Pub Date : 2025-01-24DOI: 10.1016/j.farma.2024.12.004
Fernando Becerril-Moreno, Marta Valera-Rubio, Irene Aquerreta-González, Esther Domingo-Chiva, Laura Doménech-Moral, María Martín-Cerezuela, Edurne Fernández de Gamarra-Martínez, Sara Cobo-Sacristán
The main objective of the activity carried out in an intensive care unit (ICU) and in general, in all hospitalization units, is to provide all the human and material resources to offer the best therapeutic care to admitted patients. Work in multidisciplinary teams, made up of specialists in intensive care medicine as those responsible for the patients, doctors from other specialties, specialized nursing, physiotherapists, nutritionists, and clinical pharmacists is an optimal approach to achieve the proposed objective. The activities of the clinical pharmacist can be developed at different levels (basic, intermediate, and excellent) depending on the degree of involvement, the time dedicated, the training, and the available resources. This article aims to establish an initial work guide, through recommendations aimed at the activity to be developed by the clinical pharmacist in the ICU in relation to critical patient care and quality improvement, which serves as a reference for those pharmacists who go to develop pharmaceutical care activities in critical patients.
{"title":"[Translated article] Activities of clinical pharmacists in intensive care units.","authors":"Fernando Becerril-Moreno, Marta Valera-Rubio, Irene Aquerreta-González, Esther Domingo-Chiva, Laura Doménech-Moral, María Martín-Cerezuela, Edurne Fernández de Gamarra-Martínez, Sara Cobo-Sacristán","doi":"10.1016/j.farma.2024.12.004","DOIUrl":"https://doi.org/10.1016/j.farma.2024.12.004","url":null,"abstract":"<p><p>The main objective of the activity carried out in an intensive care unit (ICU) and in general, in all hospitalization units, is to provide all the human and material resources to offer the best therapeutic care to admitted patients. Work in multidisciplinary teams, made up of specialists in intensive care medicine as those responsible for the patients, doctors from other specialties, specialized nursing, physiotherapists, nutritionists, and clinical pharmacists is an optimal approach to achieve the proposed objective. The activities of the clinical pharmacist can be developed at different levels (basic, intermediate, and excellent) depending on the degree of involvement, the time dedicated, the training, and the available resources. This article aims to establish an initial work guide, through recommendations aimed at the activity to be developed by the clinical pharmacist in the ICU in relation to critical patient care and quality improvement, which serves as a reference for those pharmacists who go to develop pharmaceutical care activities in critical patients.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143041515","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}
Pub Date : 2025-01-23DOI: 10.1016/j.farma.2024.10.011
Emilio Jesús Alegre-Del Rey, Silvia Fénix-Caballero, María Dolores Fraga Fuentes, Manuel Jesús Cárdenas Aranzana, Eduardo Lopez-Briz, Francesc Puigventós Latorre, Carmen María Domínguez-Santana
The objective of regulatory authorities is to ensure a favourable risk-benefit balance for medicines in their licenced indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licenced indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatment(s); moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties. Many cases highlight the need to establish a more specific therapeutic benefit scenario than the licenced indication. For example, abemaciclib was approved in the adjuvant setting for high-risk patients with early breast cancer, but the appropriate level of risk and how to assess it needs to be specified. Also, pembrolizumab is approved for neoadjuvant plus adjuvant treatment in lung cancer; but it remains to be analysed whether it is superior to nivolumab in neoadjuvant treatment alone, which involves less treatment and economic burden. As therapeutic positioning is always a necessary decision, whether made at a national, regional, local, or individual level, it must be made in the most appropriate way. The absence of a multidisciplinary discussion and consensus, relying only on individual decisions to determine positioning from the outset, underestimates information gaps, inter-individual variability, and the influence of drug promotion. It can be harmful and costly. To properly manage the introduction of new medicines, it is essential to establish their benefit scenario in a multidisciplinary way. This, together with consideration of the clinical benefit provided versus the appropriate alternatives and the uncertainties of the benefit, constitutes the objective of the clinical assessment and the basis for designing a well-focused economic analysis. This allows policy-makers to make the most appropriate decisions on pricing and funding new treatments. In an ideal situation, the benefit scenario considered for the new medicine would coincide with the one established for funding, but costs that are difficult to bear may lead to restrictions and affect the final positioning after the economic and budgetary impact assessment.
