Indications for systemic fluoroquinolone prescribing in Europe: a descriptive population based study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01MA) Fluoroquinolones

  Fluoroquinolones
• Medical condition to be studied:
  Sinusitis

  Bronchitis

  Urinary tract infection

Population studied

• Short description of the study population:
  Patients were included from the IMS® Disease Analyzer France and Germany with a minimum period of 1 year follow-up defined according to their consultation and prescribing observability.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Sinusitis, Bronchitis, Urinary tract infection patients
• Estimated number of subjects:
  200000

Study design details

• Main study objective:
  To provide a descriptive analysis of broad indications for treatment with systemic fluoroquinolone antibiotics in Summary of Product Characteristics across the European Economic Area (EEA). To provide a descriptive analysis of clinical indications for treatment with systemic fluoroquinolone antibiotics in France, Germany and UK electronic health records
• Outcomes:
  1) Descriptive analysis of the proportion of Summary of Product Characteristics across Europe with an indication for treatment for different indication categories. 2) Broad clinical indications for incident fluoroquinolone antibiotic prescribing in primary care.
• Data analysis plan:
  The Summary of Product Characteristics for fluoroquinolone containing antibiotic products will be screened to identify what proportion have an indication listed for sinusitis, bronchitis and urinary tract infection. Incident fluoroquinolone prescriptions will be identified for adults in each electronic health record database. Read and ICD codes will be screened to identify the likely clinical indication for such recording. These will be broadly categorised according to different systems and specific information provided for sinusitis, bronchitis and urinary tract infection cross-sectionally. Time trends in the use of incident fluoroquinolone antibiotics will be provided for different broad system categories including for sinusitis, bronchitis and urinary tract infection for each database were data is available.