广西某三甲医院取消头孢菌素类药物皮试实践

目的: 探索推进取消头孢皮试政策落地的实践和成效。方法: 抗菌药物科学化管理(AMS)小组发挥牵头作用,制定院内头孢菌素类抗菌药物皮肤过敏试验指导意见。通过信息系统维护,多维度、多途径地宣传和培训促进政策落地。通过回顾性分析头孢菌素取消皮试后相关数据以及药品不良反应发生上报情况,分析政策实施前后相关数据的变化。结果: 取消头孢菌素皮试后,抗菌药物使用结构更加合理,三代头孢及酶抑制剂复合制剂的用量明显增加,从28 704 DDDs上升至39 591 DDDs,同比增加40%;皮试人次显著下降,与2020年同期相比,2021年5-11月皮试减少37 165人次;住院患者减少近60%,急诊患者减少近70%,共节省护理工作时间18 582.5 h;皮试药品单独打包环节减少,静脉药物配置中心(PIVAS)药师工作效率大大提高;成本降低,取消皮试期间共减少皮试费用128.09万元;头孢类药物不良反应上报数量无明显变化。结论: 取消头孢菌素皮试,可以优化抗菌药物的使用结构、减少护理和药学人员的工作量,同时可降低医院成本,为患者造福。此外在具体实施过程中,AMS小组的牵头作用,信息系统的支持,多维度、多途径的宣传和培训均必不可少。     

204例冠心病监护病房用药咨询的帕累托图分析

目的：分析南京大学医学院附属鼓楼医院冠心病监护病房用药咨询的特点,以提升临床药师业务水平,促进临床合理用药。方法：回顾性收集整理2019年该院冠心病监护病房临床药师接受的药物咨询记录,累计204例。对用药咨询的人员构成、反馈结果、咨询内容、药物种类及参考资料等进行统计,并绘制帕累托图,分析主要因素。结果：204例用药咨询中,咨询人员以临床医师为主,共167例（占81.86%）;可以给出明确答案的有196例（占96.08%）。帕累托图分析结果显示,肝肾功能不全用药,用法用量、药品不良反应、静脉给药的配置及溶媒、适应证、抗菌药物皮试规范、药物比较和相互作用为咨询内容的主要因素。心血管系统、抗感染药物、消化系统以及内分泌药物为咨询种类的主要因素。说明书、说明书联合文献、文献、专科临床药师、各类标准和规范、指南及专家共识为参考资料的主要因素。结论：通过对冠心病监护病房用药咨询的帕累托图分析,专科临床药师可以更加有针对性地完善理论知识和积累实践经验,为医护患提供更加优质的药学服务。     

Deficiencies of Product Labeling Directions for the Preparation of Radiopharmaceuticals

ObjectiveTo identify potential deficiencies in product labeling (package insert) instructions for the preparation of radiopharmaceuticals.MethodsPreparation instructions, which include both reconstitution and quality control (QC) directions, as stated in the package inserts were evaluated for all commercially available reconstituted radiopharmaceuticals. Reviews of the package inserts were initially performed by each author, and then all identified deficiencies were compiled and evaluated by all authors. The preparation scenario for each package insert evaluated was based on a centralized nuclear pharmacy operation assuming typical support personnel, standard operating equipment, and workload.Main Outcome MeasureThe instructions as stated in each package insert for the preparation (including QC) were rated as inadequate if a satisfactory preparation could not be prepared by a nuclear pharmacist or physician when instructions were followed exactly.ResultsIdentified deficiencies in package insert instructions for the preparation of radiopharmaceuticals fell into the following five categories: (1) absent or incomplete directions (especially with regard to QC procedures); (2) restrictive directions (e.g., specific requirement to use designated needles, chromatography solvents, counting devices), (3) inconsistent directions (e.g., different reconstituted volumes for the same final drug product, unworkable expiration times); (4) impractical directions (e.g., unrealistically low reconstituted activity limits, dangerously high number of radiolabeled particles); and (5) vague directions (e.g., use of the words “should,” “may,” “recommend”).ConclusionManufacturers’ directions for the preparation of radiopharmaceuticals often contain deficiencies and should be viewed as standard guidance rather than as requirements. Just as physicians are permitted to use U.S. Food and Drug Administration (FDA)-approved drugs for off-label indications, nuclear pharmacists should be allowed to use alternative methods for preparing radiopharmaceuticals, provided those methods have been validated to be as good as the stated directions and that the nuclear pharmacists do not engage in activities that fall outside the normal practice of pharmacy. Manufacturers, FDA, nuclear pharmacists, and nuclear physicians should work together to address identified deficiencies in package insert directions.     

