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 AND METHODS: 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.
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 AND METHODS: 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.
Entities:
Keywords:
adverse drug reaction; off-label drug use; pediatric; pharmacovigilance; post-marketing surveillance
Authors: Caterina Palleria; Luigi Iannone; Christian Leporini; Rita Citraro; Antonia Manti; Maurizio Caminiti; Pietro Gigliotti; Rosa Daniela Grembiale; Massimo L'Andolina; Giuseppe Muccari; Maria Diana Naturale; Domenico Olivo; Giuseppa Pagano Mariano; Roberta Pellegrini; Giuseppe Varcasia; Karim Abdalla; Emilio Russo; Francesco Ursini; Giovambattista De Sarro Journal: PLoS One Date: 2018-10-24 Impact factor: 3.240
Authors: Martina P Neininger; Sarah Jeschke; Lisa M Kiesel; Thilo Bertsche; Astrid Bertsche Journal: World J Pediatr Date: 2021-11-13 Impact factor: 2.764
Authors: Giuseppe Cicala; Maria A Barbieri; Vincenza Santoro; Carmela Tata; Pia V Colucci; Francesca Vanadia; Flavia Drago; Carmelita Russo; Paola M Cutroneo; Antonella Gagliano; Edoardo Spina; Eva Germanò Journal: Front Psychiatry Date: 2020-03-24 Impact factor: 4.157