Investigating the Benefit-Risk Profile of Drugs: From Spontaneous Reporting Systems to Real-World Data for Pharmacovigilance.
Methods Mol Biol
; 2834: 333-349, 2025.
Article
em En
| MEDLINE
| ID: mdl-39312173
ABSTRACT
Rapid and detailed post-marketing surveillance of drugs and vaccine is required to enable assessment of their real-world safety and effectiveness. Spontaneous reporting from healthcare professionals and citizens is recognized as the basic method in the passive post-marketing surveillance of drugs and vaccines, allowing the identification of rare adverse drug reactions (ADRs) and adverse events following immunization (AEFIs). According to the current law, online platforms for ADRs and AEFI reporting and related databases are available in every country and at the global level. Recently, the use of electronic health records and the establishment of networks of databases as different sources of real-world data is emerging allowing high-quality, large-scale evaluations and providing real-world evidence on questions of clinical and regulatory interests. Here, we summarize the adverse event pharmacovigilance reporting systems in place at the global, European and in some European countries, and provide examples from recent literature of how the analysis of pharmacovigilance reports can provide evidence for unexpected and novel adverse drug reactions. Furthermore, we discuss the role of real-world data to generate real-world evidence in pharmacovigilance and regulatory activities.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Sistemas de Notificação de Reações Adversas a Medicamentos
/
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
/
Farmacovigilância
Limite:
Humans
Idioma:
En
Revista:
Methods Mol Biol
Assunto da revista:
BIOLOGIA MOLECULAR
Ano de publicação:
2025
Tipo de documento:
Article
País de afiliação:
Itália
País de publicação:
Estados Unidos