{"title":"[Translated article] The relevance of therapeutic positioning in the post-approval evaluation of new drugs.","authors":"Emilio Jesús Alegre-Del Rey, Silvia Fénix-Caballero, María Dolores Fraga Fuentes, Manuel Jesús Cárdenas Aranzana, Eduardo Lopez-Briz, Francesc Puigventós Latorre, Carmen María Domínguez-Santana","doi":"10.1016/j.farma.2024.10.011","DOIUrl":"https://doi.org/10.1016/j.farma.2024.10.011","url":null,"abstract":"<p><p>The objective of regulatory authorities is to ensure a favourable risk-benefit balance for medicines in their licenced indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licenced indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatment(s); moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties. Many cases highlight the need to establish a more specific therapeutic benefit scenario than the licenced indication. For example, abemaciclib was approved in the adjuvant setting for high-risk patients with early breast cancer, but the appropriate level of risk and how to assess it needs to be specified. Also, pembrolizumab is approved for neoadjuvant plus adjuvant treatment in lung cancer; but it remains to be analysed whether it is superior to nivolumab in neoadjuvant treatment alone, which involves less treatment and economic burden. As therapeutic positioning is always a necessary decision, whether made at a national, regional, local, or individual level, it must be made in the most appropriate way. The absence of a multidisciplinary discussion and consensus, relying only on individual decisions to determine positioning from the outset, underestimates information gaps, inter-individual variability, and the influence of drug promotion. It can be harmful and costly. To properly manage the introduction of new medicines, it is essential to establish their benefit scenario in a multidisciplinary way. This, together with consideration of the clinical benefit provided versus the appropriate alternatives and the uncertainties of the benefit, constitutes the objective of the clinical assessment and the basis for designing a well-focused economic analysis. This allows policy-makers to make the most appropriate decisions on pricing and funding new treatments. In an ideal situation, the benefit scenario considered for the new medicine would coincide with the one established for funding, but costs that are difficult to bear may lead to restrictions and affect the final positioning after the economic and budgetary impact assessment.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143041516","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}
Pub Date : 2025-01-22DOI: 10.1016/j.farma.2024.12.008
Juan Manuel Rodríguez-Camacho, José Manuel Caro-Teller, Sergio Plata-Paniagua, Juan Alfredo Montero-Delgado, Inés Jiménez-Lozano, Carmen María Cuadros-Martínez
Introduction: The Community Pharmacy Survey on Patient Safety Culture (CPSOPSC) is a tool created by the Agency for Healthcare Research and Quality and used in the United States to assess the patient safety culture among community pharmacy workers. This survey has been adapted for use in hospital pharmacies in other countries. However, it has not yet been implemented in Spanish hospital pharmacies due to the lack of an applicable version in Spain. This project aims to adapt and reach a consensus on the CPSOPSC for its subsequent use as a tool to improve patient safety in hospital pharmacies in Spain.
Methods: This non-clinical study will be developed in different phases: obtaining the necessary permissions, reviewing the literature to identify studies on the use of the CPSOPSC in hospital pharmacies, adapting the survey's questions to the sociocultural context, reaching a consensus on the questions using the Delphi-Rand/UCLA methodology with a panel of patient safety experts. These experts, who are hospital pharmacists, will evaluate the adapted survey in several rounds, using a Likert scale and telematic workshops to adjust the questions. Finally, a software application will be developed for the implementation, completion, and data management of the survey.
Discussion: Adapting the CPSOPSC to hospital pharmacies in Spain may be a useful tool for measuring the patient safety culture in this context. Through the Delphi-Rand/UCLA methodology, expert consensus and the relevance of the survey are ensured. Additionally, the creation of a computer application will facilitate data collection and analysis, promoting its use among professionals. The resulting survey from this project can identify specific needs and areas for improvement in Spanish hospital pharmacies, being useful for future actions aimed at improving patient safety.
