Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization

OBJECTIVE: The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and econo...

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Autores principales: Perrone, Valentina, Conti, Valentino, Venegoni, Mauro, Scotto, Stefania, Degli Esposti, Luca, Sangiorgi, Diego, Prestini, Lucia, Radice, Sonia, Clementi, Emilio, Vighi, Giuseppe
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4259870/
https://www.ncbi.nlm.nih.gov/pubmed/25506231
http://dx.doi.org/10.2147/CEOR.S71301
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author Perrone, Valentina
Conti, Valentino
Venegoni, Mauro
Scotto, Stefania
Degli Esposti, Luca
Sangiorgi, Diego
Prestini, Lucia
Radice, Sonia
Clementi, Emilio
Vighi, Giuseppe
author_facet Perrone, Valentina
Conti, Valentino
Venegoni, Mauro
Scotto, Stefania
Degli Esposti, Luca
Sangiorgi, Diego
Prestini, Lucia
Radice, Sonia
Clementi, Emilio
Vighi, Giuseppe
author_sort Perrone, Valentina
collection PubMed
description OBJECTIVE: The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. METHODS: This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. RESULTS: 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal, respiratory thoracic and mediastinal, and nervous system disorders. The most common Anatomical Therapeutic Chemical classes involved in admissions were J (anti-infectives and immunomodulating agents), B (blood and blood-forming organs), and N (nervous system). Older age, yellow and red triage, higher number of concomitantly taken drugs, and previous attendance in ED for the same ADR were significantly associated with an increased risk of hospitalization. The total cost associated with ADR management was €5,184,270, with a mean cost per patient of €585. Fifty-eight percent of the economic burden was defined as probably/definitely preventable. CONCLUSION: ADRs are a serious health/economic issue in EDs. This assessment provides a thorough estimation of their seriousness, preventability, and burden impact in a large population from a representative European region.
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spelling pubmed-42598702014-12-12 Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization Perrone, Valentina Conti, Valentino Venegoni, Mauro Scotto, Stefania Degli Esposti, Luca Sangiorgi, Diego Prestini, Lucia Radice, Sonia Clementi, Emilio Vighi, Giuseppe Clinicoecon Outcomes Res Original Research OBJECTIVE: The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. METHODS: This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. RESULTS: 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal, respiratory thoracic and mediastinal, and nervous system disorders. The most common Anatomical Therapeutic Chemical classes involved in admissions were J (anti-infectives and immunomodulating agents), B (blood and blood-forming organs), and N (nervous system). Older age, yellow and red triage, higher number of concomitantly taken drugs, and previous attendance in ED for the same ADR were significantly associated with an increased risk of hospitalization. The total cost associated with ADR management was €5,184,270, with a mean cost per patient of €585. Fifty-eight percent of the economic burden was defined as probably/definitely preventable. CONCLUSION: ADRs are a serious health/economic issue in EDs. This assessment provides a thorough estimation of their seriousness, preventability, and burden impact in a large population from a representative European region. Dove Medical Press 2014-12-03 /pmc/articles/PMC4259870/ /pubmed/25506231 http://dx.doi.org/10.2147/CEOR.S71301 Text en © 2014 Perrone et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Perrone, Valentina
Conti, Valentino
Venegoni, Mauro
Scotto, Stefania
Degli Esposti, Luca
Sangiorgi, Diego
Prestini, Lucia
Radice, Sonia
Clementi, Emilio
Vighi, Giuseppe
Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization
title Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization
title_full Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization
title_fullStr Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization
title_full_unstemmed Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization
title_short Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization
title_sort seriousness, preventability, and burden impact of reported adverse drug reactions in lombardy emergency departments: a retrospective 2-year characterization
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4259870/
https://www.ncbi.nlm.nih.gov/pubmed/25506231
http://dx.doi.org/10.2147/CEOR.S71301
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