Piperacilina-tazobactam en perfusión continua o expandida frente a perfusión intermitente / Piperacillin-tazobactam in continuous or expanded perfusion vs intermittent perfusion

Objetivo: El objetivo principal de esta revisión es analizar las diferencias de eficacia entre la administración en perfusión intermitente y la administración en perfusión continua/expandida de piperacilina-tazobactam. Como objetivos secundarios se analizan las diferencias en seguridad, parámetros farmacocinéticos/farmacodinámicos y coste-efectividad entre las 2 formas de administración. Método Se realizaron 2 búsquedas bibliográficas independientes. Se encontraron un total de 38 artículos y finalmente se incluyeron en el estudio 6. Se analizaron los artículos incluidos y se recogieron las variables diseño, tratamiento administrado a cada grupo, número de pacientes total y perteneciente a cada grupo, variables recogidas en cada estudio y resultados. Resultados Se hallaron diferencias significativas en la variable principal en 2 de los 6 estudios incluidos a favor de la perfusión continua/expandida. En el estudio de Lodise et al. se encontraron diferencias (p = 0,04) en mortalidad (31,6% en perfusión intermitente vs 12,2% en perfusión continua/expandida). En el estudio de Lorente et al. se encontraron diferencias (p = 0,001) en curación clínica (56,5% perfusión intermitente vs 89,2% en perfusión continua/expandida). En cuanto a las variables secundarias solo se encontraron diferencias en uno de los estudios en la relación coste-efectividad a favor del grupo de perfusión continua/expandida. Conclusión Los datos analizados indican que la perfusión continua/expandida sería al menos igual de eficaz que la perfusión intermitente, y que podría ser más eficaz en pacientes más graves, o con infecciones por microorganismos más resistentes, como Pseudomonas aeruginosa. Además esta forma de administración es, en teoría, más coste-efectiva (AU)

Objective: The primary objective of this review was to analyse the differences in efficacy between the administration of intermittent and continuous/expanded perfusion of piperacillin-tazobactam. Secondary objectives were to analyse the differences in safety, pharmacokinetic/pharmacodynamic parameters, and cost-effectiveness between the two forms of administration. Method: We performed two different independent bibliographic searches. We encountered a total of 38 articles, and the final number included in the study was 6. We analysed the articles and collected the following variables: design, treatment administered to each group, total number of patients and number of patients in each study, variables collected in each study, and results. Results: We encountered significant differences in the primary variable in two of the six studies favouring continuous/expanded perfusion. The study by Lodise et al found differences (P=.04)in mortality (31.6% for intermittent perfusion vs 12.2% for continuous/expanded perfusion).The study by Lorente et al found differences (P=.001) in terms of clinical recovery (56.5% for intermittent perfusion vs 89.2% for continuous/expanded perfusion). As for secondary variables, we only found differences in one of the studies in relation to cost-effectiveness, in favour of the group who underwent continuous/expanded perfusion method. Conclusion: The analysed data suggest that continuous/expanded perfusion would be at least as effective as intermittent perfusion, and that it could be more effective in severe patients with infections from more resistant micro-organisms such as Pseudomonas aeruginosa. Additionally, this form of administration is more cost-effective, at least in theory (AU)

[Piperacillin-tazobactam in continuous or expanded perfusion vs intermittent perfusion]. / Piperacilina-tazobactam en perfusión continua o expandida frente a perfusión intermitente.

OBJECTIVE: The primary objective of this review was to analyse the differences in efficacy between the administration of intermittent and continuous/expanded perfusion of piperacillin-tazobactam. Secondary objectives were to analyse the differences in safety, pharmacokinetic/pharmacodynamic parameters, and cost-effectiveness between the two forms of administration. METHOD: We performed two different independent bibliographic searches. We encountered a total of 38 articles, and the final number included in the study was 6. We analysed the articles and collected the following variables: design, treatment administered to each group, total number of patients and number of patients in each study, variables collected in each study, and results. RESULTS: We encountered significant differences in the primary variable in two of the six studies favouring continuous/expanded perfusion. The study by Lodise et al found differences (P=.04) in mortality (31.6% for intermittent perfusion vs 12.2% for continuous/expanded perfusion). The study by Lorente et al found differences (P=.001) in terms of clinical recovery (56.5% for intermittent perfusion vs 89.2% for continuous/expanded perfusion). As for secondary variables, we only found differences in one of the studies in relation to cost-effectiveness, in favour of the group who underwent continuous/expanded perfusion method. CONCLUSION: The analysed data suggest that continuous/expanded perfusion would be at least as effective as intermittent perfusion, and that it could be more effective in severe patients with infections from more resistant micro-organisms such as Pseudomonas aeruginosa. Additionally, this form of administration is more cost-effective, at least in theory.

