我院2011-2013年药品质量问题分析

目的:了解我院收集上报的出现质量问题的药品情况及趋势,确保患者用药安全。方法:对我院2011-2013年收集上报的出现质量问题的药品的批次、售价金额、部门、剂型、厂家属性等进行回顾性统计、分析。结果与结论:我院2011-2013年收集上报的出现质量问题药品分别有261、206、155批次,呈逐年下降趋势;售价金额分别为13 722.41、30 264.80、13 160.96元;门诊药房每年收集上报的出现质量问题的药品最多,依次是121、103、71批次;注射剂每年的质量问题批次最多,依次是147、120、77批次;外购药品中,国产药各年度的质量问题批次最多,依次是191、147、103批次。在问题属性分布方面,内外包装破损、漏液、稳定性异常和包装标示缺失、残缺、不易辨识等较常见。对于质量问题较突出的国产药、注射剂,应进一步采取提高我院遴选国产药品质量标准,督促生产厂家提高药品的工艺设计质量、加强药品生产风险管理和相关人员的培训、完善药品流通过程中的质量管理等,与药品供应商、生产厂家等及时沟通并与委托医院制剂生产单位共建合作等措施,以确保患者用药安全。     

北京积水潭医院口服药品质量问题分析及管理对策

目的:总结北京积水潭医院(以下简称我院)HIS系统上报的口服药品质量问题记录,为医改过程中降低药品消耗、控制管理成本、减少患者投诉提供依据及对策。方法:从我院HIS系统中调取2009—2016年药品质量问题上报记录,其中涉及口服药品共655批次,按年份、企业类型、剂型、问题内容进行比较分析。结果:口服制剂在上报的药品质量问题记录中总体呈逐年上涨趋势;问题药品生产厂家以国内企业居多,医院自制制剂质量问题较为突出;药品剂型以片剂、合剂、胶囊为主;上报药品质量问题主要为包装破损及药品污染。结论:医疗机构应完善其药品质量管理体系;药师在药学服务中应具备甄别质量问题药品的意识;医务人员应注重医患沟通,收集患者对药品质量的反馈;药品生产企业应提高产品质量、改进药品包装及物流运输方式。     

我院住院药房药品损耗情况分析及建议

目的：对我院住院药房药品损耗情况进行调查研究,为减少药品资源浪费提供相关建议。方法：对我院住院药房药品损耗情况从药品包装损耗类型、自动包药机造成的药品损耗等几方面进行统计、分析,探讨降低药品损耗的措施方法。结果与结论：外包装损耗类型主要包括玻璃瓶破损等,多由药品运输和包装质量引起;自动包药机主要是由于机器发生故障而造成部分药品损耗。建议生产厂家改进药品外包装,药品运输时加强注意,药房工作人员加强责任心等,将药品损耗率降到最低。     

住院药房药品管理中存在的问题与对策

目的：研究并探讨住院药房药品管理中存在的问题并制定相应对策。方法选取我院住院药房自2010年5月至2015年5月登记的500例药品管理问题进行分析。结果药品管理问题中药品破损占64．80％,药品摆放不规范占17．20％,药品过期占9．80％,回收药品质量不佳占8．20％。结论药房药品管理的水平直接影响住院病患的治疗效果以及医院的经济效益与社会效益,因此,解决药品管理中存在的问题极为重要,可以有效保障病患及其医院的利益。     

2009~2011年我院住院药房麻醉药品使用情况分析

目的 了解2009~2011年我院住院药房的麻醉药品使用情况及用药趋势,分析我院住院药房麻醉药品的使用情况,为促进临床合理用药提供依据,为临床合理用药和加强国家特殊药品的管理提供参考.方法 采集我院住院药房2009~2011年麻醉药品的使用数据,统计药品名称、规格、用法用量等.结果 麻醉药品使用趋于多元化,使用总频度逐年降低.其中芬太尼注射液和芬太尼透皮贴的使用频度呈上升趋势,而哌替啶注射液和吗啡缓释片的使用频度则呈下降趋势.结论 住院药房麻醉药品使用情况基本合理,但也存在一些问题,今后仍应加强用药监管,遵循"癌症三阶梯止痛治疗原则"用药.     

