Pharmacovigilance center internal medicine ...
Document type :
Article dans une revue scientifique: Article original
PMID :
Permalink :
Title :
Pharmacovigilance center internal medicine interactions: a useful diagnostic tool
Author(s) :
Rochoy, Michael [Auteur]
Gautier, Sophie [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U1171
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Bordet, Regis [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U1171
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Caron, Jacques [Auteur]
Launay, David [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Hachulla, Eric [Auteur]
Lille Inflammation Research International Center - U 995 [LIRIC]
Hatron, P. -Y [Auteur]
Lambert, Marc [Auteur]
Lille Inflammation Research International Center (LIRIC) - U995
Lille Inflammation Research International Center - U 995 [LIRIC]
Gautier, Sophie [Auteur]
Troubles cognitifs dégénératifs et vasculaires - U1171
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Bordet, Regis [Auteur]

Troubles cognitifs dégénératifs et vasculaires - U1171
Troubles cognitifs dégénératifs et vasculaires - U 1171 - EA 1046 [TCDV]
Caron, Jacques [Auteur]
Launay, David [Auteur]

Lille Inflammation Research International Center - U 995 [LIRIC]
Hachulla, Eric [Auteur]

Lille Inflammation Research International Center - U 995 [LIRIC]
Hatron, P. -Y [Auteur]
Lambert, Marc [Auteur]

Lille Inflammation Research International Center (LIRIC) - U995
Lille Inflammation Research International Center - U 995 [LIRIC]
Journal title :
La Revue de medecine interne
Abbreviated title :
Rev. Med. Interne
Volume number :
36
Pages :
516-521
Publication date :
2015-08-01
ISSN :
0248-8663
English keyword(s) :
reactions
Drug-related side effects and adverse
Pharmacovigilance
Internal medicine
Decision support techniques
Drug-related side effects and adverse
Pharmacovigilance
Internal medicine
Decision support techniques
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
OBJECTIVE: Patients hospitalized in internal medicine often have unexplained clinical symptoms for which a drug origin can be considered. The prevalence of patients hospitalized for iatrogenic is estimated between 4-22%. ...
Show more >OBJECTIVE: Patients hospitalized in internal medicine often have unexplained clinical symptoms for which a drug origin can be considered. The prevalence of patients hospitalized for iatrogenic is estimated between 4-22%. We wanted to evaluate the diagnostic value of the regional center of pharmacovigilance to identify or confirm an iatrogenic disease in the department of internal medicine of Lille and characterize factors associated with drug-related side effect. METHODS: This is a single-center prospective diagnostic study. We included all subsequent requests from the department of internal medicine with the Nord-Pas-de-Calais regional pharmacovigilance center between 2010 and 2012. The opinion of the regional pharmacovigilance centre was held on the record of the adverse drug reaction in the national pharmacovigilance database and analyzed according to the conclusion of iatrogenic used by clinicians in internal medicine (reference diagnosis) with a follow-up to June 2013. The variables relating to the patient, medication and adverse events were analyzed by binary logistic regression. RESULTS: We analyzed 160 contacts: 118 concordant cases, 38 false-positives (drug-related side effect retained by the regional pharmacovigilance center only), 4 false negatives. Registration in the national pharmacovigilance database had a sensitivity of 96% (95% CI [0.92 to 0.99]), a specificity of 46% (95% CI [0.38 to 0.53]), a value positive predictive of 69% (95% CI [0.62 to 0.76]), a negative predictive value of 89% (95% CI [0.84 to 0.94]) and a negative likelihood ratio of 0.1. False-positive had chronological and semiological accountabilities questionable (adjusted RR=2.1, 95% CI [1.2 to 2.8]). CONCLUSIONS: In our study, the regional pharmacovigilance center confirms the clinician's suspicion of drug-related side effects and helps to exclude drug-induced with a high negative predictive value.Show less >
Show more >OBJECTIVE: Patients hospitalized in internal medicine often have unexplained clinical symptoms for which a drug origin can be considered. The prevalence of patients hospitalized for iatrogenic is estimated between 4-22%. We wanted to evaluate the diagnostic value of the regional center of pharmacovigilance to identify or confirm an iatrogenic disease in the department of internal medicine of Lille and characterize factors associated with drug-related side effect. METHODS: This is a single-center prospective diagnostic study. We included all subsequent requests from the department of internal medicine with the Nord-Pas-de-Calais regional pharmacovigilance center between 2010 and 2012. The opinion of the regional pharmacovigilance centre was held on the record of the adverse drug reaction in the national pharmacovigilance database and analyzed according to the conclusion of iatrogenic used by clinicians in internal medicine (reference diagnosis) with a follow-up to June 2013. The variables relating to the patient, medication and adverse events were analyzed by binary logistic regression. RESULTS: We analyzed 160 contacts: 118 concordant cases, 38 false-positives (drug-related side effect retained by the regional pharmacovigilance center only), 4 false negatives. Registration in the national pharmacovigilance database had a sensitivity of 96% (95% CI [0.92 to 0.99]), a specificity of 46% (95% CI [0.38 to 0.53]), a value positive predictive of 69% (95% CI [0.62 to 0.76]), a negative predictive value of 89% (95% CI [0.84 to 0.94]) and a negative likelihood ratio of 0.1. False-positive had chronological and semiological accountabilities questionable (adjusted RR=2.1, 95% CI [1.2 to 2.8]). CONCLUSIONS: In our study, the regional pharmacovigilance center confirms the clinician's suspicion of drug-related side effects and helps to exclude drug-induced with a high negative predictive value.Show less >
Language :
Anglais
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
CHU Lille
CNRS
Inserm
Université de Lille
CNRS
Inserm
Université de Lille
Submission date :
2019-11-27T13:33:41Z
2021-06-10T13:54:19Z
2021-06-10T14:07:47Z
2021-06-10T13:54:19Z
2021-06-10T14:07:47Z