Consensus method to update the GINF formulary request form

Objective: To update the Guideline for the Introduction of New Drugs in the Formulary (GINF form) using the RAND/UCLA appropriateness method, which combines the best available evidence and an expert panel’s judgement. Study Design/Methods: Two procedures were employed to detect where improvements could be made to the former versions of the request form and to transform them into concrete scenarios, found from a telephone survey with GINF form users, and a structured review of the scientific literature. The list of scenarios was later assessed by an expert panel. In a series of successive rounds, the rest of the research team critically assessed the expert panel’s result, applying a score. Results: A total of 52 improvement proposals were registered; 31 of them dealt with the form structure and the remaining 21 referred to the form process. Six formulary request forms were selected from the literature review. The final version included 24 assessed scenarios mainly addressing clinical trials’ validity, qualitative assessment and local implications of the requested drug. Conclusions: A new version of the GINF form has been developed. Much improvement has been made based on the guide users’ opinion, available evidence and similar experiences that have been carried out internationally. The whole process has been subject to the experts’ opinion following a contrasted, consensus methodology: RAND/UCLA appropriateness method (AU)

Objetivo: Diseñar una nueva versión de la Guía para la Introducción de Nuevos Fármacos (GINF), ˜utilizando para ello la metodología RAND/UCLA sobre el uso adecuado, que combina la mejor evidencia disponible con el juicio de un panel de expertos. Diseño del estudio/métodos: ˜ Se emplearon 2 procedimientos para detectar oportunidades de mejora de las versiones anteriores de la guía, que fueron transformadas en escenarios concretos: una encuesta telefónica a usuarios de la GINF, y una revisión estructurada de la literatura científica. Esta lista de escenarios fue evaluada por un panel de expertos mediante rondas sucesivas. El resto del equipo de investigación evaluó críticamente el resultado del panel de expertos. Resultados: Se registraron 52 propuestas de mejora, 31 de ellas se refieren a la estructura de la guía y las 21 restantes se refieren al procedimiento de utilización de la guía. En cuanto a la búsqueda bibliográfica, 6 de las guías de inclusión de nuevos medicamentos fueron seleccionadas. La versión final incluyó 24 de los escenarios propuestos orientados principalmente a la validez del ensayo clínico, la evaluación cualitativa y las consecuencias locales del fármaco solicitado. Conclusiones: La nueva versión de la guía GINF llevada a cabo incluye muchas mejoras extraídas tanto de la opinión de los usuarios de guía como de la mejor evidencia disponible y las experiencias similares que se han llevado a cabo a nivel internacional. Todo el proceso ha sido sometido a la opinión de los expertos tal como indica la metodología de consenso RAND/UCLA (AU)

Consensus method to update the GINF formulary request form.

OBJECTIVE: To update the Guideline for the Introduction of New Drugs in the Formulary (GINF form) using the RAND/UCLA appropriateness method, which combines the best available evidence and an expert panel's judgement. STUDY DESIGN/METHODS: Two procedures were employed to detect where improvements could be made to the former versions of the request form and to transform them into concrete scenarios, found from a telephone survey with GINF form users, and a structured review of the scientific literature. The list of scenarios was later assessed by an expert panel. In a series of successive rounds, the rest of the research team critically assessed the expert panel's result, applying a score. RESULTS: A total of 52 improvement proposals were registered; 31 of them dealt with the form structure and the remaining 21 referred to the form process. Six formulary request forms were selected from the literature review. The final version included 24 assessed scenarios mainly addressing clinical trials' validity, qualitative assessment and local implications of the requested drug. CONCLUSIONS: A new version of the GINF form has been developed. Much improvement has been made based on the guide users' opinion, available evidence and similar experiences that have been carried out internationally. The whole process has been subject to the experts' opinion following a contrasted, consensus methodology: RAND/UCLA appropriateness method.

[Work of a multidisciplinary team in the control of the prescription of ertapenem]. / Actuación de un equipo multidisplinario en el control de la prescripción de ertapenem.

