Agentes hemostáticos tópicos de uso quirúrgico / Topical hemostatic agents for surgical use

Introducción: La morbilidad, mortalidad y costes tras la cirugía se hallan influenciados en gran medida por la pérdida hemática o hemorragia y las consecuencias derivadas de la misma. Para controlar la hemorragia, es frecuente el uso de agentes hemostáticos tópicos en combinación o en adyuvancia a otras técnicas hemostáticas, cuando éstas resultan ineficaces o impracticables. Material y métodos: Se realizó una revisión sistemática en Cochrane y MEDLINE desde el año 2000 a 2017 para identificar las publicaciones relacionadas con el uso de hemostáticos pasivos, activos y sellantes en comparación con otros agentes hemostáticos en todos los tipos de intervenciones quirúrgicas. Resultados: Se seleccionaron 20 ensayos clínicos. La variable principal de eficacia en el 95% fue el tiempo hasta la hemostasia y en el 5% la disminución del sangrado. Las intervenciones quirúrgicas más frecuentes fueron; cirugía hepática (30%), vascular (20%), cardíaca (10%), espinal (10%), general (5%), plástica (5%), y otros tipos de cirugía (20%).Los estudios se dividieron en 7 grupos, en función del tipo de agente hemostático a estudio y el comparador: a) hemostáticos mixtos versus pasivos (10%), b) sellantes de fibrina versus hemostáticos activos (5%), c) sellantes de fibrina versus hemostáticos pasivos (50%), d) hemostáticos mixtos entre sí (15%), e) sellantes de fibrina entre sí (5%), f) hemostáticos pasivos entre sí (5%), g) hemostáticos activos entre sí (10%).Conclusiones: Los hemostáticos activos, mixtos y sellantes de fibrina demuestran superioridad frente a los pasivos en términos de eficacia clínica, con un coste superior y un perfil de efectos adversos similar. (AU)

Introduction: Morbidity, mortality, and costs after surgery are greatly influenced by blood loss or bleeding and the consequences of it.To control bleeding, the use of topical hemostatic agents in combination or adjuvant to other hemostatic techniques is frequent, when these are ineffective or impractical.Method: A systematic review was conducted in Cochrane and PubMed from 2000 to 2017 to identify publications related to the use of passive, active and sealant hemostatics compared to other hemostatic agents in all types of surgical interventions.Results: Twenty clinical trials were selected. The main variable of efficacy in 95% was the time to hemostasis and in 5% the decrease in bleeding.The most frequent surgical interventions were; liver surgery (30%), vascular (20%), cardiac (10%), spinal (10%), general (5%), plastic (5%), and other types of surgery (20%).The studies were divided into 7 groups, depending on the type of hemostatic agent under study and the comparator: a) mixed hemostatic versus passive (10%), b) fibrin sealants versus active hemostatic agents (5%), c) fibrin sealants versus passive hemostatic (50%), d) mixed hemostatic with each other (15%), e) fibrin sealants with each other (5%), f) passive hemostatic with each other (5%), g) active hemostatic with each other (10%).Conclusions: Active and mixed hemostatics and fibrin sealants showed superiority over the passive hemostatics in terms of clinical efficacy, with a higher cost and a similar profile of side effects. (AU)

Optimización de la farmacoterapia en un hospital de Traumatología / Optimisation of pharmacotherapy in a trauma centre

Objetivo Evaluar los resultados de la implantación de un programa de atención farmacéutica dirigido a optimizar el tratamiento farmacoterapéutico individualizado en un hospital de Traumatología con historia clínica informatizada (HCI) y sistema integral de dispensación individualizada de medicamentos (SIDIM).Métodos Estudio retrospectivo observacional de 3 años de duración (2007-2009). Se realizó un seguimiento diario del tratamiento farmacoterapéutico de los pacientes ingresados en unidades de hospitalización con SIDIM. Mediante el registro en un documento normalizado, se clasificaron los problemas relacionados con los medicamentos (PRM) y/o errores de medicación (EM) identificados, así como las intervenciones farmacéuticas realizadas de acuerdo con la idoneidad y el grado de aceptación de las mismas. Para la identificación de pacientes con oportunidades de mejora en su farmacoterapia (PRM y/o EM) se empleó el método IASER®.Resultados Se realizaron 1.971 intervenciones farmacéuticas (IF) tras revisar 124.336 líneas de tratamiento correspondientes a 12 IF por cada 100 pacientes. La prevalencia de pacientes con PRM fue del 12% distribuidos de la siguiente manera: 50,66% categorizados en seguridad, 22,98% en indicación, 12,23% en efectividad y 14,13% en adherencia. Los grupos fármacológicos principalmente implicados fueron: antiinfecciosos (29%), fármacos para el aparato locomotor (..) (AU)

