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Methods for the Study of Physical and Chemical Stability and Container-Content Interactions: Report of a GERPAC Workshop 物理化学稳定性和容器-内容物相互作用的研究方法:GERPAC研讨会报告
Pub Date : 2019-06-01 DOI: 10.1515/pthp-2019-0009
V. Sautou, F. Lagarce
Abstract This opinion paper describes the discussions of the attendees of the last GERPAC European conference workshop on the question of chemical stability and container-content interactions. Pharmacists discussed the steps to implement to carry out those studies that are particulary important to asses the quality of the compounded preparations in hospital pharmacies.
摘要:本意见文件描述了最后一次GERPAC欧洲会议研讨会上关于化学稳定性和容器内容物相互作用问题的与会者的讨论。药剂师讨论了开展这些研究的步骤,这些研究对评估医院药房复方制剂的质量特别重要。
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引用次数: 0
Frontmatter
Pub Date : 2019-06-01 DOI: 10.1515/pthp-2019-frontmatter2
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引用次数: 0
Profile of Centralization Practices for Preparation of Non-Hazardous Drugs in Quebec Hospitals 魁北克省医院非危险药品集中配制做法简介
Pub Date : 2019-06-01 DOI: 10.1515/pthp-2019-0016
Lucie Painchart, Marie Palamini, P. Odou, J. Bussières
Abstract Background The preparation of many drugs intended for parenteral administration is centralized in the pharmacy of healthcare institutions. However, no data are available describing the range of drugs with centralized preparation. The objective was to establish a profile of centralization practices for the preparation of non-hazardous drug doses in the pharmacy departments of Quebec healthcare institutions. Methods For this cross-sectional descriptive study, an e-mail survey was distributed in March 2017 to the directors of the pharmacy departments of Quebec healthcare institutions. Respondents were asked to estimate the percentage of parenteral drug doses that were prepared centrally in the pharmacy, the name of each drug prepared this way, the criteria used to select drugs for central preparation, and the barriers to centralizing preparation of drug doses. Only descriptive statistical analyses were performed. Results Of the 30 directors of pharmacy departments invited to participate, 27 (90 %) responded, representing a total of 40 Quebec healthcare facilities. Overall, 232 individual drugs were centrally prepared in one or more of these facilities, for an overall median of 22 drugs per facility (min: 1, max: 101). Conclusions This is the first survey in Quebec and indeed all of Canada to identify the many medications that are centrally prepared in hospital pharmacies. The survey showed that the selection of drugs for central preparation differed widely across facilities. It would be desirable for pharmacy departments in this province to collaborate on standardizing practices for central preparations.
摘要背景许多肠外给药药物的制备集中在医疗机构的药房。然而,没有数据描述集中制备的药物范围。目的是建立一份关于在魁北克保健机构的药剂科集中编制无害药物剂量做法的概况。方法采用横断面描述性研究,于2017年3月向魁北克省卫生保健机构药剂科主任发放电子邮件调查。受访者被要求估计在药房集中配制的肠外药物剂量的百分比,以这种方式配制的每种药物的名称,选择集中配制药物的标准,以及集中配制药物剂量的障碍。仅进行描述性统计分析。结果受邀参加调查的30位药学部门主任中,27位(90%)做出了回应,代表魁北克省总共40家医疗机构。总体而言,232种药物在这些设施中的一个或多个设施集中制备,每个设施的总体中位数为22种药物(最小:1,最大:101)。结论:这是魁北克省乃至整个加拿大首次对医院药房集中配制的许多药物进行调查。调查显示,中心制剂的药物选择在各设施之间差别很大。这将是可取的药房部门在该省的中心制剂的标准化做法进行合作。
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引用次数: 0
Physicochemical Stability of Cefotaxime Sodium in Polypropylene Syringes at High Concentrations for Intensive Care Units 重症监护病房高浓度聚丙烯注射器中头孢噻肟钠的物理化学稳定性
Pub Date : 2019-05-17 DOI: 10.1515/PTHP-2019-0006
E. D’huart, J. Vigneron, F. Blaise, A. Charmillon, B. Demoré
