国家食品药品监督管理总局党组成员边振甲赴国家食品质量安全监督检验中心调研

<正>2014年1月2日,国家食品药品监督管理总局党组成员边振甲赴国家食品质量安全监督检验中心(以下简称"中心")调研食品安全风险监测相关工作。边振甲参观了中心理化、微生物及功能评价实验室,听取了中心负责人对实验室环境、设备、人员、技术能力、科研成果以及食品安全风险预警等方面的工作汇报,详细了解了中心管理运行现状,并就食品安全风险监测、预警和交流等工作进行了交流。边振甲指出,中心在食品安全检验检测及技术保障等方     

信息预警在规避药品风险中的应用

为有效控制医院药品风险,提出信息预警的风险管理模式。信息预警系统利用信息采集、信息分析评估、信息报告等对药品风险进行预警,详细说明了该预警体系的建立、运作机制、模式及关键技术环节。     

基于多智能体系统的药品供给应急管理多元主体信息交互机制研究

目的:为提高我国药品供给应急管理效率提供参考。方法:借鉴多智能体系统的基本原理,以药品生产流通企业、医疗机构、政府、患者和媒体为主体,构建药品供给应急管理多元主体信息交互机制。结果与结论:本研究初步构建了以风险信息中转协同机制、信息共享机制和应急任务分解机制为内在机制的药品供给应急管理多元主体信息交互机制,其过程可分为风险预防、风险预警、风险应对和风险平息等4个阶段。所构建的药品供给应急管理多元主体信息交互机制对提高药品供给应急管理过程中关键信息的传递效率有一定的适用性,可为相关部门提高药品供给风险识别与应对能力提供新的思路,进而有助于完善我国药品信息监测系统及供应保障体系。     

ADR咨询

系列问答99——药物不良反应监测是否属于医疗质量保障体系?医疗质量保障体系一般包含准入体系、控制体系、评价体系、检查监督体系、医疗责任(风险)保障制度以及监测、信息、预警体系。监测、信息、预警体系是在收集各种医疗事件信息的基础上,发出预警信号,提醒各医疗机构及时采取预防措施,避免类似情况的出现。我国目前实行的医疗事故监测、院内感染监测、药物不良反应监测均属于监测、信息、预警体系,为医疗质量保障体系的一部份。然而,就我国药物不良反应监测工作而言,该项工作自1984年由卫生部启动至今已历时20余年,虽然取得了明显进展…     

北京市药品安全预警机制现状分析与对策研究

目的健全药品安全预警机制,提高药品安全风险应对能力。方法主要采取逻辑分析方法,结合北京市药品监管实践,通过分析得出结论。结果与结论当前应当采取组建药品安全预警信息系统、建立预警信息发布机制、完善药品安全预警相关政策法规、大力发展和构建预警系统的技术支撑体系等措施推动预警体系的建立和发展。     

药品安全预警理论研究

目的:界定药品安全预警的内涵,研究药品安全预警的理论模式。方法:查阅相关文献,在分析药品安全概念和预警相关理论的基础上,探索药品安全预警模式的建立。结果与结论:阐明药品安全预警的概念和逻辑过程,提出了建立包括信息采集系统、信息分析处理系统、信息反馈系统3个基本功能模块的药品安全预警系统。     

美国食品与药物管理局药品不良反应信号的定量评价方法概述及启示

目的:分析美国食品与药物管理局(FDA)药品不良反应(ADR)信号的定量评价方法,为我国ADR评价工作提供参考。方法:采用文献研究、对比分析、数据归纳等方法,探讨美国FDA药品评价与研究中心对ADR信号的评价方法。结果与结论:美国FDA药品评价与研究中心通过采用多项伽玛泊松缩减法对ADR信号进行定量评价,可早期发现ADR信号,有效提升ADR信息的风险预警能力。我国有必要借鉴其ADR信号评价方法,运用各种数据分析手段,建立高质量的ADR评价数据库;同时,注重药物流行病学及统计学在ADR评价中的应用,将ADR评价方法由定性评价逐步向定量评价转变。     

我国药品安全风险交流现状研究

目的 探讨我国药品风险交流的现状,促进药品风险交流工作的开展,为下一步制定药品安全风险交流工作指南提供依据.方法 通过查阅文献,检索我国相关法律法规,浏览官方网站等方式,分析我国目前药品风险交流的主要方式与途径,揭示目前存在的问题并提出完善我国药品安全信息交流的建议.结果 与结论我国的药品风险沟通制度尚不完善,缺乏与之...     