{"title":"[Translated article] Protocol for the adaptation and consensus of the Community Pharmacy Survey on Patient Safety Culture to hospital pharmacy in Spain.","authors":"Juan Manuel Rodríguez-Camacho, José Manuel Caro-Teller, Sergio Plata-Paniagua, Juan Alfredo Montero-Delgado, Inés Jiménez-Lozano, Carmen María Cuadros-Martínez","doi":"10.1016/j.farma.2024.12.008","DOIUrl":"https://doi.org/10.1016/j.farma.2024.12.008","url":null,"abstract":"<p><strong>Introduction: </strong>The Community Pharmacy Survey on Patient Safety Culture (CPSOPSC) is a tool created by the Agency for Healthcare Research and Quality and used in the United States to assess the patient safety culture among community pharmacy workers. This survey has been adapted for use in hospital pharmacies in other countries. However, it has not yet been implemented in Spanish hospital pharmacies due to the lack of an applicable version in Spain. This project aims to adapt and reach a consensus on the CPSOPSC for its subsequent use as a tool to improve patient safety in hospital pharmacies in Spain.</p><p><strong>Methods: </strong>This non-clinical study will be developed in different phases: obtaining the necessary permissions, reviewing the literature to identify studies on the use of the CPSOPSC in hospital pharmacies, adapting the survey's questions to the sociocultural context, reaching a consensus on the questions using the Delphi-Rand/UCLA methodology with a panel of patient safety experts. These experts, who are hospital pharmacists, will evaluate the adapted survey in several rounds, using a Likert scale and telematic workshops to adjust the questions. Finally, a software application will be developed for the implementation, completion, and data management of the survey.</p><p><strong>Discussion: </strong>Adapting the CPSOPSC to hospital pharmacies in Spain may be a useful tool for measuring the patient safety culture in this context. Through the Delphi-Rand/UCLA methodology, expert consensus and the relevance of the survey are ensured. Additionally, the creation of a computer application will facilitate data collection and analysis, promoting its use among professionals. The resulting survey from this project can identify specific needs and areas for improvement in Spanish hospital pharmacies, being useful for future actions aimed at improving patient safety.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143029499","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}
Pub Date : 2025-01-20DOI: 10.1016/j.farma.2024.12.003
Laura Doménech-Moral, Javier Santader-Reboreda, Meri Martin-Cerezuela, Amaia Egüés Lugea, Marcos Buj Vicente, Sofía Contreras Medina
Objective: 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.
Method: 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.
Discussion: 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.
{"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":"https://doi.org/10.1016/j.farma.2024.12.003","url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Discussion: </strong>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.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-20","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}
Pub Date : 2025-01-02DOI: 10.1016/j.farma.2024.11.006
Yolanda Hernández Gago, Pedro Alcalá Minagorre, Belén Rodríguez Marrodán, Laura Hernández Sabater, María José Cabañas Poy, Cristina Martínez Roca, Jimena Pérez Moreno
Introduction: Pediatric patients are more likely to experience medication-related errors and serious associated harms. The identification of high-risk medications (HRM) and their study in special populations, such as children with excess body weight (EBW), is a part of safety improvement strategies.
Objective: To generate, through a consensus technique structured by an interdisciplinary group of pediatricians and hospital pharmacists, an operational and updated list of HRM for hospital use in children over 2 years of age. The document was part of a collaboration project between the Spanish Society of Hospital Pharmacists and the Spanish Society of Pediatric Hospital Medicine.
Methods: The study was carried out in 2 sequential phases: (a) preparation of a preliminary list of HRM through bibliographic review and (b) subsequent application of the double-round Delphi method to agree on a definitive list of HRM. The results obtained were validated by calculating the probability of chance agreement and the modified Kappa statistic for each drug.
Results: The original list obtained by bibliographic review included 26 pharmacological classes and 96 drugs. Of the total of 37 experts, 32 (86.4%) completed both rounds of the Delphi. The final consensus list of HRM incorporated 24 pharmacological classes and 101 drugs. The modified Kappa statistic reflected a high percent agreement (94.9%) in the consensus reached by the participants.
Conclusion: This list can establish a tool for future studies and interventions to improve the safety of medications in general pediatric population, as well as in high-risk subgroups, such as pediatric patients with EBW.