Abstract Background Cefotaxime sodium is an antibiotic used to treat severe infections such as in intensive care units (ICUs). The recommended dose of cefotaxime sodium can vary from 3 grams (g) to 24 g per day and publications have demonstrated that continuous administration of cefotaxime sodium is the preferred mode of administration. In ICUs, a minimum volume is used for patients requiring fluid restriction, leading to high concentrations of cefotaxime sodium. The objective was to study the stability of cefotaxime sodium solutions at 83.3 mg/mL and 125 mg/mL, diluted in 0.9 % sodium chloride (0.9 % NaCl) or in 5 % glucose (G5 %), stored in polypropylene syringes, after the preparation and after a 6-hour and a 12-hour storage at 20–25 °C. Methods Three syringes for each condition were prepared. At each time of the analysis, three samples for each syringe were prepared and analysed by high performance liquid chromatography (HPLC) coupled to a photodiode array detector. The method was validated according to the International Conference on Harmonisation Q2(R1). Physical stability was evaluated by visual and subvisual inspection (turbidimetry by UV spectrophotometry at 350, 410 and 550 nm as recommended by the European Consensus Conference). pH and osmolality values were measured at each time of the analysis. Results For each solvent, cefotaxime sodium solutions at 83.3 mg/mL and 125 mg/mL retained more than 90 % of the initial concentration after 12 hours. During the stability study, pH values decreased slightly, the intensity of the yellow colour increased and values of absorbance increased progressively for each wavelength and each condition. An additional peak with a relative retention of 3.01 was also observed after the forced degradation gradually increased up to 4.01 % and 3.17 % of the total of surface area of the peaks present on the chromatogram after 12 hours in 0.9 % NaCl and in G5 % respectively. Conclusions In view of the results and despite the fact that solutions retained more than 90 % of the initial concentration after HPLC analysis, we propose to limit the stability of cefotaxime sodium in 0.9 % NaCl and G5 % at 83.3 and 125 mg/mL at 6 hours. These stability data of highly concentrated solutions provide an additional knowledge to assist ICUs in daily practice. This work also demonstrates that highly concentrated cefotaxime sodium solutions are physically unstable after a 6-hour storage and cannot be administered as a daily infusion.
背景头孢噻肟钠是一种用于重症监护病房(icu)等重症感染治疗的抗生素。头孢噻肟钠的推荐剂量可以从每天3克(g)到24克不等,出版物表明,连续给药头孢噻肟钠是首选的给药方式。在icu中,对于需要限制液体的患者,使用最小容量,导致头孢噻肟钠浓度较高。目的是研究83.3 mg/mL和125 mg/mL头孢噻肟钠溶液,在0.9%氯化钠(0.9% NaCl)或5%葡萄糖(g5%)中稀释,在聚丙烯注射器中储存,制备后,在20-25℃下储存6小时和12小时的稳定性。方法各配制3支注射器。在每次分析时,每个注射器制备3个样品,并通过高效液相色谱(HPLC)耦合到光电二极管阵列检测器进行分析。该方法根据国际协调会议Q2(R1)进行了验证。通过目视和亚目视检查评估物理稳定性(欧洲共识会议推荐的350、410和550 nm的紫外分光光度浊度法)。在每次分析时测量pH和渗透压值。结果83.3 mg/mL和125 mg/mL的头孢噻肟钠溶液在12 h后仍保持初始浓度的90%以上。在稳定性研究过程中,在每个波长和每个条件下,pH值略有下降,黄色强度增加,吸光度值逐渐增加。在0.9% NaCl和g5% NaCl溶液中,强制降解作用12 h后,分别增加到色谱峰表面积的4.01%和3.17%,形成了一个相对保留率为3.01的附加峰。结论尽管经HPLC分析,头孢噻肟钠溶液保留了90%以上的初始浓度,但我们建议限制头孢噻肟钠在0.9% NaCl和g5%浓度下的稳定性,分别为83.3和125 mg/mL,维持6 h。这些高浓度溶液的稳定性数据为icu的日常实践提供了额外的知识。这项工作还表明,高浓度头孢噻肟钠溶液在储存6小时后物理不稳定,不能作为每日输注给药。
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引用次数: 8
Frontmatter
Pub Date : 2019-03-01 DOI: 10.1515/pthp-2019-frontmatter1
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引用次数: 0
Physical Compatibility of Intravenous Drugs Commonly Used in Intensive Care Units: An Observational Study and Physical Compatibility Laboratory Tests on Anti-Infective Drugs 重症监护病房常用静脉注射药物的物理相容性:抗感染药物的观察性研究及物理相容性实验室试验
Pub Date : 2019-03-01 DOI: 10.1515/PTHP-2019-0005
E. D’huart, J. Vigneron, B. Demoré
