DARWIN EU® – Monitoring prescription of medicines for public health emergencies at risk of shortages

Study type

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

Study drug and medical condition

• Name of medicine:
  AMOXICILLIN

  AZITHROMYCIN

  CEFOTAXIME

  CEFTRIAXONE

  CEFUROXIME

  CLARITHROMYCIN

  MEROPENEM

  PENICILLIN VK

  PIPERACILLIN/TAZOBACTAM TEVA
• Anatomical Therapeutic Chemical (ATC) code:
  (J01CA04) amoxicillin

  amoxicillin

  (J01FA10) azithromycin

  azithromycin

  (J01DD01) cefotaxime

  cefotaxime

  (J01DD04) ceftriaxone

  ceftriaxone

  (J01DC02) cefuroxime

  cefuroxime

  (J01FA09) clarithromycin

  clarithromycin

  (J01DH02) meropenem

  meropenem

  (J01CE02) phenoxymethylpenicillin

  phenoxymethylpenicillin

  (J01CR05) piperacillin and beta-lactamase inhibitor

  piperacillin and beta-lactamase inhibitor

Population studied

• Short description of the study population:
  The study cohort will comprise all individuals present in the database during the study period (the last 10 years of available data counting backwards from the respective latest date of data lock of the respective databases).

Study design details

• Study design:
  Retrospective cohort studies will be conducted using routinely-collected health data from 7 databases.
• Main study objective:
  (i) To estimate monthly incidence rates of use prescriptions or dispensations of the 11 selected medicines during a 10-year period from the most recent data available, stratified by age and sex, in each of the databases.; (ii) To conduct time series modelling by fitting an ARIMA model to data generated in objective 1 for short-term (12-month) forecasting.;