Objective To evaluate the results for implementing a pharmaceutical care programme aimed at optimising personalised pharmacotherapeutic treatment in a Trauma Centre with electronic medical records (EMR) and an integral system for personalised medication dispensing (ISPMD).Method A three-year observational, retrospective study (2007-2009). On a daily basis, we checked the pharmaceutical treatment of patients admitted to hospital units with ISPMD. The medication-related problems (MRP) and medication errors (ME) were identified and classified by recording them on a standardised document. We also recorded data on the Pharmaceutical Interventions performed in accordance with fitness and level of acceptance. We used the laser® method to identify patients with pharmacotherapy improvement opportunities (MRP and/or ME).Results One thousand nine-hundred and seventy-one pharmaceutical interventions (PI) were found after having reviewed 124 336 treatment lines, resulting in 12 PI for every 100 patients. The prevalence of patients with MRP was 12%, distributed as such: 50.66% were safety-related, 22.98% indication-related, 12.23% effectiveness-related and 14.13% adherence-related. The main drug groups involved were: anti-infectious agents (29%), drugs for the musculoskeletal system (21%), drugs for blood and haematopoietic organs (12%), and drugs for the nervous system (11%). The active ingredient that required most PI in 2007 was dexketoprofen (15.6%), followed by ketorolac (12.4%). In 2008, it was dexketoprofen (22.0%) followed by gentamicin (7.3%), and in 2009 enoxaparin (19.0%) followed by dexketoprofen (14.3%). The origin of MRP was due to ME in 91% of cases in 2007and 81% in 2008, decreasing (..) (AU)

[Optimisation of pharmacotherapy in a trauma centre]. / Optimización de la farmacoterapia en un hospital de Traumatología.

OBJECTIVE: To evaluate the results for implementing a pharmaceutical care programme aimed at optimising personalised pharmacotherapeutic treatment in a Trauma Centre with electronic medical records (EMR) and an integral system for personalised medication dispensing (ISPMD). METHOD: A three-year observational, retrospective study (2007-2009). On a daily basis, we checked the pharmaceutical treatment of patients admitted to hospital units with ISPMD. The medication-related problems (MRP) and medication errors (ME) were identified and classified by recording them on a standardised document. We also recorded data on the Pharmaceutical Interventions performed in accordance with fitness and level of acceptance. We used the laser method to identify patients with pharmacotherapy improvement opportunities (MRP and/or ME). RESULTS: One thousand nine-hundred and seventy-one pharmaceutical interventions (PI) were found after having reviewed 124 336 treatment lines, resulting in 12 PI for every 100 patients. The prevalence of patients with MRP was 12%, distributed as such: 50.66% were safety-related, 22.98% indication-related, 12.23% effectiveness-related and 14.13% adherence-related. The main drug groups involved were: anti-infectious agents (29%), drugs for the musculoskeletal system (21%), drugs for blood and haematopoietic organs (12%), and drugs for the nervous system (11%). The active ingredient that required most PI in 2007 was dexketoprofen (15.6%), followed by ketorolac (12.4%). In 2008, it was dexketoprofen (22.0%) followed by gentamicin (7.3%), and in 2009 enoxaparin (19.0%) followed by dexketoprofen (14.3%). The origin of MRP was due to ME in 91% of cases in 2007 and 81% in 2008, decreasing to 53% in 2009. PI fitness, as percentages (CI 95%) were considered: Important PI [30.29 (10.19-49.95)]; Very important PI [38.36 (35.45-73)]; Acceptable PI [82.10 (52.28-111.10)]. CONCLUSIONS: Optimising personalised pharmacotherapeutic treatment by implementing an interdisciplinary Pharmaceutical Care programme promotes team work, and as a result improves rational and safe medication dispensing.

[Antineoplastic oral agents and drug-nutrient interactions: a sistematic review]. / Interacción de los antineoplásicos orales con los alimentos: revisión sistemática.

