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OBJECTIVE: To design a homogeneous methodology for the registration and analysis of pharmaceutical interventions performed in Spanish critical adults' care units. METHOD: Observational, prospective and multicenter study. In the first stage, a national registry of pharmaceutical interventions will be agreed upon and subsequently all the pharmaceutical interventions performed on adult patients admitted to Spanish CCUs during eight weeks will be recorded. Variables related to the type of CCU, the drug involved in the intervention, type of intervention (indication, effectiveness, safety), recommendation made by the pharmacist and the degree of acceptance will be evaluated. Risk and incidence will be calculated for each of the medication errors detected. The χ2-squared test or Fisher exact test will be used for categorical variables and Mann-Whitney U or Kruskal-Wallis test for continuous variables. All tests will be performed with a significance level αâ¯=â¯0.05 and confidence intervals with confidence 1- α. DISCUSSION: The results obtained from this project will make it possible to obtain a homogeneous classification of the pharmaceutical interventions performed in CCU, a national record and an evaluation of the weak points with the aim of developing strategies for improvement in the pharmaceutical care of the critically ill patient.
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Introduction: Actions to reduce and optimize antimicrobial use are crucial in the management of infectious diseases to counteract the emergence of short- and long-term resistance. This is particularly important for pediatric patients due to the increasing incidence of serious infections caused by resistant bacteria in this population. The aim of this study was to evaluate the impact of a pediatric antimicrobial stewardship program (PROA-NEN) implemented in a Spanish tertiary hospital by assessing the use of systemic antimicrobials, clinical indicators, antimicrobial resistance, and costs. Methods: In this quasi-experimental, single-center study, we included pediatric patients (0-18 years) admitted to specialized pediatric medical and surgical units, as well as pediatric and neonatal intensive care units, from January 2015 to December 2019. The impact of the PROA-NEN program was assessed using process (consumption trends and prescription quality) and outcome indicators (clinical and microbiological). Antibiotic prescription quality was determined using quarterly point prevalence cross-sectional analyses. Results: Total antimicrobial consumption decreased during the initial three years of the PROA-NEN program, followed by a slight rebound in 2019. This decrease was particularly evident in intensive care and surgical units. Antibiotic use, according to the WHO Access, Watch and Reserve (AWaRe) classification, remained stable during the study period. The overall rate of appropriate prescription was 83.2%, with a significant increase over the study period. Clinical indicators did not substantially change over the study period. Direct antimicrobial expenses decreased by 27.3% from 2015 to 2019. Conclusions: The PROA-NEN program was associated with reduced antimicrobial consumption, improved appropriate use, and decreased costs without compromising clinical and/or microbiological outcomes in patients.
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BACKGROUND: Data on antifungal prescribing in neonatal patients are limited to either single-center or single-country studies or to 1-day recording. Therefore, we assessed antifungal longitudinal usage in neonatal units (NUs) within Europe. METHODS: CALYPSO, a prospective weekly point prevalence study on antifungal drug usage in NUs in 18 hospitals (8 European countries), was conducted in 2020 during a 12-week period. All patients receiving systemic antifungals were included. Ward demographics were collected at the beginning; ward and patient data including indication, risk factors and antifungal regimen were weekly collected prospectively. RESULTS: Among 27 participating NUs, 15 (56%) practiced antifungal prophylaxis for neonates with birth weight <1000 g or <1500 g and additional risk factors. In total, 174 patients received antifungals with a median frequency per week of 10.5% ranging from 6.9% to 12.6%. Indication for antifungal prescribing was prophylaxis in 135/174 (78%) courses and treatment in 22% [39 courses (69% empirical, 10% preemptive, 21% targeted)]. Fluconazole was the most frequent systemic agent used both for prophylaxis (133/135) and treatment (15/39, 39%). Among neonates receiving prophylaxis, the most common risk factors were prematurity (119/135, 88%), mechanical ventilation (109/135, 81%) and central vascular catheters (89/135, 66%). However, gestational age <28 weeks was only recorded in 55/135 (41%) courses and birth weight <1000 g in 48/135 (35%). Most common reason for empirical treatment was late-onset sepsis; all 8 targeted courses were prescribed for invasive candidiasis. CONCLUSION: Antifungal usage in European NUs is driven by prophylaxis and empirical treatment with fluconazole being the most prescribed agent for both indications.
