Evaluation of a simplified pharmacovigilance tool for general practitioners: 5 years of insight.
Sci Rep
; 14(1): 1766, 2024 01 20.
Article
em En
| MEDLINE
| ID: mdl-38243051
ABSTRACT
Spontaneous reporting of adverse drug reactions (ADRs) is the cornerstone of pharmacovigilance. However, major underreporting exists. The main objective of this study was to assess the use of a pharmacovigilance simplified reporting tool (PSRT) by general practitioners (GPs) and, secondarily, to describe the quality of ADR reports during this period. The PSRT was proposed on June 1st, 2015, for the 1290 GPs in the Western Normandy Region. The number and quality of ADRs reported monthly by GPs were prospectively collected from June 1st, 2015, to May 31st, 2020 (Period 2), and compared to those reported during a control period (June 1st, 2010, to May 31st, 2015, Period 1). During all the periods, 920 reports were made by 307 GPs (198 reports in Period 1 and 722 reports in Period 2), with 477 reports (51.8%) using the PSRT. During Period 2, the monthly number of reports was multiplied by 3.5 (p < 0.0001), and the number of GPs was 1.4 compared to that in Period 1 (p = 0.01). Our PSRT showed effectiveness in quantitative and qualitative terms. It must now go further and be integrated into GP software to facilitate ADR reporting nationwide.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
/
Clínicos Gerais
Tipo de estudo:
Qualitative_research
Limite:
Humans
Idioma:
En
Revista:
Sci Rep
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
França
País de publicação:
Reino Unido