INTRODUCTION: Studies on bioavailability are part of the clinical development of drugs for oral use in order to identify potential drug-food interactions. For oral antitumor drugs, their clinical importance is currently recognized although regrettably the information available presents variability concerning the scientific evidence. OBJECTIVES: To review the available scientific evidence about oral anti-tumor medications and establish the recommendations for their administration with foods. METHODS: We carried out a bibliographic search in Medline and The Cochrane Library for the period January of 1966 to March of 2008, focused on identifying those publications about drug-food interactions with oral antitumor medications. The bibliographical analysis was made in two steps. During the first phase, we excluded those articles in which the title or their content did not correspond with the objective settled; during the second phase, we deleted all the references duplicated in both databases. The inclusion criteria to select the articles were: design (systematic reviews, meta-analysis, Phase I and Phase II randomized clinical trials), population (adult patients; >19 years of age), intervention evaluated (administration of oral anti-tumor drugs under fasting conditions or with food) and measurement of the iFA results (calculation of the 90% CI of the odds ratio between the geometric mean of the values under the curve of the plasma concentrations (ABC) or the maximal plasma concentration (Cmax) with and without foods). We excluded those publications that did not make reference to the bioequivalence dictamen established by the Food and Drugs Administration (FDA) in their outcomes measurement. A critical appraisal of the selected articles was done according to the recommendations that the FDA established to be met by these studies. RESULTS: At the initial search we obtained 850 references (98.5% Medline + and 1.4% Cochrane). During the first phase, we excluded 87.7% (746) of the articles, 100% of them corresponding to the search in Medline. During the second phase, 40 studies remained (5.2% of the initial ones) for full-text critical appraisal, to which four studies were added not indexed in Medline. From the critical appraisal of the 44 final articles, 25 were excluded (20 original articles, 4 short communications, and 1 meta-analysis) because they did not include as an outcome measure the bioequivalence dictamen. The 19 (2.2%) remaining articles provided information on 19 oral anti-tumor drugs in 210 patients and 146 healthy volunteers. Of these 19 drugs, 63% did not present drug-food interactions, with the possibility of administering them either with or without food; 21% have to be administered with foods and only 16% present drug-food interactions, so they have to be administered without foods. DISCUSSION: Currently, the clinical importance of drug-food interactions with oral anti-tumor drugs is identified more directly with the patient's safety than with the efficacy of the therapy. Given the development of these oral agents, their incorporation into the oncologic strategy displacing parenteral therapy, with monthly costs of thousands of Euros, it is necessary to perform well-designed studies on pharmacokinetics and pharmacodynamics. Their goal has to be comparing their bioavailability in the presence or absence of foods with the clinical response. In the meanwhile, to establish recommendations for their administration in relation to foods is inconsistent for some of these drugs and their results is uncertain given the lack of studies based on the FDA bioequivalence dictamen.

Interacción de los antineoplásicos orales con los alimentos: revisión sistemática / Antineoplastic oral agents and drug-nutrient interactions: a sistematic review