广州市越秀区社区医院使用抗菌药物的情况调查

目的:为制订有效的干预措施指导基层医院合理使用抗菌药物提供依据。方法:采用问卷调查的方式对广州市越秀区社区医院的医师、药师及患者使用抗菌药物情况进行调查。结果与结论:在300份问卷中,有效问卷293份,有效率为97.6%。社区医院不合理使用抗菌药物的情况仍较为严重,必须采取相应的措施对社区医院进行干预,加强对抗菌药物合理使用的管理。     

我院常用75种注射用抗感染药物药品说明书分析

目的:了解我院常用注射用抗感染药物药品说明书标注内容的完整性,为临床合理使用注射用抗感染药物提供参考。方法:根据《药品说明书规范细则(暂行)》和《药品说明书和标签管理规定》,对我院常用注射用抗感染药物药品说明书应包含项目进行调查和统计分析。结果:本次调查共纳入75种注射用抗感染药物药品说明书,药品说明书中规定应有的项目标注率较高,但一些与临床用药密切相关的项目,例如用法用量、儿童用药、药物过量、易过敏药物的皮试等详细标注的比例较低,药动学、药理毒理、不良反应等项目内容详细程度差异较大,尤其是国产药品叙述较为简单。结论:建议生产厂家细化药品过量、特殊人群用药等项目的标注内容,详细说明药物使用方法,使之更具有指导性,确保临床用药安全、有效。     

头孢菌素类抗菌药物皮肤过敏试验现状的医疗风险分析

目的:甄别头孢菌素类药皮肤过敏试验的医疗风险,为最小化用药风险提供参考。方法:采用药品风险管理理论,归纳头孢菌素类药皮试的医疗风险并进行分析。结果:头孢菌素类药皮试的医疗风险可分为天然风险和人为风险。前者主要以药品不良反应形式存在,多由药品自身属性决定;后者则由于药政部门的管理机制不完善、药品生产厂家的药品说明书缺陷以及临床医师不合理用药等导致。结论:医疗风险的存在,给临床用药安全埋下了隐患。建议确立具有指导性的行业规定,明确药品生产厂家的责任主体意识,规范临床理论依据的差异化表述,并重视和加强医师的医德医风教育,从而将临床用药的风险降至最低。     

浅谈西医师临床应用中成药的几点注意事项

目的:为临床合理应用中成药提供借鉴。方法:结合中医药基本理论,分析目前综合性医院西医师应用中成药的常见问题,总结中成药临床应用的注意事项。结果与结论:西医师应结合具体情况,详细了解中成药的成分组成及有关临床资料,严格按照药品说明书规定用药。     

Drug resistance of Pseudomonas aeruginosa in four community hospitals: influence of antimicrobial use density

We investigated the relation between hospital antimirobial use density (AUD) and minimum inhibitory concentrations (MIC) for Pseudomonas aeruginosa in four community hospitals. Subjects were a total of 476 strains isolated from urine, sputum, and pus during a total of seven years since 2002, for which 50- and 90-percentile MICs were analyzed. Hospitals A, B, and C moved in 2000, 2005, and 2009, respectively, but MIC50 and MIC90 were stable. MIC values showed significance in five drugs, in which Hospital B showed maximal values in five and Hospital D showed minimal values in four drugs. AUD values were different in nine drugs, Hospital B showing the highest data in meropenem, flomoxef, and sulbactam/cefoperazone while Hospital D having the lowest data in meropenem, ceftazidime, cefotaxime, and sulbactam/cefoperazone. Thus MIC for P aeruginosa may show resistance in the presence of high AUD with wide antimicrobial spectrum.     