Abstract Background The objectives were to perform an observation of the administration of injectable drugs in three ICUs, to identify injectable drugs administered by Y-site infusion or mixed in the same container, to compare with physical compatibility data available in the literature and to test the physical compatibility for missing data. Methods An observational study was realised over two weeks and patients receiving more than one injectable drug in the same line simultaneously were included. Physical compatibilities were assessed in pairs by comparing with three databases. For some missing data, three tests were realised for pairs including an anti-infective drug. Visual and subvisual evaluations were performed after the preparation, 1 and a 4-hour storage. Results A total of 389 combinations between two injectable drugs was observed for Y-site infusions and 31 mixtures in the same container. According to the literature, 21.1 % associations were physically compatible, 1.8 % as physically compatible potentially, 8.0 % as physically incompatible, 6.4 % have divergent data according to the databases and 62.7 % have no data. Two mixtures were documented. 37 pairs were tested and 70.3 % were physically compatible, 8.1 % were physically incompatible after visual evaluation and 21.6 % after subvisual evaluation. Conclusions In the majority of cases, no compatibility data are available in the literature. Laboratory tests give additional information.
目的:观察3个icu的注射药物给药情况,鉴别y位输注或同一容器混合给药的注射药物,与文献中已有的物理相容性数据进行比较,并对缺失的数据进行物理相容性检验。方法采用两周以上的观察性研究,同时接受一种以上注射药物治疗。通过对比三个数据库,两两评估物理兼容性。对于一些缺失的数据,对包括抗感染药物在内的配对进行了三次测试。分别在制备1小时和4小时后进行视觉和亚视觉评价。结果y部位输注两种注射药物共出现389种组合,同一容器内共出现31种组合。根据文献,21.1%的关联是物理相容的,1.8%是物理潜在相容的,8.0%是物理不相容的,6.4%根据数据库有不同的数据,62.7%没有数据。记录了两种混合物。37对被试,经目视评价生理不相容者占70.3%,经亚目视评价生理不相容者占8.1%,经亚目视评价生理不相容者占21.6%。结论:在大多数情况下,文献中没有相容性数据。实验室测试提供了更多的信息。
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引用次数: 10
The Importance of a Scientific Journal in the Field of Pharmaceutical Technology in Hospitals 科学期刊在医院药学技术领域的重要性
Pub Date : 2019-03-01 DOI: 10.1515/PTHP-2019-2010
F. Lagarce
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引用次数: 0
Automation of Aseptic Sterile Preparation: Risk Analysis and Productivity Comparison with Manual Process 无菌无菌制备的自动化:风险分析及与手工工艺的生产率比较
Pub Date : 2019-03-01 DOI: 10.1515/PTHP-2019-0001
Jeanne Heloury, Guillaume Bouguéon, T. Deljehier, A. Jourand, A. Berroneau, S. Crauste-Manciet
Abstract Two automation methods for aseptic preparation in hospital pharmacy, robot and peristaltic pump, were compared to manual process both for risk analysis using Failure Modes Effects and Criticality Analysis (FMECA) method and for productivity using time analysis grids built for each process. The results obtained with the different workflow organizations showed that the worst-case conditions for productivity was production “on demand” of tailor-made preparations. in that case, the manual process was not significantly different from the robotic process (p-value=0.72). For the standardized preparations, the semi-automatic process preparing a batch from bulk solution from “to be reconstituted” drugs was significantly superior to the robotic process preparing repetitive series of doses (p-value<0.01). Productivity of the robot was dramatically increased when the robot performed standardized preparations either from ready to use solutions or mixed cycles due to the robot design. When different processes were FMECA analyzed for risk analysis the robotic process was found as the safer process in comparison to others with a total of Criticality Indexes of 1060, 719, 656 for manual, semi-automatic and robot, respectively. Except for the robotic, semi-automatic and manual processes needed additional IT control systems to limit the risk of failures.
