Caracterización de las condiciones de la tención primaria de salud en Villa Clara para la conducción de ensayos clínicos oncológicos
Fecha
2016-07
Autores
Fiffe Polanco, Edilfredys
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Editor
Universidad Central “Marta Abreu” de Las Villas. Facultad de Química Farmacia. Departamento de Farmacia
Resumen
Villa Clara ha tenido un desarrollo destacado en la conducción de ensayos clínicos en instituciones de la Atención Secundaria de Salud. A partir del 2010, se incorpora la Atención Primaria de Salud a estos estudios, representado por los 6 policlínicos de la cabecera provincial. En el año 2015 se decide su extensión a toda la provincia, por lo que resultó necesario evaluar las condiciones de estas instituciones para enfrentar estas investigaciones. Es por ello que este trabajo tiene como Objetivo: Caracterizar la situación de la Atención Primaria de Salud en Villa Clara para la conducción de ensayos clínicos oncológicos. Materiales y métodos: Se realizó un estudio descriptivo, transversal entre los meses de septiembre y octubre del 2015. Se visitaron 18 policlínicos de la provincia Villa Clara y el Hospital “Celestino Hernández Robau”. En cada institución se evaluaron indicadores relacionados con los recursos humanos, así como las condiciones de la consulta de ensayos clínicos, el local destinado a la administración del producto en investigación y el almacén de medicamentos o farmacia. Se emplearon las técnicas de observación directa, entrevista estructurada y revisión documental, mediante instrumentos previamente validados. Con estos resultados se calcularon los indicadores definidos estableciendo dos categorías de evaluación “Adecuado” o “No adecuado” Resultados: De los 10 indicadores evaluados, 6 fueron considerados “Adecuados”, y 4 “No Adecuados”. Las principales no conformidades estuvieron relacionadas con la capacitación de los recursos humanos, la disponibilidad de consultas para la administración del producto en investigación y las condiciones para la conservación del producto en investigación. Conclusiones La evaluación global de la estructura se consideró “No Adecuada”, por ello se elaboró un plan de medidas para solucionar las no conformidades detectadas y de esta forma propiciar que la Atención Primaria en Villa Clara cuente con condiciones que le permitan asumir la conducción de ensayos clínicos oncológicos.
Villa Clara has had a prominent role in the conduct of clinical trials in institutions Secondary Health Care development. Since 2010, the primary health care to these studies, represented by the 6 polyclinics joined the provincial capital. In 2015 its extension to the whole province is decided, so it was necessary to assess the conditions of these institutions to deal with these investigations. That is why this work is Objective: To characterize the situation of Primary Health Care in Villa Clara for conducting oncology clinical trials. Materials and Methods: A descriptive, cross-sectional study was conducted between September and October 2015. 18 polyclinics in the province Villa Clara and the "Celestino Hernández Robau" Hospital were visited. In each institution related to human resources indicators they were evaluated, as well as query conditions of clinical trials, local for administration of the investigational product and drug store or pharmacy. direct observation techniques, structured interviews and document review, using previously validated instruments were used. With these results the defined indicators were calculated by establishing two categories of assessment "Suitable" or "Not suitable". Results: Of the 10 indicators tested, 6 were considered "suitable" and 4 "not suitable". The main nonconformities were related to the training of human resources, availability of consultation for administering the investigational product and the conditions for preservation of the product under investigation. Conclusions: The overall assessment of the structure "not adequate" was therefore considered a plan of action to address nonconformities and thus promote the Primary Care in Villa Clara count on conditions that allow it to take the driving test was developed clinical oncology.
Villa Clara has had a prominent role in the conduct of clinical trials in institutions Secondary Health Care development. Since 2010, the primary health care to these studies, represented by the 6 polyclinics joined the provincial capital. In 2015 its extension to the whole province is decided, so it was necessary to assess the conditions of these institutions to deal with these investigations. That is why this work is Objective: To characterize the situation of Primary Health Care in Villa Clara for conducting oncology clinical trials. Materials and Methods: A descriptive, cross-sectional study was conducted between September and October 2015. 18 polyclinics in the province Villa Clara and the "Celestino Hernández Robau" Hospital were visited. In each institution related to human resources indicators they were evaluated, as well as query conditions of clinical trials, local for administration of the investigational product and drug store or pharmacy. direct observation techniques, structured interviews and document review, using previously validated instruments were used. With these results the defined indicators were calculated by establishing two categories of assessment "Suitable" or "Not suitable". Results: Of the 10 indicators tested, 6 were considered "suitable" and 4 "not suitable". The main nonconformities were related to the training of human resources, availability of consultation for administering the investigational product and the conditions for preservation of the product under investigation. Conclusions: The overall assessment of the structure "not adequate" was therefore considered a plan of action to address nonconformities and thus promote the Primary Care in Villa Clara count on conditions that allow it to take the driving test was developed clinical oncology.
Descripción
Palabras clave
Atención Primaria de Salud, Villa Clara, Ensayos Clínicos Oncológicos