OBJECTIVE: To determine the effectiveness of the intervention of a multidiscipline antimicrobial control group in the correct prescription of Ertapenem. METHOD: A four-month long, prospective study into prescriptions for Ertapenem was carried out in a third-level hospital. Assessment into the degree of suitability of each prescription according to the infections commission usage criteria. In the situation where prescriptions were not suitable, recommendations were given and acceptance of this was recorded. The effectiveness of the antimicrobial treatment used was assessed and treatment was considered effective when there was remission of the signs and symptoms of the infection when the treatment was completed. The treatment was considered to have failed when the signs and symptoms of infection persisted or progressed, requiring the addition of another antimicrobial agent, changing antibiotics or the prolongation of the treatment for longer than 2 weeks. Lastly, the differences in the average length of stay and the duration of the antibiotic treatment between groups were analysed. RESULTS: Forty-eight prescriptions were assessed. The usage criterion was adequate in 48 % of cases, with 78 % effectiveness in this group. In the cases where the prescription was not adequate, but a change in prescription was accepted, the effectiveness was 92 %, with 55.5 % of those cases not accepting recommendation for change. The average stay was higher in this last group (p = 0.07). The duration of the antibiotic treatment in the patients who accepted the change in prescription was significantly less than in those who did not accept it (2 vs 7.4 days, p < 0.0001). CONCLUSIONS: The control of Ertapenem prescriptions by a multidisciplinary team was effective.

Actuación de un equipo multidisplinario en el control de la prescripción de ertapenem* / Work of a multidisciplinary team in the control of the prescription of ertapenem

Objetivo: Determinar la efectividad de la intervención de un grupo multidisciplinario de control antimicrobiano en la correcta prescripción de ertapenem. Método: Estudio prospectivo, durante un período de 4 meses, de las prescripciones de ertapenem realizadas en un hospital de tercer nivel. Evaluación del grado de adecuación de cada prescripción a los criterios de utilización de la comisión de infecciones. En las situaciones en las que no se adecuaban, se emitió una recomendación y se registró la aceptación de éstas. Se evaluó la efectividad del tratamiento antimicrobiano utilizado; para ello, se consideró tratamiento efectivo cuando hubo remisión de los signos y los síntomas de la infección al finalizar el tratamiento. Se consideró fracaso del tratamiento cuando los signos y los síntomas de la infección persistieron o progresaron, requiriendo la adición de otro antimicrobiano, la sustitución por otro/s antibiótico/s o la prolongación del tratamiento más allá de 2 semanas. Finalmente, se analizaron las diferencias de estancia media y duración de tratamiento antibiótico entre los grupos. Resultados: Se evaluaron 48 prescripciones. Se adecuaron a los criterios de uso un 48 % de éstas, con una efectividad del 78 % en este grupo. En los casos en los que la prescripción no se adecuó, pero se aceptó un cambio de tratamiento, la efectividad fue del 92 %, y fue del 55,5 % en los casos en los que no se aceptó esta recomendación. La tendencia de la estancia media fue mayor en este último grupo (p = 0,07). La duración del tratamiento antibiótico en los pacientes en los que se aceptó el cambio fue significativamente menor que en los que no se aceptó (2 frente a 7,4 días; p < 0,0001). Conclusiones: El control de las prescripciones de ertapenem por un equipo multidisciplinario fue efectivo (AU)

Objective: To determine the effectiveness of the intervention of a multidiscipline antimicrobial control group in the correct prescription of Ertapenem.Method: A four-month long, prospective study into prescriptions for Ertapenem was carried out in a third-level hospital. Assessment into the degree of suitability of each prescription according to the infections commission usage criteria. In the situation where prescriptions were not suitable, recommendations were given and acceptance of this was recorded. The effectiveness of the antimicrobial treatment used was assessed and treatment was considered effective when there was remission of the signs and symptoms of the infection when the treatment was completed. The treatment was considered to have failed when the signs and symptoms of infection persisted or progressed, requiring the addition of another antimicrobial agent, changing antibiotics or the prolongation of the treatment for longer than 2 weeks. Lastly, the differences in the average length of stay and the duration of the antibiotic treatment between groups were analysed.Results: Forty-eight prescriptions were assessed. The usage criterion was adequate in 48 % of cases, with 78 % effectiveness in this group. In the cases where the prescription was not adequate, but a change in prescription was accepted, the effectiveness was 92 %, with 55.5 % of those cases not accepting recommendation for change. The average stay was higher in this last group (p = 0.07). The duration of the antibiotic treatment in the patients who accepted the change in prescription was signifi cantly less than in those who did not accept it (2 vs 7.4 days, p < 0.0001).Conclusions: The control of Ertapenem prescriptions by a multidisciplinary team was effective (AU)

[Implementation of the guidelines for the introduction of new drugs (GINF) in Andalusian hospitals]. / Implantación de la guía para la incorporación de nuevos fármacos (GINF) en los hospitales andaluces.

