Evaluación de un protocolo de intercambio terapéutico de antidepresivos de segunda generación: resultados clínicos / Assessing a Therapeutic Exchange Protocol for Second-generation Antidepressants: Clinical Results

Objetivo Diseñar un protocolo de intercambio terapéutico de antidepresivos y evaluarlo clínicamente a través de variables como: grado de cumplimiento, frecuencia de casos con aumento clínicamente significativo en la escala de morbilidad psicofarmacológica Udvalg-für-Kliniske-Undersogelser (UKU), análisis de eventos adversos, análisis de la evolución global de la puntuación en la UKU y grado de aceptación de los pacientes; objetivos secundarios fueron correlacionar aspectos del tratamiento psicofarmacológico con el grado de morbilidad farmacoterapéutica y evaluar el impacto clínico de medidas de optimización farmacoterapéuticas. Método El protocolo se diseñó de acuerdo con una revisión bibliográfica y fue aprobado por la Comisión de Farmacia y Terapéutica. Se realizaron, sobre una muestra de 30 pacientes seleccionados secuencialmente, 3 mediciones (basal, a las 48-72h y a las 1-3 semanas) en las que se cuantificó la morbilidad farmacoterapéutica mediante la escala UKU y la Impresión Clínica Global, implantando medidas de optimización farmacoterapéutica en aquellos sujetos con niveles de morbilidad farmacoterapéutica elevada. Resultados El grado de cumplimiento fue del 73,3%. Un paciente experimentó un aumento ≥ 25% en la escala UKU y otro paciente experimentó un evento adverso. La puntuación final en la escala UKU alcanzó la significación estadística en comparación con las medidas realizadas a las 48-72h (p=0,032) y con la medida basal (p=0,007). El grado de aceptación de los pacientes fue del 90%. El impacto de las medidas de optimización sobre el nivel de morbilidad farmacoterapéutica fue clínica y estadísticamente significativo (p<0,001).Conclusiones El protocolo propuesto presenta una amplia aceptación y puede considerarse seguro para su implementación en un hospital general (AU)

Objective To design a therapeutic exchange protocol for antidepressants and clinically assess variables, such as compliance level, frequency of cases with clinically significant increase on the Udvalg-für-Kliniske-Undersogelser (UKU) psychopharmacological scale, adverse effects analysis, overall analysis of UKU rating development and patients’ level of acceptance. Secondary objectives were to correlate psychopharmacological treatment aspects with the pharmacological morbidity level, and evaluate the clinical impact of pharmacotherapeutic optimisation measures. Method The protocol is designed in accordance with a bibliographical review, which was approved by the Pharmacy and Therapeutics Commission. Sequential study was carried out with a sample of 30 patients. Three measurements were taken (base line, at 48–72h and at 1–3weeks) to calculate the pharmacotherapeutic morbidity with the UKU rating scale and the Global Clinical Impression. Pharmacotherapeutic optimisation measures were used for those patients with high pharmacotherapeutic morbidity levels. Results The compliance level was 73.3%. One patient experienced ≥25% increase on the UKU rating scale and another patient suffered from an adverse effect. The final UKU rating reached statistical significance compared with the measurements taken at 48–72h (P=.032) and with the base line measurement (P=.007). Patient acceptance was 90%. The impact of optimisation measurements on the pharmacotherapeutic morbidity level was clinically and statistically significant (P<.001).Conclusions The proposed protocol has been widely accepted and it is quite certain that it is to be introduced in at a general hospital level (AU)

Assessing a therapeutic exchange protocol for second-generation antidepressants: clinical results.

OBJECTIVE: To design a therapeutic exchange protocol for antidepressants and clinically assess variables, such as: compliance level, frequency of cases with clinically significant increase on the Udvalg-für-Kliniske-Undersogelser (UKU) psychopharmacological scale, adverse effects analysis, overall analysis of UKU rating development and patients' level of acceptance. Secondary objectives were to correlate psychopharmacological treatment aspects with the pharmacological morbidity level, and evaluate the clinical impact of pharmacotherapeutic optimisation measures. METHOD: The protocol is designed in accordance with a bibliographical review, which was approved by the Pharmacy and Therapeutics Commission. Sequential study was carried out with a sample of 30 patients. Three measurements were taken (base line, at 48-72 hours and at 1-3 weeks) to calculate the pharmacotherapeutic morbidity with the UKU rating scale and the Global Clinical Impression. Pharmacotherapeutic optimisation measures were used for those patients with high pharmacotherapeutic morbidity levels. RESULTS: The compliance level was 73.3%. One patient experienced ≥25% increase on the UKU rating scale and another patient suffered from an adverse effect. The final UKU rating reached statistical significance compared with the measurements taken at 48-72 hours (P=.032) and with the base line measurement (P=.007). Patient acceptance was 90%. The impact of optimisation measurements on the pharmacotherapeutic morbidity level was clinically and statistically significant (P<.001). CONCLUSIONS: The proposed protocol has been widely accepted and it is quite certain that it is to be introduced in at a general hospital level.