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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.
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OBJECTIVE: Pulmonary administration of voriconazole involves advantages, including optimization of lung penetration and reduction of adverse effects and interactions. However, there is scarce evidence about its use and there are no commercial presentations for nebulization. We aim to characterize a compounded voriconazole solution for nebulization and describe its use in our center. METHOD: This is a retrospective observational study including patients who received nebulized voriconazole to treat fungal lung diseases (infection or colonization). Voriconazole solution was prepared from commercial vials for intravenous administration. RESULTS: The pH and osmolarity of voriconazole solutions were adequate for nebulization. Ten patients were included, nine adults and a child. The dosage was 40 mg in adults and 10 mg in the pediatric patient, diluted to a final concentration of 10 mg/ml, administered every 12-24 hours. The median duration of treatment was 139 (range: 26-911) days. There were no reported adverse effects and the drug was not detected in plasma when nebulized only. CONCLUSION: Voriconazole nebulization is well tolerated and it is not absorbed into the systemic circulation; further research is needed to assess its efficacy.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Pneumopatias Fúngicas , Adulto , Criança , Humanos , Administração Intravenosa , Antifúngicos/efeitos adversos , Voriconazol/efeitos adversos , Estudos RetrospectivosRESUMO
BACKGROUND: Inhaled antibiotics have achieved or stabilised the clinical condition of patients with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa infection. We aimed to determine the effectiveness of aztreonam lysine inhaled solution (AZLI) in patients with CF and chronic P. aeruginosa infection. METHODS: A retrospective observational study was conducted on patients with CF and chronic P. aeruginosa infection who received AZLI between July 2012 and September 2018 inclusive in three Spanish hospitals in a routine clinical practice setting. The primary endpoint was the absolute change in the percentage of predicted forced expiratory volume in 1 second (FEV1) compared with the previous 12 months, at the start of AZLI treatment and 12 months after starting the drug. Other variables analysed were exacerbations, hospitalisations, type and route of antibiotics prescribed, weight and body mass index (BMI) and adverse drug reactions. RESULTS: In a cohort of 52 patients, AZLI treatment led to stabilisation of FEV1, changing from a mean (SD) value of 55.60 (21.3)% at the start of treatment to 56.8 (20.4)% after 12 months of treatment (p=0.5296) in patients who had not previously received the drug. In addition, it significantly reduced exacerbations from a median (P25; P75) of 2.0 (1.0; 3.0) in the 12 months prior to AZLI to 1.0 (1.0; 2.0) in the 12 months after treatment initiation (p=0.0350). AZLI also reduced the need for other antibiotics and prevented a decrease in BMI, with an adequate safety profile. CONCLUSIONS: AZLI achieved stabilisation of lung function measured by FEV1 in patients with CF and chronic P. aeruginosa infection, along with an adequate safety profile.
