Incidence, prevalence, and characterisation of medicines with suggested drug shortages in Europe

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AD11) tenecteplase

  tenecteplase

  (L04AC14) sarilumab

  sarilumab

Population studied

• 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:
  200000

Study design details

• Main study objective:
  To investigate the incidence and prevalence of use of medicines with (suggested) shortages and their alternatives stratified by annual period (calendar year) and healthcare setting for each database during the study period 2010-2023, and to characterize the patients and the use of medicines regarding potential indication, treatment duration, and dosage.
• Outcomes:
  To investigate the incidence and prevalence of use of medicines with (suggested) shortages and their alternatives stratified by annual period (calendar year) and healthcare setting for each database during the study period 2010-2023. To characterise the patients and the use of medicines regarding potential indication, treatment duration, and dosage.
• Data analysis plan:
  Population-level drug utilisation study: annual period prevalence of the medicine use and annual incidence proportion. Patient-level drug utilisation study: Large-scale patient-level characterisation will be conducted in incident and in prevalent users, defined as follows: I) in incident users, the index date will be the date of a prescription qualifying as a "new prescription" (i.e. after at least 30 days of non-use) of the specific medicine of interest for each person, II) the index date in prevalent users will be the earliest date of a prescription in the calendar year. Frequency of potential indication at index date will be assessed. Treatment duration will be estimated and the minimum, p25, median, p75, and maximum will be provided. Furthermore, daily dosage will be estimated and the minimum, p25, median, p75, and maximum will be provided.