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Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)

BACKGROUND: Adverse drug event (ADEs) are a significant cause of emergency department (ED) visits and consequent hospitalization. Preventing ADEs and their related ED visits in outpatients remains a public health safety challenge. In this context, the aims of the present study were to describe the f...

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Autores principales: Lombardi, Niccolò, Crescioli, Giada, Bettiol, Alessandra, Tuccori, Marco, Capuano, Annalisa, Bonaiuti, Roberto, Mugelli, Alessandro, Venegoni, Mauro, Vighi, Giuseppe Danilo, Vannacci, Alfredo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7153477/
https://www.ncbi.nlm.nih.gov/pubmed/32327995
http://dx.doi.org/10.3389/fphar.2020.00412
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author Lombardi, Niccolò
Crescioli, Giada
Bettiol, Alessandra
Tuccori, Marco
Capuano, Annalisa
Bonaiuti, Roberto
Mugelli, Alessandro
Venegoni, Mauro
Vighi, Giuseppe Danilo
Vannacci, Alfredo
author_facet Lombardi, Niccolò
Crescioli, Giada
Bettiol, Alessandra
Tuccori, Marco
Capuano, Annalisa
Bonaiuti, Roberto
Mugelli, Alessandro
Venegoni, Mauro
Vighi, Giuseppe Danilo
Vannacci, Alfredo
author_sort Lombardi, Niccolò
collection PubMed
description BACKGROUND: Adverse drug event (ADEs) are a significant cause of emergency department (ED) visits and consequent hospitalization. Preventing ADEs and their related ED visits in outpatients remains a public health safety challenge. In this context, the aims of the present study were to describe the frequency, seriousness and preventability of outpatients’ ADE-related ED visits and hospitalizations in the Italian general population, and to identify the presence of potential predictors of ADE-related hospitalization. METHODS: We performed a nationwide, multicentre, observational, retrospective study based on reports of suspected ADEs collected between January 1, 2007 and December 31, 2018 in 94 EDs involved in the MEREAFaPS project. Patients’ demographic characteristics, their clinical status, suspected and concomitant drugs, ADE description, and its degree of seriousness, were collected. Causality and preventability were assessed using validated algorithms, and logistic regression analyses were used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of ADE-related hospitalization, considering the following covariates: age, sex, ethnicity, number of implicated medications, parenteral administration, presence of interaction, therapeutic error, and/or complementary and alternative medicines (CAM). RESULTS: Within 12 years, 61,855 reports of suspected ADE were collected, of which 18,918 (30.6%) resulted in hospitalization (ADE defined as serious). Patients were mostly female (56.6%) and Caucasians (87.7%), with a mean age of 57.5 ± 25.0 years. 58% of patients were treated with more than two drugs, and 47% of ADEs leading to hospitalization were preventable. Anticoagulants, antibiotics, and nonsteroidal anti-inflammatory drugs (NSAIDs) were the most frequently implicated agents for ED visits and/or hospitalization, which included clinically significant ADEs, such as haemorrhage for anticoagulants, moderate to severe allergic reactions for antibiotics, and dermatologic reactions and gastrointestinal disturbances for NSAIDs. Older age (1.54 [1.48–1.60]), higher number of concomitantly taken drugs (2.22 [2.14–2.31]), the presence of drug-drug interactions (1.52 [1.28–1.81]), and therapeutic error (1.54 [1.34–1.78]), were significantly associated with an increased risk of hospitalization. CONCLUSION: Our long-term active pharmacovigilance study in ED provided a valid estimation of ADE-related hospitalization in a representative sample of the Italian general population and can suggest further focus on medication safety in outpatients, in order to early recognise and prevent ADEs.
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spelling pubmed-71534772020-04-23 Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study) Lombardi, Niccolò Crescioli, Giada Bettiol, Alessandra Tuccori, Marco Capuano, Annalisa Bonaiuti, Roberto Mugelli, Alessandro Venegoni, Mauro Vighi, Giuseppe Danilo Vannacci, Alfredo Front Pharmacol Pharmacology BACKGROUND: Adverse drug event (ADEs) are a significant cause of emergency department (ED) visits and consequent hospitalization. Preventing ADEs and their related ED visits in outpatients remains a public health safety challenge. In this context, the aims of the present study were to describe the frequency, seriousness and preventability of outpatients’ ADE-related ED visits and hospitalizations in the Italian general population, and to identify the presence of potential predictors of ADE-related hospitalization. METHODS: We performed a nationwide, multicentre, observational, retrospective study based on reports of suspected ADEs collected between January 1, 2007 and December 31, 2018 in 94 EDs involved in the MEREAFaPS project. Patients’ demographic characteristics, their clinical status, suspected and concomitant drugs, ADE description, and its degree of seriousness, were collected. Causality and preventability were assessed using validated algorithms, and logistic regression analyses were used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of ADE-related hospitalization, considering the following covariates: age, sex, ethnicity, number of implicated medications, parenteral administration, presence of interaction, therapeutic error, and/or complementary and alternative medicines (CAM). RESULTS: Within 12 years, 61,855 reports of suspected ADE were collected, of which 18,918 (30.6%) resulted in hospitalization (ADE defined as serious). Patients were mostly female (56.6%) and Caucasians (87.7%), with a mean age of 57.5 ± 25.0 years. 58% of patients were treated with more than two drugs, and 47% of ADEs leading to hospitalization were preventable. Anticoagulants, antibiotics, and nonsteroidal anti-inflammatory drugs (NSAIDs) were the most frequently implicated agents for ED visits and/or hospitalization, which included clinically significant ADEs, such as haemorrhage for anticoagulants, moderate to severe allergic reactions for antibiotics, and dermatologic reactions and gastrointestinal disturbances for NSAIDs. Older age (1.54 [1.48–1.60]), higher number of concomitantly taken drugs (2.22 [2.14–2.31]), the presence of drug-drug interactions (1.52 [1.28–1.81]), and therapeutic error (1.54 [1.34–1.78]), were significantly associated with an increased risk of hospitalization. CONCLUSION: Our long-term active pharmacovigilance study in ED provided a valid estimation of ADE-related hospitalization in a representative sample of the Italian general population and can suggest further focus on medication safety in outpatients, in order to early recognise and prevent ADEs. Frontiers Media S.A. 2020-04-06 /pmc/articles/PMC7153477/ /pubmed/32327995 http://dx.doi.org/10.3389/fphar.2020.00412 Text en Copyright © 2020 Lombardi, Crescioli, Bettiol, Tuccori, Capuano, Bonaiuti, Mugelli, Venegoni, Vighi, Vannacci and the MEREAFaPS Study group http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Lombardi, Niccolò
Crescioli, Giada
Bettiol, Alessandra
Tuccori, Marco
Capuano, Annalisa
Bonaiuti, Roberto
Mugelli, Alessandro
Venegoni, Mauro
Vighi, Giuseppe Danilo
Vannacci, Alfredo
Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)
title Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)
title_full Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)
title_fullStr Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)
title_full_unstemmed Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)
title_short Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)
title_sort italian emergency department visits and hospitalizations for outpatients’ adverse drug events: 12-year active pharmacovigilance surveillance (the mereafaps study)
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7153477/
https://www.ncbi.nlm.nih.gov/pubmed/32327995
http://dx.doi.org/10.3389/fphar.2020.00412
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