¿Qué medicamento prescribiría a un paciente con enfermedad celiaca? / What medication should be prescribed to a patient with coeliac disease?

La enfermedad celiaca es una intolerancia permanente a las proteínas del gluten de trigo, centeno, cebada y triticale. El único tratamiento eficaz es una dieta sin gluten durante toda la vida, aunque la adherencia estricta es complicada. Incluso algunos medicamentos contienen almidón como excipiente. La legislación vigente obliga a analizar el contenido en proteínas del almidón de trigo utilizado como excipiente o la ausencia de almidones de otro origen en caso de que se empleen almidones de arroz, maíz o patata. Sin embargo, no especifica que se haga referencia a las trazas de gluten que sean residuos del proceso de producción de los principios activos de los medicamentos. A propósito del caso que se describe, es necesario reflexionar sobre la importancia de informar adecuadamente al paciente y de revisar/actualizar la legislación actual para garantizar el uso seguro de los medicamentos

Coeliac disease is a permanent intolerance to gluten proteins from wheat, rye, barley and triticale. Although strict adherence is complicated, the only effective treatment is a gluten-free diet throughout life. Some drugs contain starch as an excipient, and there is a risk related to the gluten content, which must be avoided in these patients. Current legislation requires the analysis of the protein content of wheat starch, or the absence of starches from another source where rice, maize, or potato starches are used as excipients. But, it does not specify that reference should be made to traces of gluten that are residues of the process of production of the active ingredient. As regards the case described, there needs to be awareness of the importance of adequately informing patients and reviewing/updating current legislation to ensure the safe use of drugs

[What medication should be prescribed to a patient with coeliac disease?] / ¿Qué medicamento prescribiría a un paciente con enfermedad celiaca?

Coeliac disease is a permanent intolerance to gluten proteins from wheat, rye, barley and triticale. Although strict adherence is complicated, the only effective treatment is a gluten-free diet throughout life. Some drugs contain starch as an excipient, and there is a risk related to the gluten content, which must be avoided in these patients. Current legislation requires the analysis of the protein content of wheat starch, or the absence of starches from another source where rice, maize, or potato starches are used as excipients. But, it does not specify that reference should be made to traces of gluten that are residues of the process of production of the active ingredient. As regards the case described, there needs to be awareness of the importance of adequately informing patients and reviewing/updating current legislation to ensure the safe use of drugs.

Trascendencia clínica del contenido en sodio de la antibioticoterapia intravenosa / Clinical significance of the sodium content of intravenous antibiotic therapy

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[Clinical significance of the sodium content of intravenous antibiotic therapy]. / Trascendencia clínica del contenido en sodio de la antibioticoterapia intravenosa.

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Evaluación de la calidad de la identificación de las muestras para investigación clínica tras la aplicación de la normativa europea / Quality identification evaluation on investigational drugs after European regulatory requirements application

Objetivo: Evaluar la calidad de la identificación de las muestras para investigación clínica tras la aplicación de la normativa vigente. Método: Estudio retrospectivo. Fuentes de recogida de datos: registros de los controles de recepción realizados por el Servicio de Farmacia. Resultados: Se evaluaron 339 controles de recepción correspondientes a 76 muestras diferentes de 52 ensayos clínicos. El 71,1% de las muestras (n=54) correspondieron a ensayos en los que el promotor fue un laboratorio farmacéutico, para un 23,7% (n=18) fue una sociedad científica y en un 5,2% (n=4) un grupo de investigadores. La identificación fue correcta para el 21,1% (n=16) de las muestras. El cumplimiento medio en función de la entidad promotora fue del 93,7% para los laboratorios farmacéuticos, 91,1% para las sociedades científicas y 88,5% para los grupos de investigadores. Conclusiones: 1. El grado de adecuación del etiquetado a la normativa vigente es bajo (21,1% de las muestras). 2. Cuando el promotor es un laboratorio farmacéutico se alcanza el mayor porcentaje de cumplimiento (93,7% de los ítem)

Aim: To evaluate the quality on identification of investigational drugs, by analysing their adaptation to the regulatory requirements. Method: Retrospective study. Data sources: registries of reception control made by Pharmacy Service. Results: 339 reception controls were evaluated corresponding 76 differents investigational drugs and 52 clinical trials. 71,1% (n=54) investigational drugs were belonging to clinical trials sponsored by pharmaceutical laboratory, 23,7% (n=18) by scientific society and 5,2% (n=4) by a group of investigators. Identification was corrected in 21,1% (n=16) of investigational drugs. The average fulfillment based on promotional organization was 93,7% for pharmaceutical laboratories, 91,1% for scientific societies and 88,5% for group of investigators. Conclusion: 1. Identification adjustment to the regulatory requirements was low (21,1% of investigational drugs). 2. When sponsor was a pharmaceutical laboratory the greater percentage of fulfillment (93,7% of item) was reached

[Influence of gender on clinical research]. / Influencia del género en investigación ckínica.