Evaluación de la efectividad del colirio de suero autólogo en el tratamiento de patologías oculares / Effectiveness of 100% autologous serum drops in ocular surface disorders

Objetivo: Evaluar la efectividad del tratamiento con colirio de suero autólogo al 100% en pacientes con diversas patologías oculares. Métodos Estudio descriptivo, observacional, prospectivo de mayo de 2005 a febrero de 2009. La población del estudio fueron los pacientes que iniciaron tratamiento con colirio de suero autólogo al 100% elaborado en dosis unitarias. Para la evaluación de la efectividad del estudio se valoraron la desaparición o la mejoría de la sintomatología ocular en los pacientes mediante un cuestionario sobre los signos y los síntomas apreciados por el paciente al inicio y al final del tratamiento. Resultados Se evaluó a un total de 15 pacientes (24 ojos). Los síntomas, como el ojo rojo, el ardor o la quemazón, los pinchazos y la pesadez de los ojos, mejoraron en el 100% de los pacientes que los sufrían, mientras que la sensación del ojo seco y la arenilla mejoraron en el 92% de los casos. Para el 66,7% de los pacientes evaluados la mejoría en los síntomas justificó la incomodidad por la extracción de sangre. Con respecto a la tolerancia del colirio al 100%, solo un paciente presentó alguna molestia relacionada con la instilación del colirio. Conclusión La utilización de colirio de suero autólogo al 100% se asoció a una mejoría de la sintomatología ocular en la mayoría de los pacientes evaluados(AU)

Objective: To evaluate the effectiveness of 100% autologous serum eye drops for the treatment of various ocular surface disorders. Methods: A descriptive prospective observational study carried out from May 2005 to February2009 which included patients with ocular surface disorders treated with single-dose autologous serum eye drops. Treatment effectiveness was evaluated by using a clinical questionnaire inorder to assess symptoms experienced by patients at the beginning and end of treatment. Results: A total of 15 patients (24 eyes) were evaluated. Clinical symptoms such as redness, burning, sharp pain and tired eyes improved in 100% of the patients, whereas dryness and sandy/gritty sensation improved in 92% of the patients. The overall improvement of clinical symptoms was worth the inconvenience of venipuncture according to 66.7% of the patients. Regarding tolerance for autologous serum eye drops, only one patient experienced some discomfort when using the single-dose eye drops. Conclusion: The treatment with 100% autologous serum eye drops improved ocular symptoms for most patients (AU)

Análisis de la estabilidad de dos suspensiones orales de carbamazepina / Analysing the stability of two oral carbamazepine suspensions

Objetivo Analizar la estabilidad fisicoquímica y microbiológica de dos suspensiones orales de carbamazepina al 2,5 y al 5%.MétodoLas suspensiones orales se elaboraron a partir de carbamazepina en polvo y los vehículos comerciales Ora-sweet SF® y Ora-plus®. Se realizaron controles de calidad físicos (pH, estado de la suspensión y características organolépticas), químicos (cromatografía líquida de alta resolución [HPLC]) y microbiológicos a los 2, 4 y 6 meses de la preparación. Resultados La concentración a los 6 meses de las suspensiones de carbamazepina al 2,5% y al 5% resultó de 22,9mg/ml y de 45,9mg/ml, respectivamente, con valores de riqueza obtenidos mediante la cromatografía líquida de alta resolución se encontraron entre el 90 y el 110%, tal y como exige la Farmacopea Americana 23 NF18. Durante el período del estudio no se observó modificación de los parámetros físicos ni crecimiento en los cultivos microbiológicos realizados. Conclusiones Ambas suspensiones orales son estables física, química y microbiológicamente durante al menos 6 meses a temperatura ambiente y en frasco de vidrio topacio (AU)

Objective To assess the physical, chemical and microbiological stability of two oral suspensions of carbamazepine at concentrations of 2.5% and 5%.MethodsBoth oral suspensions were compounded from powdered carbamazepine and Ora-Sweet SF® and Ora-Plus® commercial compounding excipients. At the 2, 4 and a 6-month marks, different quality assays were performed, comprising physical (pH, state of the suspension, organoleptic properties), chemical (HPLC) and microbiological assays. Results The final concentration at 6 months for both the 2.5% and 5% carbamazapine suspensions was 22.9 and 45.9mg/ml respectively, with calculated richness values between 90 and 110% fulfilling USP23 NF18 requirements. No changes in physical properties and no culture growth were observed during the study period. Conclusion Both oral suspensions are physically, chemically and microbiologically stable for at least 6 months when preserved at room temperature in amber glass flasks(AU)

Analysing the stability of two oral carbamazepine suspensions.

