FARMACIA HOSPITALARIA最新文献

{"title":"[Translated article] New roles and challenges of the hospital pharmacist","authors":"Teresa Bermejo Vicedo , Maria Queralt Gorgas , Luis Margusino Framinan","doi":"10.1016/j.farma.2024.07.008","DOIUrl":"10.1016/j.farma.2024.07.008","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324001247/pdfft?md5=35c7b8005f9fb4ef8965e9171c74ade6&pid=1-s2.0-S1130634324001247-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Translated article] Creating a profession","authors":"Olga Delgado Sánchez","doi":"10.1016/j.farma.2024.05.015","DOIUrl":"10.1016/j.farma.2024.05.015","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324000953/pdfft?md5=de85e476caf5a8a32fe00fe1cb210083&pid=1-s2.0-S1130634324000953-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Desarrollo y consenso de un cuadro de mando para evaluar la actividad investigadora en los servicios de farmacia hospitalaria en España","authors":"Vicente Escudero-Vilaplana ,&nbsp;Ana Belén Guisado-Gil ,&nbsp;Bernardo Santos-Ramos ,&nbsp;Ana Herranz","doi":"10.1016/j.farma.2023.12.007","DOIUrl":"10.1016/j.farma.2023.12.007","url":null,"abstract":"<div><h3>Objective</h3><p>To develop by consensus a dashboard model to standardize and promote the evaluation of research activity in Spanish Hospital Pharmacy Services.</p></div><div><h3>Methods</h3><p>The study was carried out in 5 phases following the modified Delphi methodology: constitution of the coordinating group, elaboration of a list of scenarios, selection of participating centers, evaluation of the list of scenarios, and analysis of the results.</p><p>The coordinating group designed a questionnaire with 114 questions. General research questions and different scenarios (indicators) were included to form the dashboard. The Hospital Pharmacy Services with the highest number of publications were identified to participate in the Delphi consultation. Two rounds of consultations were conducted in which the \"Need\" and/or \"Feasibility\" of their measurement was evaluated for each of the scenarios, using a numerical scale from 1 (lowest score) to 9 (highest score).</p></div><div><h3>Results</h3><p>Sixteen Hospital Pharmacy Services, belonging to 8 different autonomous communities, participated in the Delphi consultation. A total of 100% of them responded to all the questions in the 2 rounds of consultations. It was considered that the Hospital Pharmacy Services should have a research dashboard (need = 100%) with a basic structure and a common minimum set of data for all them (need = 87.5%). The consensus was reached on distinguishing research projects led by the Hospital Pharmacy Services from those led by other groups in which the Hospital Pharmacy Services collaborate (need = 87.5%), and a definition was approved on the leadership of these projects according to whether they are single-center or multicenter.</p><p>A consensus was reached on 40 indicators to form the dashboard, which evaluates publications (13 indicators), human resources (12 indicators), research projects (9 indicators), doctoral theses (4 indicators), and patents and intellectual property registrations (2 indicators).</p></div><div><h3>Conclusions</h3><p>This is the first consensus dashboard developed to evaluate the research activity of the Hospital Pharmacy Services, which will help to analyze the productivity and impact of research systematically and continuously. In addition, it will allow comparison between them and will help to establish synergies and identify trends, patterns, and challenges.</p></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324000072/pdfft?md5=79cd688149ef5c0a14b71edf5c88c802&pid=1-s2.0-S1130634324000072-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Artículo traducido] Entrevista telemática en telefarmacia: documento de consenso para el seguimiento farmacoterapéutico y la entrega informada de medicamentos","authors":"Sara Barbadillo-Villanueva ,&nbsp;Vera Áreas del Aguila ,&nbsp;María de las Aguas Robustillo-Cortés ,&nbsp;Mercedes Gimeno-Gracia ,&nbsp;Elena Sánchez Yáñez ,&nbsp;Marta Hermenegildo-Caudevilla ,&nbsp;Herminia Navarro Aznárez ,&nbsp;Alicia Lázaro López ,&nbsp;Esther Vicente ,&nbsp;Emilio Monte-Boquet","doi":"10.1016/j.farma.2024.04.008","DOIUrl":"10.1016/j.farma.2024.04.008","url":null,"abstract":"<div><p>Telepharmacy is defined as the practice of remote pharmaceutical care, using information and communication technologies. Given its growing importance in outpatient pharmaceutical care, the Spanish Society of Hospital Pharmacy developed a consensus document, <em>Guía de entrevista telemática en atención farmacéutica</em>, as part of its strategy for the development and expansion of telepharmacy, with key recommendations for effective pharmacotherapeutic monitoring and informed dispensing and delivery of medications through telematic interviews.