FARMACIA HOSPITALARIA最新文献

{"title":"[Translated article] 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.2026.08.007","DOIUrl":"https://doi.org/10.1016/j.farma.2026.08.007","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":1.7,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149116271","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] Listening to transform: Impact of patient experience on the improvement of an outpatient pharmacy unit.","authors":"Silvia Vázquez-Gómez, Susana Castro-Luaces, Leticia Herrero-Poch, Mónica Gayoso-Rey, David Rodríguez-Lorenzo, Mercedes Freire-González, Noemí Martínez-López de Castro","doi":"10.1016/j.farma.2026.08.008","DOIUrl":"https://doi.org/10.1016/j.farma.2026.08.008","url":null,"abstract":"<p><strong>Objective: </strong>Patient experience is currently recognised as one of the pillars of healthcare quality and a key tool for guiding organisational improvement. This study aimed to evaluate how the systematic collection of patient experience through surveys, integrated into a Quality Management System (QMS), can drive improvement interventions in pharmaceutical care for outpatients attending a Hospital Pharmacy Service (HPS).</p><p><strong>Methods: </strong>An observational, descriptive and retrospective study based on repeated annual cross-sectional patient experience surveys was conducted between 2023 and 2025 among outpatients treated at the HPS of a tertiary hospital. The questionnaire assessed patient experience across four thematic domains: facilities, organisation, pharmaceutical consultation and overall satisfaction. Items were rated using a five-point Likert scale, and open-ended fields were included to collect qualitative comments. The surveys were distributed electronically via the Galician Health Service platform. The results were integrated into the PIC/EM continuous improvement cycle (Plan, Implement, Control/Evaluate and Improve) within a QMS certified according to ISO 9001:2015.</p><p><strong>Results: </strong>A total of 15,056 surveys were distributed, and 3,175 responses were obtained, yielding a response rate of 21.1%. Overall satisfaction with the HPS remained high and stable throughout the study period, with mean scores of 4.30 for in-person care and 4.38 for remote care, both exceeding the overall hospital rating. Interaction with the pharmacist, including professional treatment, clarity of information and time devoted to the consultation, was the most highly rated aspect. Survey analysis identified areas for improvement related to telephone communication, appointment management and certain organisational aspects. These findings were used as a strategic input for the QMS to implement interventions aimed at improving accessibility, communication and the humanisation of care.</p><p><strong>Conclusions: </strong>The integration of PREMs into an ISO 9001:2015-certified QMS strengthened patient-centred care by transforming the users' voice, through the PIC/EM cycle, into specific improvement actions, including FarmaLink. The HPS achieved a high satisfaction score, 4.32, which was higher than the hospital average. This co-design model may help optimise strategic resources; future research should assess its actual impact on adherence, clinical outcomes and continuity of care.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149116237","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.2026.08.009","DOIUrl":"https://doi.org/10.1016/j.farma.2026.08.009","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, the European Medicines Agency, and Japan's Pharmaceuticals and Medical Devices Agency, 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 Food and Drug Administration accelerates development via robust tax credits and seven-year market exclusivity, though high pricing remains challenging. The European Medicines Agency emphasizes unmet medical needs and ten-year exclusivity, ensuring more homogeneous pricing despite slower approvals. Japan's Pharmaceuticals and Medical Devices Agency 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":1.7,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149082281","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":"Cardiac arrest due to acute hyperkalemia during liposomal amphotericin B infusion in an infant: A case report.","authors":"Alejandro Donoso, Gianfranco Tomarelli, Daniela Arriagada, Gonzalo Valenzuela","doi":"10.1016/j.farma.2026.07.003","DOIUrl":"https://doi.org/10.1016/j.farma.2026.07.003","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149082251","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":"Measuring what matters: Patient-reported outcomes and experience in value-based healthcare.","authors":"Gabriel Mercadal-Orfila, Sergio Salvador-Pareja, Manuel Pinteño-Blanco","doi":"10.1016/j.farma.2026.09.001","DOIUrl":"https://doi.org/10.1016/j.farma.2026.09.001","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149082242","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":"Immune checkpoint inhibitors versus chemotherapy in COVID-19 among cancer patients.","authors":"Maria Susana Fortes Gonzalez, Leticia Herrero Poch, Silvia Vazquez Blanco, Nerea Garcia Beloso, Iria Sanjuan Casanova, Elena Cerdeira Regueira, Susana Castro Luaces, Carla Fernandez Oliveira, Antonio Perez Landeiro, Noemi Martinez-Lopez de Castro","doi":"10.1016/j.farma.2026.07.012","DOIUrl":"https://doi.org/10.1016/j.farma.2026.07.012","url":null,"abstract":"<p><strong>Objective: </strong>The impact of immune checkpoint inhibitors (ICIs) on SARS-CoV-2 infection in cancer patients remains unclear. The aim of the study was to compare the incidence and severity of COVID-19 in patients treated with ICIs versus chemotherapy (CT).