Introducción: Los estudios de biodisponibilidad son parte integrante del desarrollo clínico de medicamentos para administración oral con el fin de identificar potenciales interacciones fármaco-alimento (iFA). Actualmente, para los antineoplásicos orales se empieza a reconocer su importancia clínica, aun cuando lamentablemente, la información disponible presenta variabilidad en su evidencia científica. Objetivos: Revisar la evidencia científica disponible sobre las interacciones de los alimentos con medicamentos antineoplásicos orales y establecer recomendaciones para su administración. Métodos: Se realizó una búsqueda bibliográfica en Medline y The Cochrane Library para el periodo comprendido entre enero de 1966 a marzo de 2008, enfocada a identificar las publicaciones sobre interacciones fármaco alimento con antineoplásicos orales. El análisis bibliográfico consta de dos fases. En la primera fase se excluyeron los artículos que por título y contenido del resumen no se correspondían con el objetivo planteado; en la segunda fase se eliminaron las referencias duplicadas en ambas bases de datos. Los criterios de inclusión para seleccionar los artículos fueron: diseño (revisiones sistemáticas, metaanálisis, ensayos clínicos randomizados Fase I y II), población (pacientes adultos; >19 años de edad), intervención evaluada (administración de antineoplásicos orales bajo condiciones de ayuno o con alimentos) y medida del resultado de la iFA (cálculo del IC90% de la razón entre la media geométrica de valores del área bajo la curva de concentraciones plasmáticas (ABC) o la concentración plasmática máxima (Cmax) con y sin alimentos). Se excluyeron las publicaciones que como medida de resultado no hacían referencia al dictamen de bioequivalencia establecido por la Food and Drugs Administration (FDA). La valoración crítica de los artículos seleccionados se realizó según las recomendaciones que de acuerdo con la FDA deben cumplir estos estudios. Resultados: En la búsqueda inicial se obtuvieron 850 referencias (98,5% Medline + y 1,4% Cochrane). En la primera fase se excluyeron el 87,7% (746) de los artículos, correspondiendo el 100% a la búsqueda en Medline. En la segunda fase, quedaron 40 artículos (5,2% de los iniciales) para su lectura crítica a texto completo, a los que se añadieron cuatro más no indexados en Medline. De la lectura crítica de los 44 artículos finales, se excluyeron 25 artículos (20 artículos originales, 4 comunicaciones cortas y 1 metanálisis) por no incluir como medida de resultado el dictamen de bioequivalencia. Los 19 (2,2%) artículos restantes proporcionaron información sobre 19 fármacos antineoplásicos orales, en 210 pacientes y 146 voluntarios sanos. De estos 19 fármacos, el 63% no presentan iFA o interacciones fármaco-alimento, pudiéndose administrar indistintamente con/sin alimentos; el 21% se deben administrar con alimentos y sólo el 16% presentan interacción fármaco alimento, por lo que se deben administrar sin alimentos. Discusión: Actualmente, la importancia clínica de las interacciones fármaco alimento con antineoplásicos orales se identifica más directamente con la seguridad del paciente que con la efectividad del tratamiento. Ante el desarrollo de estos agentes orales, su irrupción en la terapia oncológica desplazando a la terapia parenteral, con costes mensuales de miles de euros, hay necesidad de realizar estudios farmacocinéticos y farmacodinámicos bien diseñados. Su objetivo debe de ser comparar su biodisponibilidad en presencia o ausencia de alimentos con la respuesta clínica. Mientras tanto, establecer recomendaciones para su administración en relación con los alimentos, es inconsistente para algunos de estos fármacos y su resultado incierto por la falta de estudios fundamentados en el dictamen de bioequivalencia establecido por la FDA (AU)

Introduction: studies on bioavailability are part of the clinical development of drugs for oral use in order to identify potential drug-food interactions. For oral antitumor drugs, their clinical importance is currently recognized although regrettably the information available presents variability concerning the scientific evidence. Objectives: To review the available scientific evidence about oral anti-tumor medications and establish the recommendations for their administration with foods. Methods: We carried out a bibliographic search in Medline and The Cochrane Library for the period January of 1966 to March of 2008, focused on identifying those publications about drug-food interactions with oral antitumor medications. The bibliographical analysis was made in two steps. During the first phase, we excluded those articles in which the title or their content did not correspond with the objective settled; during the second phase, we deleted all the references duplicated in both databases. The inclusion criteria to select the articles were: design (systematic reviews, meta-analysis, Phase I and Phase II randomized clinical trials), population (adult patients; >19 years of age), intervention evaluated (administration of oral anti-tumor drugs under fasting conditions or with food) and measurement of the iFA results (calculation of the 90% CI of the odds ratio between the geometric mean of the values under the curve of the plasma concentrations (ABC) or the maximal plasma concentration (Cmax) with and without foods). We excluded those publications that did not make reference to the bioequivalence dictamen established by the Food and Drugs Administration (FDA) in their outcomes measurement. A critical appraisal of the selected articles was done according to the recommendations that the FDA established to be met by these studies. Results: At the initial search we obtained 850 references (98.5% Medline + and 1.4% Cochrane). During the first phase, we excluded 87.7% (746) of the articles, 100% of them corresponding to the search in Medline. During the second phase, 40 studies remained (5.2% of the initial ones) for full-text critical appraisal, to which four studies were added not indexed in Medline. From the critical appraisal of the 44 final articles, 25 were excluded (20 original articles, 4 short communications, and 1 meta-analysis) because they did not include as an outcome measure the bioequivalence dictamen. The 19 (2.2%) remaining articles provided information on 19 oral anti-tumor drugs in 210 patients and 146 healthy volunteers. Of these 19 drugs, 63% did not present drugfood interactions, with the possibility of administering them either with or without food; 21% have to be administered with foods and only 16% present drug-food interactions, so they have to be administered without foods. Discussion: Currently, the clinical importance of drugfood interactions with oral anti-tumor drugs is identified more directly with the patient's safety than with the efficacy of the therapy. Given the development of these oral agents, their incorporation into the oncologic strategy displacing parenteral therapy, with monthly costs of thousands of Euros, it is necessary to perform well-designed studies on pharmacokinetics and pharmacodynamics. Their goal has to be comparing their bioavailability in the presence or absence of foods with the clinical response. In the meanwhile, to establish recommendations for their administration in relation to foods is inconsistent for some of these drugs and their results is uncertain given the lack of studies based on the FDAbioequivalence dictamen (AU)

