FARMACIA HOSPITALARIA最新文献_第8页

[Translated article] Therapeutic drug monitoring of dalbavancin: A systematic review of strategies and clinical applications in the treatment of complex infections 【翻译文章】达巴文星治疗药物监测：复杂感染治疗策略及临床应用的系统综述。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.08.003

Laura Moñino-Dominguez , Alicia Aguado-Paredes , Jaime Cordero-Ramos

Introduction

dalbavancin is approved for treating acute bacterial skin and soft tissue infections, but its off-label use for treating complex chronic infections has become increasingly common. Currently, there is no established dosing regimen for such infections. Given the need for prolonged treatments, a dosing adjustment strategy based on therapeutic drug monitoring may optimize its use and allow for individualized regimens. This systematic review analyzes dalbavancin dosing in complex infections and TDM-based strategies to optimize treatment.

Materials and methods

A search was conducted in PubMed, Embase, Scopus, and the Cochrane Library (2014–2024) using the following keywords: “dalbavancin”, “pharmacokinetics”, “pharmacodynamics”, “therapeutic drug monitoring”, and “TDM”. Three independent reviewers selected and evaluated the studies. Clinical studies related to the pharmacokinetics of dalbavancin and the use of TDM in complex infections requiring prolonged regimens were included. Due to the heterogeneity among the studies, a qualitative analysis of the data was performed.

Results

A total of 241 articles were identified. After removing duplicates and applying the inclusion and exclusion criteria, 10 studies were included. These studies exhibited heterogeneity in design (6 retrospective and 4 prospective) and sample size, encompassing 457 patients and 1.298 samples. Most studies focused on osteoarticular infections treated with dalbavancin using an initial two-dose regimen of 1,500 mg administered one week apart, followed by dose adjustments based on plasma level monitoring. The most commonly targeted pharmacokinetic/pharmacodynamic parameters were a trough concentration above 8 μg/ml and an area under the curve/minimum inhibitory concentration ratio greater than 111.1. Therapeutic Drug Monitoring-Guided strategies were found to optimize dosing and maintain adequate plasma levels. Significant interindividual variability in plasma concentrations was observed, influenced by factors such as renal function and body surface area.

Discussion

The use of Therapeutic Drug Monitoring in dalbavancin dosing optimizes the treatment of complex chronic infections by adjusting dosing intervals and maintaining adequate therapeutic levels over extended periods. However, further validation and definition of specific pharmacokinetic/pharmacodynamic targets is required.

dalbavancin被批准用于治疗急性细菌性皮肤和软组织感染，但其标签外用于治疗复杂的慢性感染已变得越来越普遍。目前，尚无针对此类感染的既定给药方案。鉴于需要长期治疗，基于治疗药物监测的剂量调整策略可以优化其使用并允许个体化方案。本系统综述分析了达尔巴文星在复杂感染中的剂量和基于tdm的优化治疗策略。材料与方法：检索PubMed、Embase、Scopus、Cochrane Library(2014-2024)，检索关键词：dalbavancin、pharmacodynamics、therapeutic drug monitoring、TDM。三位独立审稿人选择并评估了这些研究。包括与达巴文星的药代动力学和TDM在需要长期治疗的复杂感染中的应用相关的临床研究。由于研究的异质性，我们对数据进行了定性分析。结果：共鉴定出241篇文献。在剔除重复项并应用纳入和排除标准后，纳入了10项研究。这些研究在设计（6项回顾性研究和4项前瞻性研究）和样本量上呈现异质性，共纳入457例患者和1.298份样本。大多数研究集中在用达尔巴文星治疗骨关节感染上，最初的两剂方案为1500 mg，间隔一周给药，随后根据血浆水平监测调整剂量。最常见的目标药代动力学/药效学参数为谷浓度大于8 μg/ml，曲线下面积/最小抑制浓度比大于111.1。发现治疗药物监测指导策略可优化剂量并维持适当的血浆水平。观察到血浆浓度的显著个体差异，受肾功能和体表面积等因素的影响。讨论：治疗药物监测在达巴文星剂量中的应用通过调整给药间隔和在较长时间内保持适当的治疗水平，优化了复杂慢性感染的治疗。然而，需要进一步验证和定义特定的药代动力学/药效学靶点。