Use of antibiotics at hospitals in Stockholm: a benchmarking project using internet

PURPOSE: To evaluate the internet way of feedback to prescribing physicians, providing data on antimicrobial use and to assess the applicability of the DU90% (i.e. Drug Utilisation 90%--the number of drugs accounting for 90% of the volume of usage in defined daily doses, (DDDs)) methodology in the hospital setting. METHODS: Antimicrobial drug use was evaluated in all major departments in seven hospitals in Stockholm in the year 2000. All data were presented anonymously on www.janusinfo.org. Aggregate data on antimicrobial drug use were expressed as the number of DDDs and costs per 100 bed-days. We focused on the number of drugs accounting for 90% of the volume (DDD), including the level of adherence to guidelines. The chief physicians assessed this feedback by a questionnaire. RESULTS: The number of DDDs/100 bed-days varied among different clinics and ranged from 39 to 57 (internal medicine) to 102 to 161 (infectious disease). The cost per 100 bed-days varied more than two-fold. The number of different antibiotics within the DU90% segment ranged from 9 to 13 (orthopaedic clinics) to 16 to 23 (infectious disease). According to the questionnaire, data were considered to be clearly presented and physicians would like to receive this kind of reports in the future, not only for antibiotics but also for other drugs. CONCLUSION: Presenting physicians with aggregate data on drug use via internet could provide a stimulus for prescribing improvement.     

我院药敏试验对抗菌药物合理用药的重要意义分析

目的 分析药敏试验对抗菌药物合理用药的重要意义.方法 抽取本院收治的11105例使用抗菌药物的患者,随机分为实验组和对照组,实验组患者首先进行药敏试验,根据试验结果对抗菌药物的使用进行干预,对照组患者给予使用抗菌药物的一般干预措施,半个月后观察两组患者抗菌药物使用的合理性和用药后不良反应发生的情况.结果 经过不同的干预措施后,实验组患者在药物选择、给药途径、用药剂量、给药频次等方面的合理性均明显优于对照组,差异有统计学意义（P＜0.05）,对照组患者使用抗菌药物后不良反应的总发生率（74.36％）明显高于实验组（29.25％）,差异有统计学意义（P＜0.05）.结论 对使用抗菌药物的患者首先进行药敏试验检测,可以有效提高合理使用抗菌药物的情况和降低不良反应的发生,效果明显,值得在临床推广.     

Alternative methods for eye and skin irritation tests: an overview

The evaluation of eye and skin irritation potential is essential to ensuring the safety of individuals in contact with a wide variety of substances designed for industrial, pharmaceutical or cosmetic use. The Draize rabbit eye and skin irritancy tests have been used for 60 years to attempt to predict the human ocular and dermal irritation of such products. The Draize test has been the standard for ocular and dermal safety assessments for decades. However, several aspects of the test have been criticised. These include: the subjectivity of the method; the overestimation of human responses; and the method's cruelty. The inadequacies of the Draize test have led to several laboratories over the last 20 years making efforts to develop in vitro assays to replace it. Protocols that use different types of cell cultures and other methods have been devised to study eye and skin irritation. Different commercial kits have also been developed to study eye and skin irritation, based on the action of chemicals on these tissues. This article presents a review of the main alternatives developed to replace the use of animals in the study of chemical irritation. Particular attention is paid to the reproducibility of each method.     

我院门急诊抗菌药物分类管理前后临床用药调查分析

目的探讨我院门急诊抗菌药物的分级使用管理情况，了解抗菌药物分级管理前后临床用药的变化。方法将我院使用的抗菌药物分为非限制使用、限制使用与特殊使用三类进行分级管理，在不同的医师范围内使用。结果抗菌药物使用率由69％下降到50％，合理使用率由59％上升到78％。三联使用抗菌药物的比率由8．4％下降到2％，不存在过去四联、五联使用抗菌药物现象。非限制使用类抗菌药物、限制使用类抗菌药物所占的百分比各上升了13．74％和3．97％，而特殊使用类抗菌药物所占的百分比下降为0．5％。结论抗菌药物分级管理可提高医务人员合理用药意识。     

中国医疗机构医师抗菌药物管理相关知识知晓现状分析

目的：了解全国各级医疗机构医师对抗菌药物管理相关知识掌握情况，为进一步做好抗菌药物管理工作提供支持。方法：采用问卷进行调研，问卷内容包括调查对象的基本情况、抗菌药物管理基本知识、药师和患者对医师抗菌药物使用的影响、医师在抗菌药物使用过程中的难点等四个部分。调研数据采用描述性统计分析、方差分析、线性回归分析方法。结果：抗菌药物管理基本知识19个题中只有6个回答正确率达到60%以上，国家要求进行专档管理的抗菌药物的正答率最低，越级应用特殊使用级抗菌药物需在多长时间内完善相关手续正答率最高。医师抗菌药物管理基本知识得分最显著的影响因素为年龄，其次为学历、科室等。4.49%的医师抗菌药物使用行为会受到患者的影响。当药师与医师意见不统一时，90.22%的医师会选择与药师讨论，达成一致。医师在抗菌药物使用过程中还存在诸多困惑。结论：应加大医务人员的培训力度，加强国家发布的抗菌药物管理相关政策的落实和执行，加强对临床医师提供抗菌药物使用技术指导。     