Estabilidad de haloperidol-butilescopolamina-midazolamen sistemas de infusión continua de 24 horas / No disponible

Objetivo: determinar la estabilidad de la mezcla ternaria haloperidolbutilescopolamina-midazolam para establecer su validez terapéutica. Material y método: se estudiaron mezclas ternarias de haloperidol, butilescopolamina (Br), y midazolam, utilizando como vehículo glucosa 5%, a concentraciones de 0,2 y 0,8 mg/ml para haloperidol. Para los otros dos componentes la concentración (1,2 mg/ml) permaneció invariable. El estudio se realizó bajo condiciones asépticas, a temperatura ambiente, sin fotoprotección, por duplicado y durante un periodo de 84 horas. Como criterios de compatibilidad física: cambio de color, aparición de opalescencia, variación de peso y pH. La estabilidad química de los componentes se evaluó mediante cromatografía líquida de alta resolución ultravioleta-visible. Como parámetro de validez clínica se empleó el T90, considerando para su cálculo el valor obtenido al interpolar el límite inferior del intervalo de confianza del 95% de la recta representativa de la cinética lineal, para una concentración del 90% de la concentración inicial de los componentes. Resultados: los valores de las concentraciones de los componentes se ajustaron a una cinética de orden uno. El valor de T90 obtenido no fue inferior a 72 horas en las mezclas estudiadas. Durante las 84 horas que duró el ensayo ninguna de las mezclas presentó cambio de color, aparición de opalescencia, variación de peso ni de pH. Conclusión: las mezclas intravenosas a las concentraciones estudiadas de haloperidol (hasta 0,8 mg/ml), butilescopolamina (Br) (1,2 mg/ml) y midazolam (1,2 mg/ml), preparadas en glucosa 5%, en sistemas de infusión elastoméricos portátiles, son físicamente compatibles y químicamente estables durante al menos 72 horas (AU)

Objective: to determine the stability of ternary mixtures of haloperidol, midazolam, and scopolamine in order to establish their therapeutic validity. Material and methods: ternary mixtures of haloperidol, scopolamine, and midazolam were prepared in 5% glucose as vehicle at concentrations of 0.2 and 0.8 mg/mL for haloperidol. Concentration (1.2 mg/mL) remained invariable for the other two components. The study was conducted under aseptic conditions, at room temperature, without photoprotection, in duplicate, and during a period of 84 hours. Chemical stability was evaluated by high pressure liquid chromatography, and physical compatibility by changes in colour, development of opalescence, and changes in weight and pH. The T90 parameter was used to establish clinical validity, and was calculated for each drug in the mixture by considering the time at which the 95% one-sided confidence limit for the mean curve intersects 90% of the drug's initial concentration. Results: concentrations were adjusted to a first-order kinetic equation. The value of T90 was obtained after no less than 72 hours in the mixtures studied. During the 84-hour test none of the mixtures developed changes in colour, opalescence, or changes in weight or pH. Conclusion: the intravenous mixtures studied, consistent of haloperidol (up to 0.8 mg/mL), scopolamine (1.2 mg/mL), and midazolam (1.2 mg/mL) prepared in 5% glucose within elastomeric portable infusion systems, are physically compatible and chemically stable for at least 72 hours (AU)

[Acute intoxication with sustained-release lithium carbonate tablets. A propos of a case]. / Intoxicación aguda por comprimidos de liberación sostenida de carbonato de litio. A propósito de un caso clínico.

