The Impact of COVID-19 Pandemic on Drug Use: Implications for Regulatory Intervention Impact Studies

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Population studied

• 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:
  70000

Study design details

• Main study objective:
  To assess whether the short- and/or long-term drug utilisation patterns were impacted by the COVID-19 pandemic.
• Outcomes:
  To describe the trends of prescribing the selected medicinal products from January 1, 2017, to December 31, 2023. To identify potential structural breaks in prescribing patterns of selected medicinal products over time. To assess if structural breaks in trends (if they are present) align with restrictions implemented due to the COVID-19 pandemic. To conduct sensitivity analyses to determine what assumptions reduce the probability of detecting structural breaks due to the COVID-19 pandemic in the secular trends of drug use (if they are present).
• Data analysis plan:
  The study design will be a retrospective population-based dynamic cohort study. We will use interrupted time series analysis to identify the potential breaks in drug utilisation patterns before and during the COVID pandemic.