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Outpatient parenteral antimicrobial therapy (OPAT) is a useful treatment strategy against Pseudomonas aeruginosa and other multidrug-resistant bacteria. However, it is hindered by the lack of stability data for the administration of antibiotics under OPAT conditions. Our objective was to investigate the stability of nine antipseudomonal and broad-spectrum beta lactam antibiotics (aztreonam, cefepime, cefiderocol, ceftazidime, ceftazidime/avibactam, ceftolozane/tazobactam, meropenem, meropenem/vaborbactam, and piperacillin/tazobactam) to allow the spread of OPAT programs. All the antibiotics were diluted in 500 mL 0.9% sodium chloride and stored at 4, 25, 32, and 37 °C for 72 h in two different devices (infusion bags and elastomeric pumps). The solutions were considered stable if the color, clearness, and pH remained unchanged and if the percentage of intact drug was ≥90%. All the antimicrobials remained stable 72 h under refrigerated conditions and at least 30 h at 25 °C. At 32 °C, all the antibiotics except for meropenem and meropenem/vaborbactam remained stable for 24 h or more. At 37 °C, only aztreonam, piperacillin/tazobactam, cefepime, cefiderocol, and ceftolozane/tazobactam were stable for at least 24 h. The stability results were the same in the two devices tested. All the antibiotics studied are actual alternatives for the treatment of antipseudomonal or multidrug-resistant infections in OPAT programs, although the temperature of the devices is crucial to ensure antibiotic stability.
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Isavuconazole (ISA) is approved for treating invasive aspergillosis and mucormycosis in adults, but its use in children remains off-label. We report on the use of ISA in real-world pediatric practice with 15 patients receiving ISA for treatment of invasive fungal infections. Therapeutic drug monitoring (TDM) was performed in all patients, with 52/111 (46.8%) Ctrough determinations out of range, thus supporting the need for TDM in children, especially those receiving extracorporeal membrane oxygenation (ECMO).
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Aspergilose , Infecções Fúngicas Invasivas , Adulto , Humanos , Criança , Antifúngicos/uso terapêutico , Monitoramento de Medicamentos , Triazóis/uso terapêutico , Aspergilose/tratamento farmacológico , Nitrilas/uso terapêutico , Infecções Fúngicas Invasivas/tratamento farmacológicoRESUMO
BACKGROUND: Temocillin is an interesting alternative to carbapenems for susceptible Enterobacteriaceae. Although its use in outpatient parenteral antimicrobial therapy (OPAT) programmes has generated interest, this has been hampered by the lack of stability data. OBJECTIVES: The purpose of the present study was to evaluate the physical and chemical stability of temocillin at the recommended dose for its use in OPAT programmes, contained in polypropylene infusion bags or polyisoprene elastomeric devices at different temperatures, and to describe a novel LC-MS/MS developed for the quantification of temocillin. METHODS: Temocillin daily dose (6 g) was diluted in 500 mL of 0.9% sodium chloride to obtain a final concentration of 12 g/L. This solution was stored at 4°C, 25°C, 32°C and 37°C for 72 h, both in polypropylene infusion bags and in polyisoprene elastomeric pumps. Physical and chemical stability were evaluated during 72 h after manufacturing. Solutions were considered stable if colour, clearness and pH remained unchanged and if the percentage of intact drug was ≥90%. RESULTS: Temocillin attained the chemical stability criterion of ≥90% of the original concentration for the whole experiment in both devices at 4°C, 25°C and 32°C. At 37°C, temocillin was stable for 24 h but its concentration dropped below 90% from that timepoint. No precipitation occurred and minor colour changes were observed. CONCLUSIONS: Temocillin is stable under OPAT conditions and it would be an appropriate candidate for the treatment of patients who can be discharged to complete therapy in an OPAT programme. For this study, an LC-MS/MS method was developed.
