The importance of monitoring adverse drug reactions in pediatric patients: the results of a national surveillance program in Italy.
Expert Opin Drug Saf
; 13 Suppl 1: S1-8, 2014 Sep.
Article
en En
| MEDLINE
| ID: mdl-25171154
ABSTRACT
OBJECTIVE:
To gain information on safety of drugs used in pediatrics through a 4-year post-marketing active pharmacovigilance program. The program sampled the Italian population and was termed 'Monitoring of the Adverse Effects in Pediatric population' (MEAP). RESEARCH DESIGN ANDMETHODS:
Adverse drug reactions (ADRs) were collected for individuals aged 0 - 17 years treated in hospitals and territorial health services in Lombardy, Tuscany, Apulia and Campania; located to gain an appropriate sampling of the population. ADRs were evaluated using the Adverse Drug Reaction Probability Scale (Naranjo) and analyzed with respect to time, age, sex, category of ADR, seriousness, suspected medicines, type of reporter and off-label use.RESULTS:
We collected and analyzed reports from 3539 ADRs. Vaccines, antineoplastic and psychotropic drugs were the most frequently pharmacotherapeutic subgroups involved. Seventeen percent of reported ADRs were serious; of them fever, vomiting and angioedema were the most frequently reported. Eight percent of ADRs were associated with off-label use, and 10% were unknown ADRs. Analysis of these revealed possible strategies of therapy optimization.CONCLUSIONS:
The MEAP project demonstrated that active post-marketing pharmacovigilance programs are a valid strategy to increase awareness on pediatric pharmacology, reduce underreporting and provide information on drug actions in pediatrics. This information enhances drug therapy optimization in the pediatric patients.Palabras clave
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
/
Sistemas de Registro de Reacción Adversa a Medicamentos
/
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
/
Farmacovigilancia
Tipo de estudio:
Observational_studies
/
Risk_factors_studies
/
Screening_studies
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