</p><p><strong>Methods: </strong>Retrospective study in adult patients with solid tumors who received at least one cycle of ICI or CT during the pandemic. Patients with hematologic malignancies, concomitant autoimmune diseases, or receiving combined ICI + CT were excluded. The primary endpoint was COVID-19 infection rate (PCR or antigen test) according to the type of treatment received. Secondary endpoints included infection severity according to SEIMC criteria. Differences between groups were analyzed using the chi-square test or Fisher's test for categorical variables. Associated factors were assessed using logistic regression.</p><p><strong>Results: </strong>A total of 235 patients treated with ICI (n = 75) or CT (n = 160) were included. The median age was 64 years and 68.9% were men. Most patients had lung cancer and metastatic disease with good performance status. The overall incidence of COVID-19 was 8.1% (12% ICI vs 6.3% CT, χ² test, p = 0.132). No significant differences were found in infection severity (33.3% ICI vs 66.7% CT, Fisher's test p = 0.370) or mortality (0 deaths ICI vs 3 CT, Fisher's test p = 0.211). Vaccination was associated with a lower risk of infection (OR 0.2, p = 0.003). On the contrary, comorbidity acts as a risk factor (OR 1.6, p = 0.016). No association was found between the duration of ICI treatment and COVID-19 incidence (<3 months [11.1%] vs 3-9 months [22.2%] vs >9 months [66.7%]; χ² test, p = 0.103).</p><p><strong>Conclusions: </strong>Immunotherapy was not associated with a higher risk or greater severity of COVID-19 compared to chemotherapy. Vaccination showed a significant protective effect, whereas each additional comorbidity increased the risk of infection by 60%. These findings should be interpreted with caution given the limited number of COVID-19 events.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149082297","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] PROA-KIDDDs study protocol: Evaluation of antimicrobial use and appropriateness in pediatric and neonatal care in Spain.","authors":"Paloma Suárez-Casillas, Marta Mejías-Trueba, José María Gutiérrez-Urbón, Walter A Goycochea-Valdivia, Elena Varela-Rubio, Olaf Neth, María Goretti López-Ramos, Maria Victoria Gil-Navarro, Ana Belén Guisado-Gil","doi":"10.1016/j.farma.2026.07.005","DOIUrl":"https://doi.org/10.1016/j.farma.2026.07.005","url":null,"abstract":"<p><strong>Objective: </strong>To analyze the use of antimicrobials in the pediatric and neonatal population at a national level in order to identify consumption patterns, assess treatment appropriateness, and detect potential areas for improvement in therapeutic management.</p><p><strong>Method: </strong>We designed a retrospective, cross-sectional, multicenter observational study that included neonatal (<1 month) and pediatric (<15 years) inpatients with at least one active prescription of systemic antibacterials or antifungals. The study consists of two phases. The first phase involves the analysis of antimicrobial consumption through quarterly data collection, expressed as pediatric and neonatal defined daily doses (DDD) per 100 patient-days. A temporal trend analysis will be performed using segmented regression and calculation of the average quarterly percent change with 95% confidence intervals, identifying change points through the Monte Carlo permutation method. The second phase focuses on evaluating prescription appropriateness based on indication, antimicrobial selection, timing of administration, dose, frequency, route of administration, treatment duration, monitoring of efficacy and adverse effects, and documentation in the medical record. The review will be conducted by a hospital pharmacist and an infectious diseases specialist, with interobserver verification in 25% of cases. A sample size of 379 patients (270 pediatric and 109 neonatal) has been estimated for this phase. Differences between variables will be analyzed using Student's t-test, Mann-Whitney U test, Chi-squared test, or Fisher's exact test as appropriate. Inter-rater agreement will be assessed using Cohen's Kappa coefficient, and factors associated with differences in appropriateness will be analyzed through binary logistic regression and generalized lineal mixed models.</p><p><strong>Discussion: </strong>This study will allow the identification of antimicrobial consumption patterns and the evaluation of prescription appropriateness in pediatric and neonatal populations, providing objective and comparable information across centers. The findings will help strengthen Antimicrobial Stewardship Programs, serve as a solid basis for future research, and support the development of targeted national strategies, ultimately improving patient safety and helping to curb the progression of antimicrobial resistance.