{"title":"[Translated article] High-risk pediatric medications: A listing proposal by interdisciplinary consensus technique.","authors":"Yolanda Hernández Gago, Pedro Alcalá Minagorre, Belén Rodríguez Marrodán, Laura Hernández Sabater, María José Cabañas Poy, Cristina Martínez Roca, Jimena Pérez Moreno","doi":"10.1016/j.farma.2024.11.006","DOIUrl":"https://doi.org/10.1016/j.farma.2024.11.006","url":null,"abstract":"<p><strong>Introduction: </strong>Pediatric patients are more likely to experience medication-related errors and serious associated harms. The identification of high-risk medications (HRM) and their study in special populations, such as children with excess body weight (EBW), is a part of safety improvement strategies.</p><p><strong>Objective: </strong>To generate, through a consensus technique structured by an interdisciplinary group of pediatricians and hospital pharmacists, an operational and updated list of HRM for hospital use in children over 2 years of age. The document was part of a collaboration project between the Spanish Society of Hospital Pharmacists and the Spanish Society of Pediatric Hospital Medicine.</p><p><strong>Methods: </strong>The study was carried out in 2 sequential phases: (a) preparation of a preliminary list of HRM through bibliographic review and (b) subsequent application of the double-round Delphi method to agree on a definitive list of HRM. The results obtained were validated by calculating the probability of chance agreement and the modified Kappa statistic for each drug.</p><p><strong>Results: </strong>The original list obtained by bibliographic review included 26 pharmacological classes and 96 drugs. Of the total of 37 experts, 32 (86.4%) completed both rounds of the Delphi. The final consensus list of HRM incorporated 24 pharmacological classes and 101 drugs. The modified Kappa statistic reflected a high percent agreement (94.9%) in the consensus reached by the participants.</p><p><strong>Conclusion: </strong>This list can establish a tool for future studies and interventions to improve the safety of medications in general pediatric population, as well as in high-risk subgroups, such as pediatric patients with EBW.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142928237","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}
Pub Date : 2025-01-01DOI: 10.1016/j.farma.2024.03.013
Ramón Morillo Verdugo , Beatriz Bernardez Ferrán , Aurora Fernández Polo , Luis Margusino Framiñan , José Manuel Martínez Sesmero , Manuel Vélez-Díaz-Pallarés , Esther Vicente-Escrig
Objective
To prioritize the initiatives to be developed for the development of the Strategic Map of Outpatient Care (MAPEX) project to improve the quality of care and Pharmaceutical Care for patients seen in Hospital Pharmacy outpatient clinics in the period 2024–2027 in Spain.
Method
The study was carried out in 4 phases between January and December 2023.
For phase 1, a literature review of the evolution of the project was carried out by the coordinating committee with the aim of establishing a basis on which to define a new proposal for initiatives. In addition, an analysis was made of the health trends that will have an impact in the coming years.
In phase 2, a working group of 19 specialists from all the autonomous communities was created, who were called regional ambassadors. They all made a preliminary proposal of initiatives and established revisions for their adjustment and final version both online and in telematic meetings.
In phase 3, a consensus was established based on the Delphi-Rand/UCLA methodology with two rounds of online voting to select the initiatives classified as: priority and key or breakthrough.
Between the first and second round of voting, a face-to-face “Consensus Conference” was held, where the results of the first round were presented.
In phase 4, a public presentation was made in scientific forums and through the web.
Results
Ten trends in the health sector were identified. A list of 34 initiatives grouped into five lines of work was established. A total of 103 panelists participated in the first round and 76 in the second. Finally, five initiatives were established as priority and 29 as key. Among those prioritized were external visibility, adaptations to the CMO methodology, strengthening certification and improving training.
Conclusions
The initiatives agreed upon as priorities were aimed at improving professional visibility, broadening the methodology of care work, expanding the quality of care, enhancing the training of professionals and the voice of patients.
