Dissemination of additional risk minimisation measures for patients and healthcare professionals in EU/EEA countries

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  XELJANZ

  AUBAGIO

  LEMTRADA

  EYLEA
• Medicinal product name, other:
  Valproate containing medicinal products ; Retinoids containing medicinal products
• Study drug International non-proprietary name (INN) or common name:
  TOFACITINIB CITRATE

  TERIFLUNOMIDE

  ALEMTUZUMAB

  AFLIBERCEPT

  EDOXABAN

  ACITRETIN

  ADAPALENE

  ALITRETINOIN

  BEXAROTENE

  ISOTRETINOIN

  TRETINOIN

  TAZAROTENE

Population studied

• Short description of the study population:
  Patients using these drugs, HCPs prescribing these drugs, Competent Authorities, pharmacists, Marketing AuthorizationHolders (MAH)

Study design details

• Study design:
  Focus groups, interviews, and surveys among the different populations, desk research
• Main study objective:
  1. To describe and analyse aRMM dissemination: Process & frequency ; key stakeholders involved; roles & responsibilities by type of aRMM, by dissemination method, by medicinal product and by country; 2. To describe and analyse how access is ensured by type of aRMM, by medicinal product, by key stakeholder involved, and by country; 3. To identify key challenges of disseminating healthcare professional- and patient-targeted aRMMs by type of aRMM, by dissemination method, by key stakeholder involved and by country; 4. To identify and describe preferences for aRMM tools by type of aRMM, by dissemination method, by key stakeholder involved and by country; 5. To provide recommendations by identifying feasible and concrete steps at each step of implementation pathway
• Outcomes:
  Relevant outcomes were: 1) process including the frequency of how aRMM materials are disseminated and the roles and responsibilities of key stakeholders (prescriber, pharmacist, MAH, NCA) in the dissemination process; 2) access to aRMM materials for patients and HCPs; 3) key challenges of disseminating aRMM; 4) preferences for aRMM tools for patients and HCPs and 5) usefulness of the materials. Data sources were scientific and grey literature, interviews with MAHs, focus groups with NCAs, focus groups/interviews with patients and HCPs, online questionnaires for patient organisations, patients and HCPs and a webinar for all stakeholders.