Respuesta: Regulación de la obtención de muestras procedentes de cadáveres / Reply: Regulation of specimen from corpses

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Aspectos prácticos de la nueva normativa para el almacenamiento de muestras destinadas a la investigación en España / Practical issues of the new normative of research samples storage in Spain

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Spanish regulatory approach for biobanking.

The Spanish regulatory framework for storage of samples for research responds to most issues raised by both researchers and society regarding biobanking. The Spanish regulation currently foresees three possible ways in which these samples are to be handled: (a) gathering for use in a specific project, (b) storage in a collection, and (c) storage in a Biobank. Samples incorporated into a 'collection' can only be used by the investigator who requested them and cannot be transferred to third parties or used in research projects outside the particular research line foreseen in the original consent. On the other hand, the legal entity 'Biobank' refers not only to a set of physical facilities but to the management of the samples stored under that label, and particularly to the requirements for their cession. An approach based on putting most of the regulatory weight on the biobank side has been chosen in order to guaranty the rights of the donors as well as to ease the task of the researchers. A Biobank requires both to be authorized and to be registered in a public Registry. The requirements are quite stringent, allowing for the consent to be given as 'broad' in scope without implying being 'blank.' In this regard, for Biobanks to justify the taking on of some of the donors' rights, a key requirement is to have an external ethics committee supervising the adequacy of samples cession and use, notwithstanding the need for a previous bioethical supervision of the target protocol.

Estudios postautorización de tipo observacional en España: justificación y bases de una nueva normativa / Non-interventional post-authorisation studies in Spain: Justification and basisofa new regulation

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Trends in the consumption of opioid analgesics in Spain. Higher increases as fentanyl replaces morphine.

OBJECTIVE: During the past few years there have been changes in the availability of opioids in Spain, and new policies on palliative care have been implemented. The aim of this study was to describe the new pattern of opioid consumption in Spain and the associated economic impact. METHODS: A search in the ECOM (Especialidades Consumo de Medicamentos) database of the Ministry of Health and Consumer Affairs for the 1992-2006 period was carried out. This database contains information on prescriptions of primary care medicines that are covered by the National Health System in Spain. RESULTS: Since 1992, overall opioid consumption has increased 14-fold, from 0.3 DDD/1000 inhabitants per day to 4.4 DDD/1000 inhabitants per day. For the six drugs that require a special prescription form--morphine, methadone, oxycodone pethidine, tilidine and fentanyl--consumption increased from 0.1 DDD/1000 inhabitants per day in 1992 to 1.2 in 2006. During this same period, the total costs of these prescriptions increased by 36.8-fold, and the cost per day and per patient doubled. CONCLUSION: A huge increase in opioid consumption has occurred during the time period covered by this study, with fentanyl consumption accounting for most of that increase. Although oral morphine is the first-choice drug among strong opioids, fentanyl is currently the most consumed.

[Quality of observational post-authorization studies registered in Spain before their regulation]. / Calidad de los estudios postautorización de tipo observacional registrados en España antes de su regulación.

BACKGROUND AND OBJECTIVE: In July, 2002, observational post-authorization studies were subjected to regulation in Spain, giving rise to an uproar among sponsors and investigators. The aim of the present report was to assess the scientific and ethical quality of the studies presented during the year before the regulation came into force. In addition, we explored how many of them reached publication. MATERIAL AND METHOD: We extracted information relative to administrative procedures, methods, follow-up and ethical issues from the protocol of the studies presented to the Spanish Agency for Medicines and Healthcare Products (AEMPS) during 2001. RESULTS: A total of 162 studies intended to recruit 306,539 patients were registered as post-authorization studies in 2001. The most widely used design was the <> (122 studies; 75%). Physicians were the only source of information in 99% of the studies. In 43% of them, the sample size was neither specified nor justified. In 83% of the studies the observation period per patient was less than 12 months. An ethical review was requested for only 13% of the studies while a procedure to inform patients was planned in 44%. Eleven studies (10% of those finalized) had been published in scientific journals (1 of them international) and 13 (12% of those finalized) were reported as a communication to a national (11) or international (2) congress. CONCLUSIONS: Most post-authorization studies presented to the AEMPS in 2001 had poor methodological and ethical quality. Only a few became published, raising doubts about their scientific aims. These results give empirical support to the regulation adopted.