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Anti-Infecciosos , Polipropilenos , Humanos , Cromatografia Líquida , Pacientes Ambulatoriais , Espectrometria de Massas em Tandem , Estabilidade de MedicamentosRESUMO
Currently, ampicillin plus ceftriaxone (AC) is one of the preferred treatments for Enterococcus faecalis infective endocarditis. However, there is a lack of stability data for the combination of both drugs in elastomeric devices, so the inclusion of AC in Outpatient Parenteral Antimicrobial Therapy (OPAT) programs is challenging. The objective of the study was to determine the stability of AC in elastomeric pumps when stored at 8 ± 2 °C, 25 ± 2 °C, 30 ± 2 °C and 37 ± 2 °C using LC-MS/MS. The combination was diluted in 0.9% sodium chloride and the final concentrations were ampicillin 24 g/L plus ceftriaxone 8 g/L. Physical and chemical stability were evaluated at 12, 20, 24, 36 and 48 h after preparation. Stability was met at each time point if the percentage of intact drug was ≥90% of its respective baseline concentration and color and clearness remained unchanged. The drug combination was stable for 48 h when it was kept at 8 ± 2 °C. At 25 ± 2 °C and 30 ± 2 °C, they were stable for 24 h of storage. At 37 ± 2 °C, the stability criterion was not met at any time point. These results prove that AC could be included in OPAT programs using elastomeric infusion devices for the treatment of E. faecalis infections.
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In Spain, many programs have been introduced in recent years to optimize antimicrobial stewardship in pediatric care (known as pediatric PROA). However, information on the current situation of these programs is scarce. The present study assesses current antimicrobial use in pediatric care in the hospitals of Catalonia affiliated with the VINCat pediatric PROA group. Between December 2020 and January 2021, an electronic survey related to the design and use of PROA was administered to members of PROA teams in our hospital network. The survey was conducted at 26 hospitals. Twelve percent of the hospitals had pediatric PROA in operation, 42% were included in adult PROA, and 46% carried out pediatric PROA activities but not as part of an established program. At 81%, the pediatric PROA team included a pediatrician, in 58% a pharmacist, and in 54% a microbiologist. The main activities were monitoring the use of antimicrobials and bacterial resistance. Twenty-seven percent measured indicators regularly. The VINCat Pediatric PROA group's hospitals have implemented measures for optimizing antimicrobial stewardship, but few have a pediatric PROA program in place. Specific measures and indicators must be defined, and the resources available should be increased. The development of pediatric PROA should be monitored in the coming years.
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In 2012, The Spanish Societies of Infectious Diseases and Clinical Microbiology (SEIMC), Hospital Pharmacy (SEFH), and Preventive Medicine, Public Health and Healthcare Management (SEMPSGS) lead a consensus document including recommendations for the implementation of antimicrobial stewardship (AMS) programs (AMSP; PROA in Spanish) in acute care hospitals in Spain. While these recommendations were critical for the development of these programs in many centres, there is a need for guidance in the development of AMS activities for specific patient populations, syndromes or other specific aspects which were not included in the previous document or have developed significantly since then. The objective of this expert recommendation guidance document is to review the available information about these activities in these patient populations or circumstances, and to provide guidance recommendations about them. With this objective the SEIMC, SEFH, SEMPSPGS, the Spanish Society of Intensive Care Medicine (SEMICYUC) and the Spanish Pediatric Infectious Disease Society (SEIP) selected a panel of experts who chose the different aspects to include in the document. Because of the lack of high-level evidence in the implementation of the activities, the panel opted to perform a narrative review of the literature for the different topics for which recommendations were agreed by consensus. The document was open to public consultation for the members of these societies for their comments and suggestions, which were reviewed and considered by the panel.
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Gestão de Antimicrobianos , Doenças Transmissíveis , Criança , Humanos , Hospitais , Espanha , Cuidados CríticosRESUMO
INTRODUCTION: Outpatient parenteral antimicrobial treatment (OPAT) is an alternative to in-patient care in carefully selected patients. This study presents a self-administration OPAT program integrated within the pediatric antibiotic stewardship program (ASP) in a pediatric tertiary care center. MATERIAL AND METHODS: Descriptive, retrospective and unicentric study. Data from all patients under 20 years of age who were prescribed treatment by a pediatric unit during 2019 and 2020 were included. Data regarding number of saved beds and estimating the opportunity cost of the OPAT program for the hospital were analyzed. RESULTS: Fifty-seven patients received 106 episodes of treatment. Favorable clinical outcome occurred in 74.5% of the episodes. The main cause of premature interruption was unfavorable clinical outcome of the infection (37.1%). A total of 2.62 beds/day were saved, resulting in an economic benefit of 1,069,963 . CONCLUSION: A self-administration OPAT program integrated within the pediatric ASP has proven to be safe and effective and provides economic benefits.