OBJECTIVE: To describe the case of a patient who ingested 50 sustained release lithium carbonate 400 mg tablets, and reached a late peak concentration above 3 mEq/L. CASE REPORT: A 32-year-old male with bipolar mood disorder ingested 50 sustained-release lithium carbonate tablets. Upon admission to the emergency room, a gastric wash was performed,from which several tablet remnants were obtained, as well as an intestinal lavage using activated carbon. PHYSICAL EXAMINATION: good general status, no fever, blood pressure 160/90 mm Hg, no edemas. Neurologic, pulmonary, and cardiac examinations were normal. CBC and the chemistry panel were normal. The patient's psychopathological examination suggested a stable status with no apparent manifestations arising from a decompensated mood disorder. Five hours after his massive lithium ingestion the drug's plasma levels were 0.75 mEq/L. At 22 hours post-ingestion a chemistry panel was obtained, which showed serum creatinin at 1.38 mg/dL and a lithium plasma concentration of 3.15 mEq/L. A hemodyalisis trial was attempted for 4 hours. At 73 hours post-ingestion, lithium plasma levels were 0.6 mEq/L, that is, within therapeutic range. The patient was hemodynamically stable and serial blood tests were normal; he was discharged. COMMENT: Acute lithium intoxication with plasma levels above 3 mEq/l can be fatal or result in irreversible neurologicsequelae in almost one third of cases, with persistent cerebellar dysfunction in association with dementia of variable degree, andrenal, blood, and liver disturbances. Sustained-release tablets may prolong absorption and delay peak plasma concentrations. In such cases, therefore, it is recommended that drug plasma concentrations be monitored during 48-72 hours post-ingestion.

[Pharmaceutical care of patients with rheumatoid and psoriatic arthritis receiving etanercept]. / Atención farmacéutica a pacientes con artritis reumatoide y psoriásica en tratamiento con etanercept.

OBJECTIVE: To evaluate a pharmaceutical care protocol for patients with rheumatoid arthritis (RA) or psoriatic arthritis who begin treatment with etanercept with the objective of identifying potential medication-related problems and implementing therapeutic measures to improve the way this drug is used. METHOD: An observational, prospective, 3-month study of patients with RA receiving etanercept therapy from March to December 2003 was conducted and a pharmaceutical care protocol was set up. During the first visit, a pharmacotherapeutic record was initiated for each patient, including socio-demographic data, personal history, diagnosis, DMARDs (disease-modifying anti-rheumatic drugs) previously received, and concomitant therapies for other underlying conditions. Patients were briefed on dosage, administration route, and potential adverse events both orally and in writing. Correct drug administration and preservation were verified during the second visit, where potential adverse effects were identified, treatment adherence was confirmed, and, if needed, potential drug interactions with other ongoing medications were disclosed. During the third visit, adherence was assessed, adverse events were recorded, and patients evaluated their response to treatment. RESULTS: Fifty patients were included, 40 with a diagnosis of rheumatoid arthritis (80%) and 10 diagnosed with psoriatic arthritis (20%). In all, 72% had received previous treatment with methotrexate (MTX), 40% with leflunomide, 20% with infliximab, 56% with corticoids, 2% with analgesics, 56% with NSAIDs, and 30% with other DMARDs. CONCLUSIONS: No significant drug interactions were found. Regarding adherence to treatment, 7.7% of patients skipped one or more doses, with travelling being the most common reason. Adverse events reported included: injection site reaction (27%), headache (7.7%) and nausea (7.7%). At 3 months after treatment onset, a reduction of MTX doses was seen in 18% of patients, of leflunomide dosage in 8%, of corticoids in 18%, of analgesic usage in 6%, and of NSAIDs in 8% of patients. In agreement with these results, 92% of patients reported having experienced improvment.

Atención farmacéutica a pacientes con artritis reumatoide y psoriásica en tratamiento con etanercept / Pharmaceutical care of patients with rheumatoid and psoriatic arthritis receiving etanercept