OBJECTIVE: To measure the level of implementation of the GINF (guidelines for the introduction of new drugs) in Andalusian hospitals, describe the characteristics of this implementation and analyse if any of the hospital s dependent variables could influence these characteristics. METHOD: A telephone survey was carried out in the hospitals included in the Department of Health list. The survey consisted of 11 closed questions on different variables in the hospital and the GINF use profile, and an open question about the improvements carried out and proposals for improvement. The results were analysed according to the type of hospital (category, training, geographical location) in order to detect possible differences. RESULTS: A target population of 31 hospitals was identified. The survey was carried out in 29 of these; the level of implementation was 96.5% in the responding hospitals. 23 hospitals used the GINF for 100% of drugs, 6 had carried out local modifications and 80% made proposals for improvement. Significant differences were found in the implementation of the GINF according to resident/intern pharmacist training (p = 0.049), the geographical location (p = 0.004) and the hospital category (p < 0.001). CONCLUSIONS: The GINF have been implemented in almost all public Andalusian hospitals as the guidelines for requesting new drugs. Very few local modifications have been carried out to the guidelines, although numerous proposals for improvement have been made. Differences in use have been identified (No. of drugs, different versions) according to the hospital characteristics (location, training and complexity classification). They are considered a useful tool and influence the drug selection process, in particular in training hospitals with a higher classification.

Implantación de la guía para la incorporación de nuevos fármacos (GINF) en los hospitales andaluces / No disponible

Objetivo: Medir el grado de implantación de la guía GINF enlos hospitales andaluces, describir las características de dichaimplantación y analizar si algunas variables dependientes del hospitalpudieran influir en las mismas.Método: Se realizó una encuesta telefónica a los hospitalesincluidos en catálogo de la Consejería de Salud. La encuesta constabade 11 cuestiones cerradas sobre diferentes variables del hospitaly del perfil de utilización de la GINF, y una cuestión abiertaque recogía mejoras realizadas y propuestas de mejora. Se analizaronlos resultados en función del tipo de hospital (categoría, docencia,localización geográfica) para detectar posibles diferencias.Resultados: Se identificó una población diana de 31 hospitales.La encuesta pudo realizarse en 29; el grado de implantaciónfue del 96,5% en los hospitales respondedores. Veintitrés hospitalesutilizaban la GINF para el 100% de los fármacos, seis habíanrealizado modificaciones locales pero el 80% realizó propuestasde mejora. Se encontraron diferencias significativas en la implantaciónde la GINF en función de la docencia FIR (p = 0,049), lalocalización geográfica (p = 0,004) y la categoría de los hospitales(p < 0,001).Conclusiones: La guía GINF ha sido implantada en la prácticatotalidad de los hospitales públicos andaluces para la solicitudde nuevos fármacos. La guía apenas ha sido modificada localmente,aunque se recogen numerosas propuestas de mejora. Se identificandiferencias en su utilización (número de fármacos, diferentesversiones) en función de las características del hospital (localización,docencia y complejidad). Es considerada una herramientaútil e influyente en el proceso de selección de medicamentos,sobre todo en los hospitales docentes de mayor complejidad

Objective: To measure the level of implementation of theGINF (guidelines for the introduction of new drugs) in Andalusianhospitals, describe the characteristics of this implementation andanalyse if any of the hospital’s dependent variables could influencethese characteristics.Method: A telephone survey was carried out in the hospitalsincluded in the Department of Health list. The survey consisted of11 closed questions on different variables in the hospital and theGINF use profile, and an open question about the improvementscarried out and proposals for improvement. The results wereanalysed according to the type of hospital (category, training, geographicallocation) in order to detect possible differences.Results: A target population of 31 hospitals was identified.The survey was carried out in 29 of these; the level of implementationwas 96.5% in the responding hospitals. 23 hospitals usedthe GINF for 100% of drugs, 6 had carried out local modificationsand 80% made proposals for improvement. Significant differenceswere found in the implementation of the GINF according toresident/intern pharmacist training (p = 0.049), the geographicallocation (p = 0.004) and the hospital category (p < 0.001).Conclusions: The GINF have been implemented in almost allpublic Andalusian hospitals as the guidelines for requesting newdrugs. Very few local modifications have been carried out to theguidelines, although numerous proposals for improvement havebeen made. Differences in use have been identified (No. of drugs,different versions) according to the hospital characteristics (location,training and complexity classification). They are considered auseful tool and influence the drug selection process, in particularin training hospitals with a higher classification

¡Demasiados excipientes en especialidades de posible uso pediátrico! / Too many excipients in formulas of potential pediatric use!

