compounded sterile preparations

  • 文章类型: Editorial
    Objective.美国药典总则第<797>章要求进行准确性检查,以确保配药复合无菌制剂(CSP)时患者的安全。尽管这项任务很重要,缺乏培训药学学生进行CSP准确性检查的报告。本研究旨在,首先,向学生报告CSP准确性检查的教学方法,第二,确定在此内容上增加的时间和对此技能的有意关注是否会提高学生在模拟医院环境中的表现。方法。实验室教学团队确定了CSP准确性检查中最常见的六种错误类型。在2019年秋季和2020年秋季学期之间比较了关于这六个错误的学生表现和最终准确性检查的能力等级。结果。2019年秋季与2020年秋季相比,学生在准确性检查能力评估方面的整体表现更好,但2020年秋季与2019年秋季相比,学生在补救方面的表现要好得多。在每个学期,学生在第一次和第二次尝试中通常会错过不同的错误。结论。尽管加强了教学内容和实践测试的结合,学生在2020年秋季的表现比2019年秋季差。这种影响可以解释,在某种程度上,根据COVID-19大流行期间所需的虚拟环境。为了提高学生成绩,需要不断改进教学方法和重组补救过程。
    Objective. Accuracy checks are required by United States Pharmacopeia General Chapter <797> to ensure patient safety when dispensing compounded sterile preparations (CSP). Despite the importance of this task, reports of training pharmacy students to perform CSP accuracy checks are lacking. This study aimed to, first, report a method for teaching CSP accuracy checks to students and, second, determine whether increased time on this content and intentional focus on this skill would improve student performance in a simulated hospital environment.Methods. A laboratory teaching team identified the six most common types of errors in CSP accuracy checks. Student performance regarding these six errors and competency grades of final accuracy checks were compared between the fall 2019 and fall 2020 semesters.Results. Students had better overall performance on the competency assessment for accuracy checks in fall 2019 versus fall 2020, but students performed substantially better on the remediation in fall 2020 versus fall 2019. In each semester, students had different errors commonly missed during the first and second attempts.Conclusion. Despite enhanced teaching content and the incorporation of practice testing, students performed worse in fall 2020 than fall 2019. This effect could have been explained, in part, by the virtual environment required during the COVID-19 pandemic. To improve student performance, continued improvement in teaching methods and a restructured remediation process is needed.
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  • 文章类型: Journal Article
    UNASSIGNED:盐酸万古霉素复合滴眼液具有重要的临床应用,如术后抗菌预防和细菌性角膜炎。存在大量数据来支持将各种液体载体用于复方盐酸万古霉素滴眼液。然而,实施有许多限制,特别是车辆产品的频繁短缺或停产。这项研究旨在研究使用OTC洗眼产品作为常绿载体,并评估新配方的物理和化学稳定性。
    UNASSIGNED:使用AdvanceEyeRelief®洗眼剂和盐酸万古霉素注射小瓶制备10和50mg/mL万古霉素滴眼液。将溶液包装在Steri-Droppers®瓶中并在冰箱中储存14天,随后冷藏28天。包括14天的冷冻期以留出时间进行无菌测试。在预定的稳定时间点,取样进行目视检查,pH和渗透压测量,并通过稳定性指示的高效液相色谱(HPLC)方法进行分析。
    UNASHSIGNED:新鲜配制的万古霉素滴眼液清晰,无色,而且没有微粒.10和50mg/mL溶液的pH值分别为7.03和6.28,分别。两种溶液的渗透压在300-330mOsmol/kg的范围内并且认为是等渗的。通过HPLC确认所有样品的初始药物浓度在标签要求的100%-103%内。在整个稳定性研究期间,外观没有明显变化,pH值,或任何样品的渗透压。HPLC结果还证实,所有稳定性样品中的药物浓度在初始时间零值的98%-101%内,并且没有观察到显著的降解产物峰。
    UNASSIGNED:开发了一种新的复合万古霉素滴眼液,以缓解车辆采购问题。这种滴眼液配方易于制备,表现出令人满意的眼科应用性能,在冰箱中储存14天,然后在冰箱中储存28天时,在化学和物理上保持稳定。
    UNASSIGNED: Compounded eye drop solutions of vancomycin hydrochloride have important clinical applications, such as postoperative antimicrobial prophylaxis and bacterial keratitis. There exists a plethora of data to support the use of various liquid vehicles to compound vancomycin hydrochloride eye drops. However, there are a number of limitations for implementation, especially the frequent shortage or discontinuation of the vehicle products. This study was designed to investigate the use of an OTC eye wash product as the evergreen vehicle and to evaluate the physical and chemical stability of the new formulation.
    UNASSIGNED: The Advance Eye Relief® eye wash and vancomycin hydrochloride for injection vials were used to prepare 10 and 50 mg/mL vancomycin eye drop solutions. The solutions were packaged in Steri-Droppers® bottles and stored in a freezer for 14 days followed by 28 days in refrigeration. The 14-day period of freezing was included to allow time for sterility testing. At pre-determined stability time points, samples were taken for visual inspection, pH and osmolality measurement, and analysis by a stability-indicating high performance liquid chromatography (HPLC) method.