8省市县级公立医院医生知识水平对抗菌药物注射剂使用率影响研究

目的：探究中国县级公立医院医生抗菌药知识水平对抗菌药物注射剂使用率的影响,为促进中国抗菌药物注射剂合理使用提供建议。方法：通过实地调研,利用问卷对医生知识水平进行考核,收集填写问卷医生的处方以计算抗菌药物注射剂使用率,采用描述性分析、单因素分析和广义线性回归（Generalized Linear Model,GLM）分析医生知识水平对抗菌药物注射剂使用率的影响。结果：完成8省市63家医院的350名医生的问卷调查,并收集到350份有效问卷和392 490份处方。问卷平均分为（62.8±4.1）分,具有良好的信度（Cronbach α=0.700）和效度（KMO=0.655）。GLM分析显示,不同地区（P=0.001;P=0.035）、年龄（P=0.032）、日门诊量（P=0.007）和收入（P=0.016）的医生抗菌药物注射剂使用率不同。问卷得分高的医生,抗菌药物注射剂使用率低（P=0.031）。结论：中国医生的知识水平与抗菌药物注射剂的使用率相关,不同地区、科室、性别和教育程度的医生间知识水平存在差异。应加强对西部地区和儿科医生的培训教育,这有助于改善医生的抗菌药物注射剂使用现状。     

Evaluation of modified methods for determining skin irritation

The premarket testing of household cleaning products for dermal irritancy is best achieved via human testing. Animal dermal irritation testing is generally limited to screening for possible dermal hazard of totally new or unique products or ingredients prior to human testing or to meeting regulatory requirements of government bodies. Alternatives to animal tests are being sought; however, until such time that these alternatives are identified, validated, and accepted by government bodies, the judicious use of animal testing remains a necessity. Modifications to standard animal skin irritation test procedures have been evaluated against human skin irritation results with the objective of defining one method that could be used in place of current standard procedures that differ slightly from one another, and thereby avoid excessive and redundant use of animals. Hill Top Chambers (19 mm) and standard gauze patches (U.S. Department of Transportation procedure) were used to obtain comparative irritation responses for 24 cleaning products, common caustics, and acids in rabbits and humans. Exposure times were 1 or 4 hr, and responses were graded over a 72-hr period. Results indicate that use of the Chamber offers the potential to (1) reduce the number of animals used for skin irritation screening (smaller group size and up to eight test substances/concentrations per animal); (2) eliminate the need for conducting multiple tests to satisfy different governmental requirements; and (3) reduce animal stress by reducing exposure times without compromising the value of the irritancy patch test as a screening tool. When animal data are required, it is suggested that the use of a Chamber and other modifications of traditional test procedures offers advantages that could result in using fewer animals and/or have less potential for producing unnecessarily severe responses in animals.     

Pharmacy-based antimicrobial-monitoring service.

A pharmacy-based antimicrobial-monitoring service at a university teaching hospital is described. The service was developed and implemented by the pharmacy department in 1987. Antimicrobial drugs that can be misused, that are expensive, or for which bacterial resistance is a concern were targeted. When a pharmacist receives an order for a targeted antimicrobial, an antimicrobial-monitoring card is completed. Monitored drugs meeting approved criteria are dispensed as ordered. When the antimicrobial does not meet the criteria, the pharmacist contacts the physician and suggests an alternative. If the alternative is not accepted, the infectious diseases service is contacted and then informs the pharmacy department about the status of the drug. The agent is dispensed if no response is received within two hours. Qualified staff pharmacists rotate through the position of antimicrobial pharmacist, whose responsibilities include reviewing antimicrobial use throughout the hospital, checking relevant laboratory test results, and recommending adjustments to regimens. From July 1989 to June 1990, 3546 orders for monitored antimicrobials were reviewed; of these, 86% met the criteria, 9% did not meet the criteria but were approved, 2% were for drugs that were replaced by alternative therapies, 1% were for agents that were dispensed because the pharmacist was not contacted, and 2% represented medical staff overrides or drugs dispensed inappropriately. Pharmacist and physician compliance with the monitoring policy has been high. A positive, constructive, and educational relationship exists between pharmacists and physicians vis-à-vis the service. A pharmacy-based antimicrobial-monitoring service has been accepted by pharmacists and physicians and appears to be having a positive impact on prescribing habits.     

