Adverse Drug Reactions to Anti-infectives in Hospitalized Children: A Multicenter Study in Brazil

Area of Science:

• Pediatric Pharmacology
• Infectious Diseases
• Clinical Pharmacy

Background:

• Adverse drug reactions (ADRs) to anti-infectives significantly impact hospitalized children, increasing morbidity, mortality, hospital stay duration, and healthcare costs.
• Understanding the epidemiology and characteristics of these ADRs in pediatric populations is crucial for improving patient safety and healthcare outcomes.

Purpose of the Study:

• To prospectively assess the incidence, characteristics, and outcomes of ADRs associated with anti-infective drug use in hospitalized children in Brazil.

Main Methods:

• A prospective cohort study was conducted across 5 public hospitals over a 6-month period.
• Included were children aged 0-11 years and 11 months, hospitalized for over 48 hours and receiving anti-infectives for more than 24 hours.
• Data collection focused on ADR occurrence, type, causality, severity, and impact on clinical parameters.

Main Results:

• Out of 1020 eligible patients, 152 experienced 183 suspected ADRs, representing an incidence of approximately 14.9%.
• The most common ADRs involved the gastrointestinal system (65.6%) and skin reactions (18.6%).
• Reactions were predominantly of probable causality (58.5%), moderate severity (61.1%), and considered unavoidable (56.2%). ADRs were significantly associated with increased length of stay, length of therapy, and the number of anti-infectives prescribed.

Conclusions:

• Nearly 15% of hospitalized children receiving anti-infectives experienced suspected ADRs, often of moderate severity and unavoidable.
• The incidence and impact of these ADRs were significantly influenced by the duration of hospitalization and the complexity of anti-infective regimens.
• These findings highlight the need for vigilant monitoring and management of ADRs in pediatric patients undergoing anti-infective therapy.