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引用次数: 0

[Artículo traducido] Responsables de seguridad de medicamentos: un pilar de la seguridad del paciente en la farmacia hospitalaria 用药安全人员：医院药房病人安全的支柱。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.09.001

Elizabeth Hess Ford , Christina Michalek

The role of a Medication Safety Officer has emerged as a critical element in hospital pharmacy, addressing the persistent issue of medication errors. These errors, which can cause significant patient harm, have been documented for decades, prompting the establishment of formal roles dedicated to medication safety. Organizations such as the Institute for Safe Medication Practices (ISMP), the American Society of Health System Pharmacists (ASHP) as well as the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and National Health Service (NHS) have been instrumental in supporting the Medication Safety Officer role.

Medication errors can result in severe consequences, including patient harm and death. Landmark publications like the Institute of Medicine's “To Err is Human” and “Crossing the Quality Chasm” have highlighted the prevalence and impact of these errors, advocating for system improvements and the necessity of dedicated safety roles.

Medication Safety Officers lead strategies and processes related to medication safety, develop strategic plans, and implement error prevention strategies. They analyze medication error reports, collaborate with healthcare staff, and optimize medication safety technologies. Medication Safety Officers play a key role in fostering a culture of safety within organizations, influencing practices to minimize harm and support second victim programs.

Studies have shown that employing a Medication Safety Officer can significantly improve hospital safety scores, demonstrating the effectiveness of this role in enhancing patient safety. The daily responsibilities of a Medication Safety Officer include reviewing medication errors, assessing harm, attending meetings, and collaborating with healthcare practitioners.

Overall, the role of a Medication Safety Officer is essential in identifying and mitigating medication risks, making hospitals safer, and ensuring the delivery of high-quality patient care.

药物安全干事的作用已成为医院药房的一个关键因素，解决持续存在的药物错误问题。这些可能对患者造成重大伤害的错误已经记录了几十年，促使建立了专门负责药物安全的正式角色。诸如安全用药实践研究所（ISMP）、美国卫生系统药剂师协会（ASHP）以及英国药品和保健产品监管机构（MHRA）和国家卫生服务（NHS）等组织在支持药物安全官员的角色方面发挥了重要作用。用药错误可能导致严重后果，包括患者伤害和死亡。医学研究所的《人孰无过》和《跨越质量鸿沟》等具有里程碑意义的出版物强调了这些错误的普遍性和影响，倡导系统改进和专门的安全角色的必要性。药物安全官员领导与药物安全相关的策略和流程，制定策略计划，并实施预防错误的策略。他们分析用药错误报告，与医护人员协作，并优化用药安全技术。药物安全官员在组织内部培养安全文化、影响实践以尽量减少伤害和支持第二受害者项目方面发挥着关键作用。研究表明，聘用用药安全官可以显著提高医院的安全评分，证明了这一角色在提高患者安全方面的有效性。药物安全官员的日常职责包括审查药物错误、评估危害、参加会议以及与医疗保健从业人员合作。总体而言，在识别和减轻用药风险、使医院更安全以及确保提供高质量的患者护理方面，用药安全干事的作用至关重要。

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引用次数: 0

Estandarización y caracterización de las diluciones administradas por vía intravenosa en el paciente crítico pediátrico 危重儿科患者静脉药物稀释度的标准化和特征。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.03.020

Laura Torralba-Fernández , Marta García-Palomo , Miguel López de Abechuco-Ruiz , Natalia Ramos-Sánchez , Clara Jiménez-Méndez , Rocío Prieto-Galindo , María Carmen Lorenzo-Lozano , Pablo Aguado-Barroso

Objective

To standardize the drug dilutions administered intravenously in a Pediatric Intensive Care Unit and to characterize these dilutions based on their pH, osmolarity, and vesicant nature. This aims to guide the selection of the most appropriate vascular access device, minimizing associated complications, and preserving the patient's venous capital.

Methods

Through a consensus between Pharmacy and Pediatric Services, the most frequently administered intravenous drugs in the Pediatric Intensive Care Unit were selected. Two different dilutions were established for each drug, followed by the determination of their respective osmolarity and pH values. The vesicant nature of each drug was assessed according to the classification proposed by Clark et al. Additionally, vascular access device selection was guided by the algorithm proposed by Manrique et al., which considers the drug’s properties, the duration of intravenous therapy, and the patient's venous capital status.