抗菌药物不合理应用的成因及干预情况分析

目的：探讨抗菌药物不合理应用持续存在的原因及临床药师的干预其临床应用的作用.方法：对2011-2013年165例抗菌药物不合理应用、临床药师干预及被采纳的情况进行分析.结果：临床药师干预的不合理用药165例中,有105例（63.03％）被医师采纳.围术期预防用药采纳率达到100％;门诊及非手术科室的医师对禁忌证、药物相互作用、用法用量、溶媒选择以及根据患者肝肾功能选择药物等方面的建议基本上采纳;对联合不适宜、遴选不适宜、未规范诊断、无指征用药、适应证不适宜等方面的建议采纳程度很低.结论：临床药师干预抗菌药物不合理应用确实起到了一定的作用.医院还须加强行政干预力度,进一步规范抗菌药物临床应用行为,开展抗菌药物合理应用教育,才能有效促进抗菌药物的合理应用.     

The development and operation of a package inserts service system for electronic medical records

To promote the appropriate use of pharmaceuticals and to prevent side effects, physicians need package inserts on medicinal drugs as soon as possible. A medicinal drug information service system was established for electronic medical records to speed up and increase the efficiency of package insert communications within a medical institution. Development of this system facilitates access to package inserts by, for example, physicians. The time required to maintain files of package inserts was shortened, and the efficiency of the drug information service increased. As a source of package inserts for this system, package inserts using a standard generalized markup language (SGML) form were used, which are accessible to the public on the homepage of the Organization for Pharmaceutical Safety and Research (OPSR). This study found that a delay occurred in communicating revised package inserts from pharmaceutical companies to the OPSR. Therefore a pharmaceutical department page was set up as part of the homepage of the medical institution for electronic medical records to shorten the delay in the revision of package inserts posted on the medicinal drug information service homepage of the OPSR. The usefulness of this package insert service system for electronic medical records is clear. For more effective use of this system based on the OPSR homepage pharmaceutical companies have been requested to provide quicker updating of package inserts.     

2011-2013年某院抗菌药物应用与革兰阳性细菌耐药性分析

目的统计分析某三甲医院2011-2013年抗菌药物使用情况及革兰阳性细菌耐药率,为临床降低细菌耐药性和合理使用抗菌药提供依据。方法采用回顾性调查方法对某院2011-2013年送检病原菌培养结果、同期各类别抗菌药物累计使用频度和细菌耐药率情况进行统计分析。结果 2011-2013年排名前五位的革兰阳性病原菌均为金黄色葡萄球菌、表皮葡萄球菌、溶血性葡萄球菌、粪肠球菌及屎肠球菌,每年所占比例无明显变化。抗菌药物总用药频度逐年减少,从2011年的255456.37DDDs下降至2013年的155024.25DDDs,头孢菌素＋酶抑制剂类及大环内酯类用量排名逐年升高,三四代头孢菌素及喹诺酮类用量排名则逐年减少,抗真菌类及碳青霉烯类排名无明显变化。金黄色葡萄球菌和表皮葡萄球菌对左氧氟沙星耐药率有下降趋势,溶血性葡萄球菌和屎肠球菌对左氧氟沙星的耐药率呈上升趋势。结论我院的抗菌药物使用频度呈逐年下降的趋势,而部分细菌的耐药率有增加的趋势,需要更加合理使用抗菌药物,以减缓目前的耐药形势。     

我院老年门诊处方分析

目的：了解我院老年病房门诊处方药物的应用情况,评价门诊处方用药的合理性与规范性。方法：根据药品说明书、临床药理学知识及文献资料,对我院老年门诊2008年1～12月处方进行分析。结果：共抽查24350张处方,不合格用药处方为1340张,占5.50%,其中不规范处方526张,占抽查处方的2.11%,占不合格处方的39.25%。不合理用药主要表现在重复用药、选药不当、联合用药品种过多等方面。结论：临床医生用药存在不合理的现象,主要原因是临床医生对药物知识的缺乏所致,药学人员应向临床药师职能转化,向医生提供更多的药学知识,指导医生和患者合理用药,以保障患者的用药安全。