Lupe Rodríguez-de Francisco, Ángela María Villalba-Moreno, Eva Rocío Alfaro-Lara
{"title":"Authorization of off-label drugs in a tertiary hospital: 5-year perspective.","authors":"Lupe Rodríguez-de Francisco, Ángela María Villalba-Moreno, Eva Rocío Alfaro-Lara","doi":"10.1016/j.farma.2025.05.018","DOIUrl":"https://doi.org/10.1016/j.farma.2025.05.018","url":null,"abstract":"<p><strong>Introduction: </strong>The off-label use of drugs requires scientific support to balance risk/benefit, being limited to exceptional cases in which there are no therapeutic alternatives.</p><p><strong>Methods: </strong>Retrospective descriptive study of the reports of the Pharmacy and Therapeutics Committee between 2018 and 2022 in a third level hospital; analyzing the requests, drugs, final opinion, reasons, level of evidence and economic impact.</p><p><strong>Results: </strong>A total of 124 reports were analyzed, highlighting oncohematological (41.9%) and autoimmune (27.4%) diseases as main indications. Oncology (37.1%) and Pediatrics (18.5%) were the main applicants, with 87.9% for antineoplastic and immunomodulatory drugs. A total of 74.2% of the applications were approved due to lack of alternatives and solid evidence (phase II-III trials), while 25.8% were denied due to the availability of therapeutic options or insufficient evidence. In terms of cost, 53% of oncohematological drugs cost between €10,000-50,000/treatment and 62.1% of non-oncohematological drugs cost between €1,000-10,000/year. Approval of the rejected treatments would have generated an additional expenditure of €2,272,603.</p><p><strong>Conclusion: </strong>An increase of up to four times in the evaluation of off-label use drugs was evidenced, with a high approval rate.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144592620","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}
María José Otero , Belén Rodríguez Marrodan , Nuria Prieto Santos , Enrique Villalobos Pinto , Silvia Manrique Rodríguez , Rebeca Padilla Peinado , Cecilia M. Fernández-Llamazares , Aurora Madrid Rodríguez , representing the Spanish Association of Pediatrics, the Spanish Society of Hospital Pharmacy and Autonomous Communities
{"title":"[Translated article] Recommendations for the safe use of high-risk medications in pediatrics","authors":"María José Otero , Belén Rodríguez Marrodan , Nuria Prieto Santos , Enrique Villalobos Pinto , Silvia Manrique Rodríguez , Rebeca Padilla Peinado , Cecilia M. Fernández-Llamazares , Aurora Madrid Rodríguez , representing the Spanish Association of Pediatrics, the Spanish Society of Hospital Pharmacy and Autonomous Communities","doi":"10.1016/j.farma.2025.03.006","DOIUrl":"10.1016/j.farma.2025.03.006","url":null,"abstract":"<div><h3>Objective</h3><div>The objectives of this consensus document were to establish a standardized list of high-risk medications for the pediatric population and to compile the recommended practices for their safe use with the aim of promoting the implementation of medication error prevention programs in health care centers.</div></div><div><h3>Method</h3><div>The Ministry of Health, the Spanish Institute for Safe Medication Practices, the Spanish Association of Pediatrics and the Spanish Society of Hospital Pharmacy and regional administration representatives participated in the project. The <em>Recommendations for the Safe Use of High-Risk Medications</em> was used as reference, and its contents adapted and expanded to address specific issues in the pediatric population based on the current evidence.</div></div><div><h3>Results</h3><div>The document provides a reference list of high-risk medicines in pediatric care. It recommends that health care centers, in addition to prioritizing interventions in relation to anticoagulants, insulins, opioids, neuromuscular blockers, IV potassium, oral methotrexate and cytostatic agents, also consider interventions for IV adrenergic agonists, aminoglycosides and vancomycin, drugs for moderate and minimal sedation, parenteral nutrition and IV paracetamol in pediatric patients. The document emphasizes the need to implement multiple safe practices at every stage of the medication use process, prioritizing those with the greatest effectiveness, and involving pediatricians, pharmacists and other healthcare professionals. It also highlights the importance of active involvement by patients and caregivers. Finally, it provides general guidelines common to all these medications, as well as specific practices for each prioritized pharmacological group or medication, which should be combined to enhance pediatric patient safety.</div></div><div><h3>Conclusion</h3><div>Developing programs to increase the safety of high-risk medications in pediatric patients is essential in order to reduce medication errors in this vulnerable population. The implementation of safe practices should be accompanied by continuous monitoring and periodic updates to guarantee effectiveness and strengthen the safety culture in health care centers.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 4","pages":"Pages T252-T260"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144703491","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}
