compounded sterile preparations

  • 文章类型: Journal Article
    目的:介绍了2023年ASHP全国医院药房实践调查的结果。
    方法:对美国1,497家普通医院和儿童外科医院的药房主任进行了调查,采用电子邮件和邮件联系的混合模式。使用Qualtrics在线完成调查。IQVIA提供了有关医院特征的数据;调查样本来自IQVIA的医院数据库。
    结果:有效率为21.6%。住院药剂师在26.7%的医院中独立开药。5.7%的医院使用高级分析。87.3%的医院使用基本分析。药剂师在54.2%的门诊诊所或初级保健诊所工作。大多数医院(86.1%)使用自动分配柜作为维持剂量分配的主要方法。73.6%的医院使用机器可读编码来验证药房配药期间的剂量。73.4%的医院使用了电子健康记录系统中的自动验证功能。大多数医院报告说,药房服务的一些整合,以优化患者护理过渡(60.0%),而24.9%的人报告没有整合。传统的技术人员活动仍然占主导地位,但是更高级的角色正在出现。62.8%的医院使用辅助无菌产品制备的技术。
    结论:药物分布继续朝着分散模式发展,药物更接近患者。技术使这种转变能够发生,而不会对患者安全产生重大负面影响。药房劳动力稳定,更高级的职责被分配给药学技术人员,使药剂师能够增加他们的临床作用。
    OBJECTIVE: Results of the 2023 ASHP National Survey of Pharmacy Practice in Hospital Settings are presented.
    METHODS: Pharmacy directors at 1,497 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 Qualtrics. IQVIA supplied data on hospital characteristics; the survey sample was drawn from IQVIA\'s hospital database.
    RESULTS: The response rate was 21.6%. Inpatient pharmacists independently prescribe medications in 26.7% of hospitals. Advanced analytics are used in 5.7% of hospitals. Basic analytics are used in 87.3% of hospitals. Pharmacists work in ambulatory or primary care clinics in 54.2% of hospitals operating outpatient clinics. Most hospitals (86.1%) use automated dispensing cabinets as the primary method of maintenance dose distribution. Machine-readable coding is used in 73.6% of hospitals to verify doses during dispensing in the pharmacy. Autoverification functionality in the electronic health record system is used in 73.4% of hospitals. Most hospitals report some integration of pharmacy services to optimize patient care transitions (60.0%), while 24.9% report no integration. Traditional technician activities still predominate, but more advanced roles are emerging. Technologies to assist sterile product preparation are used in 62.8% of hospitals.
    CONCLUSIONS: Drug distribution continues to trend toward decentralized models with medications available closer to patients. Technologies are enabling this transition to occur without a significant negative impact on patient safety. The pharmacy workforce is stable, and more advanced responsibilities are being assigned to pharmacy technicians, enabling pharmacists to increase their clinical role.
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  • 文章类型: Journal Article
    目的:确定与促进无菌复合教育相关的经济考虑因素,以促进美国各地的学校和药学学院的学生。
    方法:向美国制药学院协会和实验室讲师特殊兴趣小组的成员发送了一项在线调查。收集了有关该机构的一般信息的定量和定性数据,学生群体,复合课程,制备的化合物的类型,设备,预算,人员,和节约成本的措施。使用SPSS计算描述性统计量。如果主要问题无法充分捕获其特定机构的信息,则受访者使用开放式答复。这些答案被添加到研究结果中。
    结果:在发送的555份调查中,40已经完成。报告的年度无菌复合预算从500美元到95,500美元不等。22%的受访者表示向学生收取实验室费用以抵消相关费用。百分之七十的受访者指定了节约成本的措施,包括使用过期药物,重复使用用品或个人防护设备,价格比较,模拟药物,和捐赠。
    结论:这项研究的结果可以帮助药房管理人员和教职员工评估与无菌复合教育相关的成本,并确定降低成本的方法,同时保持这些课程的意图和质量。
    To determine economic considerations associated with the facilitation of sterile compounding education for students in schools and colleges of pharmacy across the United States.
    An online survey was sent to members of the American Association of Colleges of Pharmacy Pharmaceutics Section and Laboratory Instructor\'s Special Interest Group. Quantitative and qualitative data were collected on general information about the institution, student cohorts, compounding courses, types of compounds prepared, equipment, budgets, personnel, and cost-saving measures. Descriptive statistics were calculated using SPSS. Open-ended responses were used by respondents if the primary question could not adequately capture their institution-specific information. These answers were added to the study findings.
    Of 555 surveys sent, 40 were completed. Reported annual sterile compounding budgets ranged from $500 to $95,500. Twenty-two percent of respondents reported collecting a lab fee from students to offset associated costs. Seventy percent of respondents specified cost-saving measures, including the use of expired drugs, reusing supplies or personal protective equipment, price comparisons, simulated drugs, and donations.
    Findings from this study may assist pharmacy administrators and faculty in evaluating the costs associated with sterile compounding education and determining ways to reduce costs while maintaining the intent and quality of these courses.
