药品分类管理给医院药学带来了哪些思考

根据国家药品监督管理局对药品分类管理工作的总体部署,我国将于2000年1月1日起开始施行处方药与非处方药管理制度.药品分类管理是国际上药品管理普遍应用的有效方法,也是我国逐步与国际上通行的药品管理模式接轨的触点.因而我国药品销售市场将出现以医院处方药销售为主导,以非处方药销售为辅的格局,这一切必将对医疗机构和社会消费行为产生深刻影响.就医院药学而言,又当如何适应药品分类管理制度带来的变化呢?     

实事求是地推进药品分类管理制度的实施

《处方药与非处方药分类管理办法》试行于２０００年１月１日起正式实施,这是我国药品监管工作的又一重大举措。但是,根据我国药品管理的现状和实际,实施分类管理尚有许多困难和问题,主要表现在：一、实施药品分类管理制度的经验不足药品分类管理是国际上通行的管理模式,在我国尚处于起步和探索阶段。我国人口众多,文化素质差异很大,社会和经济发展的地区差异不断扩大,改革不断深化与改革不配套的矛盾突出,在这种情况下实施药品分类管理制度,涉及面宽,情况复杂,尚缺乏符合中国国情的实施经验。二、群众对药品分类管理制度的…     

非处方药制度的药学伦理教育

借鉴发达国家健康保险制度和药品分类管理的经验,在我国即将建立和实行非处方药(OTC)管理制度。这一制度的实施必将对我国现行的药品管理制度和药师的药学伦理观念产生重大的影响。本文拟就OTC制度的药学伦理教育及其它相关的问题作以下探讨。 1 OTC制度和药学伦理教育的紧迫性 随着OTC制度的建立,药品市场将分为处方药和非处方药两个部分,改变了那种医师开处方药师调配的传统方式。药师将直接面对患者销售药品,医院药房将由“临床供应型”向“药品监护型”转化。因此,OTC制度也是对药师本身业务素质和职业道德的考验。不可否认,绝大多数药师都是遵循     

非处方药与临床药学

为了同国际接轨,进一步适应深化医疗卫生制度改革的形势,我国不久也将建立和实施处方药与非处方药(OTC)的分类管理制度。这一重大举措,是我国的一项开创性的系统工程,也是一种依法管理药品的具体尝试。在实施此项举措的初级阶段,不可避免地会产生这样或那样的认识模糊的情况。如有些临床药师认为,既然把药品划分为处方药和OTC进行分类管理,医院只管好处方药就行了。但事实并非如此,在实行OTC制度之后,临床药师的责任仍很大,临床药学工作只能加强,而不能削弱。只有这样,才     

加快执业药师队伍建设， 确保药品分类管理制度顺利实施

随着新千年钟声的敲响,一项重大的药品管理制度在我国诞生了。由国家药品监督管理局制定的《处方药与非处方药分类管理办法(试行)》,从2000年1月1日开始逐步在全国实施。这是我国药品管理制度的一项重大改革,它标志着我国药品管理工作从此进入一个新阶段。 药品分类管理是国际上行之有效和普遍采用的药品管理模式,是一项涉及药品监督管理、医疗卫生体制、医疗保险制度、广告管理、价格管理、医药产业政策等多方面改革的系统工程,关联面广、情况复杂、难度大,需要各方配合,通力协作。与此同时,它的实施也将推动和促进相关管理制度的改革和发展。比如,它对我国执业药师资格制度的改革和发展将产生积极而深远的影响。 所谓药品分类管理,就是根据药品安全有效、使用方便的原则,依其品种、规格、适应证、剂量及给药途径的不同,把药品分为处方药和非处方药两大类,采取不同的办法分别进行管理。处方药必须凭执业医师或执业助理医师     

关于医院执业药师重要性的探讨

近年来 ,医院药师在医院的药学和医学领域中都起着举足轻重的作用。新的《执业药师资格制度暂行规定》就执业药师制度作出了重要改革。重新明确了执业药师的定义 ,并把执业药师的执业范围扩大到药品的使用单位。而由国家监督管理局制定的《处方药与非处方药分类管理办法 (试行 )》 ,从 2 0 0 0年 1月 1日起逐步开始实施 ,这是我国药品管理制度的又一重大改革 ,面对这一改革 ,医院药师如何对待工作内容的变化 ,将成为新一代医院药师面前的一个重要课题。本文从三个方面阐述了医院执业药师在医疗工作中的重要性。1　医药体制改革 ,使医院药师…     

医院药师在药品分类管理中的作用

<处方药与非处方药分类管理办法(试行)>于2000年1月1日起施行,第一批<国家非处方药目录>同时公布,这标志我国的药品分类管理有了实质性的进展.实行药品分类管理需要相当数量的药师或执业药师.笔者就我国药师现状及肩负责任阐述如下.     

