Análisis de factores de riesgos operacionales en programa institucional de farmacovigilancia de IPS Córdoba 2019

Introduction. The Institutional Pharmacovigilance Program (PIFv) is a component of the National Pharmacovigilance Program (PNFv) executed by the Health Service Provider Institutions (IPS). Objective. Analyze the influence of operational risk factors in the PIFv of IPS with medium and high complexity...

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Detalles Bibliográficos
Autor: Castilla Hernández, Miguel Ángel
Tipo de recurso: tesis de maestría
Estado:Versión enviada para evaluación y publicación
Fecha de publicación:2021
País:Colombia
Institución:Universidad de Córdoba
Repositorio:Repositorio Institucional Unicórdoba
Idioma:español
OAI Identifier:oai:repositorio.unicordoba.edu.co:ucordoba/4181
Acceso en línea:https://repositorio.unicordoba.edu.co/handle/ucordoba/4181
Access Level:acceso abierto
Palabra clave:Farmacovigilancia
Factores de riesgo
Evento adverso
Salud pública
Pharmacovigilance
Risk factors
Adverse event
Public health
Descripción
Sumario:Introduction. The Institutional Pharmacovigilance Program (PIFv) is a component of the National Pharmacovigilance Program (PNFv) executed by the Health Service Provider Institutions (IPS). Objective. Analyze the influence of operational risk factors in the PIFv of IPS with medium and high complexity pharmaceutical service in the Department of Córdoba in 2019. Methodology. Observational, cross-sectional study of association and quantitative approach; the population as well as the sample was formed by IPS with a medium and high complexity pharmaceutical service that were the subject of a technical assistance visit to the PIFv by the health section, to collect the information from the survey, the "HPE Software - PIFv" version 00 was designed with which the "HENRI PIFv Scale for the qualification of the implementation of the pharmacovigilance program in IPS" was automated; descriptive and inferential statistics were applied. Results. The technological tool consolidated the findings of each visit into a record, reducing the survey time by 50%. 13.8% of the IPS were of a public nature and 86.2% were from the private sector; 65.5% of the institutions studied classified the PIFv status as "not implemented", 31.1% as "in implementation" and 3.4% as "implemented"; 55.1% of the IPS presented 100% underreporting of Adverse Drug Event (ADE) in 2019; 31% of the IPS that received a technical assistance visit presented a status of the PIFv “not implemented” and underreporting of EAM of 100%; Inferential statistics did not identify significant statistical associations between the variables studied. Conclusion. In the human talent responsible for the PIFv it was observed that work itinerancy, work overload and / or a low training in pharmacovigilance can constitute operational risk factors for PIFv in the IPS studied, the same effect can produce the absence of a program of pharmacovigilance in the health section.