Calidad de los estudios postautorización de tipo observacional registrados en España antes de su regulación / Quality of observational post-authorization studies registered in Spain before their regulation

Fundamento y objetivo: En julio de 2002, los estudios postautorización de tipo observacional quedaron definitivamente regulados en España. La justificación de dicha regulación ha sido cuestionada. El objetivo de este trabajo es evaluar la calidad científica y ética de los estudios registrados el año previo a la entrada en vigor de la normativa, así como el valor social de sus resultados utilizando su publicación como indicador. Material y método: Se ha recogido los datos de carácter administrativo, metodológico, ético y de seguimiento de los estudios postautorización presentados en la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) durante el año 2001. Resultados: En 2001 se presentó en la AEMPS un total de 162 estudios postautorización que pretendían incluir un total de 306.539 pacientes. El diseño más habitual fue el de «seguimiento prospectivo no controlado» (122 estudios [75%]) y prácticamente en su totalidad (99%) el médico fue la única fuente de información. En un 43% no se especifica el tamaño muestral o no se justifica. La duración de los estudios fue inferior a 12 meses en el 83%. Sólo en el 13% de los estudios se solicitó la revisión por un comité ético de investigación clínica y sólo en el 44% se preveía algún procedimiento de información a los sujetos de investigación. Once estudios se publicaron como originales en revistas (el 10% de los finalizados), 1 de ellos en una revista internacional, y 13 (el 12% de los finalizados) en forma de comunicaciones a congresos, 2 de ellos internacionales. Conclusiones: Los estudios postautorización presentados en la AEMPS durante el año 2001 tuvieron escasa calidad metodológica y ética. La mayoría de ellos no se publicó, lo cual pone en cuestión el valor de esas investigaciones al tiempo que alimenta las dudas sobre su verdadera finalidad. La regulación de esos estudios parecía, pues, justificada

Background and objective: In July, 2002, observational post-authorization studies were subjected to regulation in Spain, giving rise to an uproar among sponsors and investigators. The aim of the present report was to assess the scientific and ethical quality of the studies presented during the year before the regulation came into force. In addition, we explored how many of them reached publication. Material and method: We extracted information relative to administrative procedures, methods, follow-up and ethical issues from the protocol of the studies presented to the Spanish Agency for Medicines and Healthcare Products (AEMPS) during 2001. Results: A total of 162 studies intended to recruit 306,539 patients were registered as post-authorization studies in 2001. The most widely used design was the «non-controlled prospective follow-up study» (122 studies; 75%). Physicians were the only source of information in 99% of the studies. In 43% of them, the sample size was neither specified nor justified. In 83% of the studies the observation period per patient was less than 12 months. An ethical review was requested for only 13% of the studies while a procedure to inform patients was planned in 44%. Eleven studies (10% of those finalized) had been published in scientific journals (1 of them international) and 13 (12% of those finalized) were reported as a communication to a national (11) or international (2) congress. Conclusions: Most post-authorization studies presented to the AEMPS in 2001 had poor methodological and ethical quality. Only a few became published, raising doubts about their scientific aims. These results give empirical support to the regulation adopted

[The use of anxiolytic and hypnotic drugs in Spain (1995-2002)]. / Utilización de ansiolíticos e hipnóticos en España (1995-2002).

BACKGROUND: Recent studies have revealed a rise in the use of anxiolytic and hypnotic drugs as well as the improper use thereof in Western countries. This study is aimed at ascertaining the pattern of use of anxiolytic and hypnotic drugs in Spain within the 1995-2002 period. METHODS: The data related to the use of medications was taken from the Ministry of Health and Consumer Affairs' ECOM (Medicinal Products Consumption) database, which includes information on the use of medications delivered through the community pharmacies and reimbursed by the National Health System. The data are expressed in Defined Daily Doses per 1,000 inhabitants per day. RESULTS: The use of anxiolytic and hypnotic drugs rose from 39.71 Defined Daily Doses per 1,000 inhabitants per day in 1995 to 62.02 in 2002. Throughout the period under study, benzodiazepines having a medium-range half-life (8-24 h.) were those most used, especially lorazepam, alprazolam and lormetazepam. The active ingredient having shown the greatest drop in use was flunitrazepam. CONCLUSIONS: Although the use of anxiolytic and hypnotic drugs has undergone a considerable rise in recent years in Spain, the pattern of use has shown no major changes.

[Use of antihypertensive drugs in Spain (1995-2001)]. / Utilización de antihipertensivos en España (1995-2001).

