A Post-Authorisation Safety Study (PASS) to Assess the Effectiveness of the Risk Minimisation Measures of Domperidone – Physician Survey

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DOMPERIDONE

Population studied

• Short description of the study population:
  Prescribers, across 5 EU countries with varying prescription volumes: Belgium, France, Germany, Spain and United Kingdom.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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:
  0

Study design details

• Main study objective:
  Assess the awareness of the health care professionals and level of understanding and knowledge detailed in the risk minimisation activities (eg. DHCP) with respect to the safety and risk management of domperidone.
• Outcomes:
  Characterise prescriber's knowledge, regarding the new safety information for domperidone following the change in SmPC, including:- Indications for domperidone prescribing- Length of treatment- Maximum daily dose- concomitant use of domperidone and other drugs known to prolong the QT-interval or potent CYP3A4 inhibitors- contraindicated conditions- treated population characteristics
• Data analysis plan:
  Descriptive statistics will be used for evaluation and comparison of prescriber knowledge and awareness as measured by the study survey. The study population will be described using demographic characteristics, such as age, sex, specialty, clinical practice type, and country.Continuous variables will be presented using appropriate descriptive statistics, such as mean, median, standard deviation and range. Categorical variables will be described using frequencies.Further stratification by baseline variables may be performed and will be described in the statistical analysis plan.The primary analysis will present the rate of correct answers per question for all countries pooled together. An additional analysis will include the rates of correct answers by country. The proportion of physicians who potentially prescribe domperidone for unapproved indications will be described.