Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations

Study type

• Study topic:
  Other
• Study topic, other:
  Impact of pharmacovigilance regulatory actions
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Systematic literature review
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Population studied

• Short description of the study population:
  N/A
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 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:
  1. Perform a systematic review of published studies evaluating the impact of pharmacovigilance regulatory interventions worldwide, 2. Describe the study design used to evaluate the impact of pharmacovigilance regulatory interventions,3. Describe the analytical approach used to determine whether impact occurred, including the type of outcome measures,
• Data analysis plan:
  Descriptive statistics of extracted variables (totals and percentage)