OBJECTIVE: To assess the physical, chemical and microbiological stability of two oral suspensions of carbamazepine at concentrations of 2.5% and 5%. METHODS: Both oral suspensions were compounded from powdered carbamazepine and Ora-Sweet SF(®) and Ora-Plus(®) commercial compounding excipients. At the 2, 4 and a 6-month marks, different quality assays were performed, comprising physical (pH, state of the suspension, organoleptic properties), chemical (HPLC) and microbiological assays. RESULTS: The final concentration at 6 months for both the 2.5% and 5% carbamazapine suspensions was 22.9 and 45.9 mg/ml respectively, with calculated richness values between 90 and 110% fulfilling USP23 NF18 requirements. No changes in physical properties and no culture growth were observed during the study period. CONCLUSION: Both oral suspensions are physically, chemically and microbiologically stable for at least 6 months when preserved at room temperature in amber glass flasks.

Effectiveness of 100% autologous serum drops in ocular surface disorders.

OBJECTIVE: To evaluate the effectiveness of 100% autologous serum eye drops for the treatment of various ocular surface disorders. METHODS: A descriptive prospective observational study carried out from May 2005 to February 2009 which included patients with ocular surface disorders treated with single-dose autologous serum eye drops. Treatment effectiveness was evaluated by using a clinical questionnaire in order to assess symptoms experienced by patients at the beginning and end of treatment. RESULTS: A total of 15 patients (24 eyes) were evaluated. Clinical symptoms such as redness, burning, sharp pain and tired eyes improved in 100% of the patients, whereas dryness and sandy/gritty sensation improved in 92% of the patients. The overall improvement of clinical symptoms was worth the inconvenience of venipuncture according to 66.7% of the patients. Regarding tolerance for autologous serum eye drops, only one patient experienced some discomfort when using the single-dose eye drops. CONCLUSION: The treatment with 100% autologous serum eye drops improved ocular symptoms for most patients.

Sistema de vigilancia de productos sanitarios / Control system of medical devices

El objetivo del presente trabajo es revisar los Sistemas de Vigilancia de Productos Sanitarios en Europa, España y EE.UU. y la implicación del farmacéutico de hospital conforme a la legislación vigente y a su potencial rol profesional (AU)

Monitoring trough plasma concentrations of mycophenolate mofetil in patients with uveitis.

BACKGROUND: Mycophenolate mofetil (MMF) has been used successfully in patients with various forms of uveitis not responsive to other immunosuppressants. Nevertheless, for these patients neither recommendations for optimal dosage of MMF nor data concerning drug exposure of MMF are available. OBJECTIVE: To describe the results of the therapeutic drug monitoring (TDM) of MMF trough concentrations in a cohort of patients with uveitis, with the aim of optimizing the dosage of this drug, by maintaining a target concentration to achieve adequate immunosuppression with a minimal risk of therapeutic failure or toxicity. PATIENTS AND METHODS: This study describes the results of monitoring trough plasma concentrations of MMF in 12 patients with uveitis during a mean period of 21.4 months. Patients included one with Stevens-Johnson syndrome, one with Graves-Basedow's disease, one with Behcet's disease, one with idiopathic thrombocytopenic purpura and the rest with idiopathic uveitis. All patients were treated with steroids and additional therapy prior to treatment with MMF. RESULTS: Pharmacokinetic monitoring of mycophenolic acid (MPA) was performed with 108 trough plasma samples using an EMIT assay. Mean daily MMF dose was 24.5 +/- 6.3 mg/kg and mean trough MPA concentration was 2.9 +/- 1.9 microg/mL. Therapy was effective in 10 patients (83%). There were few side-effects: diarrhoea, excitement, agitation and cough that disappeared with daily dose reduction of MMF. CONCLUSIONS: MMF was effective in the majority of patients with uveitis with an acceptable profile of side-effects. TDM of MMF in patients with uveitis is clinically practicable and may help to optimize individual immunosuppressive therapy. We estimated that MMF dosages in the range of 0.5-1.5 g/day might be sufficient for treating uveitis and we recommend an initial target range of 2-4 microg/mL, which included 50% of our results. Randomized controlled trials are essential to confirm the efficacy of MMF in uveitis.