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149082307","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] Pharmaceutical intervention for the reduction of risks associated with medications in patients with liver cirrhosis in primary care.","authors":"Andrea Rodríguez Esquíroz, Amaya Echeverría Gorriti, Marta Marín Marín, Lorea Sanz Álvarez, Patricia García González, Javier Gorricho Mendivil, Juan Úriz Otano, Javier Garjón Parra, Inés Aguinaga Ontoso","doi":"10.1016/j.farma.2026.07.010","DOIUrl":"https://doi.org/10.1016/j.farma.2026.07.010","url":null,"abstract":"<p><strong>Introduction: </strong>The presence of cirrhosis may require adjustment of medication doses or substitution with safer alternatives. Inadequate treatment can lead to medication-related problems, which in most cases are preventable. The objectives are to describe the implementation of a safety strategy consisting of a comprehensive medication review for patients with cirrhosis, and to evaluate the acceptance rate of the intervention.</p><p><strong>Methods: </strong>It is a study of the implementation of a medication risk minimization strategy. It consisted of a medication review by hospital pharmacists, with clinical advice from a physician specializing in hepatology to patients in Primary Care.</p><p><strong>Results: </strong>A total of 307 patients were included in the study, of whom 76.2% had at least one potentially inappropriate medication prescribed, for with a safer alternative was available in 87.2% of cases. Benzodiazepines and related drugs, proton pump inhibitors, and lipid-lowering drugs were the most frequently proposed. Benzodiazepines and related drugs were the least modified by physicians. 48.1% of the 405 proposals were accepted.</p><p><strong>Conclusions: </strong>A high percentage of patients with cirrhosis were receiving inadequate treatment for their hepatic pathology, despite the availability of alternatives to minimize risks in most cases. Half of the pharmacists' recommendations were accepted and the acceptance rate of these proposals was not influenced by patient characteristics.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149065017","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.2026.08.003","DOIUrl":"https://doi.org/10.1016/j.farma.2026.08.003","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149041283","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":"Risk-free hospital at home: Strengthening safety in the patient's environment through hospital pharmacy.","authors":"Daniel Gómez-Costas, Ana de Lorenzo-Pinto, Vicente Escudero-Vilaplana, Ana Herranz-Alonso, María Sanjurjo-Sáez","doi":"10.1016/j.farma.2026.08.001","DOIUrl":"https://doi.org/10.1016/j.farma.2026.08.001","url":null,"abstract":"<p><p>Hospital at home has become an established care model capable of delivering high-complexity treatment in the patient's own environment; however, it shifts part of the medication circuit to a less controlled setting, introducing variability that may compromise pharmacotherapeutic safety. A descriptive quality-improvement study was conducted to evaluate the implementation of a multidimensional medication-safety programme in the Hospital at Home unit of a tertiary-care hospital. The programme was structured according to the Joint Commission International standards for home care and led by the Hospital Pharmacy Service. Between October 2023 and December 2024, seven strategies were implemented: high-alert medication management, restriction of concentrated electrolytes, standardization of a home emergency medication kit, introduction of a domiciliary pharmaceutical-suitability checklist, protocol updating, staff training, and development of educational resources for patients and caregivers. The initial evaluation, conducted in January and February 2025, included a before-and-after comparison of concentrated-electrolyte dispensing, two post-implementation audits of high-alert medication labelling and emergency-kit adequacy, and a descriptive analysis of the remaining process indicators. Correct labelling of high-alert medications increased from 91% to 98%, concentrated-electrolyte dispensing decreased by 100%, and emergency-kit adequacy improved from 75% to 100%. The domiciliary checklist was completed for 100% of the evaluated cases; deficiencies were identified in 28%, all of which were corrected during the first visit, with no cases of ineligibility due to medication-safety concerns. Attendance at the training sessions was 100% among physicians and 89% among nursing staff, with an overall satisfaction score of 9.45 out of 10. The findings show that a programme based on international standards and led by the Hospital Pharmacy Service can be implemented and evaluated in the home setting. Its application in other centers would require adaptation to their structure and resources, together with periodic monitoring of the indicators.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.7,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149041288","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}