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Anti-Infecciosos , Pacientes Ambulatoriais , Humanos , Criança , Antibacterianos/uso terapêutico , Estudos Retrospectivos , Anti-Infecciosos/uso terapêutico , Assistência Ambulatorial/métodosRESUMO
OBJECTIVE: To provide a practical guide for the implementation and use of Pharmaceutical Care through Telepharmacy by healthcare professionals and patients in its different scopes of application. To establish a definition of Telepharmacy and describe the technological tools necessary, advantages, and keys to facilitating its implementation. METHOD: Between December 2020 and January 2021, the Board of Directors of the Spanish Society of Hospital Pharmacy, along with the coordinators of the project "Outpatient Care Strategies" ("Mapa Estratégico para la Atención al Paciente Externo") designed a strategy to foster the development and expansion of Telepharmacy in Spain. This strategy involved four courses of action. To develop the first course of action, a call was made in March 2021 among the Spanish Society of Hospital Pharmacy members to develop seven methodological guidelines. The purpose of these documents was to meet the needs for the implementation of Telepharmacy, the most relevant being the development of specific guides for professionals and patients. The guides were developed in four stages between May and October 2021, including a literature review; consensus-based interviews, online workshops, and, finally, the drafting and validation of the final documents. Once the final draft was prepared, a public evaluation of suggestions and observations was performed for a month. The documents were also presented to the Patient Committee of the Spanish Society of Hospital Pharmacy. RESULTS: The Guide for Professionals provides guidelines for the development and implementation of Telepharmacy in its different scopes of application. These guides provide a description of specific goals, healthcare benefits, tools required, and keys to the implementation of Telepharmacy. The Guide for Patients is complementary to face-to-face pharmaceutical care from the point of view of the patient, with special emphasis being placed on the most frequently used tools, the potential benefits, and the keys to facilitating patients' understanding of the purpose and use of Telepharmacy. CONCLUSIONS: A Practical Guide for Professionals and Patients was developed to ensure the standard development, implementation, and spread of Telepharmacy in all its scopes. This guide is intended to help Hospital Pharmacy professionals benefit from Telepharmacy as a complementary tool to face-to-face pharmaceutical care.
OBJETIVO: Desarrollar una guía práctica sobre atención farmacéutica mediante Telefarmacia para profesionales y pacientes, en cada uno de sus ámbitos de aplicación. Definir en qué consiste, las herramientas utilizadas, los potenciales beneficios y las claves para facilitar su comprensión.Método: Entre diciembre de 2020 y enero de 2021, la Junta directiva de la Sociedad Española de Farmacia Hospitalaria, junto con coordinadores del proyecto "Mapa Estratégico para la Atención al Paciente Externo", diseñaron una estrategia para favorecer el desarrollo y expansión de la Telefarmacia en España. Esta estrategia incluyó cuatro líneas de actuación. Para el desarrollo de la primera, en marzo de 2021 se llevó a cabo una convocatoria dirigida a los socios de la Sociedad Española de Farmacia Hospitalaria con objeto de desarrollar siete documentos de apoyo metodológico destinados a cubrir las necesidades para la implantación de la Telefarmacia, entre las cuales se consideraron como claves el desarrollo de una guía específica para profesionales y otra para pacientes. Las guías se desarrollaron en cuatro fases entre mayo y octubre de 2021: revisión de literatura, entrevistas de consenso, desarrollo de improtalleres de trabajo online y debate y, por último, laboración y validación de los documentos finales. Una vez elaborado el borrador definitivo se llevó a cabo una valoración pública de sugerencias y alegaciones durante un mes, así como una presentación al comité de pacientes de la Sociedad Española de Farmacia Hospitalaria. RESULTADOS: La guía para profesionales se ha orientado para dar las pautas para el desarrollo e implementación de programas de Telefarmacia en cada uno de sus ámbitos de aplicación. Está estructurada de forma que resalte los objetivos concretos, los beneficios asistenciales, las herramientas necesarias, así como las claves para implantarla. La guía para pacientes se ha desarrollado como herramienta complementaria a la atención farmacéutica presencial desde la visión del paciente, destacando las herramientas más comúnmente utilizadas, los potenciales beneficios y las claves para facilitar la comprensión sobre la finalidad y uso de estas intervenciones. CONCLUSIONES: Se ha desarrollado una guía práctica de apoyo, tanto a profesionales como a pacientes, para estandarizar el desarrollo, implantación y expansión de la Telefarmacia en todos sus ámbitos de actuación. La guía pretende ayudar al colectivo de farmacia hospitalaria a alcanzar los potenciales beneficios de una herramienta que se presenta como complementaria a la atención farmacéutica presencial.