PDCA循环在住院药房药品质量管理中的应用

目的:应用PDCA循环对住院药房药品质量进行有效管理,确保药品质量与用药安全。方法:按照PDCA步骤,分析住院药房药品质量管理中的实际问题,制定实施针对性整改措施,并检查评价、处理余留问题。结果与结论:PDCA循环应用后,药品破损率逐步下降,由药师发现的药品质量问题比率得到提升,发出的药品质量更有保障,住院药品质量管理更为规范。     

西药房调剂差错处方分析及防范对策

目的:探讨茂名市人民医院(以下简称"我院")西药房处方调剂差错发生的原因及相关预防措施。方法:收集2012—2014年我院西药房所调剂的处方共2 205张,对其中存在差错处方的数量、类型及原因等进行统计与分析,并制订相应的防范措施。结果:我院西药房处方调剂差错类型主要有药品品种差错、药品数量差错、错发患者、用法与用量差错及用药禁忌差错。调剂差错原因类型主要有同种药品不同规格、药品包装相似、药品名称相似、药师或医师对于用药禁忌不熟知及患者和环境因素等。从总体看来,我院西药房近3年的处方调剂差错发生率呈逐年下降趋势。结论:针对我院近年来在西药房调剂处方方面出现的问题,应加强门诊药房管理,增强医师、药师的专业素养与工作责任心,完善处方审核制度,提高处方调剂的质量,降低调剂差错发生率,以保障患者用药安全。     

现有药品包装存在问题与医院调剂需求探讨

目的:为使药品包装更符合目前医院信息化、自动化管理需求提供参考。方法:对我院在用药品从整箱体积与质量、同一生产企业的药品内外包装形状、有无中包装、有无药品安全监管条形码(唯一码)等方面进行统计分析,探讨其对医院调剂需求的影响并提出相关建议。结果与结论:整箱药品的质量与材质将直接影响药品出厂后B型(出厂后产生的)药品破损问题的发生;外包装向轻便、小巧方向发展;对于同一生产企业的外包装形状相似的药品,可以采用不同外观形状或增加明显标识来区分;无中包装药品将降低医院药师药品配发效率;整箱、中包装、小包装药品无安全监管码将直接影响药师对药品的验收、出库物流效率及窗口药品配发的安全。建议将新引进药品的包装情况纳入药事会作为引进新药的重要依据;大型医院门/急诊药房可引进智能化整盒自动调配设施,同时结合电子化药品物流进行调配。     

医院药品质量控制与现有药品质量监管体系不足的探讨

目的:促进药品质量的不断提高。方法:对我院3年来登记的药品质量数据从入库拒收原因、质量问题分类、质量登记综合情况等进行统计分析,从各角度阐述药品质量变化趋势,并结合质量数据对现有药品质量监管体系中存在的不足进行剖析。结果与结论:出厂前即已存在的药品质量问题发生比例在逐年下降,药品在运输中出现的破损率在逐年上升;药品检验所抽样药品检验样本存在被动性和偶然性且检验报告时间过长。建议监管层纳入药品身份编码和外包装等的图片信息为管理范围,建立药品质量信息平台,确保监管部门、生产企业、经销企业和医院担当各自在药品安全中的职责。     

我院门诊药房相似药品差错及接近失误的监控及质量改进

目的：探讨质量改进监控在门诊药房相似药品管理的应用,减少和消除门诊药房相似药品导致的差错和接近失误事件。方法：以“减少门诊药房相似药品差错及接近失误率”为质量改进项目,通过调查统计门诊药房中一些易发错药品的品种,对我院2015年监控的差错和接近失误事件记录进行总结与分析。结果：随着质量改进监控的进行,2015年我院门诊药房相似药品差错及接近差错率呈下降趋势。结论：门诊药房相似药品差错及接近失误率质量改进监控可使门诊用药更加规范有效,保障了病人的用药安全。     

Efficacy of gut lavage,hemodialysis, and hemoperfusion in the therapy of paraquat or diquat intoxication

