Survey on the knowledge and use of the Jext prescriber’s checklist among physicians – a post-authorisation safety study (XX-JX-01)

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:
  Other
• Non-interventional study design, other:
  Post authorization study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C01CA24) epinephrine

  epinephrine

Population studied

• Short description of the study population:
  Physicians who has received Jext prescriber’s checklist.
• 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:
  50

Study design details

• Main study objective:
  The Jext prescriber’s checklist constitutes a risk minimisation measure (RMM) for Jext, and is included in the Jext risk management plan. As a consequence, effectiveness of the RMM should be evaluated following its implementation into the market. The objective of this study is to assess the effectiveness of the implementation of the Jext prescriber’s checklist.
• Outcomes:
  To assess the effectiveness of the implementation of the Jext prescriber’s checklist.
• Data analysis plan:
  Data analysis stage will consist of preparing the total tally of responses for each question posed. In addition, cross tabulations will be prepared for all survey questions against various sub-groups, e.g. physician types, caseloads and practice setting. In addition to the responses to the questions of the main questionnaire, the number of respondents who have prescribed Jext, but are not familiar with the prescriber’s checklist, will be calculated.