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