Evaluating the effectiveness of the revised alli® pack information in helping pharmacy staff within the EU supply alli® appropriately (204675)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Survey

Study drug and medical condition

• Name of medicine:
  ALLI
• Medical condition to be studied:
  Weight loss diet

Population studied

• Short description of the study population:
  Male or female who was qualified and practising community pharmacist or pharmacy assistant in UK, Finland and Spain.
• Age groups:
  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:
  480

Study design details

• Main study objective:
  1. To evaluate whether revisions to the on-pack label for alli are effective in enabling pharmacy staff make an appropriate decision to supply alli to consumers based on BMI, age and contraindications and special warnings to use alli.2. To identify whether there are specific criteria which pharmacy staff do not recognize as indications, contraindications or warnings.
• Outcomes:
  The primary endpoint will be the proportion of correct answers bythe pharmacy staff to: a) Supply alli® when the virtual customer is suitable for theproductb) Not supply alli® when the virtual customer is not suitable for the product, a) The proportion of correct responses for each sub-score (indications, contraindications and warnings) analysedb) The proportion of false positives by the pharmacy staffc )The proportion of false negatives by the pharmacy staff
• Data analysis plan:
  80% correct answers will be considered to signify that the revised label is effective with respect to each sub-score (indication, contraindication and warning) in enabling pharmacy staff to supply alli®.The proportions of correct and incorrect pharmacy staff responses overall and by criteria, and their 95% confidence intervals will be calculated and presented.

Documents

Study results

204675-Clinical-Study-Result-Summary