Effectiveness of Risk Minimisation Interventions for Vandetanib in Canada
As part of the new drug approval process in Canada, AstraZeneca has committed to Health
Canada to conduct a Drug Utilization Study among patients recently treated with CAPRELSA
(vandetanib) and a Knowledge and Understanding Survey among the prescribing physicians to
determine whether the product monograph, communication plan, and educational material
developed by AstraZeneca Canada for vandetanib are adequate to provide knowledge about the
potential risks associated with this product, and if other medications taken concomitantly
with vandetanib are managed adequately.
Observational Model: Cohort, Time Perspective: Prospective
Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib
QT prolongation/Torsades de Pointes, diarrhea, rash and other skin reactions- adequate or inadequate for each safety issue (defined by correct response).
Yola Moride, PHD
Université de Montréal
Canada: Health Canada