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Assistência Farmacêutica , Telemedicina , Humanos , Assistência Ambulatorial , Espanha , Atenção à SaúdeRESUMO
OBJECTIVE: To determine the prevalence and appropriateness of antimicrobial use in Spanish hospitals through a pharmacist-led systematic cross-sectional review. METHOD: A nationwide multicenter cross-sectional study was conducted on 10% of the patients admitted to the participating hospitals on one day in April 2021. Hospital participation was voluntary, and the population was randomly selected. The study sample was made up of patients who, on the day of the study, received at least one antimicrobial belonging to groups J01, J02, J04, J05AB, J05AD or J05AH in the Anatomical Therapeutic Chemical Classification System. The pharmacist in charge made a record and carried out an evaluation of the appropriateness of antimicrobial use following a method proposed and validated by the Pharmaceutical Care of Patients with Infectious Diseases Working Group of the Spanish Society of Hospital Pharmacy. The evaluation method considered each of the items comprising antimicrobial prescriptions. An algorithm was used to assess prescriptions as appropriate, suboptimal, inappropriate and unevaluableResults: One-hundred three hospitals participated in the study and the treatment of 3,568 patients was reviewed. A total of 1,498 (42.0%) patients received antimicrobial therapy, 424 (28.3%) of them in combination therapy. The most commonly prescribed antimicrobials were moxicillin-clavulanic acid (7.2%), ceftriaxone (6.4%), piperacillin-tazobactam (5.8%), and meropenem 4.0%. As regards appropriateness, prescriptions were considered appropriate in 34% of cases, suboptimal in 45%, inappropriate in 19% and unevaluable in 2%. The items that most influenced the assessment of a prescription as suboptimal were completeness f medical record entries, choice of agent, duration of treatment and monitoring of efficacy and safety. The item that most influences the assessment of a prescription as inappropriate was the indication of ntimicrobial agent. Conclusions: The method used provided information on the prevalence and appropriateness of the use of antimicrobials, a preliminary step in the design and implementation of actions aimed at measuring the impact of the use of ntimicrobials within the antimicrobial stewardship programs.