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  • 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
    目的:在符合《美国药典》第797章标准的药学课程中引入无菌技术验证测试并没有得到很好的描述。在分配卫生系统入门和高级药学实践经验之前,验证测试处于最佳位置。
    方法:实施与隔离复合区域一致的环境和工程控制。纳入中等风险介质填充和戴手套的指尖测试(GFT)测试,以实现第二和第三课程年的初始和后续培训,分别。
    结果:对于2018年至2020年的毕业班,234名学生完成了验证测试和知识评估。介质填充测试失败并不常见。最初的GFT测试失败发生在16.1%至22.1%的二年级学生和3.2%至5.8%的三年级学生中。三个连续的学生班级之间没有显着差异。
    结论:合并验证测试是成功的,结果一致。程序和结果提供有关学生班级规模的指导,可用的设施/设备需求,验证协议的实施,和相关资源。为每个学生提供符合卫生系统药学实践现有标准的年度培训和验证测试文件。
    OBJECTIVE: Incorporation of aseptic technique validation testing in a pharmacy curriculum consistent with United States Pharmacopeia Chapter 797 Standards is not well described. Validation testing is optimally placed prior to assignment to health-system introductory and advanced pharmacy practice experiences.
    METHODS: Environmental and engineering controls consistent with a segregated compounding area were implemented. Medium risk media fill and gloved fingertip test (GFT) testing were incorporated to achieve initial and subsequent training in the second and third curricular years, respectively.
    RESULTS: For the graduating classes of 2018 through 2020, 234 students completed validation testing and knowledge assessment. Failure of the media fill test was uncommon. Failure of the initial GFT testing occurred in 16.1% to 22.1% of second-year students and 3.2% to 5.8% of third-year students. No significant differences were seen between three consecutive student classes.
    CONCLUSIONS: Incorporation of validation testing was successful, with consistent results. Procedures and results provide guidance with respect to student class size, available facility/equipment needs, implementation of validation protocols, and associated resources. Each student is provided with documentation of annual training and validation testing consistent with existing standards for health-system pharmacy practice.
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  • 文章类型: Journal Article
    介绍了2020年ASHP全国医院药房实践调查的结果,该调查涉及为应对2019年冠状病毒病(COVID-19)大流行而实施的药房运营变化。
    使用电子邮件和邮件联系的混合模式方法,对美国1,437家普通和儿童内科/外科医院的药房主任进行了调查。调查完成在线。
    有效率为18.7%。百分之七十三的医院对医院单位实施了变更,其中46%增加了重症监护病房床位容量;94%对药房供应链收购做出了改变,产品的变化,和/或增加库存。69%的医院实施了人员配置改革,最常见的是裁员(55%)和减薪(16%)。86%的医院实施了药物使用变更,最常见的是COVID-19治疗指南(79%)和开放体恤使用或研究性药物研究(55%)。84%的医院实施了无菌混合过程的更改。个人防护设备(PPE)短缺导致71%的医院修改了无菌复合中的PPE使用标准。87%的医院改变了业务活动,例如改变药物返还做法(56%),药物和解过程(46%),静脉注射药物回收(38%),和出院咨询(37%)。医院经历了许多药物短缺,包括沙丁胺醇吸入剂(60%),镇静剂和麻醉剂(58%),神经肌肉阻滞剂(43%),皮质类固醇(34%),心血管药物(24%),研究人员(24%),和透析溶液(6%)。
    在2020年COVID-19大流行期间,药学行业对手术和患者护理的无数威胁做出了回应。
    Results of the 2020 ASHP national survey of pharmacy practice in hospital settings pertaining to pharmacy operational changes implemented in response to the coronavirus disease 2019 (COVID-19) pandemic 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.
    The response rate was 18.7%. Seventy-three percent of hospitals implemented changes to hospital units, including 46% that increased intensive care unit bed capacity; 94% made changes to pharmacy supply chain acquisition, changes to products, and/or increased inventory. Staffing changes were implemented by 69% of hospitals, with the most common being staffing reductions (55%) and salary reductions (16%). Medication-use changes were implemented by 86% of hospitals, with treatment guidelines for COVID-19 treatment (79%) and opening compassionate use or investigational drug studies (55%) being the most common. Changes in sterile compounding processes were implemented by 84% of hospitals. Personal protective equipment (PPE) shortages led to 71% of hospitals modifying PPE use standards in sterile compounding. Eighty-seven percent of hospitals changed operational activities, such as changing medication return practices (56%), medication reconciliation processes (46%), intravenous medication recycling (38%), and discharge counseling (37%). Hospitals experienced shortages of many medications, including albuterol inhalers (60%), sedatives and anesthetic agents (58%), neuromuscular blockers (43%), corticosteroids (34%), cardiovascular agents (24%), investigational agents (24%), and dialysis solutions (6%).
    The pharmacy profession responded to myriad threats to operations and patient care during the COVID-19 pandemic in 2020.
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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
    UNASSIGNED: To evaluate implementation of safety standards of compounded sterile preparations in different hospitals.
    UNASSIGNED: 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.
    UNASSIGNED: 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.
    UNASSIGNED: 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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