Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence (ValproateRiskAware)

Study type

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

  Drug utilisation

  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:
  Health care professional study, Patient study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N03AG01) valproic acid

  valproic acid

Population studied

• Short description of the study population:
  Health care professionals (both GPs and specialists) and community pharmacists who had prescribed valproate and related products among women in childbearing age from 8 European countries: Belgium, Denmark, Greece, Latvia, Portugal, The Netherlands, Slovenia and Spain. Midwives may be included, if they have had experience with at least one woman treated with valproate and related products. ; Inclusion criteria: ; • female aged between 15-50 years; • having used valproate or related products in the past 5 years or are currently using
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  1) To assess the extent of the influence of recommendations from regulatory authorities on patients’, prescribers’ and pharmacists’ awareness about the risk of adverse teratogenic effects and neurodevelopmental disorders to children of women exposed to valproate and related substances during pregnancy, and to investigate whether knowledge, attitudes and practices have been affected.
• Data analysis plan:
  The surveys will generate descriptive statistics, describing the distribution of characteristics of patients and HCPs for the variables included in the questionnaires. Univariate and bivariate analyses will be conducted according to stratifying variables, including HCP characteristics (age, gender, country, specialism, years of experience) and patient characteristics (age, diagnosis, past use of valproate and related products, type of prescriber, country) For the qualitative data, the analysis involves an inductive content analysis based on a close line-by-line reading of the responses and developing a conceptual coding scheme based on the major themes in the interview guides. Transcripts will be categorized individually by two coders in each country in native languages. Coders from all countries will meet prior to the analysis to predefine categories and codes to be used. They meet again to evaluate the categories identified and to write up the results using illustrative quotes.