我国药物警戒信息与风险控制措施的分析与探讨（一）

目的对国家药品不良反应监测中心已发布的22期《药品不良反应信息通报》警戒信息中涉及的品种及风险点进行了梳理,并对我国已尝试开展的药品风险控制措施进行了系统分析。方法探讨了针对药品风险因素我国从药品生命周期不同阶段和药品风险效益评估两个不同角度已采取的多种药品风险控制模式,提出积极开展药品上市后研究并制定相关技术指南、出台上市后评价法规并制定技术评价规范、制定相对统一共同遵循的风险控制原则和尺度。结果与结论逐步建立符合我国国情的药品风险管理模式是今后药品风险管理研究的内容及方向。     

地市级药品安全监测数据综合管理平台构建研究

目的：通过构建药品安全监测数据综合管理平台,实现对药品安全监测数据的管理与分析利用。方法：运用信息化手段,以国家药品不良反应监测系统为依托,将数据采集检索、报告质量管理、数据统计分析、实时风险预警、风险信号挖掘五大功能融为一体,实现一站式服务。以“机器换人”为导向,将人工难以实现的计算任务转为机器计算功能,并引入可视化模型用于数据分析和信号挖掘,体现基于数据的价值创造。结果：利用数据综合管理平台,可有效管理和分析全市药品安全监测信息,极大提高了监测效率及风险预警能力。结论：数据综合管理平台体现了药品安全的智慧监测,具有较好的应用前景。     

Degraded and undegraded carrageenans and experimental gastric and duodenal ulceration

The prevention of histamine-induced gastric and duodenal ulceration in the guinea-pig has been examined using a series of undegraded and degraded carrageenans. Undegraded carrageenans were active at lower doses than degraded carrageenans. The high viscosity of the undegraded carrageenans in solution prevented their use in larger doses. Degradation of carrageenan without serious loss of sulphate, gives a product which allows the dose to be increased to an extent that its effect more than offsets the slight loss in activity caused by the degradation. No single feature of carrageenan structure can be related to anti-ulcer activity although degradation, and hence reduction of molecular size, generally reduces activity. Sulphate contents over 30% have little apparent effect on activity; κ-carrageenans were not consistently different in anti-ulcer activity from Λ-carrageenans. This contrasts with the antipeptic activity of carrageenans where κ-carrageenans are less active than their Λ-counter-parts. As with antipeptic activity, the degree of anti-ulcer activity is probably determined by a combination of structural features which includes molecular size and polyanionic properties.     

Affective and Anxiety Disorders and Alcohol and Drug Dependence:

Depression and anxiety frequently coexist in patients with substance use disorders. This clinically-oriented article examiens the relationship between these conditions and emphasizes data showing that substances of abuse can cause signs and symptoms of both depression and anxiety. These substance-related syndromes appear to have a different course and prognosis than uncomplicated, independent anxiety and major depressive disorders, and clinicians should consider the role of alcohol and other drugs in all patients presenting with these complaints. The authors will also outline an approach for diagnosing and managing patients with the combination of a substance use and depressive or anxiety disorder.     

Alcohol and Substance Use and Abuse in Women and Children

No abstract available for this article.     

Excretion and biotransformation of alfentanil and sufentanil in rats and dogs

The excretion and biotransformation of alfentanil (ALF) and sufentanil (SUF), two recent analogues of the synthetic opioid fentanyl, were studied after single iv administration of the tritium-labeled drugs in male rats and dogs. The drugs were almost completely metabolized in the two species, which resulted in a large number of metabolites. The excretion of the metabolites was rapid and exceeded 95% within 4 days, except for that of ALF metabolites in dogs (about 85%). For ALF, excretion of the radioactivity with the urine (73% in rats, about 76% in dogs) exceeded that with the feces. For SUF, excretion of the radioactivity with the urine amounted to 38 and 60% and that with the feces to 62 and 40%, in rats and dogs, respectively. Bile-cannulated rats excreted 68% with the bile within 24 hr after SUF dosing, and about 22% of this biliary radioactivity was subjected to enterohepatic circulation. After an ALF dose, the biliary excretion amounted to 24%, and the enterohepatic circulation was minimal. The main metabolic pathways of the two drugs were the oxidative N-dealkylation at the piperidine nitrogen and at the amide nitrogen, oxidative O-demethylation, aromatic hydroxylation, and the formation of ether glucuronides. N-[4-(Hydroxymethyl)-4-piperidinyl]-N-phenylpropanamide (M6) was the main metabolite of both ALF and SUF in rats. In dogs, the glucuronide of N-(4-hydroxyphenyl)propanamide (M5) was the main metabolite of ALF. After SUF dosing in dogs, N-[4-(methoxymethyl)-4-piperidinyl]-N-phenylpropanamide was more abundant than M5.