Diseño de matriz de riesgo para control microbiológico en área de contaminación controlada en oncología : Unidad Centralizada de Mezclas de Medicamentos Estériles, Recetario Magistral, Hospital del Salvador
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Archivos
Fecha
2023
Autores
Profesor/a Guía
Facultad/escuela
Idioma
es
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Universidad Andrés Bello
Nombre de Curso
Licencia CC
Licencia CC
Resumen
Los preparados citostáticos son una subcategoría de los preparados estériles y estos
corresponden a sustancias químicas que afectan el crecimiento y la proliferación de
las células. La vía de administración de estos fármacos es predominantemente
intravenosa, requiriéndose con frecuencia de manipulación previa de estos
preparados. Dicha acción constituye un riesgo de contaminación microbiológica
relevante por lo que se deben tomar las medidas necesarias para garantizar su
estabilidad y esterilidad con el fin de contribuir en el éxito de la terapia farmacológica
y evitar posibles daños que esto podría ocasionar en el paciente.
Estos preparados se realizan en un área de contaminación controlada (UEPC) del
Recetario Magistral (RM), dicha área debe cumplir con exigencias según la normativa
vigente. Entendiendo la importancia de los medicamentos citostáticos se hace
imprescindible elaborar constantemente diversas estrategias para evitar cualquier tipo
de riesgo inminente a la preparación de estas formulaciones. Uno de los instrumentos
que ayudan en ello es la elaboración de matrices de riesgo, las que constituyen una
herramienta de gestión que evalúa la probabilidad y gravedad de un proceso lo que
finalmente nos ayudará a facilitar la toma de decisiones e intervenciones que se
ameriten.
El presente estudio mediante la observación y la investigación bibliográfica diseñó una
propuesta de matriz de riesgo óptima y adecuada para una zona con control
microbiológico mediante la identificación de puntos críticos que son determinantes en
el proceso, considerando aspectos que pueden influir y contribuir a una contaminación
microbiana de preparados citostáticos con la finalidad de prever los riesgos asociados
a la elaboración de este tipo de preparados.
Finalmente se logró identificar que un 53,8 % de los sucesos iniciadores identificados
dentro del estudio poseen un nivel de riesgo medio, mientras que un 46,2% poseen un
nivel de riesgo alto que contribuye a la eventual contaminación de los preparados
citostáticos. De esta forma, se puede definir de manera concreta la importancia de esta
herramienta y se concluye que la elaboración de esta matriz finalmente aporta en la
minimización de problemas y consultas en salud además de contribuir en la gestión de
calidad de la UCMME del Hospital del Salvador.
Cytostatic preparations are a subcategory of sterile preparations, and these correspond to chemicals that affect growth and proliferation of cells. The route of administration of these drugs is predominantly intravenous, often requiring prior handling of these preparations. Such action constitutes a risk of relevant microbiological contamination so the measures necessary to ensure their stability and sterility in order to contribute to the success of drug therapy and avoid possible damage that this could cause to the patient. These preparations are made in an area of controlled contamination (UEPC) of the “Recetario Magistral” (RM) and this area must comply with requirements according to current regulations. Understanding the importance of cytostatic drugs, it is essential to constantly develop various strategies to avoid any type of imminent risk to the preparation of these formulations. One of the instruments that help in this is the elaboration of risk matrices, which constitute a management tool that evaluates the probability and severity of a process which will ultimately help us facilitate decision-making. The present study through observation and bibliographic research designed a proposal for an optimal and adequate risk matrix for an area with microbiological control by identifying critical points that are decisive in the process, considering aspects which may influence and contribute to microbial contamination of cytostatic preparations in order to foresee the risks associated with the production of this type of preparations. Finally, it was possible to identify that 53.8 % of the initiating events identified within the study have a medium risk level, while 46.2% have a high level of risk that contributes to the eventual contamination of cytostatic preparations. In this way, the importance of this tool can be defined in a concrete way, and it is concluded that the elaboration of this matrix finally contributes to the minimization of problems and consultations in health in addition to contributing to the quality management of the "Hospital del Salvador".
Cytostatic preparations are a subcategory of sterile preparations, and these correspond to chemicals that affect growth and proliferation of cells. The route of administration of these drugs is predominantly intravenous, often requiring prior handling of these preparations. Such action constitutes a risk of relevant microbiological contamination so the measures necessary to ensure their stability and sterility in order to contribute to the success of drug therapy and avoid possible damage that this could cause to the patient. These preparations are made in an area of controlled contamination (UEPC) of the “Recetario Magistral” (RM) and this area must comply with requirements according to current regulations. Understanding the importance of cytostatic drugs, it is essential to constantly develop various strategies to avoid any type of imminent risk to the preparation of these formulations. One of the instruments that help in this is the elaboration of risk matrices, which constitute a management tool that evaluates the probability and severity of a process which will ultimately help us facilitate decision-making. The present study through observation and bibliographic research designed a proposal for an optimal and adequate risk matrix for an area with microbiological control by identifying critical points that are decisive in the process, considering aspects which may influence and contribute to microbial contamination of cytostatic preparations in order to foresee the risks associated with the production of this type of preparations. Finally, it was possible to identify that 53.8 % of the initiating events identified within the study have a medium risk level, while 46.2% have a high level of risk that contributes to the eventual contamination of cytostatic preparations. In this way, the importance of this tool can be defined in a concrete way, and it is concluded that the elaboration of this matrix finally contributes to the minimization of problems and consultations in health in addition to contributing to the quality management of the "Hospital del Salvador".
Notas
Seminario (Química Farmacéutica)
Palabras clave
Medicamentos, Medidas de Seguridad