{"title":"Priorización de iniciativas 2024–2027 del mapa estratégico de atención farmacéutica al paciente externo de la Sociedad Española de Farmacia Hospitalaria","authors":"Ramón Morillo Verdugo , Beatriz Bernardez Ferrán , Aurora Fernández Polo , Luis Margusino Framiñan , José Manuel Martínez Sesmero , Manuel Vélez-Díaz-Pallarés , Esther Vicente-Escrig","doi":"10.1016/j.farma.2024.03.013","DOIUrl":"10.1016/j.farma.2024.03.013","url":null,"abstract":"<div><h3>Objective</h3><div>To prioritize the initiatives to be developed for the development of the Strategic Map of Outpatient Care (MAPEX) project to improve the quality of care and Pharmaceutical Care for patients seen in Hospital Pharmacy outpatient clinics in the period 2024–2027 in Spain.</div></div><div><h3>Method</h3><div>The study was carried out in 4 phases between January and December 2023.</div><div>For phase 1, a literature review of the evolution of the project was carried out by the coordinating committee with the aim of establishing a basis on which to define a new proposal for initiatives. In addition, an analysis was made of the health trends that will have an impact in the coming years.</div><div>In phase 2, a working group of 19 specialists from all the autonomous communities was created, who were called regional ambassadors. They all made a preliminary proposal of initiatives and established revisions for their adjustment and final version both online and in telematic meetings.</div><div>In phase 3, a consensus was established based on the Delphi-Rand/UCLA methodology with two rounds of online voting to select the initiatives classified as: priority and key or breakthrough.</div><div>Between the first and second round of voting, a face-to-face “Consensus Conference” was held, where the results of the first round were presented.</div><div>In phase 4, a public presentation was made in scientific forums and through the web.</div></div><div><h3>Results</h3><div>Ten trends in the health sector were identified. A list of 34 initiatives grouped into five lines of work was established. A total of 103 panelists participated in the first round and 76 in the second. Finally, five initiatives were established as priority and 29 as key. Among those prioritized were external visibility, adaptations to the CMO methodology, strengthening certification and improving training.</div></div><div><h3>Conclusions</h3><div>The initiatives agreed upon as priorities were aimed at improving professional visibility, broadening the methodology of care work, expanding the quality of care, enhancing the training of professionals and the voice of patients.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 1","pages":"Pages 3-10"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140869326","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}
Pub Date : 2025-01-01DOI: 10.1016/j.farma.2024.04.003
F. Dámaso Fernández-Ginés , María T. Gómez Sánchez , Marina Sánchez Valera , Beatriz Tauste Hernández , Marta Garrido Ortiz , Manuel Cortiñas-Sáenz
Purpose
To review and analyze the available literature on peripheral administration of noradrenaline (NA) with the aim of providing recommendations to ensure correct use and patient safety.
Methods
Systematic review on the databases PubMed, ISI Web of Science, SCOPUS and Science Direct, using the following search terms: (“Noradrenaline” [Mesh]) AND (“Norepinephrine” [Mesh]) AND (“Vasopressors” [Mesh]) AND (“Peripheral infusions” [Mesh]) OR (“Extravasations” [Mesh]). A total of 1,040 articles were identified. Animal studies and studies written in languages other than English were excluded. Finally, 83 articles were included.
Results
NA can be administered peripherally. The risk of extravasation should be taken into account, with phentolamine being the first pharmacological line of treatment. It has also been related to the appearance of thrombophlebitis, cellulitis, tissue necrosis, limb ischemia and gangrene, although its incidence seems to be low. The use of peripheral NA in children seems to be carried out without obvious complications. The use of standard concentrations is suggested to reduce the risk of errors. It is recommended to use 0.9% saline as the default diluent for peripheral NA.
Conclusions
Peripheral infusions of NA could be a safe and beneficial option in early resuscitation provided that a number of guidelines are followed that reduce the likelihood of complications associated with this route.
