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Original Article
DOI: 10.1016/j.enfcle.2020.10.011
Available online 18 March 2021
Reporting of suspected adverse drug reactions by nursing in Spain. An observational-descriptive retrospective study
Notificación de sospechas de reacciones adversas a medicamentos por enfermeras en España. Un estudio observacional descriptivo retrospectivo
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Verónica Velasco-Gonzáleza,b,c,d,e, Laura Loya-Péreza, Ester Navarro-Garcíab,
Corresponding author
esternavarrog@gmail.com

Corresponding author.
, María Sáinz-Gilb,f
a Departamento de Enfermería, Facultad de Enfermería, Universidad de Valladolid, Valladolid, Spain
b Centro de estudios Sobre la Seguridad de los Medicamentos, Facultad de Medicina, Universidad de Valladolid, Valladolid, Spain
c Instituto de Oftalmobiología Aplicada, Universidad de Valladolid, Valladolid, Spain
d Grupo de Investigación en Cuidados Enfermeros (GICE), Universidad de Valladolid, Valladolid, Spain
e Grupo de investigación «Farmacogenética, Genética del Cáncer, Polimorfismos Genéticos y Farmacoepidemiología», Universidad de Valladolid, Valladolid, Spain
f Centro de Farmacovigilancia de Castilla y León, Facultad de Medicina, Universidad de Valladolid, Valladolid, Spain
Received 13 March 2020. Accepted 25 October 2020
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Abstract
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Table 1. Distribution of the number of cases reported according to the group of drugs involved.
Abstract
Objective

This study aimed to gain knowledge of the nurses’ involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal characteristics of the reported cases, identifying points of improvement.

Methods

A descriptive observational retrospective study was based on the data from FEDRA, the database created by the SEFV-H. The sample taken was the spontaneous adverse drug reactions reported to SEFV-H by nurses during the first 6 months of the 2018.

Results

Complete data was provided by 6,370 suspicions of ADR reported to SEFV-H by all healthcare professionals. Only 4,8% of the samples were taken by nurses, 62,7% came from medical centers. The majority of the ADR were not considered a serious disease (78%). The most frequently adverse drug reactions reported by nurses were local reactions. The patients most involved were children and vaccines were the most reported drugs (58,3%), followed by the intravenous contrast agents used in diagnostic tests.

Conclusions

Nurses report very few cases to SEFV-H and are mostly related to the administration of vaccines and are sent by nurses working in the out-of-hospital setting. Most cases are not serious and usually report known adverse reactions to the suspected drug. This observed under-notification raises the need to promote increased pharmacovigilance training among these notifying nurses so that they can continue to report, and also for those who do not do so in their daily practice, so that they can begin to do so.

Keywords:
Pharmacovigilance
Spontaneous notification method
Patients safety
Adverse drug reaction
Nurse
Resumen
Objetivo

Conocer el grado de participación de las enfermeras en la notificación espontánea de sospechas de reacciones adversas a medicamentos (RAM) al Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano (SEFV-H), describir las características principales de los casos notificados e identificar puntos de mejora.

Método

Estudio observacional descriptivo retrospectivo a partir de la información contenida en la base de datos FEDRA del SEFV-H. Se tomaron como muestra las notificaciones espontáneas de las RAM realizadas por enfermeras durante los seis primeros meses del 2018.

Resultados

De las 6.370 sospechas de RAM notificadas por profesionales sanitarios en el periodo considerado, tan solo un 4,8% fueron realizadas por enfermeras. El 62,7% procede de centros extrahospitalarios y la mayoría de las RAM son consideradas no graves (78%). Las reacciones notificadas con más frecuencia son las reacciones locales. Los pacientes más implicados son los niños y las vacunas los medicamentos más notificados (58,3%), seguidas de los contrastes intravenosos para la realización de pruebas diagnósticas.

Conclusiones

Las enfermeras notifican muy pocos casos al SEFV-H y están en su mayoría relacionados con la administración de vacunas y son enviados por enfermeras que trabajan en el medio extrahospitalario. La mayoría de los casos no presentan gravedad y suelen referir reacciones adversas conocidas para el fármaco sospechoso. Esta infranotificación observada plantea la necesidad de promover la formación en materia de farmacovigilancia entre estas enfermeras notificadoras para que continúen notificando, y también a las que no lo hacen en su práctica diaria, para que puedan comenzar a hacerlo.

Palabras clave:
Farmacovigilancia
Notificación espontánea
Seguridad del paciente
Reacciones adversas a medicamentos
Enfermera

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