</p><p>The document was developed by a working group of hospital pharmacists with experience in the field. It highlights the benefits of telematic interviewing for patients, hospital pharmacy professionals, and the healthcare system as a whole, reviews the various tools for conducting telematic interviews, and provides recommendations for each phase of the interview. These recommendations cover aspects such as tool/platform selection, patient selection, obtaining authorization and consent, assessing technological skills, defining objectives and structure, scheduling appointments, reviewing medical records, and ensuring humane treatment.</p><p>Telematic interview is a valuable complement to face-to-face consultations but its novelty requires a strategic and formal framework that this consensus document aims to cover. The use of appropriate communication tools and compliance with recommended procedures ensure patient safety and satisfaction. By implementing telematic interviews, healthcare institutions can improve patient care, optimize the use of resources and promote continuity of care.</p></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324000588/pdfft?md5=81353d5b997f7f583e365b035aac5574&pid=1-s2.0-S1130634324000588-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141082309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Translated article] Development and consensus of a dashboard model to evaluate research activity in Spanish Hospital Pharmacy Services","authors":"Vicente Escudero-Vilaplana ,&nbsp;Ana Belén Guisado-Gil ,&nbsp;Bernardo Santos-Ramos ,&nbsp;Ana Herranz","doi":"10.1016/j.farma.2024.03.006","DOIUrl":"10.1016/j.farma.2024.03.006","url":null,"abstract":"<div><h3>Objective</h3><p>To develop by consensus a dashboard model to standardise and promote the evaluation of research activity in Spanish Hospital Pharmacy Services.</p></div><div><h3>Methods</h3><p>The study was carried out in 5 phases following the modified Delphi methodology: constitution of the coordinating group, elaboration of a list of scenarios, selection of participating centres, evaluation of the list of scenarios, and analysis of the results.</p><p>The coordinating group designed a questionnaire with 114 questions. General research questions and different scenarios (indicators) were included to form the dashboard. The Hospital Pharmacy Services with the highest number of publications were identified to participate in the Delphi consultation. Two rounds of consultations were conducted in which the “Need” and/or “Feasibility” of their measurement was evaluated for each of the scenarios, using a numerical scale from 1 (lowest score) to 9 (highest score).</p></div><div><h3>Results</h3><p>Sixteen Hospital Pharmacy Services, belonging to 8 different Autonomous Communities, participated in the Delphi consultation. A total of 100% of them responded to all the questions in the 2 rounds of consultations. It was considered that the Hospital Pharmacy Services should have a research dashboard (Need<!--> <!-->=<!--> <!-->100%) with a basic structure and a common minimum set of data for all them (Need<!--> <!-->=<!--> <!-->87.5%). The consensus was reached on distinguishing research projects led by the Hospital Pharmacy Services from those led by other groups in which the Hospital Pharmacy Services collaborate (Need<!--> <!-->=<!--> <!-->87.5%), and a definition was approved on the leadership of these projects according to whether they are single-centre or multicentre.</p><p>A consensus was reached on 40 indicators to form the dashboard, which evaluates publications (13 indicators), human resources (12 indicators), research projects (9 indicators), doctoral theses (4 indicators), and patents and intellectual property registrations (2 indicators).