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.

[Intravenous inmunoglobulins in pediatrics]. / Inmunoglobulinas intravenosas en pediatría.

The use of intravenous immunoglobulins remains controversial after their introduction in therapeutics during the 80s. Their mechanism of action remains unexplained for certain pathologies, but their application to new indications and their economical impact makes them a target of many studies and protocols of use. Intravenous immunoglobulins are administred as substitution therapy in primary and secondary immunodeficiencies. On the other hand, their immunomodulating effect is the basis of their use on a great variety of autoimmune diseases and inflammatory processes, although not always following the authorised indications. This study reviews the use of intravenous immunoglobulins in pediatric population, making the distinction between the indications authorised by the regulatory authorities, and those non-authorised but supported by scientific publications.

Inmunoglobulinas intravenosas en pediatría / Intravenous immunoglobulins in pediatrics

El uso de inmunoglobulinas intravenosas sigue siendo controvertido tras su aparición en la terapéutica en la década de los ochenta. Su mecanismo de acción aún no explicado en ciertas patologías, su aplicación en nuevas indicaciones y su impacto económico, las hace objeto de numerosos estudios y protocolos de utilización.La administración de inmunoglobulinas intravenosas como terapia de sustitución se aplica en el tratamiento de inmunodeficiencias primarias y secundarias. Por otra parte tienen un efecto inmunomodulador que es la base para su utilización en un amplio abanico de enfermedades autoinmunes y procesos inflamatorios, si bien no siempre se emplean para las indicaciones autorizadas.En este trabajo se realiza una revisión del uso de las inmunoglobulinas intravenosas en la población pediátrica, distinguiendo en una primera parte las indicaciones autorizadas por el Ministerio de Sanidad y a continuación las indicaciones no autorizadas pero descritas en la literatura científica (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.

[Pharmacokinetics of antibiotics in malnutrition]. / Farmacocinética de los antibióticos en la desnutrición.

Human malnutrition is a complex, multirelated problem. Malnutrition and drug kinetics interaction was never studied in depth, despite the fact that as with antibiotics, medication is more often administered to malnourished than normonourished individuals, because of a higher rate of infection among members of the former group. We have studied the physiological changes resulting from malnutrition, and possible variations such state may have on absorption, distribution, protein binding capacity, drug metabolism and excretion processes in the body, in relation to possible dosage changes. Further studies are required on the effects of malnutrition on drug pharmacokinetics, especially in relation to antibiotics. Such assessment must be performed on different population subsets and under different environmental conditions, so as to obtain improved knowledge on each drug's clinical pharmacokinetics, that coupled with a more sensible way of handling plasma levels and careful patient clinical evaluation will lead to more rational therapy.