OBJECTIVES: In the last few years there have been changes in the pattern of consumption of antihypertensive drugs in Spain. This study aimed to describe the pattern of use in Spain from 1995 to 2001, its compliance with guidelines, and its economic impact. An aim of particular interest for our study was the impact of angiotensin II receptor antagonists on the consumption of the drugs from other therapeutic subgroups. PATIENTS AND METHOD: Information on drug utilization was obtained from the ECOM database of the Spanish Ministry of Health, which records the number of packages charged to the National Health System. Data were expressed in defined daily dose (DDD) and DDD per 1000 inhabitants per day (DHD). RESULTS: Antihypertensive consumption in Spain increased from 113.1 DHD in 1995 to 182.8 in 2001 (an increase of 61.65%). In 2001, angiotensin II receptor antagonists accounted for 25% of the costs and 14% of the consumption. Overall, costs increased from 646.42 million euros in 1995 to 1144.77 million euros in 2001. CONCLUSIONS: The consumption of antihypertensive drugs in Spain has increased remarkably in the last 7 years. Likewise, costs have increased proportionately, although the contributions of different therapeutic subgroups have been unequal. The impact of angiotensin II receptor antagonists has been considerable, both on consumption and on costs.

Oferta de medicamentos en la Unión Europea. El caso de los antiagregantes plaquetarios / Availability of drugs in the European Union. The case of antiplatelet agents

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[Evolution of antipsychotic drug consumption in the autonomous community of Castile and Leon, Spain (1990-2001)]. / Evolución del consumo de fármacos antipsicóticos en Castilla y León (1990-2001).

BACKGROUND: Over the past ten years, new drugs and new approaches to treatment have been implemented making it possible to assume changes in the use of antipsychotic drugs in our environment. This study is aimed at characterizing the pattern of use of antipsychotic drugs in Castile and Leon throughout the 1990-2001 period as well as ascertaining the bearing which the marketing of new antipsychotic drugs may have had on the pattern of consumption of these drugs. METHODS: The drug consumption data was obtained from the Ministry of Health and Consumer Affairs' consumption database ECOM (Especialidades Consumo de Medicamentos). This database contains information on the consumption of medications dispensed charged to the Social Insurance system in community pharmacies nationwide. To estimate the consumption outside of the National Health System, data from the IMS (International Marketing Services) firm for the years 2000 and 2001 was used. The data was given in Defined Daily Doses/1000 inhabitants/day. RESULTS: The use of antipsychotic drugs rose by 146% within the 1990-2001 period. Throughout the period studied, haloperidol was the antipsychotic drug most used in Spain and in Castile and Leon. The atypical antipsychotic drugs totaled 49% of the total consumption for 2001 and 90% of the costs, a strong trend being found toward an increase in the consumption of these atypical antipsychotic drugs in detriment to the typical antipsychotic drugs. It has been estimated that 14% of the antipsychotic drugs used in Castile and Leon were used outside of the National Health System.. Appreciable differences exist among the different provinces. CONCLUSIONS: The consumption of antipsychotic drugs in Castile and Leon grew by 146% throughout the twelve months studied. The marketing of new atypical antipsychotic drugs and the legal measures related to the deinstitutionalization of mental patients may have played a major role in this increase. The marketing of the new antipsychotic drugs has led to a change in their pattern of use and has give rise to an rise in the direct costs. The consumption of these medications not charged to the National Health System is minor, but not negligible.

[Hormonal replacement therapy in Spain]. / Tratamiento hormonal sustitutivo en España. Un estudio de utilización.

BACKGROUND: The consumption of hormonal replacement therapy (HRT) in Spain is not known. Therefore, we have conducted a study to know the mean features of that consumption and to find out the prevalence of use among women older than 40. SUBJECTS AND METHOD: To know the consumption, we have used the information contained in ECOM database from the Ministry of Health regarding medicines sold to the Spanish Health System. Also, data gathered by the General Practitioner Sentinel Network of Castilla y León had been used. The data of consumption are presented in daily defined dose per 1000 women more than 40 years (DHD); prevalence of use per year and for ages was also estimated. RESULTS: The HRT consumption in Spain throughout the National Health System was 6,94 DHD in 1989 and 39.92 DHD in 1999. The percentage of women using this therapy was 0.7% in 1989 and 3,4 in 1999; the group 50-54 years had the highest prevalence of use, 10,84% (IC 95%, 10.66-11.01). CONCLUSIONS: The release into the market of those transdermal forms of HRT facilitated an increase in the consumption. Nonetheless, the proportion of postmenopausal women on HRT in Spain is lower than that of the other countries from the European Union. The proportion of women treated with estrogens and progestins is also small compared with current recommendations.