</p></div><div><h3>Conclusions</h3><p>This is the first consensus dashboard developed to evaluate the research activity of the Hospital Pharmacy Services, which will help to analyse the productivity and impact of research systematically and continuously. In addition, it will allow comparison between them and will help to establish synergies and identify trends, patterns, and challenges.</p></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324000424/pdfft?md5=f7bde704a578a928e4cb56521db634ce&pid=1-s2.0-S1130634324000424-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acercando la inteligencia artificial a los servicios de farmacia hospitalaria","authors":"Yared González-Pérez ,&nbsp;Alfredo Montero Delgado ,&nbsp;Jose Manuel Martinez Sesmero","doi":"10.1016/j.farma.2024.02.007","DOIUrl":"10.1016/j.farma.2024.02.007","url":null,"abstract":"<div><p>Artificial intelligence (AI) is a broad concept that includes the study of the ability of computers to perform tasks that would normally require the intervention of human intelligence. By exploiting large volumes of healthcare data, artificial intelligence algorithms can identify patterns and predict outcomes, which can help healthcare organizations and their professionals make better decisions and achieve better results. Machine learning, deep learning, neural networks or natural language processing are among the most important methods, allowing systems to learn and improve from data without the need for explicit programming. AI has been introduced in biomedicine, accelerating processes, improving safety and efficiency, and improving patient care.</p><p>By using AI algorithms and Machine Learning, hospital pharmacists can analyze a large volume of patient data, including medical records, laboratory results, and medication profiles, aiding them in identifying potential drug-drug interactions, assessing the safety and efficacy of medicines, and making informed recommendations. AI integration will improve the quality of pharmaceutical care, optimize processes, promote research, deploy open innovation, and facilitate education. Hospital pharmacists who master AI will play a crucial role in this transformation.</p></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S113063432400028X/pdfft?md5=bb30155f99ee033a5977a82ea839934b&pid=1-s2.0-S113063432400028X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Translated article] Retrospective study of home antibiotic infusion therapy using elastomeric infusion pumps","authors":"Sara Ferro Rodríguez ,&nbsp;Yelco Chantres Legaspi ,&nbsp;Eva María Romay Lema ,&nbsp;Blanca Ayuso García ,&nbsp;Paloma Castellano Copa ,&nbsp;Pedro Peinó Camba ,&nbsp;Andrea Barcia Losada ,&nbsp;Cristina Rodríguez Díaz","doi":"10.1016/j.farma.2024.03.011","DOIUrl":"10.1016/j.farma.2024.03.011","url":null,"abstract":"<div><h3>Objectives</h3><p>To describe the experience of home antibiotic infusion therapy using elastomeric infusion pumps, administered to patients admitted to the Home Hospitalisation Unit of a tertiary hospital for 3 years and to analyse clinical evolution and mortality.</p></div><div><h3>Method</h3><p>Retrospective observational study. The medical history of the patients included in the study was reviewed. Information was obtained on personal history, antimicrobial therapy received, and clinical evolution. Statistical analysis was performed using SPSS® 19 software.</p></div><div><h3>Results</h3><p>81 patients were included, 61.7% men, with a mean age of 73.5<!--> <!-->±<!--> <!-->17.5 years. The most frequent comorbidities were diabetes mellitus (30.9%) and chronic kidney disease (28.4%). Patients received a mean of 11.9<!--> <!-->±<!--> <!-->8.5 days of antibiotic treatment in an elastomeric infusion pump. The main focus of infection was respiratory (27.2%), followed by bacteremia (16%) and skin and soft tissue infections (12.3%). Of the infections, 65.4% were monomicrobial, with <em>Pseudomonas aeruginosa</em> being the main microorganism involved (39.6%). The most commonly used antimicrobial was piperacillin/tazobactam (33.3%). The clinical course was good in 85.2% of the patients, but the mortality rate in the 30 days following the end of treatment was 24.7%. In the univariate analysis, a history of neoplasia in the last 5 years (<em>p</em> <!