Vandetanib Risk Minimisation Effectiveness

• Knowledge and Understanding Survey: Knowledge of the key safety issues pertaining to vandetanib [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  QT prolongation/Torsades de Pointes, diarrhea, rash and other skin reactions- adequate or inadequate for each safety issue (defined by correct response).
  
  
• Drug Utilisation Study: Use of vandetanib - duration of treatment at baseline [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  Discontinuation, interruption, continuous
  
  
• Drug Utilisation Study: Use of vandetanib - duration of treatment at 3 months [ Time Frame: At 3 months ] [ Designated as safety issue: Yes ]
  Discontinuation, interruption, continuous
  
  
• Drug Utilisation Study: Use of vandetanib - duration of treatment at 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]
  Discontinuation, interruption, continuous
  
  
• Drug Utilisation Study: Use of vandetanib - duration of treatment at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
  Discontinuation, interruption, continuous
  
  
• Drug Utilisation Study: Use of vandetanib - dosage at baseline [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  
• Drug Utilisation Study: Use of vandetanib - dosage at 3 months [ Time Frame: At 3 months ] [ Designated as safety issue: Yes ]
  
• Drug Utilisation Study: Use of vandetanib - dosage at 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]
  
• Drug Utilisation Study: Use of vandetanib - dosage at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
  
• Drug Utilisation Study: Concomitant use of QT-prolonging drugs at baseline [ Time Frame: At baseline ] [ Designated as safety issue: Yes ]
  Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
  
  
• Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 3 months [ Time Frame: At 3 months ] [ Designated as safety issue: Yes ]
  Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
  
  
• Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]
  Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
  
  
• Drug Utilisation Study: Concomitant use of QT-prolonging drugs at 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
  Dichotomous variable - yes/no + total number of concomitant QT-prolonging drugs
  
  

• Knowledge and Understanding Survey: Practice characteristics [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  Main geographical location, average days devoted to patient care, total number of medullary thyroid cancer patients followed up to date.
  
  
• Knowledge and Understanding Survey: Previous exposure to vandetanib safety concerns other than product monograph or mandatory online training [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  Participation in a trial on vandetanib, giving CME conferences, member of a data safety monitoring board.
  
  
• Knowledge and Understanding Survey: Sources of information on key safety messages for vandetanib [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  Product monograph, online training, Dear Healthcare Professional letter sent by AstraZeneca, company's sales forces, continuing medical education, conferen.
  
  

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.