Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (D05BB02) acitretin

  acitretin

  (D10BA01) isotretinoin

  isotretinoin

  (D11AH04) alitretinoin

  alitretinoin

Population studied

• Short description of the study population:
  Female subjects of childbearing potential aged 12-55 years using oral retinoid containing medicinal products identified from the data sources of Netherlands, Denmark, Italy and Spain between 01 January 2010 and 31 December 2020.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  9000000

Study design details

• Main study objective:
  This study will address the research question, "What was the effect of the EU label changes and the revised pregnancy prevention programme (2018) on utilization of oral retinoids and to what extent did prescribers and patients comply with recommendations?".
• Outcomes:
  - retinoid use (dispensing/prescription) (objective 1) - pregnancy test (objective 2) - contraceptive use (objective 2) - pregnancy (objective 3) - use of alternative medicines (objective 4), - reason for discontinuation of retinoids (objective 1)
• Data analysis plan:
  1. Descriptive and hypothesis testing (objectives 1 through 4) - Incidence rates and quarter-year prevalences of outcomes will be calculated. - Interrupted time series analysis will be performed to test changes in outcomes before vs. after implementation of PRAC intervention. 2. Overall evaluation (objective 5) - The results of objectives 1-4 will be summarized qualitatively.

Documents

Study results

Finalreports_retinoids_v2.1_SUMMARY

Study publications

Durán CE, Riera-Arnau J, Abtahi S, Pajouheshnia R, Hoxhaj V, Gamba M, Alsina E,…

Sturkenboom, Miriam, Klungel, Olaf, Durán, Carlos E., Riera-Arnau, Judit, Abtah…