-->=<!--> <!-->.01) and having received fewer days of antibiotic therapy prior to the start of outpatient antimicrobial therapy in infusion pump (<em>p</em> <!-->=<!--> <!-->.04) were associated with worse clinical outcome.</p><p>Age over 80 years was associated with better outcome (<em>p</em> <!-->=<!--> <!-->.03). The diagnosis of heart failure was associated with higher mortality (<em>p</em> <!-->=<!--> <!-->.026) and patients from surgical services, with lower mortality (<em>p</em> <!-->=<!--> <!-->.047). In the multivariate analysis, the presence of neoplasia was associated with unfavourable evolution (<em>p</em> <!-->=<!--> <!-->.012) and heart failure with higher mortality (<em>p</em> <!-->=<!--> <!-->.027).</p></div><div><h3>Conclusions</h3><p>Outpatient antimicrobial therapy in elastomeric infusion pumps is an alternative in patients requiring prolonged intravenous treatment, and age is not a conditioning factor for inclusion in these programs. However, the presence of certain comorbidities can negatively affect the clinical course and mortality of patients.</p></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324000473/pdfft?md5=71f40a095bc0908c395a9598d88fb1d2&pid=1-s2.0-S1130634324000473-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140866109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of retreatment with monoclonal antibodies in chronic/episodic migraine: Real world data","authors":"Patricia García-Lloret ,&nbsp;Mercedes Galván-Banqueri ,&nbsp;María de las Aguas Robustillo-Cortés ,&nbsp;María Fernández-Recio","doi":"10.1016/j.farma.2024.02.003","DOIUrl":"10.1016/j.farma.2024.02.003","url":null,"abstract":"<div><h3>Objective</h3><p>To analyze the response to retreatment in patients with chronic/episodic migraine who discontinued therapy with erenumab/fremanezumab after 1 year of treatment.</p></div><div><h3>Methods</h3><p>Observational, retrospective, single-center, multidisciplinary study in patients with chronic/episodic migraine who received therapy with erenumab/fremanezumab for at least 1 year and discontinued it after achieving an adequate response (optimization). The evaluation of the response after retreatment included the following variables: DMM, MIDAS, and HIT-6 scales at the beginning of retreatment and 3 months later. The response was evaluated in different subgroups (episodic/chronic, erenumab/fremanezumab, and time until retreatment).</p></div><div><h3>Results</h3><p>48 patients were included. 70.8% (<em>n</em> <!-->=<!--> <!-->34) required retreatment with mAb, with a median of 3.9 (2.9–6.4) months until reintroduction. Clinical response after retreatment was achieved in 67.6% (<em>n</em> <!-->=<!--> <!-->23) of patients. No statistically significant differences were found in the analyzed subgroups.</p></div><div><h3>Conclusion</h3><p>Interruption of treatment with erenumab/fremanezumab for chronic/episodic migraine produces a clinical worsening of the disease requiring retreatment in most cases, approximately after 4 months. Two out of three patients respond positively after restarting monoclonal therapy. This response does not appear to be related to the type of migraine, the specific monoclonal antibody prescribed, or the time to retreatment.</p></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324000230/pdfft?md5=02b70001951d147fbddf2188c93d7139&pid=1-s2.0-S1130634324000230-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140068845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Translated article] Real-world persistence with dolutegravir/lamivudine versus bictegravir/emtricitabine/tenofovir-alafenamide among persons with HIV","authors":"Lorena Martín-Zaragoza ,&nbsp;Javier Sánchez-Rubio-Ferrández ,&nbsp;Alberto Onteniente-González ,&nbsp;Marcos Gómez-Bermejo ,&nbsp;Sergio Julio Rodríguez-Álvarez ,&nbsp;Alfonso Monereo-Alonso ,&nbsp;Teresa Molina-García","doi":"10.1016/j.farma.2024.02.016","DOIUrl":"10.1016/j.farma.2024.02.016","url":null,"abstract":"<div><h3>Objetives</h3><p>The main objective was to compare the persistence between dolutegravir/lamivudine (DTG/3TC) and bictegravir/emtricitabine/tenofovir-alafenamide (BIC/FTC/TAF) and to analyze reasons for discontinuation.