OBJETIVO: Conocer la prevalencia y el grado de adecuación del uso de antimicrobianos en los hospitales españoles mediante una revisión sistemática transversal realizada por farmacéuticos.Método: Estudio multicéntrico, nacional, transversal sobre el 10% de los pacientes ingresados en los hospitales participantes un día del mes de abril de 2021. La participación de los hospitales fue voluntaria y la selección de la población aleatoria. De la población se disgregó la muestra de estudio, constituida por los pacientes que recibían el día del corte al menos un antimicrobiano perteneciente a los grupos J01, J02, J04, J05AB, J05AD y J05AH del Sistema de Clasificación Anatómica, Terapéutica y Química. Sobre la muestra de estudio, el farmacéutico realizó un registro y evaluación de la adecuación del tratamiento antimicrobiano siguiendo una metódica propuesta y validada por el Grupo de trabajo de Atención Farmacéutica al Paciente con nfermedad Infecciosa de la Sociedad Española de Farmacia Hospitalaria. La metódica de evaluación consideró cada una de las dimensiones que conforman la prescripción del antimicrobiano e incluyó un algoritmo para calificar la prescripción global como adecuada, mejorable, inadecuada y no valorable. RESULTADOS: Participaron 103 hospitales y se revisó el tratamiento de 3.568 pacientes, de los que 1.498 (42,0%) recibieron terapia antimicrobiana, 424 (28,3%) en combinación. La prevalencia de los antimicrobianos más frecuentes fue: amoxicilina-clavulánico 7,2%, ceftriaxona 6,4%, piperacilina- tazobactam 5,8% y meropenem 4,0%. Respecto a la adecuación del tratamiento la prescripción, fue considerada adecuada en el 34% de los casos, mejorable en el 45%, inadecuada en el 19% y no valorable en el 2%. Las dimensiones que más influyeron en la calificación de la prescripción como mejorable fueron el registro en la historia clínica, la elección del agente, la duración del tratamiento y la monitorización de la eficacia y seguridad, y como inadecuada la indicación de antimicrobiano. CONCLUSIONES: La metódica utilizada permite conocer la prevalencia y adecuación del uso de antimicrobianos, paso previo para diseñar y emprender acciones de mejora y medir el impacto de su implantación en el marco de los programas de optimización del uso de antimicrobianos.
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Anti-Infecciosos , Ceftriaxona , Antibacterianos/uso terapêutico , Anti-Infecciosos/uso terapêutico , Ácido Clavulânico , Estudos Transversais , Hospitais , Humanos , Meropeném , Piperacilina , Prevalência , TazobactamAssuntos
Gestão de Antimicrobianos , Pediatria , Antibacterianos/uso terapêutico , Criança , HumanosRESUMO
BACKGROUND: Antimicrobial defined daily dose (DDD), a standardized metric to assess antimicrobial consumption in adult population, has limitations hampering its use in neonatal patients. This study proposes an alternative DDD design applicable for neonates. METHODS: Neonates (<1 month-old) from 6 Spanish hospitals during a 12-months period were included. Weight and weeks gestational age of each neonate were the variables collected. DDD (g) for each antimicrobial was calculated by multiplying the obtained weight times the recommended dose (mg/kg) of the antimicrobial for the most common infectious indication selected by the Delphi method. RESULTS: A total of 4820 neonates were included. Mean age was 36.72 weeks of gestational age and Mean weight was 2.687kg. Standardized DDD (intravenous; oral route) for representative antimicrobials were: Amoxicillin (0.08; 0.08), amoxicillin-clavulanic acid (0.27; 0.08), ampicillin (0.27; x), cloxacillin (0.13; 0.13), penicillin G sodium (0.12), cefazolin (0.13), cefuroxime (0.27; x), cefotaxime (0.27), ceftazidime (0.27), ceftriaxone (0.13), cefepime (0.27) piperacillin-tazobactam (0.54), aztreonam (0.24), azithromycin (0.03; 0.03), clindamycin (0.04; 0.04), amikacin (0.04), gentamicin (0.01), metronidazole (0.04; 0.08), ciprofloxacin (0.04; 0.05), levofloxacin (x;x), fluconazole (0.02; 0.02), itraconazole (0.01; 0.01), fosfomycin (0.27). Restricted antimicrobials: meropenem (0.11), teicoplanin (0.02), vancomycin (0.08; 0.11), linezolid (0.08; 0.08), daptomycin (x), amphotericin B liposomal (0.01). CONCLUSIONS: A useful method for antimicrobial DDD measurement in neonatology has been designed to monitor antimicrobial consumption in hospital settings. It should be validated in further studies and thereby included in the design for neonatal antimicrobial stewardship programs in the future.
