Study of impact of EU label changes for fluoroquinolone containing medicinal products for systemic and inhalation use - post-referral prescribing trends

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000096303

  ofloxacin

  100000096304

  ciprofloxacin

  100000096308

  norfloxacin

  100000096309

  lomefloxacin

  100000096314

  levofloxacin

  100000096316

  moxifloxacin

Population studied

• Short description of the study population:
  The study population in each database will include all patients who contribute observation person-time at risk in each database during the study time period and meet the study selection criteria.; ; In each country, patients who meet all of the inclusion criteria and none of the exclusion criteria will be selected.; Inclusion Criteria; The inclusion criteria are:; • All patients with an active registration status during the study time period; • Continuous enrolment in the database for more than 12 months; ; Exclusion Criteria; Patients will be excluded if they are; • Missing age or sex
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  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:
  800000

Study design details

• Main study objective:
  The overall aim of this study is to evaluate the impact of the regulatory actions taken for fluoroquinolone containing medicinal products following the 2018 referral procedure, using healthcare databases of six European countries.
• Data analysis plan:
  This is a drug utilization study with a time series analysis component to identify the potential impact of regulatory interventions on fluoroquinolones prescribing trends. An initial exploratory descriptive analysis will be conducted for each database-specific cohort. Crude and stratified incidence of drug use, drug discontinuation and use of alternative treatment use will be calculated. A Joinpoint regression model will be used to investigate changes in prescribing patterns over calendar time. Prescriber compliance with labelled warnings for use mentioned in the product information will be investigated, as well as, using incidence of drug use across indications and risk factors.

Documents

Study results

Final_Report_Fluoro