[Pharmacokinetic interaction between valproic acid and carbapenem-like antibiotics: a discussion of three cases]. / Interacción farmacocinética entre ácido valproico y antibióticos carbapenémicos: descripción de tres casos.

A number of literature references suggest that carbapenem-like antibiotics decrease plasma concentrations of valproic acid in epileptic patients. This interaction may result in a recurrence of epileptic seizures in these patients. To clarify the possible mechanism of such carbapenem-valproic acid interaction several experimental studies have been carried out in animals. However, the mechanism of this drug-drug interaction is as yet uncertain. in this article we report three new cases that were observed in our hospital within three months. One of these patients developed seizures. We also review the different mechanisms proposed, as well as cases published to this day. All these data demonstrate that care should be taken in using these potent antibiotics in patients receiving valproic acid.

Interacción farmacocinética entre ácido valproico y antibióticos carbapenémicos: descripción de tres casos / Pharmacokinetic interaction between valproic acid and carbapenem-like antibiotics: a discussion of three cases

Existen referencias en la literatura que indican que los antibióticos carbapenémicos disminuyen las concentraciones plasmáticas de ácido valproico en pacientes epilépticos. El resultado de esta interacción podría traducirse en la aparición de crisis epilépticas en estos pacientes. Con el fin de clarificar el posible mecanismo implicado en la interacción entre carbapenemes y ácido valproico se han desarrollado diversos estudios en animales de experimentación. Sin embargo, el mecanismo concreto sigue sin determinarse. En este trabajo se describen tres casos detectados en nuestro hospital durante un periodo de tiempo de tres meses, coincidiendo uno de ellos con la aparición de convulsiones. Además, se recogen los distintos mecanismos de interacción propuestos, así como los casos publicados hasta la fecha. De todo ello se desprende la necesidad de proceder con precaución a la hora de emplear estos potentes antibióticos en asociación con ácido valproico (AU)

Etanolemia y etilometría: un punto de discusión / Ethanolaemia and ethylometry: a point of controversy

El etanol es causa directa de muchos accidentes de circulación.Los efectivos policiales emplean la determinación de alcohol etílico en aire expirado mediante etilómetros de precisión como medida indirecta para conocer la concentración de etanol en sangre.Nuestro estudio pretende comparar la etilometría con la determinación directa de la concentración de etanol en sangre a partir de muestras de suero mediante un método enzimático, así como conocer la concentración de alcohol etílico en una muestra en el momento de su extracción y tras diez días de congelación.Los resultados muestran que no existe buena correlación entre etilometría o medida de etanol en aire expirado y la medida directa en sangre mediante método enzimático. Por otra parte, la congelación se presenta como un método adecuado de transporte y conservación de las muestras que contienen alcohol etílico, hecho ya demostrado en trabajos anteriores. (AU)

Viscosuplementacion: revisión de los diferentes hialuronatos en España / Viscosupplementation: review of hyaluronic acids in Spain

En el presente trabajo procedemos a revisar y comparar las propiedades de seis viscoelásticos compuestos por ácido hialurónico o derivados comercializados en España como productos sanitarios (implantes clínicos, clase III) y de cada vez mayor aplicación en patología degenerativa por osteoartrosis, principalmente de rodilla. Concluimos con la posible recomendación de abordar estos productos desde el punto de vista farmacológico aunque estén registrados como producto sanitario. Asimismo son necesarios mayor número de trabajos y estudios más específicos que en un primer lugar comparen entre sí los distintos productos comercializados y que en un segundo lugar refuercen sus ventajas e inconvenientes en la práctica clínica diaria (AU)

[A study of the stability of lipid emulsions in mixtures for peripheral parenteral nutrition]. / Estudio de la estabilidad de emulsiones lipídicas en mezclas para nutrición parenteral por vía periférica.

This study is an attempt to contribute practical information on the stability of the mixtures of parenteral nutrition administered peripherally, using two different brands of lipids and amino acids for peripheral administration, with the addition of polivitamins and calcium. The tests performed included the determination of osmolarity, pH and size of lipidic globule using two methods: Coulter Counter and microscopic interference contrast method. The time factor and conservation temperature were taken into account in the stability of the mixtures.