Effect of Pharmacist Involvement on Patient Reporting of Adverse Drug Reactions: A Multiregional Italian Study

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘Not applicable’, further details on the study type:
  Active surveillance, Stimulated reporting
• If ‘other’, further details on the scope of the study:
  Promotion and Information of patient reporting
• Data collection methods:
  Primary data collection

Population studied

• Short description of the study population:
  Patients who had received at least one drug
• 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:
  115000

Study design details

• Main study objective:
  To assess the potential impact of an intevention to promote patient reporting in community pharmacies and to compare the characteristics of patients and general practitioners reports of adverse drug reactions (ADRs).
• Outcomes:
  improve patient reporting
• Data analysis plan:
  ADR reports with all mandatory fields were and will be entered into the Italian Pharmacovigilance Database. Drugs were and will be coded using national terminology and following the ATC classification. Drugs reactions were classified usign MedDRA. The characteristics of ADR reports sent by patients were and will be compared with those sent by GPs in the Veneto Region. The Chi- square test was used to compare patient and GPS reports. All calculation were made using Epi Info, a a standard statistical software program developed by the Centers for Disease Control and Prevention, Atlanta, US.