医院药学工作改革之思考

几十年来,医院药学工作一贯是供应任务型管理模式,这种模式不仅不能适应现代化医院发展的需要、也限制了医院药学自身的发展。本文就当前医院药学管理的改革谈点个人看法。１医院可开设ＯＴＣ药房 随着我国医药卫生改革的深入,处方药品与非处方药品（ＯＴＣ）的分类管理制度已经推出,“大病进医院,小病进药房”将成为广大群众的共识。医院应发挥药师专业人才的作用,利用药房的设备开设ＯＴＣ药房,由药师参与咨询指导,使病人在正确指导下购买ＯＴＣ药品,既方便了病人,又提高了医院经济效益,从而改变传统的医院药学主要为临床提供…     

实施药品分类管理加强药品流通监管

遵照中共中央、国务院在《中共中央、国务院关于卫生改革与发展的决定》中作出的国家建立并完善处方药与非处方药分类管理制度的重要决定,根据国家药品监督管理局对药品分类管理工作的总体部署,我国将于２０００年１月 １日起开始施行处方药与非处方药分类管理制度。为了积极稳妥地推进药品分类管理工作,药品分类管理流通试点工作己于１９９９年１０月１８日开始启动,计划于 ２０００年 ４月结束。 实施处方药与非处方药分类管理制度,是中共中央、国务院作出的重要决策,是我国药品监督管理模式的深刻变革,将大大提高我国的药品监管水…     

执业药师在药品分类管理中的作用探讨

目的 为推进药品分类管理,加强执业药师队伍建设提出建议。方法 梳理国内外药品分类管理法规现状及其对执业药师的要求,分析执业药师队伍在药品分类管理中的作用。结果 国内外药品分类管理制度注重执业药师职责,国外对执业药师提出具体、细化的职责要求。我国执业药师在落实药品分类管理工作中具备必要性、可行性、代表性、广泛性特点,应充分发挥其作用,推进药品分类管理。结论 建议加快修订《处方药与非处方药分类管理办法（试行）》;执业药师职责与药品品种分类要求相衔接;多措并举加快执业药师队伍发展;加强能力提升培训和宣传教育,促进药品安全合理使用,推进药品分类管理。     

Quantitative in vivo and in vitro sex differences in artemisinin metabolism in rat

1. The pharmacokinetics of the antimalarial compound artemisinin were compared in the male and female Sprague-Dawley rat after single dose i.v. (20 mg.kg) or i.p. (50 mg.kg) administration of an emulsion formulation. 2. Plasma clearance of artemisinin was 12.0 (95% confidence interval: 10.4, 13.0) l.h. kg in the male rat and 10.6 (95% CI: 7.5, 15.0) l.h. kg in the female rat suggesting high hepatic extraction in combination with erythrocyte uptake or clearance. Artemisinin half-life was 0.5 h after both routes of administration in both sexes. Values for plasma clearance and half-lives did not statistically differ between the sexes. 3. After i.p. administration artemisinin AUCs were 2-fold higher in the female compared with male rat (p 0.001). Artemisinin disappearance was 3.9-fold greater in microsomes from male compared with female livers and it was inhibited in male microsomes by goat or rabbit serum containing antibodies against CYP2C11 and CYP3A2 but not CYP2B1 or CYP2E1. 4. The unbound fraction of artemisinin in plasma was lower (p 0.001) in plasma obtained from the male (8.8 2.0%) compared with the female rat (11.7 2.2%). 5. The possibility of a marked sex difference, dependent on the route of administration, has to be taken into account in the design and interpretation of toxicological studies of artemisinin in this species.     

Quantitative in vivo and in vitro sex differences in artemisinin metabolism in rat

1. The pharmacokinetics of the antimalarial compound artemisinin were compared in the male and female Sprague-Dawley rat after single dose i.v. (20 mg x kg(-1)) or i.p. (50 mg x kg(-1)) administration of an emulsion formulation. 2. Plasma clearance of artemisinin was 12.0 (95% confidence interval: 10.4, 13.0) 1 x h(-1) x kg(-1) in the male rat and 10.6 (95% CI: 7.5, 15.0) 1 x h(-1) x kg(-1) in the female rat suggesting high hepatic extraction in combination with erythrocyte uptake or clearance. Artemisinin half-life was approximately 0.5 h after both routes of administration in both sexes. Values for plasma clearance and half-lives did not statistically differ between the sexes. 3. After i.p. administration artemisinin AUCs were 2-fold higher in the female compared with male rat (p < 0.001). Artemisinin disappearance was 3.9-fold greater in microsomes from male compared with female livers and it was inhibited in male microsomes by goat or rabbit serum containing antibodies against CYP2C11 and CYP3A2 but not CYP2B1 or CYP2E1. 4. The unbound fraction of artemisinin in plasma was lower (p < 0.001) in plasma obtained from the male (8.8 +/- 2.0%) compared with the female rat (11.7 +/- 2.2%). 5. The possibility of a marked sex difference, dependent on the route of administration, has to be taken into account in the design and interpretation of toxicological studies of artemisinin in this species.     