Filipa Alves da Costa , Fernando Fernandez-Llimos , Shane Desselle , Isabelle Arnet , Zaheer Babar , Christine Bond , Maria Cordina , Victoria Garcia Cardenas , Maguy S. El Hajj , Ramune Jacobsen , Anandi V. Law , Lotte S. Nørgaard , Carlo Polidori , Natalia Shcherbakova , Derek Stewart , Fernanda S. Tonin , Anita E. Weidmann
{"title":"The International Collaboration of Pharmacy Journal Editors (ICPJE) formally constituted to foster quality around clinical and social pharmacy practice research publications","authors":"Filipa Alves da Costa , Fernando Fernandez-Llimos , Shane Desselle , Isabelle Arnet , Zaheer Babar , Christine Bond , Maria Cordina , Victoria Garcia Cardenas , Maguy S. El Hajj , Ramune Jacobsen , Anandi V. Law , Lotte S. Nørgaard , Carlo Polidori , Natalia Shcherbakova , Derek Stewart , Fernanda S. Tonin , Anita E. Weidmann","doi":"10.1016/j.farma.2024.12.002","DOIUrl":"10.1016/j.farma.2024.12.002","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 4","pages":"Pages 195-197"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144703736","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}
Teresa Rovira Medina , Pablo Yanes Sánchez , Miriam Bullich Ramon , Maria Oliver Cervelló , Mònica Gómez-Valent
{"title":"[Translated article] Abstinence syndrome following ingestion of poppy seed tea: A case report","authors":"Teresa Rovira Medina , Pablo Yanes Sánchez , Miriam Bullich Ramon , Maria Oliver Cervelló , Mònica Gómez-Valent","doi":"10.1016/j.farma.2025.01.005","DOIUrl":"10.1016/j.farma.2025.01.005","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 4","pages":"Pages T261-T263"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143587683","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}
Manuel David Gil-Sierra , Maria del Pilar Briceño-Casado , Cristina Moreno-Ramos
{"title":"[Translated article] Clinical decision making on retreatment with monoclonal antibodies in chronic/episodic migraine","authors":"Manuel David Gil-Sierra , Maria del Pilar Briceño-Casado , Cristina Moreno-Ramos","doi":"10.1016/j.farma.2025.01.003","DOIUrl":"10.1016/j.farma.2025.01.003","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 4","pages":"Pages T264-T265"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774566","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}
Filipa Alves da Costa , Fernando Fernandez-Llimos , Shane Desselle , Isabelle Arnet , Zaheer Babar , Christine Bond , Maria Cordina , Victoria Garcia Cardenas , Maguy S. El Hajj , Ramune Jacobsen , Anandi V. Law , Lotte S. Nørgaard , Carlo Polidori , Natalia Shcherbakova , Derek Stewart , Fernanda S. Tonin , Anita E. Weidmann
{"title":"[Artículo traducido] La International Collaboration of Pharmacy Journal Editors (ICPJE) se constituye formalmente para fomentar la calidad en torno a las publicaciones de investigación sobre farmacia práctica, clínica y social","authors":"Filipa Alves da Costa , Fernando Fernandez-Llimos , Shane Desselle , Isabelle Arnet , Zaheer Babar , Christine Bond , Maria Cordina , Victoria Garcia Cardenas , Maguy S. El Hajj , Ramune Jacobsen , Anandi V. Law , Lotte S. Nørgaard , Carlo Polidori , Natalia Shcherbakova , Derek Stewart , Fernanda S. Tonin , Anita E. Weidmann","doi":"10.1016/j.farma.2025.06.005","DOIUrl":"10.1016/j.farma.2025.06.005","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 4","pages":"Pages T195-T197"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144530308","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}
Manuel David Gil-Sierra , Maria del Pilar Briceño-Casado , Cristina Moreno-Ramos
{"title":"Toma de decisiones clínicas sobre el retratamiento con anticuerpos monoclonales en la migraña crónica/episódica","authors":"Manuel David Gil-Sierra , Maria del Pilar Briceño-Casado , Cristina Moreno-Ramos","doi":"10.1016/j.farma.2024.10.006","DOIUrl":"10.1016/j.farma.2024.10.006","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 4","pages":"Pages 264-265"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142740901","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}
Laura Doménech-Moral , Javier Santader-Reboreda , Meri Martin-Cerezuela , Amaia Egüés Lugea , Marcos Buj Vicente , Sofía Contreras Medina
