Código Tipo de Farmaindustria de Protección de Datos personales en el ámbito de la Investigación Clínica y de la Farmacovigilancia / No disponible

El Código Tipo establece criterios uniformes en la aplicación sectorial de la Ley Orgánica de Protección de Datos (LOPD) y en su Reglamento de desarrollo, aumenta las garantías de su cumplimiento y disminuye el nivel de incertidumbre en su implementación. Contempla dos actividades fundamentales en la industria farmacéutica, como son la investigación clínica y la farmacovigilancia, desarrolla todos los escenarios que se llevan a cabo en la práctica diaria de estas actividades y establece tanto procedimentos de utilización de datos personales como de disociación irreversible, eximiendo éstos últimos de la aplicación de la normativa en materia de protección de datos. Desarrolla un protocolo que incluye las directrices a seguir para la atención del ejercicio de los derechos de acceso, rectificación, cancelación y oposición ejercitados por los afectados y prevé las funciones de supervisión de dicho Código por parte del Comité de Seguimiento

The Type Code established uniform criteria in the sectoral application of the Organic La won Data Protection (LOPD) and its implementing Regulation increases the guarantee of its compliance and reduces the level of uncertainty as to its implementation. Two key activities in the pharmaceutical industry are considered, namely clinical research and pharmacovigilance, all scenarios that take place n the daily practice of these activities are developed and procedures for the use of personal data and irreversible dissociation are established, with these last being exempt from the application of data protection legislation. It develops a protocol that includes the guidelines to follow with regard to the exercise of rights of access, rectification, cancellation and opposition exercised by those affected an stipulates the supervisory functions of the Code by the Monitoring Committee

[Type Code of the pharmaceutical industry for the protection of personal data in the field of clinical research and pharmaceutical surveillance]. / Código Tipo de Farmaindustria de Protección de Datos personales en el ámbito de la Investigación Clínica y de la Farmacovigilancia.

The Type Code establishes uniform criteria in the sectoral application of the Organic Law on Data Protection (LOPD) and its implementing Regulation increases the guarantee of its compliance and reduces the level of uncertainty as to its implementation. Two key activities in the pharmaceutical industry are considered, namely clinical research and pharmacovigilance, all scenarios that take place in the daily practice of these activities are developed and procedures for the use of personal data and irreversible dissociation are established, with these last being exempt from the application of data protection legislation. It develops a protocol that includes the guidelines to follow with regard to the exercise of rights of access, rectification, cancellation and opposition exercised by those affected and stipulates the supervisory functions of the Code by the Monitoring Committee.

Evolution in the management of acute myocardial infarction in the autonomous community of valencia (Spain): ten years of the primvac registry (1995-2004).

INTRODUCTION AND OBJECTIVES: Several registries of acute myocardial infarction (AMI) have been carried out in Spain, but few remain active. This work analyses the evolution of the characteristics and control of patients with AMI during the first 10 years of the PRIMVAC registry, initiated in 1995. METHODS: The demographical and clinical characteristics, therapeutic-diagnostic procedures and pharmacological treatment of patients admitted with AMI between January 1995 and December 2004, were analysed in 17 coronary centres in the Autonomous Community of Valencia (South eastern Spain). RESULTS: The mean age of the 19,719 patients recruited was of 65. The percentage of women, hypertension, hypercholestrolemia and diabetes increased during registry period. The median time of symptoms onset-hospital arrival was 151 minutes, without a decrease over the time, and the delay of thrombolysis fell from 200 to 154 minutes (p<0.01). Percentage of thrombolytic treatment oscillated between 39% and 48%. The mortality in the coronary units decreased (14.1% vs. 8.9%; p<0.001). The number of coronary angiography and percutaneous revascularisation performed increased up to 61% and 32%, respectively, of patients included. On discharge, the use of beta-blockers (29.3% vs. 66.7%), angiotensin-converting enzyme (ACE) inhibitors (41.7% vs. 57.9%) and statins (29.3% vs. 71%) went up. CONCLUSIONS: Overall mortality in the coronary unit decreased, without any variation in the incidence of serious complications. Time to thrombolysis was reduced over the time, with no significant increment in its use. The performance of coronary angiography and percutaneous revascularisation increased, with a low use of primary angioplasty. The use of beta-blockers, ACE inhibitors and statins increased at discharge.

[Reinfarction as a complication of acute myocardial infarction. PRIMVAC Registry data]. / El reinfarto como complicación del infarto agudo de miocardio. Datos del registro PRIMVAC.

