Paediatric adverse drug reactions can be fatal
Notice bibliographique
Résumé
A recent American publication by the Food and Drug Administration looked at more than 7000 adverse drug events reported in infants and children younger than two years of age. Of the 1902 different drugs and products that were identified, only 17 were suspected in 54% of all serious and fatal adverse drug reactions (ADRs). Four drugs, palivizumab (15%), nitric oxide (11%), indomethacin (10%) and cisapride (3%) accounted for 38% of reported deaths (1). Although results pertain to the United States, they nevertheless focus attention on the important clinical and public health implications of better understanding adverse drug events in the Canadian context. ADRs are an important cause of morbidity and mortality in children. No reliable Canadian data are available on the incidence of ADRs in children. Premarket clinical drug trials often do not include children who may be at risk for unique ADRs, or an increased frequency of ADRs compared with the general population. Many drug products are not labelled for use in children or for specific paediatric age groups. The current voluntary passive reporting system of postmarketing surveillance is hampered by under-reporting of ADRs. Clearly, the time has come for Canada to collect data through a research study focused on the paediatric population. The Canadian Paediatric Surveillance Program (CPSP), now into its eighth year of active surveillance, offers a viable surveillance system through which to gather these data from more than 2300 paediatricians and paediatric subspecialists responsible for the care of a large geographically diverse paediatric population. Through the CPSP, a member of the International Network of Paediatric Surveillance Units (INoPSU), international comparison and collaboration is also possible, as similar studies have been undertaken in Australia (adverse effects associated with the use of complementary or alternative medicines), Britain (suspected fatal adverse drug reactions), and the Netherlands (severe complications of medical therapy). To determine the feasibility of an active surveillance system (CPSP) to identify serious and life-threatening paediatric ADRs not currently captured by existing spontaneous reporting systems. To identify the products most frequently causing ADRs in children, the type of reactions encountered, as well as the characteristics of those affected. To determine the usefulness of the data collected for meaningful analysis and interpretation. The CPSP welcomes the challenge of undertaking the surveillance of adverse drug reactions in children. It is anticipated that this active surveillance tool will address some of the barriers of the current passive system to provide a more accurate profile of ADRs in the paediatric population. By raising awareness, the ADR study will bring Canadian children one step closer to improved monitoring of drug safety.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,011 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,000 | 0,002 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,011 | 0,004 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».