Results

A total of 60 dilutions corresponding to 30 drugs from the following therapeutic groups were analyzed: antimicrobials (56%), antiepileptics (13%), sedatives (7%), diuretics (7%), anti-inflammatory and analgesics (7%), and others (10%). Twenty-five percent of the dilutions exhibited at least one high-risk factor for phlebitis (osmolarity > 600 mOsm/L or pH < 4 or > 9), while 35% were classified as intermediate risk (osmolarity 450–600 mOsm/L or pH 4–5 or > 7.5–9). Only 10% of the analyzed drugs were classified as vesicants (acyclovir, phenytoin, and vancomycin). Seventeen dilutions of nine different drugs were identified that should not be administered through a peripheral venous catheter, even in short-term treatments. Of these, 15 had a high risk of causing phlebitis, while 2 had an intermediate risk.

Conclusions

The physicochemical properties (osmolarity and pH) and vesicant nature of drugs are key factors contributing to the development of phlebitis in critically ill pediatric patients. Standardizing and characterizing drug dilutions will facilitate the selection of the most appropriate vascular access device, improving the safety and effectiveness of intravenous therapy.

目的：规范儿科重症监护室静脉给药的药物稀释度，并根据其pH值、渗透压和发泡剂性质对这些稀释度进行表征。目的是指导选择最合适的血管通路装置，尽量减少相关并发症，并保留患者的静脉资本。方法：通过药房和儿科部门之间的共识，选择儿科重症监护病房最常用的静脉注射药物。为每种药物建立两种不同的稀释度，然后测定其各自的渗透压和pH值。根据Clark等人提出的分类对每种药物的泡腾性进行评估。此外，血管通路装置的选择由Manrique等人提出的算法指导，该算法考虑了药物的性质、静脉治疗的持续时间和患者的静脉资本状态。结果：共分析了抗菌药（56%）、抗癫痫药（13%）、镇静剂（7%）、利尿剂（7%）、抗炎镇痛药（7%）和其他（10%）30种药物对应的60种稀释度。25%的稀释液至少表现出一种静脉炎的高风险因素（渗透压bbb600 mOsm/L或pH  9），而35%被归类为中等风险（渗透压450-600 mOsm/L或pH 4-5或 > 7.5-9）。只有10%的分析药物被归类为泡腾剂（阿昔洛韦、苯妥英和万古霉素）。9种不同药物的17种稀释度被确定为不应通过外周静脉导管施用，即使是在短期治疗中。其中，15人有引起静脉炎的高风险，2人有中等风险。结论：药物的理化性质（渗透压、pH）和泡沫性是导致小儿危重症患者静脉炎发生的关键因素。药物稀释度的标准化和特征化将有助于选择最合适的血管通路装置，提高静脉治疗的安全性和有效性。

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引用次数: 0

Caplacizumab en debut agudo refractario a tratamiento estándar de púrpura trombocitopénica trombótica 卡普单抗治疗标准治疗难治性急性血栓性血小板减少性紫癜。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.01.006

Yeray Reyes-de-la-Mata, Gala Cano-Martínez, Francisco Javier Salmerón-Navas, Carmen María Domínguez-Santana, Silvia Fenix-Caballero

引用次数: 0

[Translated article] Caplacizumab in acute thrombotic thrombocytopenic purpura refractory to standard treatment 卡普拉珠单抗治疗标准治疗难治性急性血栓性血小板减少性紫癜。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.05.016

Yeray Reyes-de-la-Mata, Gala Cano-Martínez, Francisco Javier Salmerón-Navas, Carmen María Domínguez-Santana, Silvia Fenix-Caballero

引用次数: 0

La certificación Board of Pharmacy Specialties (BPS) como estrategia del desarrollo profesional continuo de la farmacia hospitalaria BPS认证作为医院药房持续专业发展的战略。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.03.010

Josep Maria Guiu Segura

引用次数: 0

Pharmacokinetics and pharmacodynamics studies of phage therapy 噬菌体治疗的药代动力学和药效学研究。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.07.007