    UNASSIGNED: Freshly prepared vancomycin eye drops were clear, colorless, and free of particulates. The pH readings were 7.03 and 6.28 for the 10 and 50 mg/mL solutions, respectively. The osmolality of both solutions were within the range of 300-330 mOsmol/kg and considered isotonic. Initial drug concentrations of all samples were confirmed by HPLC to be within 100%-103% of the label claims. Throughout the stability study period, there were no significant changes in the appearance, pH, or osmolality of any samples. The HPLC results also confirmed that the drug concentrations in all stability samples were within 98%-101% of the initial time zero values and no significant degradation product peaks were observed.
    UNASSIGNED: A new compounded vancomycin eye drop formulation was developed to mitigate vehicle sourcing issues. This eye drop formulation was easy to prepare, exhibited satisfactory properties for ophthalmic applications, and remained stable chemically and physically when stored for 14 days in freezer followed by 28 days in refrigerator.
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  • 文章类型: Journal Article
    Results of the 2020 ASHP national survey of pharmacy practice in hospital settings are presented.
    Pharmacy directors at 1,437 general and children\'s medical/surgical hospitals in the United States were surveyed using a mixed-mode method of contact by email and mail. Survey completion was online. IQVIA supplied data on hospital characteristics; the survey sample was drawn from the IQVIA hospital database.
    The response rate was 18.7%. Almost all hospitals (92.5%) have a method for pharmacists to review medication orders on demand. Most hospitals (74.5%) use automated dispensing cabinets (ADCs) as their primary method for drug distribution. A third of hospitals use barcodes to verify doses during dispensing in the pharmacy and to verify ingredients when intravenous medications are compounded. More than 80% scan barcodes when restocking ADCs. Sterile workflow management technology is used in 21.3% of hospitals. Almost three-quarters of hospitals outsource some sterile preparations. Pharmacists can independently prescribe in 21.1% of hospitals. Pharmacist practice in ambulatory clinics in 46.2% of health systems and provide telepharmacy services in 28.4% of health systems.
    Pharmacists continue their responsibility in their traditional role in preparation and dispensing of medications. They have successfully employed technology to improve safety and efficiency in performance of these duties and have employed emerging technologies to improve the safety, timeliness, and efficiency of the administration of drugs to patients. As pharmacists continue to expand their role to all aspects of medication use, new opportunities highlighted in ASHP\'s Practice Advancement Initiative 2030 have been identified.
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  • 文章类型: Journal Article
    Results of the 2019 ASHP national survey of pharmacy practice in hospital settings are presented.
    Pharmacy directors at 4,863 general and children\'s medical/surgical hospitals in the United States were surveyed using a mixed-mode method of contact by email and mail. Survey completion was online, using an online survey application. IQVIA supplied data on hospital characteristics; the survey sample was drawn from the IMS Health hospital database.
    The response rate was 10.8%. Pharmacists are increasingly managing medication use in the areas of vancomycin therapy, antibiotic selection and dosing, and anticoagulation. Electronic health record (EHR) decision support is guiding prescribing, and nearly 50% of hospitals are customizing drug warnings. Adoption of compounding technology continues, with 43.6% of hospitals using technology in their sterile compounding processes. Nearly half of hospitals have active opioid stewardship programs, and pharmacists are leading these efforts. Specialty pharmacy operations are growing in health systems. Human resource commitments to support new services are increasing; however, vacancy rates for technicians are challenging. Staff credentialing continues to expand for pharmacist and technicians.
    Pharmacists continue to assume greater responsibility for writing medication orders, dosing, ordering laboratory tests, and monitoring outcomes. Health-system pharmacists are taking a leading role in addressing the opioid crisis, advancing safety in compounded sterile preparations through adoption of intravenous workflow technologies, and optimizing EHR applications to leverage clinical decision support tools to improve the safe prescribing and use of medications.
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  • 文章类型: Journal Article
    目的:评价不同医院复方无菌制剂安全性标准的执行情况。
    方法:这项横断面研究包括来自19个国家的124家医院。根据安全用药实践研究所(ISMP)的无菌制剂配制指南和安全实践进行了调查,并使用SurveyMonkey软件发送给海湾地区及其他地区的静脉和肠胃外营养专家网络(IVPN专家网络)的成员。
    结果:邀请124名药剂师参与本研究。来自7个国家的39名(31.5%)药剂师回答:16名(41%)参与者是药房主管,23人(59%)的工作经验>10年。然而,多数,27(69%),受访者来自沙特阿拉伯。37家(95%)医院提供了无菌制剂配制的书面政策和程序。从28家(72%)医院的所有患者护理区域去除浓缩电解质,30家(77%)医院将这些药物明确标记为高度戒备药物。使用先进的技术,如条形码验证或IV机器人,对于复合无菌制剂,27家(69%)医院未实施.
