FARMACIA HOSPITALARIA最新文献

{"title":"Role of the pharmacist in antimicrobial stewardship programs in critically ill patients.","authors":"Miguel Ángel Amor García, Irene Aquerreta González, Carla Bastida Fernández, Amaia Egüés Lugea, Sara Cobo Sacristán, Fernando Becerril Moreno, María Martín-Cerezuela, Esther Domingo Chiva, Tatiana Betancor García, Marta Albanell Fernández, Laura Doménech-Moral, Sara Ortiz Pérez, Aurora Fernández Polo","doi":"10.1016/j.farma.2026.04.014","DOIUrl":"https://doi.org/10.1016/j.farma.2026.04.014","url":null,"abstract":"<p><p>The design and implementation of antimicrobial stewardship programs for patients admitted to intensive care units must consider the specific characteristics of this population, including infection severity, organ dysfunction, and pharmacokinetic/pharmacodynamic alterations. The creation of a multidisciplinary team and the establishment of clear, targeted objectives are essential to improve treatment appropriateness, reduce the emergence of antimicrobial resistance, and ensure the sustainability of healthcare system. Pharmaceutical care contributes to the optimisation of antimicrobial use through antimicrobial therapy review, dose individualisation based on pharmacokinetic/pharmacodynamic parameters, and treatment monitoring, while also facilitating the development of systems for monitoring clinical outcomes, microbiology, and antimicrobial consumption.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148057457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Milrinone in aneurysmal subarachnoid hemorrhage: A long way ahead.","authors":"Begoña Guardiola, Jesús Antonio Sánchez-Martín, Jon Pérez-Bárcena, Juan Antonio Llompart-Pou","doi":"10.1016/j.farma.2026.04.016","DOIUrl":"https://doi.org/10.1016/j.farma.2026.04.016","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148043879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhancing strategies to mitigate psychotropic drug continuation post-ICU discharge: A critical perspective on the PSICU-ALTA protocol.","authors":"Parth Aphale, Himanshu Shekhar, Shashank Dokania","doi":"10.1016/j.farma.2026.04.001","DOIUrl":"https://doi.org/10.1016/j.farma.2026.04.001","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148017922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Guideline to radiopharmaceutical procedures for in vitro labeling of leukocytes.","authors":"Inmaculada Romero-Zayas, María de Arcocha-Torres, Iván Peñuelas, Elena Martínez Montalbán, María Carmen Plancha Masanet, Antonio de Jesús Fernández Sánchez, Juan Antonio Pérez Iruela","doi":"10.1016/j.farma.2026.04.004","DOIUrl":"https://doi.org/10.1016/j.farma.2026.04.004","url":null,"abstract":"<p><p>This guide outlines the radiopharmaceutical procedure for the in vitro labelling of leukocytes. Scintigraphy using leukocytes labeled with [^99mTc]Tc-exametazime or [¹¹¹In]In-oxine is a highly valuable diagnostic tool in infectious and inflammatory diseases due to its high sensitivity and specificity. It is based on established guidelines and consensus protocols, which incorporate the recent Spanish regulations on the extemporaneous preparation of radiopharmaceuticals, this document provides detailed and precise instructions for the safe and effective preparation and quality control of in vitro labeled leukocytes. The clinical indications for leukocyte scintigraphy are described, along with the technical requirements for both facilities and equipment. The various stages of the radiolabelling procedure are developed and substantiated, including blood sample collection, leukocyte fraction separation and isolation, incubation and subsequent radiolabelling with either [^99mTc]Tc-exametazime or [¹¹¹In]In-oxine, radiopharmaceutical conditioning for administration, and the necessary quality control procedures. The document concludes with a section describing drug interactions reported in the literature. Two annexes are included, providing example labeling protocols for both radiopharmaceuticals.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147949910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Orphan drug regulation: a global comparison of the United States Food and Drug Administration, European Medicines Agency, and Japanese pharmaceuticals and medical devices agency approaches.","authors":"Robinraja Elango, Russell Martin, Shivanand K Mutta","doi":"10.1016/j.farma.2026.04.003","DOIUrl":"https://doi.org/10.1016/j.farma.2026.04.003","url":null,"abstract":"<p><strong>Objective: </strong>To perform a comparative review of orphan drug policies and designation criteria implemented by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), assessing their influence on development, approval, and access.</p><p><strong>Method: </strong>A targeted review of legislation, guidance documents, and peer-reviewed analyses from each regulatory body was conducted.