Lucía Blasco , Inés Bleriot , Patricia Fernández-Grela , José Ramón Paño-Pardo , Jesús Oteo-Iglesias , María Tomás

The need for new antimicrobial treatments that work alternatively or synergistically with antibiotics to address the problem of the emergence and transmission of antimicrobial resistance has increased interest in the use of minority therapies such as phage therapy. For safe and widespread application of this therapy, it is necessary to establish the pharmacokinetic and pharmacodynamic parameters for its use in humans. This systematic review analyzes the criteria necessary to establish the PK/PD of this therapy, as well as its current application, based on a review of 66 clinical cases that catch diverse infections and phage administration routes.

为了解决抗菌素耐药性的出现和传播问题，需要开发可与抗生素替代或协同作用的新型抗菌素治疗方法，这增加了人们对使用噬菌体治疗等少数疗法的兴趣。为了安全、广泛地应用该疗法，有必要建立其在人体内使用的药代动力学和药效学参数。本系统综述基于66例不同感染和噬菌体给药途径的临床病例，分析了建立该疗法的PK/PD所需的标准，以及其目前的应用。

引用次数: 0

[Translated article] New Alzheimer disease's treatments: Hope or disappointment 阿尔茨海默病的新疗法：希望还是失望

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.08.008

Daniel Sevilla-Sánchez , Alejandro J. Garza-Martínez

引用次数: 0

Monitorización terapéutica de dalbavancina: revisión sistemática de estrategias y aplicaciones clínicas en el tratamiento de infecciones complejas 达巴文星的治疗药物监测：治疗复杂感染的策略和临床应用的系统综述。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.03.002

Laura Moñino-Dominguez , Alicia Aguado-Paredes , Jaime Cordero-Ramos

Introduction

dalbavancin is approved for acute bacterial skin and soft tissue infections, but its off-label use in complex chronic infections has become increasingly common. Currently, no established dosing regimen exists for such infections. Given the need for prolonged treatments, a dose adjustment strategy based on therapeutic drug monitoring may optimize its use and allow for individualized regimens. This systematic review analyzes dalbavancin dosing in complex infections and TDM-based strategies to optimize treatment.

Materials and methods

A search was conducted in PubMed, Embase, Scopus, and the Cochrane Library (2014–2024) using the keywords: “dalbavancin”, “pharmacokinetics”, “pharmacodynamics”, “therapeutic drug monitoring”, and “TDM”. Three independent reviewers selected and evaluated the studies. Clinical studies related to the pharmacokinetics of dalbavancin and the use of TDM in complex infections requiring prolonged regimens were included. Due to heterogeneity among studies, a qualitative analysis of the data was performed.

Results

A total of 241 articles were identified. After removing duplicates and applying inclusion and exclusion criteria, 10 studies were included. These studies exhibited heterogeneity in design (6 retrospective and 4 prospective) and sample size, encompassing 457 patients and 1.298 samples. Most studies focused on osteoarticular infections treated with dalbavancin using an initial two-dose regimen of 1,500 mg administered one week apart, followed by dose adjustments based on plasma level monitoring. The most commonly targeted pharmacokinetic/pharmacodynamic parameters were a trough concentration above 8 μg/ml and an area under the curve/minimum inhibitory concentration ratio greater than 111.1. Therapeutic Drug Monitoring-Guided strategies were found to optimize dosing and maintain adequate plasma levels. Significant interindividual variability in plasma concentrations was observed, influenced by factors such as renal function and body surface area.

Discussion

The use of Therapeutic Drug Monitoring in dalbavancin dosing optimizes the treatment of complex chronic infections by adjusting dosing intervals and maintaining adequate therapeutic levels over extended periods. However, further validation and definition of specific pharmacokinetic/pharmacodynamic targets are needed.