</p></div><div><h3>Methods</h3><p>We conducted a retrospective, non-interventional, descriptive, and longitudinal study. All human immunodeficiency virus <strong>(</strong>HIV) patients over 18 years treated with DTG/3TC or BIC/FTC/TAF in our center were included.</p><p>Persistence after first year was compared using the χ² test. Kaplan–Meier survival analysis was performed.</p></div><div><h3>Results</h3><p>Three hundred fifty-eight patients were included. 99.5% versus 90.99% of patients were persistent after the first year for DTG/3TC and BIC/FTC/TAF respectively (<em>p</em> <!-->=<!--> <!-->.001).</p><p>Persistence with DGT/3TC was 1237 days (IC95% 1216–1258) and persistence with BIC/FTC/TAF was 986 days [(IC95% 950–1021); <em>p</em> <!-->&lt;<!--> <!-->.001]. The difference was remained after adjusting for covariates with the cox regression model [HR<!--> <!-->=<!--> <!-->8.2 (IC95% 1.03–64.9), <em>p</em> <!-->=<!--> <!-->.047].</p><p>The main reasons for discontinuation for BIC/FTC/TAF were toxicity/tolerability.</p></div><div><h3>Conclusion</h3><p>In our study, patients have a high persistence. Patients on DTG/3TC treatment are more persistent compared to BIC/FTC/TAF, although BIC/FTC/TAF have worse baseline characteristics. The main reason for discontinuation of BIC/FTC/TAF is tolerability/toxicity.</p></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324000606/pdfft?md5=543fedfd0d261c18fbdf714cd6d15b97&pid=1-s2.0-S1130634324000606-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141162601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Translated article] New challenges in advanced therapies","authors":"Juan Eduardo Megías-Vericat ,&nbsp;Ana Bonora-Centelles A ,&nbsp;Tomás Palanques-Pastor ,&nbsp;Cristóbal Eduardo Aguilar Gallardo ,&nbsp;Manuel Guerreiro ,&nbsp;Inés Gómez Seguí ,&nbsp;Javier De La Rubia ,&nbsp;José Luis Poveda Andrés","doi":"10.1016/j.farma.2024.05.001","DOIUrl":"10.1016/j.farma.2024.05.001","url":null,"abstract":"<div><p>The huge development that advanced therapy medicinal products (AMTPs) have experienced in recent years, both commercial and research, represent a challenge for hospital pharmacy at all levels. The aim of this article is to describe the implementation of an advanced therapies unit (AUT) and the process of preparation of the AMTPs according to the “good manufacturing practices” (GMP), as well as the results obtained in a tertiary hospital, as an example of the challenges posed by MTA's academic production.</p><p>The AUT meets the requirements established in the GMP by guaranteeing that the medicines produced therein are of the quality required for the use for which they are intended, and also provides support to various research groups involved in the development of AMTPs. The AUT is composed of a highly qualified multidisciplinary team, qualified and trained in GMP, and is authorized for the preparation of 5 types of AMTPs consisting of allogeneic virus-specific T cells (VST) with various viral specificities. A circuit has been established in collaboration between the UTA and the pharmacy service with the hematology service for the assessment of the clinical indication, the request, and preparation of VST, which allows the treatment of patients receiving hematopoietic stem cell transplants who present viral reactivations resistant or refractory to standard treatment, or who cannot tolerate it due to toxicity. Preliminary results from these AMTPs suggest that VSTs are an effective and safe alternative.</p><p>Academic AMTPs have special interest in orphan indications or in the absence of alternative treatments, and their production through the “hospital exemption” can favor early access in the initial phases of development and at a lower cost. It is essential to promote the training of hospital pharmacists in GMP and their participation in collaboration with other clinicians and researchers to develop AMTPs that meet all logistical and regulatory requirements.</p></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1130634324000813/pdfft?md5=73f8c86507315e88855c74138b051d34&pid=1-s2.0-S1130634324000813-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}