目的:回顾并分析有关外周给药去甲肾上腺素(NA)的现有文献,旨在为确保正确使用和患者安全提供建议:使用以下检索词对 PubMed、ISI Web of Science、SCOPUS 和 Science Direct 等数据库进行系统综述:("去甲肾上腺素"[Mesh])和("去甲肾上腺素"[Mesh])和("血管加压剂"[Mesh])和("外周输注"[Mesh])或("外渗"[Mesh])。共鉴定出 1,040 篇文章。排除了动物研究和以英语以外语言撰写的研究。最后,纳入了 83 篇文章:结果:NA 可以经外周给药。应考虑到外渗的风险,酚妥拉明是第一种药物治疗方法。它还与血栓性静脉炎、蜂窝组织炎、组织坏死、肢体缺血和坏疽的出现有关,尽管其发生率似乎很低。在儿童中使用外周 NA 似乎没有明显的并发症。建议使用标准浓度以减少出错的风险。建议使用0.9%生理盐水作为外周NA的默认稀释液:结论:在早期复苏中,外周输注NA是一种安全、有益的选择,但前提是必须遵守一些准则,以降低与这种途径相关的并发症发生的可能性。
{"title":"Administración segura de noradrenalina por vía periférica: una revisión sistemática","authors":"F. Dámaso Fernández-Ginés , María T. Gómez Sánchez , Marina Sánchez Valera , Beatriz Tauste Hernández , Marta Garrido Ortiz , Manuel Cortiñas-Sáenz","doi":"10.1016/j.farma.2024.04.003","DOIUrl":"10.1016/j.farma.2024.04.003","url":null,"abstract":"<div><h3>Purpose</h3><div>To review and analyze the available literature on peripheral administration of noradrenaline (NA) with the aim of providing recommendations to ensure correct use and patient safety.</div></div><div><h3>Methods</h3><div>Systematic review on the databases PubMed, ISI Web of Science, SCOPUS and Science Direct, using the following search terms: (“Noradrenaline” [Mesh]) AND (“Norepinephrine” [Mesh]) AND (“Vasopressors” [Mesh]) AND (“Peripheral infusions” [Mesh]) OR (“Extravasations” [Mesh]). A total of 1,040 articles were identified. Animal studies and studies written in languages other than English were excluded. Finally, 83 articles were included.</div></div><div><h3>Results</h3><div>NA can be administered peripherally. The risk of extravasation should be taken into account, with phentolamine being the first pharmacological line of treatment. It has also been related to the appearance of thrombophlebitis, cellulitis, tissue necrosis, limb ischemia and gangrene, although its incidence seems to be low. The use of peripheral NA in children seems to be carried out without obvious complications. The use of standard concentrations is suggested to reduce the risk of errors. It is recommended to use 0.9% saline as the default diluent for peripheral NA.</div></div><div><h3>Conclusions</h3><div>Peripheral infusions of NA could be a safe and beneficial option in early resuscitation provided that a number of guidelines are followed that reduce the likelihood of complications associated with this route.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 1","pages":"Pages 46-52"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140899539","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}
To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units.
Methods
Observational, prospective, and multicenter study during the period May 2020–March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed.
Results
A total of 169 patients were included in the study. The average value for the different questions was 3.3 ± 0.6 out of 5, while the average final result was 29.4 points out of 45. 64.5% of the patients had an acceptable level before starting the medication (> 27 points). The multivariate analysis showed a statistically significant correlation (p < .05) with a better score at the beginning of treatment in those patients whose prescribing service was Rheumatology.
Conclusions
In general, the level of knowledge prior to biological therapy in patients is acceptable, being higher in dosage and administration technique related-factors and what is related to the dosage and administration technique and where to find information related to the medication; the worst rated were those on biosimilars-related. The factor of being followed by rheumatology, was associated with better knowledge.
{"title":"[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study","authors":"Carlos Seguí-Solanes , Lidia Estrada , Esther Ramírez Herráiz , Silvia Ruiz-García , Tomás Palanques-Pastor , Vicente Merino Bohórquez , Cristina Capilla Montes , Joaquín Borras-Blasco","doi":"10.1016/j.farma.2024.08.002","DOIUrl":"10.1016/j.farma.2024.08.002","url":null,"abstract":"<div><h3>Objective</h3><div>To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units.</div></div><div><h3>Methods</h3><div>Observational, prospective, and multicenter study during the period May 2020–March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed.</div></div><div><h3>Results</h3><div>A total of 169 patients were included in the study. The average value for the different questions was 3.3<!--> <!-->±<!--> <!-->0.6 out of 5, while the average final result was 29.4 points out of 45. 64.5% of the patients had an acceptable level before starting the medication (><!--> <!-->27 points). The multivariate analysis showed a statistically significant correlation (<em>p</em> <!--><<!--> <!-->.05) with a better score at the beginning of treatment in those patients whose prescribing service was Rheumatology.</div></div><div><h3>Conclusions</h3><div>In general, the level of knowledge prior to biological therapy in patients is acceptable, being higher in dosage and administration technique related-factors and what is related to the dosage and administration technique and where to find information related to the medication; the worst rated were those on biosimilars-related. The factor of being followed by rheumatology, was associated with better knowledge.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 1","pages":"Pages T32-T36"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142356084","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}
Pub Date : 2025-01-01DOI: 10.1016/j.farma.2024.09.006
Laura Lorente Fernández , Samuel Romero Domínguez , Asunción Albert Marí , Esperanza Núñez Benito , Eduardo López Briz , José Luis Poveda Andrés
Objective
The primary objective is to describe the real-life effectiveness and safety of nivolumab treatment in patients with relapsed or refractory classical Hodgkin's lymphoma. The secondary objective is to describe the therapeutic management after nivolumab monotherapy.