Interindividual variability in metabolic activation in humans in vivo

In assessing interindividual variability in metabolic activation, the toxic metabolite is often too unstable for conventional analysis. Possible alternatives include a stable product of the reactive metabolite e.g. cysteinyl derivatives of N-acetyl-4-benzoquinoneimine, the toxic metabolite of paracetamol, adducts with DNA or protein, and indirect measurement of the activity of the enzyme(s) producing the active metabolite. An example of the last approach is the use of furafylline, a highly specific inhibitor of human CYP1A2, to determine the extent of the metabolic activation of the cooked food mutagens PhIP and MeIQx. The extent of inhibition, determined from levels of unchanged amine in urine, is an indirect measure of the activity of the activation pathway. Further refinement of this approach, allied to improved measures of the biological process of interest should prove of value in evaluating interindividual variability and its role in the risk assessment process.     

Theophylline kinetics in peripheral tissues in vivo in humans

Several biochemical and cellular effects have been described for methylxanthines under in vitro conditions. However, it is unknown, whether threshold concentrations required to exert these effects are attained in target tissues in vivo. We therefore employed the microdialysis technique for measuring theophylline concentrations in peripheral tissues under in vivo conditions.Following in vitro and in vivo calibration, microdialysis probes were inserted into the medial vastus muscle and into the periumbilical subcutaneous adipose layer of healthy volunteers. Following single oral dose administration of 300 mg or i.v. infusion of 240 mg theophylline, in vivo time courses of theophylline concentrations were monitored in tissues and plasma. Major pharmacokinetic parameters (c_max, t_max, AUC) were calculated for plasma and tissue time courses. The mean AUC_tissue /AUC_plasma-ratio was 0.56 (p.o.) and 0.55 (i.v.) for muscle and 0.55 (p.o.) and 0.72 (i.v.) for subcutaneous adipose tissue.We conclude that microdialysis provides important information on the distribution and the tissue pharmacokinetics of theophylline.Abbreviations FPIA Fluorescence polarisation immuno assay - AUC Area under the curve - t_max Time to peak concentration - c_max Peak concentration     

休克时血中氧自由基的变化

本实验测定10名休克患者血浆和红细胞的丙二醛(MDA)、血浆总抗的氧化活性(AOA)的含量。结果表明:休克病人红细胞膜和血浆 MDA 含量(4.298±0.722;5.348±0.834)与对照组(3.235±0.682;4.356±1.081)比较明显增高(P<0.05);血浆 AOA(39.65±7.858)与对照组(48.21±10.81)比较明显降低(P<0.01)。提示:休克时,患者机体内自由基反应增强是引起组织细胞损伤的原因之一。     

Changes in angiopoietin expression in glomeruli involved in glomerulosclerosis in rats with daunorubicin-induced nephrosis

AIM: To study the potential pathological role of endogenous angiopoietins in daunorubicin-induced progressive glomerulosclerosis in rats. METHODS: Seventy male Wistar rats were allocated randomly into a daunorubicin group (DRB; n=40) or a control group (n=30). The rats in the DRB group were injected with DRB (15 mg/kg), in their tails. Subsequently, at intervals of 1, 2, 4, 6, 8, and 12 weeks, 5 male Wistar rats in each group were chosen randomly for 24 h urinary protein quantitative measurements (24 h UPQM), and determination of plasma tumor necrosis factor alpha (TNF-alpha), angiopoietin-1 (Ang1), and angiopoietin-2 (Ang2) levels. Kidney sections were examined by electron microscopy, Periodic Acid Schiff (PAS) staining, immunohistochemical staining and in situ hybridization histochemistry. RESULTS: As glomerulosclerosis progressed in the DRB group, expression of Ang1 mRNA and protein in glomeruli decreased and expression of TNF-alpha protein, Ang2 mRNA and protein in glomeruli increased. Expression of Ang1 mRNA and protein in glomeruli were negatively correlated with 24 h UPQM, Fn protein expression, and mean area of extracellular matrix (MAECM). In comparison, expression of Ang2 mRNA and protein in glomeruli were positively correlated with 24 h UPQM, Fn protein expression and MAECM; furthermore, there was a positive correlation between plasma Ang2 and 24 h UPQM. Plasma TNF-alpha and expression of TNF-alpha in glomeruli were positively correlated with expression of Ang2 mRNA and protein in glomeruli. There was a negative correlation between Ang1 protein expression and Ang2 protein expression in glomeruli. CONCLUSION: During DRB-induced glomerulosclerosis, podocyte injury led to a shift in the balance of Ang1 and Ang2 in glomeruli. Increased TNF-alpha in plasma and glomeruli may upregulate Ang2 expression in glomeruli. Elevated Ang2 in both plasma and glomeruli may mediate protein permeability through the glomerular filtration barrier. Moreover, local expression of Ang2 may facilitate the progress of glomerulosclerosis by upregulating a component expression of extracellular matrix.     

Trichinellosis in immigrants in Switzerland

We describe a case of trichinellosis diagnosed at the Division of Infectious Diseases, Hospital of Lugano, in January 2009. This case was associated with a cluster of cases and was traced to the consumption of contaminated meat after a wild boar hunt in Bosnia.