Evaluation of the effectiveness of additional risk minimisation measures (aRMMs) that aim to reduce the risks of phototoxicity, squamous cell carcinoma (SCC) of the skin and hepatic toxicity in patients receiving voriconazole in the European Union (EU)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J02AC03) voriconazole

  voriconazole

Population studied

• Short description of the study population:
  Healthcare professionals that prescribe voriconazole and received the RM tools in the following countries: UK, France, Austria, Ireland, Denmark, Germany, Spain, Italy, Netherlands, and Hungary.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  332

Study design details

• Main study objective:
  The overall objective is to evaluate the effectiveness of the additional RMMs being implemented across Europe to mitigate the risks of phototoxicity, SCC of the skin and hepatic toxicity with the use of voriconazole.
• Data analysis plan:
  Data collected from the survey will be reported as descriptive statistics. Frequency distributions with 95% CIs will be calculated for HCPs’ responses to all questions that address the survey objectives. Depending on the sample size, survey data will be stratified by country and medical specialty. In the final analysis of all specialists there will be weighted analysis completed based on HCP speciality.