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Abstract
BackgroundAdverse drug events (ADEs) are a significant cause of emergency department (ED) visits, with a major impact on healthcare resource utilization. A multicentre observational study, aimed to describe frequency, seriousness and preventability of ADEs reported in four EDs, was performed in Sicily (Italy) over a 1-year period.MethodsTwo trained monitors for each ED supported clinicians in identifying ADEs of patients admitted to EDs between June 1st, 2013 and May 31st, 2014 through a systematic interview of patients or their caregivers and with an additional record review. A research team analyzed each case of suspected ADE, to make a causality assessment applying the Naranjo algorithm and a preventability assessment using Schumock and Thornton criteria.Absolute and percentage frequencies with 95% confidence interval (CI) and medians with interquartile ranges (IQR) were estimated. Logistic regression models were used to evaluate independent predictors of serious and certainly preventable ADEs.ResultsOut of 16,963 ED visits, 575 (3.4%) were associated to ADEs, of which 15.1% resulted in hospitalization. ADEs were classified as probable in 45.9%, possible in 51.7% and definite in 2.4% of the cases. Moreover, ADEs were considered certainly preventable in 12.3%, probably preventable in 58.4%, and not preventable in 29.2% of the cases. Polytherapy influenced the risk to experience a serious, as well as a certainly preventable ADE. Whilst, older age resulted an independent predictor only of serious events. The most common implicated drug classes were antibiotics (34.4%) and anti-inflammatory drugs (22.6%). ADEs due to psycholeptics and antiepileptics resulted preventable in 62.7 and 54.5% of the cases, respectively. Allergic reactions (64%) were the most frequent cause of ADE-related ED visits, followed by neurological effects (10.2%) that resulted preventable in 1.9 and 37.3% of the cases, respectively.ConclusionADEs are a frequent cause of ED visits. The commonly used antibiotics and anti-inflammatory drugs should be carefully managed, as they are widely involved in mild to severe ADEs. Polytherapy is associated with the occurrence of serious, as well as certainly preventable ADEs, while older age only with serious events. A greater sensitivity to drug monitoring programs among health professionals is needed.
Highlights
IntroductionA multicentre observational study, aimed to describe frequency, seriousness and preventability of Adverse drug event (ADE) reported in four emergency department (ED), was performed in Sicily (Italy) over a 1-year period
Adverse drug events (ADEs) are a significant cause of emergency department (ED) visits, with a major impact on healthcare resource utilization
An ADE was detected in 575 cases, with an overall prevalence rate of 3.4% (95%confidence interval (CI), 3.1–3.7)
Summary
A multicentre observational study, aimed to describe frequency, seriousness and preventability of ADEs reported in four EDs, was performed in Sicily (Italy) over a 1-year period. A recent study based on an active monitoring project regarding ADEs in EDs, carried out in the United States in 2013 and 2014 (NEISS-CADES, The National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance), estimated a rate of 4.0 ED visits per 1000 inhabitants year due to ADEs [9]. The wide range of reported ADE-related ED visits may reflect some methodological variances due to different types of hospital settings, study design, data source, variability in the definition of ADE, difficulty in diagnosis and determination of ADEs [6]. In view of the above findings, the aims of this study were to determine the rate of ADEs leading to ED visits in four hospitals in Sicily (Italy) and to evaluate ADEs’ seriousness and preventability. The drug classes most frequently involved in ADEs, the characteristics of ADEs and their frequency were evaluated, in terms of both severity and preventability
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