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...
Autores principales: | , , , , , , , , , |
---|---|
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 |
_version_ | 1782348087726964736 |
---|---|
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. |
format | Online Article Text |
id | pubmed-4259870 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT perronevalentina seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT contivalentino seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT venegonimauro seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT scottostefania seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT degliespostiluca seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT sangiorgidiego seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT prestinilucia seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT radicesonia seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT clementiemilio seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization AT vighigiuseppe seriousnesspreventabilityandburdenimpactofreportedadversedrugreactionsinlombardyemergencydepartmentsaretrospective2yearcharacterization |