Risk of Drug Interactions among Children Accessing Drugs through Health Canada’s Special Access Programme
Bibliographic record
Abstract
ABSTRACT Objective: To evaluate if children treated with unlicensed medications obtained through Health Canada’s Special Access Programme (SAP) are at risk of undetected drug interactions. Methods: This case series reports on all ambulatory patients between 0 and 18 years of age who were treated at a motherand- child tertiary care teaching hospital, who received an unlicensed medication through the SAP for at least 4 months, and for whom the authors had access to the community pharmacist. All potential level I, II, and III drug interactions, as determined by 2 frequently used references, were identified from the patients’ files. Results: From January 7 to June 25, 2003, 65 (90%) of the 72 eligible patients agreed to take part in the study. The subjects were receiving the following medications: cisapride (n = 25), nitisinone (n = 10), hydroxocobalamin (n = 8), cysteamine (n = 5), melatonin (n = 4), divalproex sodium (n = 4), interferon-gamma (n = 4), stiripentol (n = 2), phenylbutyrate (n = 2), or methylcobalamin (n = 1). In total, 474 (35%) of 1351 months of treatment (for 39 patients) involved an unlicensed medication known to be associated with potential drug interactions. Three of the 39 patients (8%) actually experienced an interaction: these exposures, all involving cisapride, occurred during a total of 4 months (0.8%). Only 11 (17%) of the 66 community pharmacists noted use of an unlicensed medication in the patient’s file. Conclusion: Three of the 39 patients exposed to unlicensed medications known to have potential drug interactions did in fact have an interaction (in 4 different months). Measures should be taken to decrease the risk associated with the use of unlicensed medications available through Health Canada’s SAP. RESUME Objectif : Evaluer le risque d’interactions medicamenteuses non decelees chez les enfants qui recoivent des medicaments non homologues obtenus par le truchement du Programme d’acces special (PAS) de Sante Canada. Methodes : On a repertorie les cas de tous les patients ambulatoires âges de 0 a 18 ans qui ont recu a un hopital universitaire de soins tertiaires mere-enfant un medicament non homologue par le truchement du PAS, pendant une periode d’au moins quatre mois, et pour lesquels les auteurs de cet article avaient acces a un pharmacien communautaire. Toutes les interactions medicamenteuses potentielles de grades I, II et III, telles que definies dans deux ouvrages de reference couramment utilises, ont ete determinees a partir des dossiers medicaux des patients. Resultats : Entre le 7 janvier et le 25 juin 2003, 65 (90 %) des 72 patients admissibles ont consenti a participer a l’etude. Les sujets recevaient les medicaments suivants : cisapride (n = 25), nitisinone (n = 10), hydroxocobalamine (n = 8), cysteamine (n = 5), melatonine (n = 4), divalproex sodique (n = 4), interferongamma (n = 4), stiripentol (n = 2), phenylbutyrate (n = 2) ou methylcobalamine (n = 1). Un medicament non homologue et associe a des interactions medicamenteuses potentielles connues a ete administre pendant 474 (35 %) des 1351 mois de traitement (chez 39 patients). Une interaction medicamenteuse a ete observee chez trois de ces patients (8 %), chacune impliquant le cisapride, et est survenue sur une periode totale de quatre mois (0,8 %). Seulement 11 (17 %) des 66 pharmaciens communautaires ont consigne l’utilisation d’un medicament non homologue dans le dossier du patient. Conclusion : Une interaction medicamenteuse a ete observee (au cours de quatre mois differents) chez 3 des 39 patients qui ont pris un medicament non homologue associe a des interactions medicamenteuses potentielles connues. Des mesures devraient etre adoptees afin de reduire le risque associe a l’emploi de medicaments non homologues qu’on peut obtenir par le truchement du PAS.
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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 | 0.000 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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".