Objetivo: Evaluar un protocolo de atención farmacéutica dirigido a pacientes con artritis reumatoide y/o psoriásica que inician tratamiento con etanercept, con el propósito de detectar posibles problemas relacionados con la medicación y emprender medidas terapéuticas encaminadas a mejorar la utilización del fármaco. Método: Estudio observacional prospectivo de 3 meses de duración de aquellos pacientes con artritis reumatoide que inician tratamiento con etanercept desde marzo a diciembre de 2003. Se elabora un protocolo de atención farmacéutica. En la primera visita, se abre la historia farmacoterapéutica al paciente y se recogen datos sociodemográficos, antecedentes personales, diagnóstico, fármacos antirreumáticos modificadores de la enfermedad previos, y tratamiento concomitante para otras patologías base. Se informa verbalmente y por escrito de la posología, forma de administracióny posibles efectos adversos. En la 2ª visita se verifica la correcta administración y conservación del medicamento, se identifican posibles efectos adversos, se confirma la adherencia al tratamiento y en su caso, se informa de las potenciales interacciones farmacológicas con el resto de medicación. En la 3ª visita se constatala adherencia, se recogen los efectos adversos y el paciente valora la respuesta al tratamiento. Resultados: Se incluyen 50 pacientes, 40 de los mismos diagnosticados de artritis reumatoide (80%) y 10 de artritis psoriásica (20%). Un 72% recibe tratamiento previo con metotrexato (MTX),40% con leflunomida, 20% con infliximab, 56% con corticoides, 22% con analgésicos, 56% con AINE y un 30% con otros fármacos antirreumáticos modificadores de la enfermedad. Conclusiones: No se han encontrado interacciones farmacológicas significativas. En cuanto a la adherencia al tratamiento, un 7,7% de los pacientes ha dejado de administrarse una o más dosis, siendo el motivo más frecuente encontrarse de viaje. Los efectos adversos observados han sido: reacción en el punto de inyección (27%), cefalea (7,7%) y náuseas (7,7%). A los 3 meses de tratamientose ha constatado una reducción de la dosis de MTX en un 18% de los pacientes ha disminuido un 5% el número de pacientes tratados con leflunomida, un 18% aquellos tratados con corticoides, un 6% con analgésicos y un 8% con AINE. Acorde con estos resultados, un 92% de los pacientes ha considerado haber experimentado mejoría

Objective: To evaluate a pharmaceutical care protocol for patients with rheumatoid arthritis (RA) or psoriatic arthritis who begin treatment with etanercept with the objective of identifying potential medication-related problems and implementing therapeutic measures to improve the way this drug is used. Method: An observational, prospective, 3-month study of patients with RA receiving etanercept therapy from March to December 2003 was conducted and a pharmaceutical care protocol was set up. During the first visit, a pharmacotherapeutic record was initiated for each patient, including socio-demographic data, personal history, diagnosis, DMARDs (disease-modifyinganti-rheumatic drugs) previously received, and concomitant therapies for other underlying conditions. Patients were briefed ondosage, administration route, and potential adverse events both orally and in writing. Correct drug administration and preservation were verified during the second visit, where potential adverseeffects were identified, treatment adherence was confirmed, and, if needed, potential drug interactions with other ongoing medications were disclosed. During the third visit, adherence was assessed, adverse events were recorded, and patients evaluated their response to treatment. Results: Fifty patients were included, 40 with a diagnosis of rheumatoid arthritis (80%) and 10 diagnosed with psoriatic arthritis (20%). In all, 72% had received previous treatment with methotrexate (MTX), 40% with leflunomide, 20% with infliximab, 56% with corticoids, 2% with analgesics, 56% with NSAIDs, and 30% with other DMARDs. Conclusions: No significant drug interactions were found. Regarding adherence to treatment, 7.7% of patients skipped one or more doses, with travelling being the most common reason. Adverse events reported included: injection site reaction (27%), headache (7.7%) and nausea (7.7%). At 3 months after treatment onset, a reduction of MTX doses was seen in 18% of patients, ofleflunomide dosage in 8%, of corticoids in 18%, of analgesic usagein 6%, and of NSAIDs in 8% of patients. In agreement with these results, 92% of patients reported having experienced improvement

Intoxicación aguda por comprimidos de liberación sostenida de carbonato de litio. A propósito de un caso clínico / Acute intoxication with sustained-release lithium carbonate tablets. A propos of a case