摘要:将机器人和蠕动泵两种用于医院药房无菌制剂的自动化方法与人工流程进行比较,采用失效模式效应和临界性分析(FMECA)方法进行风险分析,并利用为每个流程构建的时间分析网格进行生产率分析。在不同的工作流程组织下得到的结果表明,生产率的最坏情况是生产“按需”定制的准备。在这种情况下,人工过程与机器人过程没有显著差异(p值=0.72)。对于标准化制剂,从“待重构”药物的原液中制备批次的半自动工艺显著优于制备重复系列剂量的机器人工艺(p值<0.01)。由于机器人的设计,当机器人从准备使用的溶液或混合循环进行标准化准备时,机器人的生产率显着提高。在对不同工艺进行FMECA风险分析时,发现机器人工艺相对于其他工艺更安全,手动、半自动和机器人的临界指数分别为1060、719、656。除了机器人,半自动和手动过程需要额外的IT控制系统来限制故障的风险。
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引用次数: 9
Assessment of an Online Training Tool for the Automated Unit-Dose Dispensing System (ADS) Process 自动单位剂量分配系统(ADS)流程在线培训工具的评估
Pub Date : 2019-03-01 DOI: 10.1515/PTHP-2019-0003
Marie Hamon, F. Capelle, R. Passemard, B. Gourieux
Abstract Background Automated unit-dose dispensing system (ADS) of oral solid medication is a complex and sensitive production process in the drug distribution system. Hence, an appropriate training of hospital pharmacy technicians (HPT) is essential. A basic training (observational and practical) of 3 weeks is first organized to evaluate the HPT, followed by an interview with both the pharmacist and the HPT chief. The importance of the human factor (daily routine and repetitive tasks) showed by the risks analysis within this process has led us to search new learning methods to keep the team engaged. An e-learning training was selected in order to further complete the HPT initial training but also as a continuous training to the HPTs who are already working in the ADS process. Process and Methods The e-learning tool was developed using the Google® platform and includes four theoretical training modules (Google® Slides): Module 1 “General organization”, Module 2 “Automatic preparation machine”, Module 3 “Repackaging” and Module 4 “Non-automated drug dispensing”. Each module ends with a self-assessment (Google® Forms). Various teaching materials are included: links to institutional procedures, videos, photos, quizzes, simulations … A minimum of 75 % of correct answers is requested to validate each module. The e-learning, once final, was validated with a new HPT and with five HPTs already in place for more than a year. A satisfaction form is available at the end of the training. Results The 6 HPTs obtained an average of 17.75/20 correct answers. The most successful modules were 1 and 4 (average per module: M1 =  18.5/20; M2=16.8/20; M3=17/20; M4=18.7/20). For module 3, two HPTs scored below 75 % and therefore had to pass this module again. The average time to complete this training was 1.5 hours. HPTs are 100 % satisfied with the training and the teaching materials used. Discussion/Conclusions The e-learning tool fit well with the initial training and the continuous training of the HPTs. Its set up is simple. The duration length spent on the training is shortened for both the pharmacist and the learner. This tool is tailored to the learner needs and constraints. It allows the integration of playful and interactive teaching tool which were appreciated. An audit will be conducted to assess the impact of this training tool on the overall ADS process.