Clinical and in vitro investigations were carried out to test the efficacy of gut lavage, hemodialysis, and hemoperfusion in the treatment of poisoning with paraquat or diquat. In a patient suffering from diquat intoxication 130 times more diquat was removed by gut lavage 30 h after ingestion than was removed by complete aspiration of the gastric contents.Determination of in vitro clearances for paraquat and diquat by hemodialysis showed that, at serum concentrations of 1–2 ppm, such as are frequently encountered in poisoning in man, toxicologically relevant quantities of herbicide cannot be removed from the body. At a concentration of 20 ppm, on the other hand, hemodialysis proved to be effective, the clearance being 70 ml/min at a blood flow rate of 100 ml/min. The efficacy of hemoperfusion with coated activated charcoal was on the whole better. Especially at concentrations around 1–2 ppm, the clearance values for hemoperfusion were some 5–7 times higher than those for hemodialysis.In a patient suffering from paraquat poisoning, both hemodialysis as well as hemoperfusion were carried out. The in vitro results could be confirmed: At serum concentrations of paraquat less than 1 ppm no clearance could be obtained by hemodialysis while by hemoperfusion with activated charcoal quite high clearance values were measured and the serum level dropped down to zero.

---

Zusammenfassung Klinische Untersuchungen und Laboratoriumsversuche wurden durchgeführt, um die Wirksamkeit von Darmspülung, Hämodialyse und Hämoperfusion bei Paraquat- und Deiquat-Vergiftungen zu prüfen.Bei einem Patienten wurde 30 Std nach Deiquat-Aufnahme durch Darmspülung 130mal mehr Deiquat entfernt als durch vollständige Aspiration des Mageninhaltes. In vitro-Versuche ergaben, daß bei Blutserumkonzentrationen von 1–2 ppm, die bei Vergiftungen oft gemessen werden, durch Hämodialyse keine toxikologisch relevanten Paraquat- oder Deiquat-Mengen entfernt werden können. Dagegen erwies sich die Hämodialyse bei 20 ppm und einer Blutumlaufgeschwindigkeit von 100 ml/min mit einer Clearance von 70 ml/min als wirksam. Die Hämoperfusion mit beschicheter Aktivkohle war in diesen Versuchen aber eindeutig überlegen, denn insbesondere bei Konzentrationen um 1–2 ppm waren die Clearance-Werte 5–7mal höher als bei der Hämodialyse.Die in vitro-Ergebnisse wurden bei einem Patienten mit einer Paraquat-Vergiftung bestätigt: Bei Konzentrationen unter 1 ppm war die Hämodialyse wirkungslos, während durch Hämoperfusion relativ hohe Clearance-Werte erreicht wurden, so daß der Serumspiegel rasch unter die Nachweisgrenze abfiel.

     

In vitro studies on sterically stabilized liposomes (SL) as enzyme carriers in organophosphorus (OP) antagonism

This study describes a new approach for organophosphorous (OP) antidotal treatment by encapsulating an OP hydrolyzing enzyme, OPA anhydrolase (OPAA), within sterically stabilized liposomes. The recombinant OPAA enzyme was derived from Alteromonas strain JD6. It has broad substrate specificity to a wide range of OP compounds: DFP and the nerve agents, soman and sarin. Liposomes encapsulating OPAA (SL)* were made by mechanical dispersion method. Hydrolysis of DFP by (SL)* was measured by following an increase of fluoride ion concentration using a fluoride ion selective electrode. OPAA entrapped in the carrier liposomes rapidly hydrolyze DFP, with the rate of DFP hydrolysis directly proportional to the amount of (SL)* added to the solution. Liposomal carriers containing no enzyme did not hydrolyze DFP. The reaction was linear and the rate of hydrolysis was first order in the substrate. This enzyme carrier system serves as a biodegradable protective environment for the recombinant OP-metabolizing enzyme, OPAA, resulting in prolongation of enzymatic concentration in the body. These studies suggest that the protection of OP intoxication can be strikingly enhanced by adding OPAA encapsulated within (SL)* to pralidoxime and atropine.     