No disponible

Concentrado de proteína C en el tratamiento de la sepsis grave en pediatría / Protein C concentrate in the treatment of severe sepsis in the pediatric setting

Los pacientes con sepsis severa desarrollan déficit adquirido de proteína C, existiendo una correlación entre el grado de deficiencia y la evolución clínica negativa. El reemplazamiento de dicha proteína puede contribuir a evitar este proceso. En el mercado existen dos tipos de proteína C, concentrada y activada. Ninguna de ellas están registradas para el tratamiento de sepsis grave en pediatría. La experiencia con proteína C en este grupo de edades es limitada. Se requiere ensayos clínicos adecuados que establezcan su eficacia y seguridad y que clarifiquen el lugar de cada tipo de proteína C en la terapéutica de esta patología en pediatría. En el presente artículo se describe la experiencia del uso de concentrado de proteína C como terapia coadyuvante a la terapia convencional en el tratamiento de tres niños con sepsis grave en la Unidad de Cuidados Intensivos Pediátrica. En los tres casos de nuestro estudio, los niveles altos de proteína C se correlacionan con normalización de los parámetros de coagulación y con disminución de los niveles de dímero D. Dos de los tres pacientes evolucionaron favorablemente en el curso del tratamiento, mientras que la tercera paciente murió al entrar en shock séptico y disfunción multiorgánica (AU)

[Protein C concentrate in the treatment of severe sepsis in the pediatric setting]. / Concentrado de proteína C en el tratamiento de la sepsis grave en pediatría.

Patients with severe sepsis develop acquired protein C deficiency, and the extent of such deficiency and negative clinical outcomes correlate. Replacing this protein may help prevent such a condition. Two protein C types are commercially available - concentrated and activated proteins. None is registered for the treatment of severe sepsis in the pediatric setting. Experience with protein C in this group of conditions is limited. Appropriate clinical trials are required to establish effectiveness and safety, and to elucidate the role of either protein C type in the management of this condition in the pediatric setting. This paper discusses experience with the use of protein C concentrate as an adjuvant treatment in addition to conventional therapy in three children with severe sepsis at a Pediatric Intensive Care Unit. In all 3 cases of our study, high levels of protein C correlated to coagulation parameter normalization and reduced dimer D levels. Two out of three had a favorable outcome following treatment, whereas the third patient died as a result of septic shock and multiple organ dysfunction.

Costs related to inappropriate use of albumin in Spain.

BACKGROUND: Albumin has been used in various treatments for > 50 years, but, recently, its use in clinical practice has become very controversial. OBJECTIVE: To assess the use of albumin in clinical practice in the public hospital setting in Andalucía, Spain, focusing on the economic repercussions of the inappropriate use of albumin. METHODS: Multicentered observational study in 22 public hospitals in which all patients receiving albumin (from start to conclusion of treatment) were assessed during a five-month period on three predetermined, nonconsecutive days. The clinical indications for albumin were evaluated on the basis of Guidelines, a consensus document created by a multidisciplinary team for dissemination by the Governmental Health Authority to all hospitals within its purview. The data were abstracted from the patient case report forms by the pharmacist selected to compile the data in each of the participating hospitals. RESULTS: A total of 242 forms reporting the use of 62,282 g of albumin were evaluated. The most frequent prescribing motives were nutritional intervention (23%), paracentesis in cirrhotic patients (19%), and radical surgery (11%). Only 59 prescriptions (24%), corresponding to 14,539 g of albumin (23%), were considered appropriate. The total cost of albumin therapy for the 242 cases was $183,796 (US$); $42,905 (23%) of this figure was the cost of appropriate use of albumin and $140,891 (77%) was the amount related to inappropriate use. CONCLUSIONS: Evaluated against model guidelines, the use of most of the albumin, deemed clinically necessary by the prescribers, was considered unnecessary or inappropriate. Hence, institutions need to define and implement guidelines that focus on responsible use of such agents in an increasingly cost-conscious healthcare environment.