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[Adverse reactions caused by drugs in pediatrics]
A Vázquez de la Villa1, J D Luna del Castillo, G Galdó Muñoz
1Servicio de Pediatría, Hospital Universitario, Granada.
Insights
This study monitored 597 children (1-8 years) for adverse drug reactions, finding a 4.4% incidence. Central nervous system and digestive system reactions were most common, often linked to bronchodilators and antibiotics.
Area of Science:
- Pediatric Pharmacology
- Clinical Pharmacy
- Drug Safety Surveillance
Context:
- Adverse drug reactions (ADRs) pose a significant risk in pediatric populations.
- Monitoring programs are crucial for identifying and mitigating medication-related harm in children.
- The University of Granada Hospital implemented a 12-month screening program for pediatric patients.
Purpose:
- To detect and characterize adverse drug reactions in children aged 1-8 years.
- To identify the most frequently affected organs/systems and causative drug classes.
- To determine key risk factors associated with ADRs in hospitalized children.
Summary:
- A 12-month screening of 597 pediatric patients revealed a 4.4% incidence of adverse drug reactions.
- Confirmed, probable, and possible reactions were recorded, with the central nervous system (40%) and digestive system (37%) most affected.
- Bronchodilators (40%) and antibiotics (30%) were the most implicated drug classes, with polytherapy and hospitalization duration identified as significant risk factors.
Impact:
- Provides critical data on pediatric drug safety in a hospital setting.
- Informs clinical practice regarding medication use and monitoring in children.
- Highlights the need for targeted surveillance of high-risk medications and patient groups.
Abstract:
The present study describes the results obtained in a screening program aimed at detecting adverse reactions to medication in children aged 1-8 years admitted to the Pediatrics Service of the University of Granada Hospital (Spain). The program is based on monitoring the patients for a period of 12 months. Of a total of 597 patients, adverse reactions were recorded in 4.4%. Within this group the reactions were classified as confirmed in 33.3%, probable in 30% and possible in 36.6%. Based on organs and systems, the CNS was most frequently affected (40%), followed in decreasing order by the digestive (37%) and cardiovascular systems (10%), skin (10%) and endocrine system (3%). The drugs most frequently involved were bronchodilators (40%), antibiotics (30%) and antiepileptics (20%). Among risk factors, polytherapy, hospitalization time and type of drug administered were the most important.