PAUSATE Study: Prevalence and appropriateness of the use of antimicrobials in Spanish hospitals

Prevalencia; AntimicrobianosPrevalence; AntimicrobialPrevalença; AntimicrobiansObjetivo: 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 Enfermedad 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.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 unevaluable. Results: 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 amoxicillin-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 of 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 antimicrobial 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 antimicrobials within the antimicrobial stewardship programs

A critical view on the current use of daptomycin in Spain: The daptomise study

Background: The Study on the Clinical Use of DAPTOMycin in Spain (DAPTOMISE Study) is a national surveillance program of daptomycin use. The objectives of this study are to evaluate the current variability in daptomycin consumption across the different hospitals and the adequacy of therapy, specially focused on underdosing. Methods: All adult and pediatric patients who received, at least, one dose of daptomycin in a single week in 98 institutions in Spain were included. The adequacy of daptomycin use was evaluated with respect to the indication, dosage, adjustments after microbiology results, switching to an oral agent and length of treatment. Results: A total of 615 patients received daptomycin during the study week. The prevalence use was 2.3 patients / 100,000 inhabitants per week, 12.4 patients / 1000 admissions and 9.2 Days of Therapy (DOT) / 1000 hospital stays. These rates varied between hospitals: from 0 to 13.9 patients / 100,000 inhabitants, from 0 to 76.1 patients / 1000 admissions and from 0 to 49.4 DOT / 1000 hospital stays. The most frequent infections were bacteremia (31.6 %) and skin and soft tissue infections (17.9 %). Microbiological results were available in only 65.4 % of infections. The most frequent microorganisms were Staphylococcus aureus (192 isolates, of which 87 were resistant to methicillin) and coagulase-negative staphylococci (124 isolates). A total of 136 prescriptions (22.1 %) were underdosed. Dosages < 8 mg/kg were used for 35.6 % of endovascular infections and for 26.2 % of osteoarticular infections. Overall, 57.2 % of prescriptions were not optimal in, at least, one item. Clinical cure rate was 76.1% and mortality attributable to the infection 8.1%. Conclusion: This is the first registry that identifies the prevalence of use of daptomycin in Spain and shows a high variability in the consumption between the different hospitals. Daptomycin underdosing was present in more than 20 % of cases. (c) 2023 Published by Elsevier Ltd on behalf of King Saud Bin Abdulaziz University for Health Sciences. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)

Adaptación nacional de la herramientaStart Smart-Then Focus para la optimización del uso de antimicrobianos

[EN] Objective: The Start Smart-Then Focus tool of the United Kingdom’s National Health System is a tool to be implemented in antimicrobial stewardship programs. The objective of this work is the adaptation of Start Smart-Then Focus tool to the Spanish health system. Method: Delphi methodology was used. Two rounds were conducted by email. In the first, a questionnaire was sent out that included the criteria of the tool. These criteria were independently assessed by 16 experts. They rated the suitability and applicability of each criterion on a scale from 1 to 9 and made free comments on each one. The tool was modified and sent out again to all the experts. They re-scored the questionnaire individually, while aware of the anonymized results of the first round. Results: The first questionnaire was made up of 19 indicators. Of these, 16 indicators had a median of more than 7 in suitability and applicability. However, regarding applicability, 3 indicators had a median of less than 7 and 10 had a minimum of less than 5. From the initial 19 indicators, we obtained 8 final indicators and 8 options were added to the sixth indicator. Conclusions: It would be very useful to implement the Spanish adaptation of the Start Smart-Then Focus tool in antimicrobial stewardship programs at a national level. It would also contribute to improving the use of antimicrobials.[ES] Objetivo: La herramienta Start Smart-Then Focus del Sistema Nacional de Salud de Reino Unido es una herramienta de ayuda de los programas de optimización de antibióticos. El objetivo de este trabajo es la adaptación de la herramienta Start Smart-Then Focus al sistema de salud español. Método: Se utilizó la metodología Delphi, mediante dos rondas de evaluación por correo electrónico. En la primera se envió un cuestionario con los criterios de la herramienta, estos fueron evaluados de forma independiente por 16 expertos. Puntuaron de 1-9 la idoneidad y aplicabilidad de cada criterio, y realizaron comentarios libres. La herramienta fue modificada y enviada de nuevo a todos los expertos, volvieron a puntuar individualmente, pero conociendo los resultados de la primera ronda. Resultados: El primer cuestionario estaba constituido por 19 indicadores; 16 indicadores obtuvieron una mediana mayor de 7 en idoneidad y aplicabilidad, 3 indicadores obtuvieron mediana menor de 7 y 10 indicadores con mínimos menores de 5 en aplicabilidad. De 19 indicadores iniciales pasamos a 8; con 8 opciones dentro del sexto indicador. Conclusiones: La adaptación de la herramienta Start Smart-Then Focus a nivel nacional puede ser de utilidad para implantarla en los programas de optimización de antibióticos y contribuir a la mejora del uso de los antimicrobianos.The training stay of María Victoria Gil-Navarro was funded by the Spanish Ministry of Health, General Directorate of Research and Knowledge Management, Modality Training stays for research and innovation. Project number: EF-0468-2018. Call for proposals 2018-19

Analysis of the appropriateness of antibiotic prophylaxis in surgical procedures in Spain. Protocol for the "ProA-Q" study

