Regional surveillance of emergency-department visits for outpatient adverse drug events

Abstract

Aims To determine the (1) incidence of adverse drug events (ADEs) in 10 emergency department (EDs) of general hospitals in the Regione Campania (southern Italy), (2) rate of ADE-related hospital admissions, (3) drug classes most frequently involved, and (4) the types of ADEs and their frequency. Methods We performed a cohort study of all patients attending the EDs. This study was carried out in two observational periods of 10 days each in 10 EDs. Demographic, clinical, and pharmacological data about all patients admitted to EDs were collected by trained and qualified monitors. Records related to ADEs were analyzed and validated by a specific scientific committee. Results Of 7,861 ED visits, 96 were ADE-related. The incidence of hospitalization was higher in patients who had taken medication than in patients with a negative drug history (24.9 vs. 16.4%). ADEs were significantly more frequent in women. Patients aged between 60 and 69 years and between 30 and 39 years were significantly more likely to experience an ADE. Serious ADEs were identified in 20 ED visits (20.8% of total sample). Antibiotics, NSAIDs, and agents acting on the renin-angiotensin system were the drugs most often involved in ADEs. In multivariate analyses, the adjusted odds ratio was 3.4 (95% CI: 1.07-2.84) for patients taking NSAIDs, 4.78 (95% CI: 2.26-10.12) for those taking β 2 -adrenergic-receptor agonists, and 6.20 (95%CI: 2.74-14.06) for those taking β-lactam antibiotics. Conclusion This study shows that ADEs are an important problem in industrialized countries. Moreover, it shows that ADEs affect hospital admission rates and reinforces the importance of drug-induced disease as a public health problem.

Atomoxetine in the treatment of attention deficit hyperactivity disorder and suicidal ideation

“…Moreover, data obtained from a case report published on Journal of Paediatrics and Child Health in 2008 revealed another case of suicidal ideation and acute agitation occurred in an 11-year-old boy who was in treatment with ATX (60 mg/day) [21]. Post-marketing surveillance activities, such as the intensive monitoring of drug studies [22,23], are important to allow the early detection of unexpected and/or serious adverse reactions, which have a considerable negative impact on both health and healthcare costs [24]. Therefore, as ADHD is a chronic disorder that requires pharmacological treatment for many years, and as suicidal-related events are rare, further long-term safety studies are needed.…”

Factors Associated with Drug-Related Emergency Department Visits at a Teaching Hospital in Malaysia

“…Drug allergy is a type of unpredictable ADR and accounts for approximately one-third of all ADRs [17]. Like others [1,8], we also found that female patients were at a higher risk for drug-related ED visits. Sex difference to drug response has been the subject of various discussions.…”

“…The use of medication has been associated with a number of adverse drug events (ADEs), which have been recognized as a significant public health problem and contribute to increased healthcare costs [1,2]. Given the nature of the working environment, the emergency department (ED) is considered particularly high risk for the occurrence of ADEs.…”

Pharmacovigilance: Empowering healthcare professionals

“…Th e trigger for proposal, fi nal approval by the European Parliament and entry into the force of the new EU regulation on pharmacovigilance was appalling statistics at the level of EU countries, in which the pharmacovigilance system was building through decades, especially when it comes to proven fatalities caused by irrational use of medicines (200 000 deaths annually in the EU due to adverse eff ects of medicines) [16] and the enormous costs of their treatment (about 709 billion euros annually) [16][17][18].…”