Pregnancy Prevention Program Section of the Risk Management Plan for Soriatane® (acitretin): Survey to Assess Physician and Pharmacist Understanding of the Risk of Teratogenicity Associated with Soriatane

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Survey
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Population studied

• Short description of the study population:
  Canadian physicians and pharmacists who are prescribers and dispensers of Soriatane.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  420

Study design details

• Main study objective:
  To understand: •How physicians prescribe Soriatane •What teratogenicity risks physicians & pharmacists are aware of & communicate to women of childbearing potential •What strategies they use to minimize the likelihood of pregnancy among women of childbearing potential •Their awareness & use of existing educational materials regarding appropriate prescription & dispensing of Soriatane
• Data analysis plan:
  Responses for all questions of each survey will be tabulated and reported descriptively, including frequencies with percentages for categorical variables as appropriate. All results will be reported in the aggregate for each survey sample.