Article disponible en castellà: http://hdl.handle.net/10230/59321Abstract: Surgical antibiotic prophylaxis is one of the most useful measures to prevent surgical wound infection. Objective: The aim of this project is to evaluate the appropriateness of the use of antibiotic prophylaxis in surgical procedures performed in Spanish hospitals, both globally and according to the type of surgery performed. Method: For this purpose, an observational, retrospective, cross-sectional, and multicentre study has been designed to collect all the variables that allow the evaluation of the appropriateness of surgical antibiotic prophylaxis by comparing the prescribed treatment, the recommendations included in the local guidelines, and the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology and the Spanish Association of Surgeons. Indication, choice of antimicrobial, dose, route and duration of administration, timing, re-dosing, and duration of the prophylaxis will be taken into account. The sample will consist of patients who underwent scheduled or emergency surgery, either as inpatients or outpatients, in hospitals in Spain. A sample size of 2335 patients has been established to estimate, with 95% confidence and 80% power, a percentage of appropriateness that is expected to be around 70%. Differences between variables will be analysed using Student's t-test, Mann–Whitney U test, Chi-square test, or Fisher's test, as appropriate. The degree of agreement between the antibiotic prophylaxis recommended by the guidelines of the different hospitals and that recommended in the literature will be analysed by calculating the Cohen's kappa indicator. Binary logistic regression analysis using generalised linear mixed models will be performed to identify possible factors associated with differences in the appropriateness of antibiotic prophylaxis. Discussion: The results of this clinical study will allow us to focus on specific surgical areas with higher rates of inappropriateness, identify key points of action and guide future strategies for antimicrobial stewardship programs in the area of antibiotic prophylaxis

Stability of ampicillin plus ceftriaxone combined in elastomeric infusion devices for outpatient parenteral antimicrobial therapy

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

Development of Antimicrobial Defined Daily Dose (DDD) for the Pediatric Population

Antimicrobial stewardship programs (ASPs) optimize antimicrobial use, improve patient outcomes, and reduce resistance. To assess the effectiveness of ASPs, it is necessary to have indicators that can be widely used. Defined daily dose (DDD) was designed by WHO for the adult population as a consumption indicator. However, there are no DDDs adapted to the pediatric population. The main objective of this study is to establish the most appropriate DDD values in this population. An observational, retrospective, multicenter study was conducted. Antimicrobial prescriptions were collected from pediatric wards of seven Spanish tertiary hospitals for 2 years. The DDDs obtained from the prescriptions were compared with the theoretical DDDs agreed upon in the first stage. To select the optimal DDD, the following were analyzed: power value, magnitude obtained from the differences in the DDD, statistical significance, and degree of agreement in the stipulated doses. A total of 4788 prescriptions were collected. Pediatric DDD was defined for 30 different antimicrobials. A potency &gt;80% was obtained in 24 antibiotics. 51.2% of the selected DDD correspond to Phase I and 39.5% from Phase II. Pediatric DDD of different antimicrobials was obtained, providing an indicator that can be used globally in different hospitals to analyze the consumption and efficacy of ASPs

Development of Antimicrobial Defined Daily Dose (DDD) for the Pediatric Population

Antimicrobial stewardship programs (ASPs) optimize antimicrobial use, improve patient outcomes, and reduce resistance. To assess the effectiveness of ASPs, it is necessary to have indicators that can be widely used. Defined daily dose (DDD) was designed by WHO for the adult population as a consumption indicator. However, there are no DDDs adapted to the pediatric population. The main objective of this study is to establish the most appropriate DDD values in this population. An observational, retrospective, multicenter study was conducted. Antimicrobial prescriptions were collected from pediatric wards of seven Spanish tertiary hospitals for 2 years. The DDDs obtained from the prescriptions were compared with the theoretical DDDs agreed upon in the first stage. To select the optimal DDD, the following were analyzed: power value, magnitude obtained from the differences in the DDD, statistical significance, and degree of agreement in the stipulated doses. A total of 4788 prescriptions were collected. Pediatric DDD was defined for 30 different antimicrobials. A potency >80% was obtained in 24 antibiotics. 51.2% of the selected DDD correspond to Phase I and 39.5% from Phase II. Pediatric DDD of different antimicrobials was obtained, providing an indicator that can be used globally in different hospitals to analyze the consumption and efficacy of ASPs

Stability of Antimicrobials in Elastomeric Pumps: A Systematic Review.

Outpatient parenteral antimicrobial therapy (OPAThttp) programs have become an important healthcare tool around the world. Portable elastomeric infusion pumps are functional devices for ambulatory delivery of antimicrobial drugs, and their stability is an essential point to guarantee an appropriate infusion administration. We conducted a systematic review to provide a synthesis and a critical evaluation of the current evidence regarding antimicrobial stability in elastomeric pumps. Data sources were PubMed, EMBASE, and Web of Sciences. The review protocol was registered on the Center for Open Science, and it was carried out following the PRISMA guidelines. Studies were eligible if the aim was the evaluation of the physicochemical stability of an antimicrobial agent stored in an elastomeric device. Of the 613 papers identified, 33 met the inclusion criteria. The most studied group of antimicrobials was penicillins, followed by cephalosporins and carbapenems. In general, the stability results of the antimicrobials that have been studied in more than one article agree with each other, with the exception of ampicillin, flucloxacillin, and ceftazidime. The antibiotics that displayed a longer stability were glycopeptides and clindamycin. Regarding the stability of antifungals and antivirals, only caspofungin, voriconazole, and ganciclovir have been investigated. The information provided in this article should be considered in patient treatments within the OPAT setting. Further stability studies are needed to confirm the appropriate use of the antimicrobials included in this program to ensure optimal patient outcomes