Tratamiento hormonal sustitutivo en España. Un estudio de utilización / Hormonal replacement therapy in Spain

FUNDAMENTO: El consumo del tratamiento hormonal sustitutivo (THS) en España no se conoce con exactitud. Por este motivo, nos hemos planteado un estudio que permita conocer el consumo cuantitativo del THS, sus características y la prevalencia de uso de esta terapia de sustitución. SUJETOS Y MÉTODO: Para conocer el consumo, se utilizó la información que ofrece la base de datos de medicamentos ECOM del Ministerio de Sanidad y Consumo. También se empleó la información proveniente de una encuesta a mujeres a las que fue prescrito THS por los médicos pertenecientes a la Red de Médicos Centinelas de Castilla y León. Los datos de consumo se presentan en dosis diarias definidas por 1.000 mujeres con más de 40 años por día (DHD); se estimó también la prevalencia de uso por año y por grupos de edad. RESULTADOS: El consumo de THS en España a través de Sistema Nacional de Salud pasó de 6,94 dosis diarias definidas (DDD) por 1.000 mujeres mayores de 40 años en 1989 a 39,92 en 1999. El porcentaje de mujeres mayores de 40 años que usaban THS pasó del 0,7 por ciento en 1989 al 3,4 por ciento en 1999; el grupo de edad 50-54 años, con el 10,8 por ciento (intervalo de confianza del 95 por ciento, 10,7-11,0), fue el de mayor consumo. Los síntomas de la menopausia fueron el motivo más frecuente de prescripción de esta medicación. En la mitad de los casos se prescribieron estrógenos solos. CONCLUSIONES: La introducción en el mercado de las formas transdérmicas de administración de THS propició un aumento del consumo; no obstante, la proporción de mujeres posmenopáusicas que reciben THS en España es baja si se compara con la de otros países. La proporción de terapia combinada de estrógenos y progestágenos es igualmente baja si tenemos en cuenta las recomendaciones para su empleo. (AU)

Hepatotoxicity associated with the new antidepressants.

BACKGROUND: Safety profiles of classical and new antidepressants are well established. Hepatotoxicity is known to occur. Recently, several cases of severe hepatic injury associated with the new antidepressants have been reported, prompting us to quantify this risk. METHOD: To estimate the cumulative incidence of hepatic adverse reactions associated with antidepressants, we used cases of hepatic damage collected via spontaneous reporting and included in the Spanish Pharmacovigilance System database; for exposure, we have used data from drug sales to the Spanish National Health System. RESULTS: The estimated reported incidence did not show major differences for the antidepressants studied, ranging from 1.28 cases per 100,000 patient-years for sertraline to 4.00 for clomipramine, except for nefazodone, which was the agent that had the highest incidence with 28.96 cases per 100,000 patient-years. CONCLUSION: The reported incidence of hepatic adverse reactions to nefazodone seems to be higher than that estimated so far. Given the high prevalence of depression and the widespread use of antidepressants, physicians should be alert to the possibility that these medications cause hepatitis and consider early discontinuation of an antidepressant if the condition is suspected.

Criterios diagnósticos de la prueba del peso sostenido en la detección de pacientes con hipertensión arterial / Diagnostic criteria of the sustained weight test for the detection of hypertensive individuals

FUNDAMENTO: La prueba del peso sostenido (PPS), que basa su principio, como otras pruebas de esfuerzo, en la reactividad cardiovascular frente a un ejercicio físico, no tiene bien definidos los criterios de validez, factibilidad y reproducibilidad. El objetivo de este trabajo fue describir los valores de la presión arterial diastólica (PAD) y presión arterial sistólica (PAS) que permiten el diagnóstico de la hipertensión arterial (HTA) con esta prueba, así como validar los criterios de diagnóstico de la HTA con la misma. SUJETOS Y MÉTODO: Se diseñó un estudio transversal con una muestra de 547 personas. Se determinaron los hipertensos y normotensos de la misma tomando como cifras de referencias los valores 140 mmHg para la PAS y/o 90 mmHg para la PAD; este criterio se utilizó como prueba de referencia. Seguidamente, se aplicó la PPS y se identificaron los valores de 140/95 mmHg y 150/100 mmHg para definir dos grupos de normotensos y dos de hipertensos con este método. Por último, se determinaron la validez, la factibilidad y la reproducibilidad del método. RESULTADOS: La correlación de la PAD y la PAS antes y después de la PPS fue muy alta. Las cifras de sensibilidad y especificidad, el valor predictivo positivo y el valor predictivo negativo con criterio de 140/95 de la PPS fueron del 93,3, 87,9, 71,4 y 97,6 por ciento, y utilizando el criterio de 150/100 mmHg del 89,6, 95,6, 87 y 96,6 por ciento, respectivamente. CONCLUSIONES: Los resultados de este estudio demuestran la alta correlación que existe entre la presión arterial medida por el método de la PPS y por el método internacional, así como la adecuada validez, factibilidad y reproductibilidad de la PPS para el diagnóstico de la HTA en la comunidad (AU)

Hepatitis colestásica por ticlopidina / Cholestatic hepatitis by ticlopidin

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