{"title":"[Translated article] Prospective observational follow-up study of psychoactive drug treatment initiated in the intensive care unit","authors":"Laura Doménech-Moral , Javier Santader-Reboreda , Meri Martin-Cerezuela , Amaia Egüés Lugea , Marcos Buj Vicente , Sofía Contreras Medina","doi":"10.1016/j.farma.2024.12.003","DOIUrl":"10.1016/j.farma.2024.12.003","url":null,"abstract":"<div><h3>Objective</h3><div>The treatment and prevention of delirium in the intensive care unit (ICU) have gained significant importance in patient care in recent years. Some studies have linked delirium with increased risks of mortality, prolonged hospital stay, and more days of mechanical ventilation. This study aims to analyse the use of psychotropic drugs initiated in the ICU and their continuation upon hospital discharge, as well as to evaluate their contribution to polypharmacy and associated adverse clinical effects.</div></div><div><h3>Method</h3><div>A multicentre prospective observational case study was designed, focusing on patients over 18 years old admitted to the ICU and treated with psychotropic drugs. Data on demographics, variables related to admission and psychotropic drug treatment, as well as clinical outcomes and adverse effects, will be collected. Among other variables, the frequency of psychotropic treatments initiated in the ICU and continued upon discharge from the ICU and the hospital will be measured. Data collection will be performed through review of electronic medical records and prescription programmes, and IBM SPSS 20.0 statistical package will be used for analysis.</div></div><div><h3>Discussion</h3><div>Delirium is common in ICU patients and is associated with long-term negative consequences. Although antipsychotics are used to treat delirium, their prolonged use can have adverse effects, and their continuation after ICU discharge contributes to polypharmacy. This study aims to provide information on the use of psychotropic drugs initiated in the ICU and their continuation upon discharge, with the goal of identifying opportunities for intervention and reducing unnecessary use of these medications.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 4","pages":"Pages T230-T234"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143013868","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}
Enrique Contreras Macías , María de las Aguas Robustillo Cortés , Ramón Morillo Verdugo
{"title":"[Artículo traducido] Trayectorias duales de polifarmacia e índice de complejidad farmacoterapéutico en personas que viven con infección por el virus de la inmunodeficiencia humana en España","authors":"Enrique Contreras Macías , María de las Aguas Robustillo Cortés , Ramón Morillo Verdugo","doi":"10.1016/j.farma.2025.02.003","DOIUrl":"10.1016/j.farma.2025.02.003","url":null,"abstract":"<div><h3>Introduction</h3><div>Polypharmacy, using six or more medications, may increase the risk of high medication regimen complexity index (MRCI). We aimed to identify the interrelationship between trajectories of polypharmacy and MRCI.</div></div><div><h3>Methods</h3><div>People living with HIV (PLWH) (aged ≥ 18) were included in from 2010 to 2021. Group-based trajectory modeling (GBTM) was used to identify polypharmacy trajectories and the complexity index of the medication regimen and the dual GBTM to identify their interrelationship.</div></div><div><h3>Results</h3><div>In total, 789 participants who met the eligibility criteria were included in the study, with a median age of 47 years. GBTM analysis was used to reveal latent polypharmacy trajectories among PLWH. The findings disclosed four distinctive trajectories, with the majority (50.8%) of the PLWH falling into the “low increasing” trajectory. Furthermore, GBTM identified two trajectories characterized by high MRCI, and a substantial proportion (80.2%) was assigned to the ‘slightly increasing low’ trajectory group. The study revealed that younger age (less than 50 years) was a significant predictor of membership in the ‘consistently low’ trajectory, while male gender was associated with the groups of ‘low increasing’ and ‘moderately decreasing’ polypharmacy trajectory.</div></div><div><h3>Conclusions</h3><div>GBTM failed to discern a discernible interrelationship between polypharmacy and the high MRCI. It is imperative to undertake future studies within this research domain, considering potential effect modifiers, notably the specific type of concomitant drug. This approach is crucial due to the outcomes induced by both polypharmacy and the magnitude of the pharmacotherapeutic complexity in PLWH.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 4","pages":"Pages T218-T224"},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143721983","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] BPS certification as strategy for continuing professional development in hospital pharmacy.","authors":"Josep Maria Guiu Segura","doi":"10.1016/j.farma.2025.06.009","DOIUrl":"https://doi.org/10.1016/j.farma.2025.06.009","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144555225","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}