</p><p><strong>Results: </strong>The FDA accelerates development via robust tax credits and seven-year market exclusivity, though high pricing remains challenging. The EMA emphasizes unmet medical needs and ten-year exclusivity, ensuring more homogeneous pricing despite slower approvals. Japan's PMDA utilizes specific subsidies and the Sakigake designation to counter \"drug loss\" and encourage innovation. Despite expedited pathways globally, significant disparities in affordability and patient access persist.</p><p><strong>Conclusions: </strong>While national incentives successfully boost orphan drug approvals, global access inequities remain unresolved. Harmonizing regulatory criteria and promoting international collaboration on evidence requirements are essential for equitable and sustainable access to rare disease therapies worldwide.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quality of life in hospitalized patients receiving palliative care: Do current tools cover all their needs?","authors":"Ivis Vinicius de Oliveira Martins, Igor Massocatto Marques, Felipe Augusto Trinca Alves da Silva, Maria Eduarda Marques Trinca, Lais Beanucci Coelho, Ana Maria Rosa Freato Gonçalves, Albert Figueras, Maria Olívia Barboza Zanetti, Leonardo Regis Leira Pereira, Maria Teresa Herdeiro, Fabiana Rossi Varallo","doi":"10.1016/j.farma.2026.04.002","DOIUrl":"https://doi.org/10.1016/j.farma.2026.04.002","url":null,"abstract":"<p><strong>Introduction: </strong>Quality of life (QoL) is a central outcome in palliative care (PC), particularly in hospital settings, where patients often present with advanced illness, complex symptoms, and multidimensional needs. Accurate QoL assessment is essential to support patient-centered and family-centered decision-making; however, the diversity of available instruments and limited validation beyond oncology populations pose challenges for their clinical and research use.</p><p><strong>Objectives: </strong>We aimed to identify tools measuring QoL in hospitalized PC patients, highlighting their domains and psychometric properties.</p><p><strong>Methods: </strong>A scoping review was conducted following Joanna Briggs Institute guidelines and the PRISMA Extension for Scoping Reviews (PRISMA-ScR). We searched MEDLINE (PubMed), CINAHL, EMBASE, The Cochrane Library, Scopus, Web of Science, Google Scholar, and LILACS from inception until April 11, 2025. Independent reviewers assessed eligibility, extracted data, and evaluated risk of bias.</p><p><strong>Results: </strong>Of 6026 studies retrieved, after removing duplicates (n = 1680) and full-text screening (n = 17), 12 met inclusion criteria, including 5 validation, 5 observational studies and 2 clinical trials. Eight tools were identified, most originally developed for advanced-stage conditions and applied in high-income countries. Main domains included physical comfort (n = 7), psychological well-being (n = 7), and spiritual well-being (n = 7). Quality of death was assessed in one instrument. Two instruments were validated for Brazilian Portuguese, primarily for cancer patients. Frequently reported psychometric properties were face validity (n = 9), content validity (n = 6), and construct validity (n = 6).</p><p><strong>Conclusion: </strong>No gold-standard instrument exists for measuring QoL in PC. Selection should consider patient and family preferences, health status, prognosis, life expectancy, and intended use. Findings highlight the need for psychometrically robust instruments applicable across disease stages and conditions. Incorporation of death preparedness, quality of death, and patient- and family-centered outcomes remains limited but is important to guide individualized, safe, and equitable hospital-based PC.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Standardisation of ready-to-use intravenous antimicrobial preparation in a paediatric hospital-at-home unit.","authors":"Alejandra Merino-Pardo, Esther Algarra Sánchez, José Antonio Hernández-Ramos, Beatriz Fernández-Rubio, Margarita Cuervas-Mons Vendrell","doi":"10.1016/j.farma.2026.04.005","DOIUrl":"https://doi.org/10.1016/j.farma.2026.04.005","url":null,"abstract":"<p><strong>Introduction: </strong>Outpatient parenteral antimicrobial therapy (OPAT) in paediatric hospital-at-home (HAH) units is expanding. Standardisation of ready-to-use presentations increases safety, reduces variability, and facilitates logistics, particularly in paediatrics, where administration volumes, maximum concentrations, and infusion times strongly condition preparation.</p><p><strong>Objective: </strong>To standardise the antimicrobials used in a paediatric HAH unit by defining preparation, final container selection, and storage, based on the available evidence on physicochemical and microbiological stability, while considering administration criteria specific to the paediatric setting.