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 identification

• EU PAS number:
  EUPAS10428
• Study ID:
  14677
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Denmark

  France

  Germany

  Hungary

  Ireland

  Italy

  Netherlands

  Spain

  United Kingdom
• Study description:
  The study is a survey of healthcare professionals (HCPs) to evaluate the effectiveness of the additional risk minimisation measures (aRMMs) being implemented across Europe to mitigate the risks associated with voriconazole (Vfend®) (i.e. phototoxicity, SCC of the skin and hepatic toxicity in patients using voriconazole). The evaluation is being conducted in 10 of the 33 countries in the EU where RM tools are being implemented. Specifically, the goals of the study are to: 1) Assess HCPs’ awareness of the RM tools, 2) Assess HCPs’ utilization of the RM tools, 3). Assess HCPs’ knowledge of the risks, 4) Assess whether HCPs’ self reported behaviour/practices with respect to minimizing the risks of phototoxicity, SCC of the skin and hepatic toxicity are in accordance with the voriconazole SmPC. The study objectives will be accomplished by means of a cross-sectional survey of all targeted HCPs who received the aRMMs and self-report as prescribers of voriconazole in 10 EU countries. Voriconazole is mainly prescribed by select specialty care physicians (i.e., infectious disease physicians, oncologists, haematologists, solid organ transplant physicians--- however the speciality that actually prescribes voriconazole can vary by country). These speciality care physicians in the 10 EU countries will constitute the study population for the survey. A structured self-administered questionnaire comprised of closed-ended questions or statements with multiple response choices will be used to collect the survey data. The questionnaire will collect data on HCP characteristics in addition to their responses pertaining to the effectiveness of the aRMMs. A sample size of 750 completed surveys is being targeted across 10 countries.
• Study status:
  Finalised

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Planned: 05/08/2013

Actual: 05/08/2013

Study start date

Planned: 01/09/2015

Actual: 02/09/2015

Data analysis start date

Planned: 02/03/2016

Actual: 02/03/2016

Date of final study report

Planned: 31/05/2016

Actual: 17/05/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)