A regional project to reduce adverse drug reactions due to medication errors in hospital

Study type

• Study topic:
  Other
• Study topic, other:
  Medication Errors, Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  All patients, aged ≥18 years, hospitalized in seven unit (three internal medicine and four geriatric) of the University Hospital of Verona during 3 months period (February- April 2013).
• 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:
  3000

Study design details

• Main study objective:
  The main objective of this study is to evaluate if educational audits organized in the second phase and directed to health care practitioners have reduced the medication errors due to adverse drug reaction in the third phase.
• Outcomes:
  All adverse drug reactions registered in all hospitalized patients during the study period and in the involved units
• Data analysis plan:
  A descriptive analysis will be conducted for all variables. The risk factors for ADRs and medication errors will be identified by studying the effects of age, the sex, the duration of stay in the department and the severity of ADRs. The results will be expressed in terms of Odds Ratio (OR) with their 95% confidence intervals (95% CI). The level of significance will be estimated at 5%.