召回的止痛贴商品名为“多瑞吉”,生产厂家为强生旗下的PriCara公司以及山德士公司。这些止痛贴存在内部药品可能渗漏到包装外的风险,如果病人或其家人直接接触到渗漏出来的大剂量的镇痛药物,可能会导致呼吸困难,过量更可致命。  相似文献   

5.
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。  相似文献   

6.
药品不良反应损害救济机制探讨   总被引:2,自引:0,他引:2  
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。  相似文献   

7.
缺陷食品召回制度是目前发达国家为避免和减少缺陷食品对人体健康的损害而普遍实行的一项食品安全管理制度。本课题研究了美国、加拿大、欧盟、澳大利亚、新西兰、日本、我国香港等地食品召回的法律规定、实施程序、管理方式、科学依据、执行部门、实施情况等关键技术内容,并将我国现行的食品召回相关法律制度与发达国家和地区进行了比较。同时对美国缺陷食品召回的实施情况进行了深入研究,包括召回的部门职责、召回的启动,召回实施中的有效性、时效性、消费者保护、相对人沟通等原则,企业时召回的认知情况,以及近年来美国的召回数量、级别、原因、召回产品来源等,并以疯牛病事件召回案例为例详述了召回的全过程。美国FSIS和CDC的监测数据表明,实行召回以后因缺陷食品导致的食源性疾病发病率明显下降。我们在研究的基础上,提出了我国食品召回制度的总体设想和本市缺陷食品召回规定的框架,并就有效实施召回制度提出了制定操作手册、建立专职机构、完善溯源系统、加强召回宣传、加强监管联系等建议。  相似文献   

8.
医疗器械召回《意见稿》及执行的思考   总被引:1,自引:0,他引:1  
医疗器械召回制度即将在我国施行,本文介绍了大致内容。我国医疗器械不良事件时有发生,但由于监测水平的落后,医疗器械召回制度在我国实施有一定的难度,我们可能在实施中不断完善。确立召回制度,无疑将对国内医械产品的质量、提高行业集中度、促进技术创新等方面产生深远影响。  相似文献   

9.
本文对澳大利亚食品召回制度的法律法规、分类与分级、运行机制及食品召回现状进行详细分析,就我国食品召回制度在以上四个方面的现状与问题进行对比研究。并就完善我国食品召回制度提出建议:健全法律法规体系,加强各级监管;提高召回工作专业性,完善召回运行机制;加强食品召回宣传教育,建立良好沟通交流机制;建立食品召回信息系统,建设权威信息公示平台。  相似文献   

10.
目的分析医疗器械上市前临床试用或验证中的缺陷,探讨医疗器械上市后的安全质量管理评价。方法采取定性分析与定量分析相结合的方法,分析医疗器械上市前临床试用中的缺陷以及医疗器械安全质量管理的途径。结果医疗器械安全质量通过医疗器械不良事件报告、医疗器械召回和医疗器械追踪得以实现。结论医疗器械进入市场后的不良事件报告、召回制度和追踪制度,是医疗器械进入市场后对其安全性、有效性和质量管理的重要环节。  相似文献   

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13.
It is important to study possible teratogenic effects of drugs used during pregnancy. Many studies of this type rely upon case-control designs in which drug intake is recalled by the mothers after having given birth. Recall bias in this situation may lead to spurious associations. We looked for indicators of recall bias by comparing self-reported drug intake with medically notified intake for specific diseases in the Hungarian Case-Control Surveillance System of Congenital Abnormalities, which includes 22,865 cases with congenital abnormalities and 39,151 controls. Recall error was present, especially for drugs used for a short time period. Furthermore, the timing of drug intake was reported slightly closer to the time of interview for cases compared than for controls. Severe or visible congenital abnormalities did not appear to be more conducive to recall bias than other abnormalities under study. A case-control surveillance system of this type may frequently cause spurious associations, with biased odds ratios up to a factor of 1.9.  相似文献   

14.
OBJECTIVES: This study examined whether adolescents' recall of antidrug advertising is associated with a decreased probability of using illicit drugs and, given drug use, a reduced volume of use. METHODS: A behavioral economic model of influences on drug consumption was developed with survey data from a nationally representative sample of adolescents to determine the incremental impact of antidrug advertising. RESULTS: The findings provided evidence that recall of antidrug advertising was associated with a lower probability of marijuana and cocaine/crack use. Recall of such advertising was not associated with the decision of how much marijuana or cocaine/crack to use. Results suggest that individuals predisposed to try marijuana are also predisposed to try cocaine/crack. CONCLUSIONS: The present results provide support for the effectiveness of antidrug advertising programs.  相似文献   