OBJECTIVE: To analyze clinical trials performed in our setting for the past three years from a gender-related standpoint. MATERIAL AND METHODS: A retrospective study of 101 trials in which the pharmacy department of a 1,240-bed university hospital took part. DATA SOURCES: protocols and summary reports by the pharmacy department, Gecos software program, trial follow-up cards, reception records, sample dispensation and returns, and yearly reports. RESULTS: 17 trials included women only, 13 trials included men only, and 71 trials included patients of both genders. In female-only trials the most commonly studied condition was breast cancer (70.6%), the most common phases were phase III (47.1%) and II (41.2%) and the most commonly studied drugs were docetaxel (17.7%) and trastuzumab (11.8%). In male-only trials the most commonly studied condition was erectile dysfunction (92.3%), the most common phase was phase III (76.9%) and the most commonly studied drugs were tadalafil (38.5%) and vardenafil (30.8%). In trials without gender-related inclusion criteria the most commonly studied conditions included colon cancer (11.3%), lung cancer (11.3%), and renal failure (9.9%); the most common phase was phase III (57.7%) and the most frequently assayed drugs were interferon alpha-2a, gemcitabine and ribavirin. Overall participation rate was 62.3% for males and 37.7% for females. CONCLUSIONS: a) Regardless of gender, the most commonly studied condition was cancer, with breast cancer being most common in female-only trials and erectile dysfunction in male-only trials; b) male and female participation followed a 2:1 ratio in trials without gender-related inclusion criteria; and c) phase III was most common amongst all trials considered, with phase II having a relevant role in women-only trials as per guidelines favoring inclusion in early trials.

Teratogénesis: clasificaciones / Teratogenesis: classifications

La prevalencia de malformaciones debidas a fármacos es baja pero también evitable. Esto hace necesario la información precisa y actualizada sobre el potencial teratogénico de los fármacos ya que la prescripción de fármacos durante el embarazo es elevada. Se han desarrollado múltiples clasificaciones de fármacos en función de su riesgo teratogénico entre las cuales la más usada es la de la Food and Drug Administration en la que los fármacos se dividen en cinco grupos (A, B, C, D, X). Existen clasificaciones similares desarrolladas en otros países (Australia, Suecia o Alemania). Otras clasificaciones de fármacos aluden a la probabilidad o frecuencia de teratogenia. La ausencia de una clasificación única, la inespecificidad de las definiciones y la falta de estudios, no nos permiten muchas veces poder valorar adecuadamente el posible riesgo para el feto. (AU)

[Parenteral nutrition in oncologic patients]. / Nutrición parenteral en pacientes oncológicos.

The aim of this work is to carry out a follow-up of oncological inpatients who received parenteral nutrition (PN). We analysed the connection between the clinical situations and the indication and type of PN administered. A retrospective review of oncological patients who received PN during 1996 was carried out. Age, sex, primary tumor, PN indication and compliance degree, nutritional evolution, different categories of nutritional intervention, characteristics of PN as well as related complications and connected with PN were analysed. 33 patients, 23 female and 10 male, between 20 and 82 years old, were studied. 39% received PN with intensive antineoplastic therapy; 55% received PN as supportive treatment in various clinical situations related to the tumor or with antineoplastic therapy; 6% received palliative PN. 25 patients received PN without lipids and 8 total PN. The mean duration of PN was 10 days. 17 patients received PN by peripheric venous route and 16 through central venous catheter. The PN was well tolerated. In conclusion, most patients (94%) complied with some of the criteria established for the PN indication. The biggest percentage of patients in treatment with PN were divided into two main groups: patients with intensive antineoplastic therapy and patients with gastrointestinal disfunction caused by tumor or antineoplastic therapy. The role of PN in oncological patients it is not defined yet. The incidence of complications due to PN was low and without clinical relevance.