Abstract
BackgroundAdverse 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.MethodsWe 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).ResultsWithin 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.ConclusionOur 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.
Highlights
Adverse drug events (ADEs) are the most common cause of iatrogenic harm in health care and have received attention in national patient safety initiatives (Shehab et al, 2016)
This is an observational retrospective study performed on data retrieved by pharmacovigilance reports of suspected ADE collected between January 1, 2007 and December 31, 2018 in the emergency department (ED) participating to the MEREAFaPS Study (“Monitoraggio Epidemiologico delle Reazioni e degli Eventi Avversi da Farmaci in Pronto Soccorso” - “Epidemiological Monitoring of Adverse Drug Reactions and Events leading to Emergency Department”), an ongoing multicentre study of active pharmacovigilance (Lombardi et al, 2018; Lombardi et al, 2019)
Considering that during the study period our monitors evaluated around 45millions of ED clinical charts, we estimated an overall incidence rate of 1.4 per 1,000 ADE-related ED visits and 0.4 per 1,000 ADE-related hospitalizations
Summary
Adverse drug events (ADEs) are the most common cause of iatrogenic harm in health care and have received attention in national patient safety initiatives (Shehab et al, 2016). In which 90% of prescription drug expenditures occur (Shehab et al, 2016), an early identification and prevention of ADEs remain a public health and patient safety challenge worldwide, with efforts often focused on medication abuse/misuse, medication errors, and reducing potentially inappropriate prescribing for general population, in children (Carnovale et al, 2014; Lombardi et al, 2018) and elderly, as defined by the Beers criteria (By the American Geriatrics Society Beers Criteria Update Expert, 2015). Adverse drug event (ADEs) are a significant cause of emergency department (ED) visits and consequent hospitalization. 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
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