摘要背景口服固体药物自动单位剂量调剂系统(ADS)是药物分配系统中一个复杂而敏感的生产过程。因此,对医院药学技术人员(HPT)进行适当的培训至关重要。首先组织为期三周的基本培训(观察和实践)来评估HPT,然后与药剂师和HPT主任进行面试。在这个过程中,风险分析显示了人为因素(日常工作和重复性任务)的重要性,这促使我们寻找新的学习方法来保持团队的参与。选择电子学习培训是为了进一步完成HPT的初步培训,也是对已经在ADS过程中工作的HPT的持续培训。电子学习工具采用Google®平台开发,包括四个理论培训模块(Google®Slides):模块1“一般组织”、模块2“自动制剂机”、模块3“重新包装”和模块4“非自动化药品调剂”。每个模块以自我评估(Google®表单)结束。各种教学材料包括:链接到机构程序,视频,照片,测验,模拟…要求至少75%的正确答案来验证每个模块。电子学习一旦完成,就会用一种新的HPT和五种已经使用了一年多的HPT进行验证。培训结束后可获得一份满意度表。结果6名hpt平均答对率为17.75/20。最成功的模块是1和4(平均每个模块:M1 = 18.5/20;M2 = 16.8/20;M3 = 17/20;M4 = 18.7/20)。对于模块3,有两门hpt得分低于75%,因此必须再次通过该模块。完成培训的平均时间为1.5小时。hpt对培训和使用的教材100%满意。讨论/结论电子学习工具适合于hpt的初始培训和持续培训。它的设置很简单。对于药剂师和学习者来说,培训的时间长度都缩短了。这个工具是根据学习者的需要和限制量身定制的。它允许整合有趣和互动的教学工具,受到赞赏。将进行审核,以评估该培训工具对整个ADS流程的影响。
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引用次数: 2
Corrigendum to: Formulation of a 3-months Stability Oral Viscous Budesonide Gel and Development of an Indicating Stability HPLC Method 3个月稳定口服粘性布地奈德凝胶的配方和指示稳定性的高效液相色谱方法的开发
Pub Date : 2019-03-01 DOI: 10.1515/PTHP-2018-9005
M. Bonnet, M. Dermu, Clara Roessle, M. Bellaiche, T. Abarou, V. Vasseur, Samira Benakouche, T. Storme
Corrigendum to: Mathilde Bonnet, Marine Dermu, Clara Roessle, Marc Bellaiche, Tarik Abarou, Véronique Vasseur, Samira Benakouche and Thomas Storme. Formulation of a 3-months Stability Oral Viscous Budesonide Gel and Development of an Indicating Stability HPLC Method. Pharmaceutical Technology in Hospital Pharmacy. Volume 3, Issue 2, pages 91–99. (DOI https://doi.org/10.1515/pthp2018-0005) In Table 1, on page 94, the formulation was based on the original formula published by Eyal Zur, compounding pharmacist and consultant from Israel, in the International Journal of Pharmaceutical Coupounding in 2012. [1]
更正:Mathilde Bonnet, Marine Dermu, Clara Roessle, Marc Bellaiche, Tarik Abarou, v尼克·瓦瑟尔,Samira Benakouche和Thomas Storme。3个月稳定口服粘性布地奈德凝胶的制备及指示稳定性高效液相色谱法的建立。医院药房的制药技术第三卷,第2期,第91-99页。(DOI https://doi.org/10.1515/pthp2018-0005)在第94页的表1中,该配方基于以色列复方药剂师和顾问Eyal Zur于2012年在《国际药物配药杂志》上发表的原始配方。[1]
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引用次数: 0
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Pharmaceutical Technology in Hospital Pharmacy
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