Sistema de farmacovigilancia activa realizada por un químico farmacéutico en pacientes hemato-oncológicos hospitalizados en el servicio de medicina del 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
Las afecciones hematoncológicas, llámense, leucemia, linfoma, mieloma, entre
otras, son afecciones neoplásicas malignas que afectan a la sangre. Al igual que
toda enfermedad cancerígena los tratamientos farmacológicos utilizados para
tratar estas patologías consisten en una variedad de drogas con estrecho margen
terapéutico y muchas veces en altas dosis, teniendo como resultado diversas
reacciones adversas a medicamentos (RAM). Estas RAM traen consigo un gasto
económico adicional, ya sea en términos de gastos asociados al control de dicha
reacción, exámenes de laboratorio adicionales a realizar o prolongación de la
estadía hospitalaria, pero debido a lo comunes que son, muchas veces los
equipos de salud consideran a las RAM como normales o inevitables y deciden
enfocarse en la efectividad de los tratamientos y en la supervivencia del paciente.
En consecuencia, la aparición de reacciones adversas no prevenibles,
prevenibles y la subnotificación de estas mismas es un fenómeno que ocurre con
frecuencia en el área oncológica, esto se traduce en altos costos en el sistema
de salud.
Este trabajo busca evaluar la seguridad y los costos asociados a las reacciones
adversas presentadas en pacientes hematoncológicos internados en el Hospital
del Salvador, utilizando un sistema de farmacovigilancia activa.
La naturaleza del estudio fue cuantitativo observacional, descriptivo y transversal
de revisión diaria de fichas clínicas, en dichas revisiones se buscaron posibles
reacciones adversas a medicamentos, a las que se les estableció la causalidad
con algún medicamento utilizando el algoritmo de Naranjo. Luego, se estableció
el carácter prevenible de cada reacción adversa utilizando el algoritmo de
Schumock and Thornton’s y se evaluó su severidad utilizando los criterios
comunes de toxicidad. Finalmente, se les asignó un costo asociado utilizando
datos extraídos de dos fuentes de literatura pertinente, extrapolándolos y
determinando la carga económica de cada evento, basados en su severidad y su
carácter prevenible.
En 42 pacientes estudiados, se encontró una incidencia de RAM del 86%, siendo
las más prevalentes las aplasias, más específicamente, plaquetopenia. El grupo
farmacológico que presento mayor cantidad de RAM fueron los antimetabolitos
aunque según el puntaje de naranjo, ninguna reacción adversa califico como
definitiva en lo que a imputabilidad trata. En cuanto a costos se estimó un valor
asociado a las RAM de $936.621.205, desde este valor se extrae $13.567.991
que corresponde solo a las reacciones adversas que se consideraron
prevenibles, existieron reacciones adversas a medicamentos cuyo valor no
fueron descritas específicamente en la bibliografía, por lo que el valor podría ser
incluso mayor.
Este estudio logro determinar una alta incidencia del 86% de RAM en pacientes
hematoncológicos las cuales fueron principalmente catalogadas como severas,
no prevenibles y tuvieron un costo asociado estimado de $936.621.205 de las
cuales $13.567.991 fueron estimados para RAM potencialmente evitables.
Haematologic neoplasms, named, leukaemia, lymphoma, myeloma, among others, are a type of cancer that affects the blood. Just like any other oncologic disease the type of drug that are used to treat this kind of pathology are of a narrow therapeutic window, and often they are used in high dosage, this results on a variety of adverse drugs reactions (ADRs). This ADRs are associated with an economic burden, being ADRs resolution’s associated costs, laboratory exams or a prolonged length of stay, however due to their common nature, a lot of times they are seen as normal or unavoidable and healthcare teams decide to focus on effectiveness and overall survival. Due to all this, unpreventable and preventable ADRs as well as the subnotification of them, are a common phenomenon on oncology, which results on high economic burden for the health care system. This study aims to evaluate the security and costs associated to ADRs on haemato-oncologic inpatients of the Hospital del Salvador, using an active pharmacovigilance system. A quantitative observational study was conducted, where medical records were reviewed actively looking for ADRs, when one was found, causality was assessed using Naranjo’s causality algorithm. Preventability was then defined for each adverse drug reaction using the Schimock and Thornston’s scale, finally severity was determined by the common toxicity criteria of adverse events (CTCAE). A cost was calculated for each individual ADR using literature available, in order to determinate the economic burden for each event based on their severity and its preventability. In the 42 patients enrolled, an ADRs incidence of an 86% was found, the most prevalent being aplasia’s, thrombocytopenia to be specific. The pharmacological group that was found to be responsible for the most ADRs were antimetabolites, but using Naranjo’s causality algorithm none of the reactions recorded were found to be definitive. A total cost of $936.621.205 pesos was calculated for all ADRs from which it was estimated a cost of $13.567.991 to only those that were considered preventable, there were however adverse drug reactions that was not possible to estimate the cost of, for this reason this value could be being underestimated. This study found an incidence of ADRs of 86% on haemato-oncologic inpatients, most of them were catalogued as severe, non-preventable and with a cost associated of $936.621.205 CLP overall and $13.567.991 only for the ADRs that were preventable.
Haematologic neoplasms, named, leukaemia, lymphoma, myeloma, among others, are a type of cancer that affects the blood. Just like any other oncologic disease the type of drug that are used to treat this kind of pathology are of a narrow therapeutic window, and often they are used in high dosage, this results on a variety of adverse drugs reactions (ADRs). This ADRs are associated with an economic burden, being ADRs resolution’s associated costs, laboratory exams or a prolonged length of stay, however due to their common nature, a lot of times they are seen as normal or unavoidable and healthcare teams decide to focus on effectiveness and overall survival. Due to all this, unpreventable and preventable ADRs as well as the subnotification of them, are a common phenomenon on oncology, which results on high economic burden for the health care system. This study aims to evaluate the security and costs associated to ADRs on haemato-oncologic inpatients of the Hospital del Salvador, using an active pharmacovigilance system. A quantitative observational study was conducted, where medical records were reviewed actively looking for ADRs, when one was found, causality was assessed using Naranjo’s causality algorithm. Preventability was then defined for each adverse drug reaction using the Schimock and Thornston’s scale, finally severity was determined by the common toxicity criteria of adverse events (CTCAE). A cost was calculated for each individual ADR using literature available, in order to determinate the economic burden for each event based on their severity and its preventability. In the 42 patients enrolled, an ADRs incidence of an 86% was found, the most prevalent being aplasia’s, thrombocytopenia to be specific. The pharmacological group that was found to be responsible for the most ADRs were antimetabolites, but using Naranjo’s causality algorithm none of the reactions recorded were found to be definitive. A total cost of $936.621.205 pesos was calculated for all ADRs from which it was estimated a cost of $13.567.991 to only those that were considered preventable, there were however adverse drug reactions that was not possible to estimate the cost of, for this reason this value could be being underestimated. This study found an incidence of ADRs of 86% on haemato-oncologic inpatients, most of them were catalogued as severe, non-preventable and with a cost associated of $936.621.205 CLP overall and $13.567.991 only for the ADRs that were preventable.
Notas
Seminario (Químico Farmacéutico)
Palabras clave
Farmacovigilancia, Medicamentos, Efectos Adversos, Pacientes Hospitalizados, Chile, Santiago