Paediatric adverse drug reactions can be fatal
Bibliographic record
Abstract
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.011 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.002 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.011 | 0.004 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".