15.
In the present study we analysed registered adverse drug reactions caused by 19 most used drugs in Bulgaria during three-year period. The cases were assembled from the spontaneous reporting system operated in our country. We described demographic characteristics of the patients, clinical diagnosis and reporting rates per 100,000 inhabitants for each drug. The data for antibiotics were compared with the results of our previous research. We analysed 188 adverse drug reactions i.e. 21% of all reports received in the Centre for Drug Safety of the National Drug Institute. Adverse drug reactions type B such as oedema, allergy, coma, etc. predominate. The number of cases with perforated ulcer and melaena caused by acetylsalicylic acid is considerable. The frequency of adverse drug reaction for the investigated drugs in "rare" according to WHO standards. It is necessary to assemble more information on adverse drug reactions and every serious case and inform medical doctors and pharmacists as a first step for improving the pharmacovigilance system in Bulgaria.  相似文献   

16.
Knibb RC  Booth DA 《Appetite》2011,57(2):439-442
The recall of personal experiences relevant to a claim of food allergy or food intolerance is assessed by a psychologically validated tool for evidence that the suspected food could have caused the adverse symptom suffered. The tool looks at recall from memory of a particular episode or episodes when food was followed by symptoms resulting in self-diagnosis of food allergy or intolerance compared to merely theoretical knowledge that such symptoms could arise after eating the food. If there is detailed recall of events that point to the food as a potential cause of the symptom and the symptom is sufficiently serious, the tool user is recommended to seek testing at an allergy clinic or by the appropriate specialist for a non-allergic sensitivity. If what is recalled does not support the logical possibility of a causal connection between eating that food and occurrence of the symptom, then the user of the tool is pointed to other potential sources of the problem. The user is also recommended to investigate remedies other than avoidance of the food that had been blamed.  相似文献   

17.
目的监测508株病原细菌的敏感率和耐药性。方法使用VITEK2Compact全自动微生物鉴定/药敏测试系统进行菌种鉴定和药敏试验。结果革兰阴性细菌占85%,耐药现象较为严重;革兰阳性细菌占15%,也呈高耐药率。结论根据细菌耐药性连续性监测报告,合理选择临床用药。  相似文献   

18.
Two hundred and eight male and female participants were given unanticipated memory and recognition tasks with which to recall and recognize medical symptoms, described on audiotapes by male and female individuals. Half of the presented symptoms were among those typically experienced by males; half were among those experienced mostly by females. Both memory and recall were better when the audiotaped reporting persons was male. Gender orientation of symptoms (male versus female orientation) was not associated with better recall or recognition, nor was the factor of subject gender. Although neither "male" nor "female" symptoms were seen generally as more serious overall, an interaction effect showed that symptoms were seen as more serious, especially in the case of the male audiotape, when they were incongruous with the gender of the reporting person. Some possible implications of the results are outlined. More research is required to assess the differential perception of medical and other types of symptoms.  相似文献   

19.
This article examines a drug manufacturer's dissemination of an over-the-counter medication voluntary recall message through its online social network. Using the CAUSE model as a theoretical framework, we extended the application of media content analysis to investigate social media presentation of risk. Researchers used a deductive coding scheme to analyse messages posted on the manufacturer's Facebook page for 10 days from the announcement of the recall. Consumers interacted with one another and with the corporation as they sought information and support through the recall discussion on Facebook. The drug manufacturer addressed all five communication challenges outlined by CAUSE in its recall communication, while consumers used the social network to seek and to share information both positively and negatively with regard to the recall and the potential risk. The analysis presented in this study highlights the importance of providing steps that are simple and clear in a product recall, and of supporting consumers’ beliefs in their self-efficacy or ability to enact these steps; problems in this domain led to much of the dissatisfaction expressed by consumers. Our findings indicate that consumers engaged in active discussion with other consumers and with the manufacturer in online social networking.  相似文献   

20.
OBJECTIVE: We compared telephone reports of hormone replacement therapy (HRT) use to claims for drugs dispensed. STUDY DESIGN AND SETTING: The study subjects included 106 women who were dispensed HRT and 107 who were not dispensed HRT. RESULTS: Recall of drug use overall was relatively good (65/79=82.3%, 95% confidence interval [CI] 73.9-90.7). Agreement between recall of drug name and the claims for dispensed drugs was lower (61/79=77.2%, 95% CI 68.0-86.5). Of 65 women reporting use of HRT in response to the indication prompt, nine (13.8%) could not identify the drug name using the drug list prompt, but all 65 women identified a drug using the photo prompt. Recall of start date of drug use was poor (29.2% agreement on month/year; 45.8% agreement within 1 month), and recall of end date of drug use was poorer yet (7.7% agreement on month/year; 21.5% agreement within 1 month). CONCLUSION: Recall of drug use and drug names is far better than recall of dates of use. Recall can be enhanced with lists of drug names and color photos, but even with memory prompts, recall remains imperfect. If drug use is the primary exposure of interest in a study, considerable effort is needed to collect it correctly. If not, then perhaps drug histories should be omitted.  相似文献   

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