Trends in cannabis adverse reaction reports: A descriptive analysis of spontaneous reporting data submitted to the Canada Vigilance Program since legalization and regulation of cannabis for non-medical purposes in Canada
Notice bibliographique
Résumé
BACKGROUND: The cannabis control framework implemented by Canada in October 2018 established a robust post-market surveillance system for cannabis products, adopting tools and practices from the existing pharmacovigilance system for pharmaceuticals and health products. The cannabis vigilance system relies on spontaneous reporting of adverse reactions, allowing Health Canada to collect, monitor and assess health effects involving cannabis. In this study, we examine trends in adverse reaction reports involving legal cannabis products since legalization and regulation in Canada. METHODS: Unique case reports of adverse reactions involving cannabis were collected through the Canada Vigilance Program. Case details were extracted from each report involving legal cannabis as a suspected product. Each case was also assessed for causality to determine the likelihood of association between the cannabis product(s) and the reported event(s). The case data was then aggregated and descriptively analyzed to identify adverse reaction case patterns, including the demographic profiles and use patterns of individuals reporting adverse reactions to cannabis. RESULTS: Overall, individuals reporting an adverse reaction to a cannabis product (n = 698) were 56.0 ± 20.0 years of age. 45.4% of reporting individuals were female, and 67.5% of individuals self-reported using cannabis for medical purposes, with pain management as the most cited reason for medical use. Most cases were reported as serious (62.3%), citing "other medically important condition" as the primary reason for seriousness (58.6%), and 68.8% of all cases involved cannabis extracts. Frequently reported events included hallucination, headache, nausea, dizziness and dyspnea. Some events were more frequently reported with products containing a greater concentration of tetrahydrocannabinol to cannabidiol, whereas others were more frequently reported with products containing a greater concentration of cannabidiol to tetrahydrocannabinol. Causality was assessed for 668 events; most were assessed as being "possibly" associated with the reported cannabis product. CONCLUSIONS: The post-market adverse reaction reporting system for cannabis products has provided valuable safety information about cannabis products available for legal retail sale in Canada. The data collected through this framework have helped identify emerging risks associated with legal cannabis products; contributed to international data about cannabis effects and risks; informed the development of communication materials related to new and emerging risks; and provided evidence to inform regulatory decisions.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,008 | 0,013 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,003 | 0,007 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
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 tête enseignante, 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 ».