Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 4 de 4
Filtrar
Mais filtros

Base de dados
País/Região como assunto
Tipo de documento
País de afiliação
Intervalo de ano de publicação
1.
Therapie ; 70(5): 465-76, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26423144

RESUMO

OBJECTIVE: Assess the validity and reproducibility of the updated version of the French causality assessment method in conditions approaching real-life use. METHODS: A random sample of 31 drug-event pairs from the French pharmacovigilance database was assessed by the consensual judgement of three experts (gold standard). Separately, a team from a pharmacovigilance centre (PhVC) and another from a pharmaceutical company assessed these pairs using the current method, then with the updated method. To test the inter- and intra-rater reproducibility, two seniors and two juniors from a PhVC and a pharmaceutical company assessed the pairs twice with the updated method. A weighted kappa coefficient was used to measure the agreement of the two causality assessment methods with the consensual expert judgement (validity) as well as the agreement of the updated causality assessment over time (intra-rater reproducibility) and between evaluators (inter-rater reproducibility). RESULTS: Agreement between the current method and consensual expert judgement was fair for the PhVC team (weighted kappa [Kw] 0.33) and moderate for the pharmaceutical company team (Kw 0.41). For the updated method, agreement was better for both the PhVC (Kw 0.58) and the pharmaceutical company (Kw 0.52) teams. The inter- and intra-rater reproducibility of the updated method based on the intrinsic imputability was satisfactory overall (Kw 0.30-0.91). Discrepancies between evaluations from PhVC and pharmaceutical companies were observed with the updated method. CONCLUSION: The updated method performed better than the current one for drug causality assessment, suggesting that it should be used in routine pharmacovigilance.


Assuntos
Causalidade , Indústria Farmacêutica , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Farmacovigilância , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Técnica Delphi , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Prova Pericial , Feminino , França , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador , Distribuição Aleatória , Reprodutibilidade dos Testes , Estudos de Amostragem , Estatísticas não Paramétricas , Adulto Jovem
2.
Therapie ; 68(2): 69-76, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23773347

RESUMO

The Imputability Working Group (CRI) updated the French drug reaction causality assessment method. This tripartite group is made up of staff from the French network of regional pharmacovigilance centres, pharmaceutical companies, and the French National Agency for the Safety of Medicines and Health Products (ANSM). After reviewing the strengths and weaknesses of the previous method, several ideas for improvement were proposed: a better-worded and more discriminating scale for certain chronological and semiological criteria, a larger scale for the intrinsic score (increased from 5 to 7 levels), a new bibliographical scale to differentiate between expected and unexpected adverse drug reactions, and a new informativeness scale.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Farmacovigilância , Causalidade , Interações Medicamentosas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , França , Humanos , Vigilância de Produtos Comercializados , Reprodutibilidade dos Testes
3.
Therapie ; 66(6): 517-25, 2011.
Artigo em Francês | MEDLINE | ID: mdl-27393472

RESUMO

A tripartite group, entitled « CRI ¼ (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de santé) has worked to update the French drug reaction assessment method. Following assessment of strengths and weaknesses of the previous method, several points for improvement are proposed : a more precise wording and a more discriminating scale for some of the chronological and semiological criteria, a wider distribution of the intrinsic score from 5 to 7 levels, a new bibliographic scale for differentiating expected and unexpected adverse drug reactions, and a new informativness scale. This updated method would lead to a more relevant assessment of relationship between a drug and the occurrence of an adverse reaction. Furthermore, this method is a teaching tool to assess the level of relationship between a drug and the occurrence of an adverse reaction.

4.
Therapie ; 66(6): 517-25, 2011.
Artigo em Francês | MEDLINE | ID: mdl-22186077

RESUMO

A tripartite group, entitled « CRI ¼ (for Cercle de réflexion sur l'imputabilité), involving French pharmacovigilance staff from the French network of the Regional centers of pharmacovigilance, from pharmaceutical companies, and from French Health Authorities (Agence française de sécurité sanitaire des produits de santé) has worked to update the French drug reaction assessment method. Following assessment of strengths and weaknesses of the previous method, several points for improvement are proposed: a more precise wording and a more discriminating scale for some of the chronological and semiological criteria, a wider distribution of the intrinsic score from 5 to 7 levels, a new bibliographic scale for differentiating expected and unexpected adverse drug reactions, and a new informativness scale. This updated method would lead to a more relevant assessment of relationship between a drug and the occurrence of an adverse reaction. Furthermore, this method is a teaching tool to assess the level of relationship between a drug and the occurrence of an adverse reaction.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/tendências , Sistemas de Notificação de Reações Adversas a Medicamentos/organização & administração , Indústria Farmacêutica , Interações Medicamentosas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , França/epidemiologia , Órgãos Governamentais , Humanos , Farmacovigilância
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA