Agreement between a regional pharmacovigilance centre and an adjudication committee regarding adverse drug reactions on a cohort of hospitalised children - 29/07/22

Doi : 10.1016/j.therap.2021.12.014

Nicolas Pages ^a, Anissa Bounabi ^a, Inesse Boussaha ^a, Marietou Ndiaye ^a, Aurélie Portefaix ^a,^b, Gaelle Simeon ^b, Claire Guy ^c, Jean Stagnara ^d, Nathalie Paret ^e, Thierry Vial ^e, Pirayeh Eftekhari ^f, Daniel Floret ^g, Vincent Gajdos ^h, Jean-Paul Langhendries ⁱ, Nathalie Bleyzac ^j, Corinne Alberti ^k, Evelyne Jacqz-Aigrain ^k, Kim An Nguyen ^b,^e,^l, Behrouz Kassai ^a,^b,^m,^⁎
EREMI Group
^a Centre d’investigation clinique, Inserm CIC 1407, 69003 Lyon, France
^b Univ Lyon, UMR 5558, CRNS, LBBE, EMET, 69008 Lyon, France
^c Centre régional de pharmacovigilance, CHU de Saint-Etienne, 42000 Saint-Etienne, France
^d Cabinet médical, 100 bis rue Montgolfier, 69006 Lyon, France
^e Département de pharmacologie, Hospices civils de Lyon, 69003 Lyon, France
^f Centre régional de pharmacovigilance, Hôpital Fernand-Widal, AP–HP, 75010 Paris, France
^g Université Claude-Bernard-Lyon-1, Hôpital Femme–Mère–Enfant, 69500 Bron, France
^h Département pédiatrique, Hôpital Antoine-Béclère, AP–HP, 92140 Clamart, France
ⁱ Département de pédiatrie and NICU, CHC Health Group, Mont-Legia, 4000 Liège-Rocourt, Belgium
^j Service de pharmacie, Hospices civils de Lyon, Groupement hospitalier Nord, Hôpital Pierre Garraud, 69005 Lyon, France
^k Centre d’investigation clinique EC 1426, Hôpital Robert-Debré/Université de Paris, AP–HP, 75019 Paris, France
^l Hospices civils de Lyon, Unité néonatale de soins intensifs, Hôpital Femme–Mère–Enfant, 69500 Bron, France
^m Service recherche et épidémiologie cliniques, Hospices civils de Lyon, Pôle Santé Publique, 69003 Lyon, France

^⁎Corresponding author. Centre d’investigation clinique, Inserm CIC 1407, 69003 Lyon, France.Centre d’investigation clinique, Inserm CIC 1407Lyon69003France

Summary

Background and purpose

The EREMI project was set up to collect data on adverse drug reactions (ADRs) occurring due to off-label and/or unlicensed drugs prescribed to hospitalised children in France. These events were evaluated by a regional pharmacovigilance centre (RPC) and an adjudication committee (AC). The aim of this study was to assess the agreement between these two different entities on their evaluation of ADRs.

Experimental approach

The RPC first validated the ADRs and assessed their causality using the Naranjo scale. The AC assessed then ADRs using all available information, including the RPC evaluation. The agreement on severity and nature of ADRs, role of treatment (suspect or concomitant) and drug causality was calculated using Cohen's nonparametric kappa coefficient (k).

Key results

Three hundred and eighty-six events were reported in 219 children. The RPC excluded 65 events and validated 321 ADRs. Agreement was very good on nature of ADRs (k=0.85) and role of treatment (k=0.81), moderate on severity of ADRs (k=0.60) and very poor on drug causality (k=0.05).

Conclusion and implications

Agreement between the RPC and the AC was not constant throughout this evaluation. They troubled to agree on severe ADRs and on drug causality.

Le texte complet de cet article est disponible en PDF.

Keywords : Drug-related side effects and adverse reactions, Causality, Pharmacovigilance, Child

Plan

Disclosure of interest

Export

Vol 77 - N° 4

P. 397-404 - juillet 2022 Retour au numéro

Article précédent

Histoire de la pharmacologie médicale lilloise
Régis Bordet, pharmacologie médicale lilloise

| Article suivant

Initial data on the safety of metopimazine during pregnancy and the risk of major birth defects and pregnancy loss – An observational study using the EFEMERIS database
Clémentine Vabre, Mélanie Araujo, Christine Damase-Michel, Caroline Hurault-Delarue, Isabelle Lacroix

Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.

Déjà abonné à cette revue ?

connectez-vous ou créez un compte

Agreement between a regional pharmacovigilance centre and an adjudication committee regarding adverse drug reactions on a cohort of hospitalised children - 29/07/22

Summary

Background and purpose

Experimental approach

Key results

Conclusion and implications

Plan

Export citations

Fichier

Contenu

Accès rapides

Mon compte

Aide & support

Plateformes Elsevier Masson

Déclaration CNIL