Method
Observational, retrospective, multidisciplinary study including all patients with relapsed or refractory classical Hodgkin's lymphoma treated with nivolumab monotherapy from November 2015 to March 2023. Patient and treatment-related variables were collected. Effectiveness was measured as overall response rate, progression-free survival, and overall survival. Safety was measured as percentage of patients with adverse effects and severity.
Results
Thirteen patients were included, median age 37.5 years (RIQ: 25.3–54.7), 84.6% male. The median number of previous lines of therapy was 3 (RIQ: 2–4.5), including autologous haematopoietic stem cell transplantation (84.6%) and brentuximab vedotin (100%). All received nivolumab 3 mg/kg/14 days, with a median of 11 cycles (RIQ: 6.5–20.5) per patient. Median time on treatment was 4.9 months (RIQ: 3–9.6) and median follow-up time was 9.2 months (RIQ: 5.6–32.3).
Complete response was achieved by 3 patients (23.1%), partial response by 3 (23.1%), stable disease by 3 (23.1%), and progression by 4 (30.8%). The objective response rate was 46.2%. Median progression-free survival was 23.9 months (95% CI: 0–49.1), median overall survival was not reached. At the study cut-off date, 5 patients had died (38.5%), 4 were in complete remission without active treatment (30.8%), and 4 were continuing treatment (30.8%).
Adverse events occurred in 76.9% of patients, 44% of severity ≥ 3, the most frequent being hypothyroidism and hepatotoxicity. One patient discontinued treatment due to pneumonitis, 2 suffered treatment delays (thrombocytopenia and hypertransaminemia), and 1 changed the regimen to monthly (pulmonary toxicity).
Conclusions
Nivolumab in the treatment of relapsed or refractory classical Hodgkin's lymphoma has confirmed favourable effectiveness data in the study sample, expressed as objective response rate of 46.2% and a clinical benefit rate of 69.2%. Safety was acceptable, manageable, and consistent with that described in the literature.
{"title":"[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma","authors":"Laura Lorente Fernández , Samuel Romero Domínguez , Asunción Albert Marí , Esperanza Núñez Benito , Eduardo López Briz , José Luis Poveda Andrés","doi":"10.1016/j.farma.2024.09.006","DOIUrl":"10.1016/j.farma.2024.09.006","url":null,"abstract":"<div><h3>Objective</h3><div>The primary objective is to describe the real-life effectiveness and safety of nivolumab treatment in patients with relapsed or refractory classical Hodgkin's lymphoma. The secondary objective is to describe the therapeutic management after nivolumab monotherapy.</div></div><div><h3>Method</h3><div>Observational, retrospective, multidisciplinary study including all patients with relapsed or refractory classical Hodgkin's lymphoma treated with nivolumab monotherapy from November 2015 to March 2023. Patient and treatment-related variables were collected. Effectiveness was measured as overall response rate, progression-free survival, and overall survival. Safety was measured as percentage of patients with adverse effects and severity.</div></div><div><h3>Results</h3><div>Thirteen patients were included, median age 37.5 years (RIQ: 25.3–54.7), 84.6% male. The median number of previous lines of therapy was 3 (RIQ: 2–4.5), including autologous haematopoietic stem cell transplantation (84.6%) and brentuximab vedotin (100%). All received nivolumab 3 mg/kg/14 days, with a median of 11 cycles (RIQ: 6.5–20.5) per patient. Median time on treatment was 4.9 months (RIQ: 3–9.6) and median follow-up time was 9.2 months (RIQ: 5.6–32.3).</div><div>Complete response was achieved by 3 patients (23.1%), partial response by 3 (23.1%), stable disease by 3 (23.1%), and progression by 4 (30.8%). The objective response rate was 46.2%. Median progression-free survival was 23.9 months (95% CI: 0–49.1), median overall survival was not reached. At the study cut-off date, 5 patients had died (38.5%), 4 were in complete remission without active treatment (30.8%), and 4 were continuing treatment (30.8%).</div><div>Adverse events occurred in 76.9% of patients, 44% of severity ≥<!--> <!-->3, the most frequent being hypothyroidism and hepatotoxicity. One patient discontinued treatment due to pneumonitis, 2 suffered treatment delays (thrombocytopenia and hypertransaminemia), and 1 changed the regimen to monthly (pulmonary toxicity).</div></div><div><h3>Conclusions</h3><div>Nivolumab in the treatment of relapsed or refractory classical Hodgkin's lymphoma has confirmed favourable effectiveness data in the study sample, expressed as objective response rate of 46.2% and a clinical benefit rate of 69.2%. Safety was acceptable, manageable, and consistent with that described in the literature.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 1","pages":"Pages T17-T23"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142477323","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}
