Evidence map›Paper›PMID 25506231›Full record

ArticleClinicoEconomics and outcomes research : CEOR2014

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

Valentina Perrone, Valentino Conti, Mauro Venegoni, Stefania Scotto, Luca Degli Esposti, Diego Sangiorgi, Lucia Prestini, Sonia Radice, Emilio Clementi, Giuseppe Vighi

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In one paragraph

Article in ClinicoEconomics and outcomes research : CEOR, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Valentina PerroneUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy.
Valentino ContiRegional Centre for Pharmacovigilance, Lombardy, Milan, Italy.
Mauro VenegoniRegional Centre for Pharmacovigilance, Lombardy, Milan, Italy.
Stefania ScottoRegional Centre for Pharmacovigilance, Lombardy, Milan, Italy.
Luca Degli EspostiCliCon Srl, Health, Economics and Outcomes Research, Ravenna, Italy.
Diego SangiorgiCliCon Srl, Health, Economics and Outcomes Research, Ravenna, Italy.
Lucia PrestiniUnit of Clinical Pharmacology and Pharmacovigilance, Niguarda Ca'Granda Hospital, Milan, Italy.
Sonia RadiceUnit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy.
Emilio ClementiUnit of Clinical Pharmacology, CNR Institute of Neuroscience, Department of Biomedical and Clinical Sciences, University Hospital Luigi Sacco, Università di Milano, Milan, Italy ; Scientific Institute, IRCCS Eugenio Medea, Lecco, Italy.
Giuseppe VighiRegional Centre for Pharmacovigilance, Lombardy, Milan, Italy ; Unit of Clinical Pharmacology and Pharmacovigilance, Niguarda Ca'Granda Hospital, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe 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.

methodsThis 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.

results8,862 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.

conclusionADRs 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.

Indexed as

adverse drug reactioneconomic impactemergency departmentpharmacovigilancepreventability

Identifiers

PMID25506231
PMCPMC4259870

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.