dalbavancin被批准用于急性细菌性皮肤和软组织感染，但其在复杂慢性感染中的超说明书使用已变得越来越普遍。目前，尚无针对此类感染的既定给药方案。鉴于需要长期治疗，基于治疗药物监测的剂量调整策略可以优化其使用并允许个体化方案。本系统综述分析了达尔巴文星在复杂感染中的剂量和基于tdm的优化治疗策略。材料与方法：检索PubMed、Embase、Scopus、Cochrane Library(2014-2024)，检索关键词：dalbavancin、pharmacodynamics、therapeutic drug monitoring、TDM。三位独立审稿人选择并评估了这些研究。包括与达巴文星的药代动力学和TDM在需要长期治疗的复杂感染中的应用相关的临床研究。由于研究之间存在异质性，我们对数据进行了定性分析。结果：共鉴定出241篇文献。在剔除重复项并应用纳入和排除标准后，纳入了10项研究。这些研究在设计（6项回顾性研究和4项前瞻性研究）和样本量上呈现异质性，共纳入457例患者和1.298份样本。大多数研究集中在用达尔巴文星治疗骨关节感染上，最初的两剂方案为1500 mg，间隔一周给药，随后根据血浆水平监测调整剂量。最常见的目标药代动力学/药效学参数为谷浓度大于8 μg/ml，曲线下面积/最小抑制浓度比大于111.1。发现治疗药物监测指导策略可优化剂量并维持适当的血浆水平。观察到血浆浓度的显著个体差异，受肾功能和体表面积等因素的影响。讨论：治疗药物监测在达巴文星剂量中的应用通过调整给药间隔和在较长时间内保持适当的治疗水平，优化了复杂慢性感染的治疗。然而，需要进一步验证和定义特定的药代动力学/药效学靶点。

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引用次数: 0

[Translated article] Cost-utility of sacubitril/valsartan in heart failure with reduced ejection fraction in Spain 【翻译文章】在西班牙，苏比里尔/缬沙坦治疗心力衰竭伴射血分数降低的成本-效用。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA

Pub Date : 2025-11-01 DOI: 10.1016/j.farma.2025.08.004

Antonio García-Quintana , Héctor Alonso Ramos , Javier Parrondo

Introduction

Heart failure is an increasingly common syndrome with a rising prevalence, which associates significant costs, mainly related to hospitalization. In fact, heart failure is the most frequent diagnosis in hospital discharges in Spain.

Objective

To analyze the economic impact of new treatments for heart failure with reduced ejection fraction such as sacubitril/valsartan in out-patient and in-patient setting.

Material and methods

The present economic evaluation study was carried out by developing a Markov model. Treatment with sacubitril/valsartan from admission or after hospital discharge was compared, with enalapril being the comparator. Total costs, years of life gained, quality-adjusted life years, and incremental cost-effectiveness ratio and incremental cost-utility ratio were analyzed. Data were obtained from the PARADIGM-HF and PIONEER-HF studies.

Results

The results of the base cases of the three comparisons made showed that sacubitril/valsartan produced benefits in years of life gained and quality-adjusted life years compared to enalapril showing incremental cost-utility ratio below €20,000/QALY and that this ratio was better in scenarios starting sacubitril/valsartan in the hospital setting once decompensation was resolved.

Conclusion

This study shows that starting sacubitril/valsartan from hospital admission for heart failure is cost-effective from the perspective of the National Health Service in Spain.

导读：心力衰竭是一种越来越常见的综合征，发病率不断上升，这与显著的费用有关，主要与住院有关。事实上，心脏衰竭是西班牙出院患者中最常见的诊断。目的：分析舒比利/缬沙坦等降低射血分数心力衰竭新疗法在门诊和住院的经济影响。材料和方法：本研究采用马尔可夫模型进行经济评价。以依那普利为对照，比较了入院或出院后服用苏比里尔/缬沙坦的治疗。分析了总成本、获得寿命年、质量调整寿命年、增量成本-效果比和增量成本-效用比。数据来自PARADIGM-HF和PIONEER-HF研究。结果：三个比较的基本案例的结果显示，与依那普利相比，沙比利/缬沙坦在获得的生命年数和质量调整生命年数方面产生了益处，其增量成本效用比低于20,000欧元/QALY，并且在医院环境中开始使用沙比利/缬沙坦的情况下，一旦失代偿得到解决，该比率更好。结论：本研究表明，从西班牙国家卫生服务的角度来看，从心力衰竭住院开始服用苏比里尔/缬沙坦具有成本效益。

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引用次数: 0