Pub Date : 2025-01-01DOI: 10.1016/j.farma.2024.08.004
Gabriel Mercadal-Orfila , Carlos Seguí-Solanes , Nuria Rudi-Sola , Maria Eugenia Escriva-Sancho , Rosa Taberner-Ferrer
Atopic dermatitis is a chronic skin condition that affects up to 20% of children and 10% of adults worldwide. Due to the high burden of dermatological signs and symptoms, atopic dermatitis has a significant impact on the quality of life of patients and their families. In the absence of objective measures to accurately assess severity and symptom burden, patient-reported outcome measures are essential to monitor the impact and progression of the disease, as well as the efficacy of treatments. Although there are currently no standardised guidelines for their use in clinical practice, there are some initiatives, such as the Harmonise Outcome Measures for Eczema and Vivir con Dermatitis Atópica, that can provide guidance. As healthcare systems move toward value-based healthcare models, patient-reported measures are becoming increasingly important for incorporating the patient perspective and improving the quality of healthcare services. The use of these measures can help monitor disease activity and guide treatment decisions. This article discusses the impact of atopic dermatitis and describes the patient-reported outcome measures commonly used in atopic dermatitis and the recommendations of the initiatives that have selected a core set of measures to best assess atopic dermatitis in clinical practice. Considering the recommendations of these initiatives and based on our experience in clinical practice, we propose the use of the Dermatology Life Quality Index to assess the impact of the disease on quality of life, the Patient-Oriented Eczema Measure to assess symptom severity, and the Numerical Rating Scale or the Visual Analogue Scale to measure itch intensity. To systematise the administration of these measures and to integrate them into hospital information systems and medical records, we emphasise the importance of telemedicine platforms that allow the electronic administration of these instruments.
{"title":"[Translated article] Patient-reported outcome measures for assessing atopic dermatitis in clinical practice","authors":"Gabriel Mercadal-Orfila , Carlos Seguí-Solanes , Nuria Rudi-Sola , Maria Eugenia Escriva-Sancho , Rosa Taberner-Ferrer","doi":"10.1016/j.farma.2024.08.004","DOIUrl":"10.1016/j.farma.2024.08.004","url":null,"abstract":"<div><div>Atopic dermatitis is a chronic skin condition that affects up to 20% of children and 10% of adults worldwide. Due to the high burden of dermatological signs and symptoms, atopic dermatitis has a significant impact on the quality of life of patients and their families. In the absence of objective measures to accurately assess severity and symptom burden, patient-reported outcome measures are essential to monitor the impact and progression of the disease, as well as the efficacy of treatments. Although there are currently no standardised guidelines for their use in clinical practice, there are some initiatives, such as the Harmonise Outcome Measures for Eczema and <em>Vivir con Dermatitis Atópica</em>, that can provide guidance. As healthcare systems move toward value-based healthcare models, patient-reported measures are becoming increasingly important for incorporating the patient perspective and improving the quality of healthcare services. The use of these measures can help monitor disease activity and guide treatment decisions. This article discusses the impact of atopic dermatitis and describes the patient-reported outcome measures commonly used in atopic dermatitis and the recommendations of the initiatives that have selected a core set of measures to best assess atopic dermatitis in clinical practice. Considering the recommendations of these initiatives and based on our experience in clinical practice, we propose the use of the Dermatology Life Quality Index to assess the impact of the disease on quality of life, the Patient-Oriented Eczema Measure to assess symptom severity, and the Numerical Rating Scale or the Visual Analogue Scale to measure itch intensity. To systematise the administration of these measures and to integrate them into hospital information systems and medical records, we emphasise the importance of telemedicine platforms that allow the electronic administration of these instruments.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 1","pages":"Pages T37-T45"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142298234","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}