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Anti-Infecciosos , Gestão de Antimicrobianos , Antibacterianos/uso terapêutico , Ceftriaxona , Ciprofloxacina , Humanos , Lactente , Recém-NascidoRESUMO
Background: Transplant-associated thrombotic microangiopathy (TA-TMA) is a serious complication of hematopoietic stem cell transplantation (HSCT) associated with high morbidity and mortality. High-risk TA-TMA (hrTA-TMA) is characterized by multifactorial endothelial damage caused by environmental stressors, dysregulation of the complement system, and genetic predisposition. Complement inhibitors have significantly decreased mortality and are the current treatment of choice. In this article, we describe our experience with the use of eculizumab in pediatric patients diagnosed with hrT-TMA after HSCT. Method: Retrospective study of pediatric patients with hrTA-TMA treated with eculizumab between January 2016 and December 2020. Results: Four pediatric patients aged 1, 12, 14, and 17 years at the time of HSCT were diagnosed with hrTA-TMA and treated with eculizumab during the study. At diagnosis, they all had renal impairment with proteinuria, and hypertension under treatment with at least two antihypertensive drugs. The patient who presented multisystemic involvement died instead of treatment. The three patients with exclusive renal involvement achieved TA-TMA resolution after treatment with eculizumab for 65, 52, and 40.6 weeks and were able to stop treatment. The two patients with follow-up data one year after eculizumab withdrawal sustained a favorable response. Eculizumab was well tolerated, and with adequate vaccination and antibiotic prophylaxis, did not increase the risk of infection. Conclusions: Eculizumab appears to be both safe and effective for the treatment of hrTA-TMA in patients with renal impairment. Early diagnosis and initiation of treatment may improve response. Eculizumab withdrawal can be contemplated in patients who achieve laboratory and clinical resolution of TA-TMA.
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BACKGROUND: Antimicrobial defined daily dose (DDD), a standardized metric to assess antimicrobial consumption in adult population, has limitations hampering its use in neonatal patients. This study proposes an alternative DDD design applicable for neonates. METHODS: Neonates (<1 month-old) from 6 Spanish hospitals during a 12-months period were included. Weight and weeks gestational age of each neonate were the variables collected. DDD (g) for each antimicrobial was calculated by multiplying the obtained weight times the recommended dose (mg/kg) of the antimicrobial for the most common infectious indication selected by the Delphi method. RESULTS: A total of 4820 neonates were included. Mean age was 36.72 weeks of gestational age and Mean weight was 2.687kg. Standardized DDD (intravenous; oral route) for representative antimicrobials were: Amoxicillin (0.08; 0.08), amoxicillin-clavulanic acid (0.27; 0.08), ampicillin (0.27; x), cloxacillin (0.13; 0.13), penicillin G sodium (0.12), cefazolin (0.13), cefuroxime (0.27; x), cefotaxime (0.27), ceftazidime (0.27), ceftriaxone (0.13), cefepime (0.27) piperacillin-tazobactam (0.54), aztreonam (0.24), azithromycin (0.03; 0.03), clindamycin (0.04; 0.04), amikacin (0.04), gentamicin (0.01), metronidazole (0.04; 0.08), ciprofloxacin (0.04; 0.05), levofloxacin (x;x), fluconazole (0.02; 0.02), itraconazole (0.01; 0.01), fosfomycin (0.27). Restricted antimicrobials: meropenem (0.11), teicoplanin (0.02), vancomycin (0.08; 0.11), linezolid (0.08; 0.08), daptomycin (x), amphotericin B liposomal (0.01). CONCLUSIONS: A useful method for antimicrobial DDD measurement in neonatology has been designed to monitor antimicrobial consumption in hospital settings. It should be validated in further studies and thereby included in the design for neonatal antimicrobial stewardship programs in the future.