Objetivo: Describir el caso de un paciente que ingirió 50 comprimidos de liberación sostenida de carbonato de litio 400 mg, alcanzando una concentración pico tardía superior a 3 mEq/L. Descripción del caso: Varón de 32 años con trastorno afectivo bipolar que ingiere 50 comprimidos de liberación sostenida de carbonato de litio. Al ingreso en urgencias se realiza lavado gástrico, obteniéndose restos de múltiples comprimidos y lavado intestinal con carbón activado. Exploración física: buen estado general, afebril, tensión arterial 160/90 mmHg, no edemas. Exploración neurológica, pulmonar y cardiaca normales. El hemograma y la bioquímica fueron normales. La exploración psicopatológica del paciente indica que presenta una situación estable, sin clínica aparente de descompensación de su trastorno afectivo. A las 5 horas de la ingesta masiva de litio, los niveles plasmáticos del fármaco son de 0,75 mEq/L. A las 22 horas posingesta se practica una bioquímica sanguínea que muestra un valor de creatinina sérica de 1,38 mg/dL y una concentración plasmática de litio de 3,15 mEq/L. Se realiza una sesión de hemodiálisis de 4 horas de duración. A las 73 horas posingesta los niveles plasmáticos de litio son de 0,6 mEq/L dentro del ámbito terapéutico. El paciente se encuentra estable hemodinámicamente con una analítica seriada sin alteraciones y es dado de alta. Comentario: La intoxicación aguda por litio con niveles plasmáticos por encima de 3 mEq/L puede ser letal e incluso dejar secuelas neurológicas irreversibles en cerca de un tercio de los casos, consistente en una disfunción cerebelosa persistente asociada a demencia de grado variable, alteraciones renales, sanguíneas y hepáticas. Cuando el litio se presenta en comprimidos de liberación retardada, se puede prolongar el periodo de absorción y retrasar la consecución de la concentración plasmática pico. Por lo tanto, en estos casos, se recomienda la monitorización de la concentración plasmática del fármaco durante un periodo de tiempo de 48-72 horas posingesta

Objective: To describe the case of a patient who ingested 50 sustained release lithium carbonate 400 mg tablets, and reached a late peak concentration above 3 mEq/L. Case report: A 32-year-old male with bipolar mood disorder ingested 50 sustained-release lithium carbonate tablets. Upon admission to the emergency room, a gastric wash was performed, from which several tablet remnants were obtained, as well as an intestinal lavage using activated carbon. Physical examination: good general status, no fever, blood pressure 160/90 mm Hg, no edemas. Neurologic, pulmonary, and cardiac examinations were normal. CBC and the chemistry panel were normal. The patient's psychopathological examination suggested a stable status with no apparent manifestations arising from a decompensated mood disorder. Five hours after his massive lithium ingestion the drug's plasma levels were 0.75 mEq/L. At 22 hours post-ingestion a chemistry panel was obtained, which showed serum creatinin at 1.38 mg/dL and a lithium plasma concentration of 3.15 mEq/L. A hemodyalisis trial was attempted for 4 hours. At 73 hours postingestion, lithium plasma levels were 0.6 mEq/L, that is, within therapeutic range. The patient was hemodynamically stable and serial blood tests were normal; he was discharged. Comment: Acute lithium intoxication with plasma levels above 3 mEq/l can be fatal or result in irreversible neurologic sequelae in almost one third of cases, with persitent cerebellar dysfunction in association with dementia of variable degree, and renal, blood, and liver disturbances. Sustained-release tablets may prolong absorption and delay peak plasma concentrations. In such cases, therefore, it is recommended that drug plasma concentrations be monitored during 48-72 hours post-ingestion

[Assessment of prescription in discharge reports at a university hospital]. / Evaluación de la prescripción de medicamentos en los informes de alta en un hospital universitario.

OBJECTIVE: To determine and analyze drug prescription at hospital discharge, mainly regarding generic drug use, use of novel but irrelevant therapeutic agents and use of low therapeutic value drugs (LTVD). MATERIAL AND METHODS: In a retrospective study 195 discharge reports from 11 different departments in a 450-bed general hospital were analyzed for a monthly period. An Access database allowed us to record the number of prescriptions, each drugs therapeutic group according to the Anatomical Therapeutic Chemical (ATC) Classification System, prescribed drugs for which generics are available, prescribed C-group drugs, LTVD drugs, etc. RESULTS: Following an analysis of results, only 6.17% of all drugs were prescribed according to their generic name, when this would have been possible in 22.8%. If only the most efficient agents had been prescribed, savings would have amounted to 589.3 Euros. In all, 1.28% of prescribed drugs were LTVD, and 1.15% had irrelevant therapeutic value. CONCLUSION: Although specialized medical prescription represents a minimum of total prescriptions in a healthcare area, measures intended to improve quality will have a positive impact on primary care prescriptions. These measures include information to physicians on more efficient preparations, plus the design of a Pharmacotherapeutic Guide to unify pharmacologic criteria in the Area.