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Archives de pédiatrie : organe officiel de la Société française de pédiatrie v.24 no.12, 2017년, pp.1179 - 1187   SCIE
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Detection and codification of adverse drug reactions in a mother-child university hospital
DEtection et codification des effets indEsirables mEdicamenteux dans un centre hospitalier universitaire mEre-enfant

Harry, M. (Département de pharmacie et unité ) ; Lebel, D. (de recherche en pratique pharmaceutique, centre hospitalier universitaire Sainte-Justine, 3175, chemin de la Côte-Sainte-Catherine, H3T 1C5, Montréal, Québec, Canada ) ; Comtois, A. (Département de pharmacie et unité ) ; Bussières, J.-F. (de recherche en pratique pharmaceutique, centre hospitalier universitaire Sainte-Justine, 3175, chemin de la Côte-Sainte-Catherine, H3T 1C5, Montréal, Québec, Canada ) ;
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    Summary Introduction In view of the underdeclaration of adverse drug reactions (ADRs), there is a need for optimizing their reporting. To improve our declaration, a pharmacovigilance program was started in 2006 at our center and measures were progressively started (weekly patient rounds, monthly report, etc.). The objectives of the study were to describe and compare the annual average incidence of the ADRs coded by the medical archivists from 1 April 1989 to 31 March 2010 (period 1) and from 1 April 2010 to 31 March 2015 (period 2), to determine the therapeutic classes of drugs associated with ADRs according to age and determine the percentage of ADRs that are declared to Health Canada. Methods This was a nonexperimental, descriptive, and retrospective study in a mother–child university hospital. All the ADRs that arose with patients less than 18 years old during period 2 were included. The results of a previous study, conducted during period 1 were used. A Student t -test was used to compare the mean annual incidence and the average number of ADRs per year between the two periods. Results The average number of ADRs per year was 225.7±65.1 ADRs during period 1 versus 429.6±52.1 ADRs during period 2 ( P P Conclusion This study highlighted a progressive increase in the codification of the ADRs in the pediatric population from 1989–1990 to 2014–2015. No causal effect could be obtained between the measures that we implemented in 2006 and the improvement seen with the ADR codification, but we can reasonably suspect a positive impact.


    REsumE Introduction Face A la sous-dEclaration des effets indEsirables mEdicamenteux (EIM), les Etablissements de santE doivent optimiser ces dEclarations. Afin d’amEliorer le systEme de pharmacovigilance local de notre Etablissement, un service de pharmacovigilance a EtE crEe en 2006 et des mesures ont EtE progressivement mises en place (tournEes hebdomadaires des unitEs de soins, bilan mensuel de pharmacovigilance, etc). Les objectifs de cette Etude Etaient de comparer l’incidence annuelle moyenne des EIM codEs par les archivistes mEdicaux du 1 er avril 1989 au 31 mars 2010 (pEriode 1) et du 1 er avril 2010 au 31 mars 2015 (pEriode 2), de dEterminer les classes thErapeutiques de mEdicaments associEes aux EIM en fonction de l’Age et la proportion d’EIM dEclarEs A SantE Canada. MEthodes Il s’agit d’une Etude descriptive et rEtrospective rEalisEe dans un centre hospitalier universitaire mEre-enfant. Ont EtE inclus tous les EIM survenus chez des patients AgEs de 18 ans et moins au cours de la pEriode 2. Les rEsultats issus d’une prEcEdente Etude (pEriode 1) ont EtE utilisEs. Un test- t de Student a EtE utilisE pour comparer l’incidence annuelle moyenne et le nombre moyen d’EIM par annEe entre les deux pEriodes. REsultats Le nombre moyen d’EIM par annEe avait EtE de 225,7±65,1 EIM au cours de la pEriode 1 et de 429,6±52,1 au cours de la pEriode 2 ( p p Conclusion Cette Etude met en Evidence une augmentation progressive de la codification des EIM dans la population pEdiatrique entre les 2 pEriodes. Nous ne pouvons toutefois pas Etablir de lien causal entre les mesures mises en place A partir de 2006 et l’augmentation de la codification des EIM mais nous pouvons raisonnablement penser qu’elles ont eu un rOle favorable.


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