Aquatic Insects and Trace Metals: Bioavailability,Bioaccumulation, and Toxicity

Abstract

The uptake of metals from food and water sources by insects is thought to be additive. For a given metal, the proportions taken up from water and food will depend both on the bioavailable concentration of the metal associated with each source and the mechanism and rate by which the metal enters the insect. Attempts to correlate insect trace metal concentrations with the trophic level of insects should be made with a knowledge of the feeding relationships of the individual taxa concerned. Pathways for the uptake of essential metals, such as copper and zinc, exist at the cellular level, and other nonessential metals, such as cadmium, also appear to enter via these routes. Within cells, trace metals can be bound to proteins or stored in granules. The internal distribution of metals among body tissues is very heterogeneous, and distribution patterns tend to be both metal and taxon specific. Trace metals associated with insects can be both bound on the surface of their chitinous exoskeleton and incorporated into body tissues. The quantities of trace meals accumulated by an individual reflect the net balance between the rate of metal influx from both dissolved and particulate sources and the rate of metal efflux from the organism. The toxicity of metals has been demonstrated at all levels of biological organization: cell, tissue, individual, population, and community. Much of the literature pertaining to the toxic effects of metals on aquatic insects is based on laboratory observations and, as such, it is difficult to extrapolate the data to insects in nature. The few experimental studies in nature suggest that trace metal contaminants can affect both the distribution and the abundance of aquatic insects. Insects have a largely unexploited potential as biomonitors of metal contamination in nature. A better understanding of the physico-chemical and biological mechanisms mediating trace metal bioavailability and exchange will facilitate the development of general predictive models relating trace metal concentrations in insects to those in their environment. Such models will facilitate the use of insects as contaminant biomonitors.     

Pharmacological treatment of COVID-19: an opinion paper

The precocity and efficacy of the vaccines developed so far against COVID-19 has been the most significant and saving advance against the pandemic. The development of vaccines has not prevented, during the whole period of the pandemic, the constant search for therapeutic medicines, both among existing drugs with different indications and in the development of new drugs. The Scientific Committee of the COVID-19 of the Illustrious College of Physicians of Madrid wanted to offer an early, simplified and critical approach to these new drugs, to new developments in immunotherapy and to what has been learned from the immune response modulators already known and which have proven effective against the virus, in order to help understand the current situation.     

Alzheimer’s disease – current trends in basic and clinical research. Highlights from the 16th ECNP

Advances in the molecular biological knowledge of neuronal nicotinic acetylcholine receptors (nAChRs) have led to a growing interest by the pharmaceutical industry in the development of novel compounds that selectively modulate nAChR function. The ability of (-)-nicotine, an activator of nAChRs, to enhance attentional aspects of cognition in animals and humans, to exert neuroprotective and anxiolytic-like effects, and presumably to mediate the negative correlation between smoking and Alzheimer's (and Parkinson's) Disease, has focused interest on the potential therapeutic utility of modulators of nAChR function for treatment of some of the deficits associated with these progressive, neurodegenerative conditions. Numerous compounds are known which activate nAChRs and which might serve as lead compounds toward the development of such agents. The pharmacologic diversity of neuronal nAChR subtypes suggests the possibility of developing selective compounds which would have more favourable side-effect profiles than existing agents. This broader class of agents, collectively called cholinergic channel modulators (ChCMs), is anticipated to encompass compounds which would have more favourable side-effect profiles than existing agents, which generally exhibit low selectivity. This selectivity may be achieved by preferentially activating some subtypes of nAChRs (i.e., Cholinergic Channel Activators, ChCAs) or inhibiting the function of other subtypes (Cholinergic Channel Inhibitors, ChCIs). An overview of the biology of nAChRs and the rationale for the use of ChCMs for the treatment of dementia related to neurodegenerative diseases are presented, followed by a discussion of lead compounds and compounds under consideration for clinical evaluation.     

Steroidal sapogenin contents in some domestic plants

In order to find out the values of the steroid resources for the future use. the compositions and contents of steroidal sapogenins from 13 domestic plants have been investigated. As a result,Dioscorea nipponica, D. quinqueloba andSmilax china were found to have large amount of diosgenin. And pennogenin inTrillium kamtschaticum andParis verticillata, yuccagenin inAllium fistulosum, hecogenin inAgave americana and neochlorogenin inSolanum nigum were appeared to be major steroidal sapogenins.