Spontaneous Reporting of Adverse Drug Reactions in a Pediatric Population in a Tertiary Hospital
Por:
Lopez-Valverde, L, Domenech, E, Roguera, M, Gich, I, Farre, M, Rodrigo, C, Montane, E
Publicada:
1 dic 2021
Resumen:
The pediatric population is a vulnerable group for adverse drug reactions (ADRs), and data on spontaneous reporting of ADRs in the hospital setting are scarce. We conducted a retrospective analysis of ADRs in pediatric patients spontaneously reported by health care professionals to a Pharmacovigilance Program in a tertiary hospital between 2010 and 2020, and we compared characteristics of ADRs between pediatric age subgroups. From 1787 spontaneously reported ADRs in an 11-year period, 103 (5.85%) were pediatric ADRs. The median age of patients with ADRs was 8.4 years (range 1 day-17 years) and 57.3% were male. The most frequent ADRs reported were nervous system disorders (13.6%) and the most frequently involved drugs were antineoplastics and immunodulators (32.4%). A 59.2% of the ADRs were serious and 55.3% were classified as being type B reactions. Medication errors were involved in 7.8% of the ADRs and 11.9% of the suspected drugs were used off-label. Spontaneous reports of ADRs in newborns, infants, and toddlers were more serious and less often described in the product data sheet than in children and adolescents (p < 0.001 and p = 0.004 respectively). Medication errors were more frequent in patients under two years of age. These results should be interpreted with caution due to under-reporting and biases in spontaneous reporting of ADRs.
Filiaciones:
Lopez-Valverde, L:
Univ Autonoma Barcelona, Dept Pharmacol Therapeut & Toxicol, Cerdanyola Del Valles 08193, Spain
Domenech, E:
Hosp Badalona Germans Trias & Pujol, Dept Pediat, Badalona 08916, Spain
Roguera, M:
Hosp Badalona Germans Trias & Pujol, Dept Pediat, Badalona 08916, Spain
Gich, I:
Univ Autonoma Barcelona, Dept Pharmacol Therapeut & Toxicol, Cerdanyola Del Valles 08193, Spain
Hosp Univ St Pau, Dept Clin Pharmacol, Barcelona 08025, Spain
Farre, M:
Univ Autonoma Barcelona, Dept Pharmacol Therapeut & Toxicol, Cerdanyola Del Valles 08193, Spain
Hosp Badalona Germans Trias & Pujol, Dept Clin Pharmacol, Badalona 08916, Spain
Rodrigo, C:
Hosp Badalona Germans Trias & Pujol, Dept Pediat, Badalona 08916, Spain
Univ Autonoma Barcelona, Dept Pediat Obstet & Gynecol, Prevent Med & Publ Hlth, Cerdanyola Del Valles 08193, Spain
Montane, E:
Univ Autonoma Barcelona, Dept Pharmacol Therapeut & Toxicol, Cerdanyola Del Valles 08193, Spain
Hosp Badalona Germans Trias & Pujol, Dept Clin Pharmacol, Badalona 08916, Spain
Green Published, gold
|