</p><p><strong>Methods: </strong>Antimicrobials included in the hospital's OPAT protocol were selected. Administration systems and consumables were reviewed, prioritising syringes and low-adsorption plastic materials. Maximum concentrations and infusion times recommended in paediatrics were compiled. Physicochemical stability was established through a literature review, selecting studies with comparable conditions (diluent, concentration, temperature, photoprotection, and primary container material) and assays that had evaluated active ingredient degradation; a content deviation of ≤10% was considered acceptable. Microbiological stability was estimated using the risk matrix for sterile preparations from the Good Preparation Practice Guide for Hospital Pharmacy Services, considering aseptic compounding in a cleanroom using a Class II biological safety cabinet and subsequent home storage.</p><p><strong>Results: </strong>Sixteen antimicrobials were standardised (acyclovir, amikacin, ampicillin, cefazolin, cefepime, ceftazidime, ceftriaxone, cefuroxime, cidofovir, clindamycin, ganciclovir, imipenem/cilastatin, meropenem, piperacillin/tazobactam, tobramycin, and vancomycin). A fixed diluent volume and filling into syringes were prioritised; bags were used when the volume exceeded 60 mL. For each drug, diluent, material, temperature, photoprotection, and maximum in-use time were defined, integrating physicochemical stability evidence and adopting a conservative approach for microbiological use due to uncontrolled home refrigeration.</p><p><strong>Conclusions: </strong>This study supports a more uniform and safer OPAT practice in paediatric HAH units and provides an operational basis for protocol implementation and future evaluation, combining stability evidence for compounded preparations with paediatric administration requirements.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943225","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Atezolizumab plus platinum-based chemotherapy and etoposide as first-line treatment for metastatic small cell lung cancer: A retrospective multicenter observational study.","authors":"Laura Moñino Domínguez, Laura Amaro Álvarez, Alicia Aguado Paredes, Isabel María Carrión Madroñal","doi":"10.1016/j.farma.2026.03.004","DOIUrl":"https://doi.org/10.1016/j.farma.2026.03.004","url":null,"abstract":"<p><strong>Introduction: </strong>The standard first-line treatment for metastatic small-cell lung cancer (SCLC) is platinum-based chemotherapy in combination with etoposide. The aim of this study was to evaluate the real-world effectiveness and safety of atezolizumab plus chemotherapy in SCLC and to explore factors associated with survival.</p><p><strong>Methods: </strong>A retrospective, observational, multicenter study was conducted in patients diagnosed with SCLC who received first-line treatment with atezolizumab in combination with platinum-etoposide chemotherapy between November 2021 and March 2025. Treatment effectiveness was evaluated by assessing the objective response rate (ORR), treatment duration, progression-free survival (PFS) and overall survival (OS). Univariate and multivariate Cox models were used to explore associations between clinical variables and survival outcomes.</p><p><strong>Results: </strong>A total of 76 patients with SCLC were included. Median age was 65 years, and 17.1% had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2. The median duration of the treatment was 4.43 months (Interquartile range: 0.4-6.2). The ORR was 81.67% (95% CI: 70.08-89.44%). The median PFS was 7.2 months (95% CI: 6.5-8.6), and the median OS was 9.4 months (95% CI: 7.0-13.06). Patients with ECOG ≥2, hepatic metastases, and age ≥ 65 years were associated with a poor survival prognosis. Sex and the presence of brain metastases were not significantly associated with survival. Grade ≥ 3 treatment-related adverse events were observed in 44.7% patients, with no treatment-related deaths.</p><p><strong>Conclusions: </strong>In this real-world cohort, atezolizumab plus platinum-etoposide achieved high response rates and acceptable survival with a manageable safety profile in extensive-stage SCLC. Baseline ECOG performance status, hepatic metastases, and older age were associated with worse survival, underscoring the prognostic value of clinical factors. These observational data complement, but do not validate, the results of IMpower133, as no randomized control group or formal trial emulation methods were used.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147934464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Computerized gravimetric control of parenteral analgesic admixtures: A retrospective quality improvement study.","authors":"Sandra Caíña-López, María Carmen Dávila-Pousa","doi":"10.1016/j.farma.2026.03.001","DOIUrl":"https://doi.org/10.1016/j.farma.2026.03.001","url":null,"abstract":"<p><strong>Objective: </strong>Postoperative pain and labor pain are among the most prevalent and intense types of acute pain. Their effective management often requires the administration of parenteral analgesic mixtures combining opioids with local anesthetics. Since no ready-to-use commercial formulations are available and given the complexity and risk of error in their preparation, the Spanish Guide to Good Medication Preparation Practices in Hospital Pharmacy Services recommends their centralized compounding in clean rooms within the pharmacy department. The aim of this study is to describe the implementation experience of a computerized gravimetric control system for stock-prepared analgesic formulations and to assess its reliability and usefulness.