Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 - 2012.
Expert Opin Drug Saf
; 13 Suppl 1: S9-20, 2014 Sep.
Article
en En
| MEDLINE
| ID: mdl-25171155
OBJECTIVE: To describe the characteristics of pediatric adverse drug reactions (ADRs) reported in Italian spontaneous reporting database. METHODS: Reports of suspected ADRs related to children and adolescents were extracted from 2001 - 2012. After exclusion of duplicates, vaccines and reports containing missing age data, the report characteristics were investigated in terms of implicated drug and adverse drug event across different age-categories. RESULTS: Among 123,129 selected reports, 8338 (6.8%) concerned pediatrics. Of these, 52.2% involved male patients compared to 47.5% female up to the age of 11. After the age of 11 this statistic reversed. 39.4% of pediatric reports were serious and of these, 75.2% required hospitalization mainly in very young children. Most of reports were issued by hospital physicians (61.9%), followed by pharmacists (10.1%), while reports from family pediatricians accounted for 8.1%. The most frequently implicated drug categories were anti-infectives for systemic use (44.9%), drugs for the nervous system (15.6%), and anti-inflammatory drugs (10.2%). The most frequently suspected compounds differed between children and adults and reports for the same drug were likely to be more serious in adults than in children. CONCLUSIONS: This ADR reporting system reflects real safety concerns for drugs used in children and emphasizes the need for stratifying analyses by age-subgroup to increase the sensitivity of signal detection procedure.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Sistemas de Registro de Reacción Adversa a Medicamentos
/
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
/
Farmacovigilancia
Tipo de estudio:
Screening_studies
Límite:
Adolescent
/
Child
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Child, preschool
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Female
/
Humans
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Infant
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Male
/
Newborn
País/Región como asunto:
Europa
Idioma:
En
Revista:
Expert Opin Drug Saf
Asunto de la revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2014
Tipo del documento:
Article
Pais de publicación:
Reino Unido