    结论:在不同国家的许多医院实施了确保无菌制剂复合安全的最低标准和最佳实践建议。然而,大多数医院没有实施先进技术。
    OBJECTIVE: To evaluate implementation of safety standards of compounded sterile preparations in different hospitals.
    METHODS: This cross-sectional study included 124 hospitals from 19 countries. A survey was developed based on the guidelines and safety practices of the Institute for Safe Medication Practices (ISMP) for sterile preparations compounding, and was sent to the members of the Intravenous and Parenteral Nutrition experts\' network (IV PN experts\' network) in the Gulf region and beyond using SurveyMonkey software.
    RESULTS: 124 pharmacists were invited to participate in this study. Only 39 (31.5%) pharmacists from seven countries responded: 16 (41%) of the participants were pharmacy supervisors, and 23 (59%) had >10 years of work experience. However, a majority, 27 (69%), of the respondents were from Saudi Arabia. Written policies and procedures for sterile preparations compounding were available in 37 (95%) hospitals. The concentrated electrolytes were removed from all patient care areas in 28 (72%) hospitals, and 30 (77%) hospitals clearly labelled those as high-alert medications. The use of advanced technologies, such as bar code verification or IV robotics, for compounding sterile preparations were not implemented in 27 (69%) hospitals.
    CONCLUSIONS: Minimum standards and best practice recommendations to ensure safety of sterile preparation compounding were implemented in many hospitals of different countries. However, advanced technologies were not implemented by the majority of the hospitals.
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  • 文章类型: Journal Article
    OBJECTIVE: Results of an evaluation of the physical and chemical stability of extemporaneously prepared adult and pediatric ophthalmic solutions containing combinations of phenylephrine, tropicamide, and cyclopentolate are reported.
    METHODS: A stability study was conducted to help determine the feasibility of innovative formulations to meet an unmet clinical need for combination mydriatic ophthalmic eyedrops. An adult mydriatic ophthalmic solution containing phenylephrine hydrochloride 2.5% and tropicamide 1.0% and a pediatric formulation containing phenylephrine hydrochloride 2.5%, tropicamide 0.5%, and cyclopentolate hydrochloride 0.5% were prepared using proper aseptic techniques. Triplicate samples of each formulation were stored for 60 days at refrigeration temperatures (2-8 °C) and analyzed on day 0 and days 7, 14, 28, and 60. At each time point, the stability samples were assessed by visual inspection, pH measurement, and stability-indicating high-performance liquid chromatography (HPLC) analysis.
    RESULTS: Over the 60-day storage period, there was no significant change in the visual appearance or pH level of any of the adult or pediatric solution samples. The results of HPLC analysis indicated that all samples retained 97-102% of the initial drug concentrations for up to 60 days.
    CONCLUSIONS: Both adult and pediatric ophthalmic formulations containing combinations of phenylephrine, tropicamide, and cyclopentolate were stable physically and chemically for up to 60 days when stored at refrigeration temperatures (2-8 °C).
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  • 文章类型: Editorial
    暂无摘要。
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  • 文章类型: Journal Article
    目的:以建构主义的方法为复合无菌制剂的实际应用设计一个全面的学习和评估环境。
    方法:复合无菌制剂实验室是一门必修的1学分课程,它建立在卫生系统设置中通常使用的培训无菌技术的主题以及课程中其他课程概念的应用。学生使用批判性思维技能来设计适当的策略来配制无菌制剂。
    结果:对无菌技术技能进行了客观评估,结构化,基于检查表的规则。大多数学生使用适当的技术成功完成了实践评估(平均评估等级=83.2%)。几乎所有学生在第一次尝试时都通过了实用的媒体填充(98%)和戴着手套的指尖采样(86%)测试;第二次尝试都通过了。
    结论:采用建构主义的支架方法来教授适当的卫生和无菌技术,使学生能够通过介质填充和戴手套的指尖测试,并在实际的复合评估中表现出色。
    OBJECTIVE: To design a comprehensive learning and assessment environment for the practical application of compounded sterile preparations using a constructivist approach.
    METHODS: Compounded Sterile Preparations Laboratory is a required 1-credit course that builds upon the themes of training aseptic technique typically used in health system settings and threads application of concepts from other courses in the curriculum. Students used critical-thinking skills to devise appropriate strategies to compound sterile preparations.
    RESULTS: Aseptic technique skills were assessed with objective, structured, checklist-based rubrics. Most students successfully completed practical assessments using appropriate technique (mean assessment grade=83.2%). Almost all students passed the practical media fill (98%) and gloved fingertip sampling (86%) tests on the first attempt; all passed on the second attempt.
    CONCLUSIONS: Employing a constructivist scaffold approach to teaching proper hygiene and aseptic technique prepared students to pass media fill and gloved fingertip tests and to perform well on practical compounding assessments.
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