INTRODUCTION AND OBJECTIVES: The clinical profile of patients with acute myocardial infarction (AMI) who have reinfarction (REAMI) during their stay in the intensive cardiologic care unit (ICCU) is not well known. The aim of this study was to identify factors predictive of REAMI, as well as its global incidence and mortality. PATIENTS AND METHOD: All patients with AMI admitted to the ICCU of 17 hospitals in the Comunidad de Valencia (Spain) in the period 1995-2000 (PRIMVAC Registry) were included. Differential characteristics between patients with or without REAMI were determined, and odds ratios (OR) for possible predictive factors were estimated with their 95% confidence intervals by logistic regression. RESULTS: A total of 12,071 patients were included. Mean age of the patients was of 65.5 years, the percentage of women was 23.8%, and the incidence of REAMI was 2.8%. The REAMI group was significantly older than the non-REAMI group. Female sex was significantly more common in the REAMI group. More diagnostic and therapeutic procedures were carried out, more drugs were used and there were more complications in the REAMI group. Mortality was significantly higher in the REAMI group (37.8% vs 12.6%). Only age, diabetes mellitus, previous myocardial infarction and the appearance of Q waves in the electrocardiogram were independently associated with the presence of REAMI. CONCLUSIONS: REAMI in the ICCU was associated with high mortality. Some clinical factors present during the first few hours after AMI were associated independently with the appearance of REAMI.

El reinfarto como complicación del infarto agudo de miocardio. Datos del registro PRIMVAC / Reinfarction as a complication of acute myocardial infarction. PRIMVAC registry data

Introducción y objetivos. El perfil clínico de los pacientes con infarto agudo de miocardio (IAM) que presentan un reinfarto (REIAM) durante su estancia en la unidad de cuidados intensivos cardiológicos (UCIC) es poco conocido. El objetivo de este trabajo es determinar los factores predictores de REIAM, su incidencia global y su mortalidad. Pacientes y método. Se incluyó a todos los pacientes con IAM ingresados en las UCIC de 17 hospitales de la Comunidad Valenciana en el período 1995-2000. Se determinaron las características diferenciales de los pacientes con y sin REIAM, y se calcularon las odds ratio y sus intervalos de confianza del 95% mediante un análisis de regresión logística para los posibles factores predictores. Resultados. Se incluyó a 12.071 pacientes con IAM. La edad media fue de 65,5 años, la proporción de mujeres del 23,8% y la incidencia de REIAM del 2,8%. La edad fue significativamente mayor en el grupo con REIAM que en el grupo sin REIAM, al igual que el porcentaje de mujeres. Se realizaron más procedimientos, se utilizaron más fármacos y hubo más complicaciones en el grupo con REIAM. La mortalidad fue significativamente mayor en el grupo con REIAM (37,8 frente a 12,6%). La edad, la diabetes mellitus, el infarto de miocardio previo y el desarrollo de onda Q en el electrocardiograma se asociaron de forma independiente con la presencia de REIAM. Conclusiones. El REIAM en la UCIC conlleva una alta mortalidad. Algunos factores presentes en las primeras horas del IAM se asocian con la aparición de REIAM

Introduction and objectives. The clinical profile of patients with acute myocardial infarction (AMI) who have reinfarction (REAMI) during their stay in the intensive cardiologic care unit (ICCU) is not well known. The aim of this study was to identify factors predictive of REAMI, as well as its global incidence and mortality. Patients and method. All patients with AMI admitted to the ICCU of 17 hospitals in the Comunidad de Valencia (Spain) in the period 1995-2000 (PRIMVAC Registry) were included. Differential characteristics between patients with or without REAMI were determined, and odds ratios (OR) for possible predictive factors were estimated with their 95% confidence intervals by logistic regression. Results. A total of 12 071 patients were included. Mean age of the patients was of 65.5 years, the percentage of women was 23.8%, and the incidence of REAMI was 2.8%. The REAMI group was significantly older than the non-REAMI group. Female sex was significantly more common in the REAMI group. More diagnostic and therapeutic procedures were carried out, more drugs were used and there were more complications in the REAMI group. Mortality was significantly higher in the REAMI group (37.8% vs 12.6%). Only age, diabetes mellitus, previous myocardial infarction and the appearance of Q waves in the electrocardiogram were independently associated with the presence of REAMI. Conclusions. REAMI in the ICCU was associated with high mortality. Some clinical factors present during the first few hours after AMI were associated independently with the appearance of REAMI