Impact of EU label changes for medicinal products containing methotrexate for weekly administration: risk awareness and adherence, A survey study

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

  Other
• Non-interventional study design, other:
  Multinational, and multichannel survey

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AX03) methotrexate

  methotrexate

Population studied

• Short description of the study population:
  The study population included healthcare professionals who had prescribed a weekly dose of methotrexate (MTX), pharmacists who had dispensed a weekly dose of MTX, and patients who had used a weekly dose of MTX in 5 European countries (France, Greece, Germany, Poland, and Sweden) for the period of 25 February 2022 to 11 April 2022. ; ; Inclusion Criteria: ; • For prescriber questionnaire: Prescribers who have prescribed MTX in a single low dose once a week for indications that require weekly dosing in the past 3 months; • For pharmacist questionnaire: Pharmacists who have dispensed MTX in a single low dose once a week for indications that require weekly dosing in the past 3 months; • For patient questionnaire: Patients who have been treated with a single low dose once a week for indications that require weekly dosing in the past 3 months; ; Exclusion Criteria:; • Prescribers, pharmacists, or patients who declare having a conflict of interest with the survey (i.e. participants employed by regulatory bodies, pharmaceutical industries); • Prescribers, pharmacists, or patients who do not provide consent for participating in the survey
• 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:
  450

Study design details

• Main study objective:
  The overall objective of the study is to evaluate the impact of these actions taken for MTX-containing medicinal products following the 2019 referral procedure.
• Outcomes:
  For prescriber: receipt and awareness of the DHPC and EMs for HCPs awareness of the patient card and the knowledge of the risks of overdose due MTX weekly use. For pharmacist, awareness of the patient card and the visual reminder of MTX, For patient: awareness and knowledge of the elements introduced to avoid incorrect administration for MTX and adherence to marking the day of intake of MTX.
• Data analysis plan:
  The statistical results of the selected countries will be presented in the same report, overall and per country. Continuous variables will be described by their number (of valid cases and missing values), mean, standard deviation, and median, first quantile (Q1), third quantile (Q3), minimum and maximum. Categorical variables will be described as the total number and relative percentage per category. These will be the percentage per category. In case of multiple-choice questions, the frequency of each option provided by the participants will be reported in the statistical results. Different combinations of the answers provided will not be considered. CIs of 95% will be evaluated, when relevant. the results will be weighted according to the real proportion of prescribers, pharmacists, and patients who in each country in order to accurately reflect the population that the survey seeks to measure.