</p><p><strong>Method: </strong>A retrospective observational study was conducted including all analgesic units prepared in the Pharmacy Department between July 2024 and April 2025. Gravimetric control was performed using an electronic balance integrated into the Pharmasuite® software, which automatically calculated the concordance between theoretical and actual weight, generating alerts in case of deviations. Primary acceptance limits were set at ±1.5-1.7% depending on the formulation, based on previous experience and the consistency observed in earlier batches. A total of seven different formulations were analyzed.</p><p><strong>Results: </strong>During the study period, 1,460 units were prepared, corresponding to 238 batches. Five out of the seven formulations achieved 100% compliance with the acceptance limit. In the remaining formulations, the proportion of non-compliant units was below 1%. The mean relative standard deviation ranged from 0.189% to 0.338%, always below 0.5%, indicating high reproducibility. The mean actual weight was very close to the theoretical weight in all formulations. Units falling outside the acceptance range were individually discarded, and no complete batch had to be rejected.</p><p><strong>Conclusions: </strong>The implementation of computerized gravimetric control in the compounding of analgesic formulations proved to be an effective and safe strategy to ensure accuracy, detect errors, and reinforce traceability. The experience described represents a quality improvement tool that may be extrapolated to other centers.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147934376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Translated article] Safety of Bruton kinase inhibitors in chronic lymphocytic leukemia: Real world clinical practice.","authors":"Rocío Bello-Calvo, Rita González-Resina, Araceli Rubio-Martínez, Itziar Larrodé-Leciñena, María Pilar Delgado-Beltrán, María Reyes Abad-Sazatornil","doi":"10.1016/j.farma.2026.03.010","DOIUrl":"https://doi.org/10.1016/j.farma.2026.03.010","url":null,"abstract":"<p><strong>Introduction: </strong>Bruton's tyrosine kinase inhibitors (BTKi) have replaced immunochemotherapy in patients with chronic lymphocytic leukemia (CLL). The safety profile, particularly in monotherapy indications under real-world clinical practice conditions, is key to optimizing outcomes.</p><p><strong>Objective: </strong>To describe the safety and tolerability of continuous/indefinite BTKi therapy in patients with CLL treated in the first line and relapse/refractory (R/R) conditions with BTKi monotherapy, within labeled indications, at a tertiary care hospital.</p><p><strong>Methods: </strong>Observational, retrospective, single-centre study including patients with CLL treated with iBTK (2015-2024). Demographic data, previous lines of treatment, dose adjustments and suspensions, and adverse events (AEs) by system and severity were recorded. Proportions were compared using Fisher's exact test. Treatment continuation was analyzed using Kaplan-Meier curves, log-rank tests, and Cox regression.</p><p><strong>Results: </strong>Eighty-three patients (50.6% male) were included, with a mean age at diagnosis of 67.2 years. Forty-eight (58%) received iBTK as first-line therapy and 35 (42%) in R/R. The most commonly used iBTK was ibrutinib (62.5% in first-line and 88.6% in R/R). Median follow-up was 20.8 months. Overall, 28.9% required dose adjustment, with no differences between the two groups (p = 0.158). Treatment discontinuation was more frequent in patients with R/R patients (74.3% vs. 39.6%; RR 1.81; 95% CI: 1.23-2.66; p = 0.002). AE were the most common reason for treatment discontinuation (15.7%). A total of 161 AEs were recorded, with infectious AE being the most frequent category. Respiratory infections were significantly more common in R/R patients (p = 0.046). Patients with prior exposure to immunochemotherapy had an increased risk of treatment discontinuation (HR = 2.15; 95% CI: 1.18-3.89; p = 0.012).</p><p><strong>Conclusions: </strong>BTKi showed a manageable safety profile, with infections as the most common toxicity and secondary malignancies occurring at rates comparable to those reported in the literature. Treatment discontinuation was less frequent in the frontline setting, underscoring the influence of clinical context and prior therapies. Despite the limitations of a retrospective, single-centre design, this study provides information applicable to daily practice and highlights the importance of close follow-up to optimize both safety and treatment continuity.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147857494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}