Adverse drug events in hospitalized children with medical complexity

Objectives: To identify and characterize adverse drug events (ADE) in children with medical complexity hospitalized in a tertiary teaching hospital in Brazil. Method: A retrospective medical record review using predefined triggers to identify ADE was conducted. A simple random sample of pediatric hospitalizations in 2016 was used. Events were assessed for causality and degree of harm. Statistical analysis included logistic regression to identify associated factors. Results: The sample comprised 133 hospitalizations, with a median age of 1.7 years and a predominance of males (52.6%). Thirty-one ADE were identified in 17 hospitalizations, corresponding to rates of 23.3 ADE per 100 hospitalizations and 19.7 ADEs per 1,000 patient-days. A total of 12.8% of patients experienced at least one ADE. The most frequent ADE were hemoptysis (22.6%), diarrhea (12.9%), and pruritus (12.9%). Antibacterials were the drug class most frequently implicated in ADE. Multiple regression analysis demonstrated an association between ADE detection and increasing age. Conclusion: ADE were identified in more than 10% of the population, highlighting the importance of pharmacotherapy monitoring in hospitalized children. The clinical profile of the population—comprising cystic fibrosis and neurological syndromes—as well as the high number of hospitalizations due to pneumonia, influenced the occurrence of ADE because of their relationship with the use of antimicrobials and central nervous system–acting drugs. These findings reinforce the importance of ADE monitoring for early detection, prevention, and mitigation of medication-related harm, thereby promoting greater medication safety.