Isotretinoin and the effectiveness of the pregnancy prevention programmes in Europe

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

• Study drug International non-proprietary name (INN) or common name:
  ISOTRETINOIN

Population studied

• Short description of the study population:
  1. For the drug utilisation study: females who have received ≥1 prescription for an oral isotretinoin product at anytime during the study period; 2. For the factors predictive of PPP failure study: females of child bearing age (11-50 years) who have received ≥1 prescription for isotretinoin
• 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:
  30000

Study design details

• Main study objective:
  The main objective of the study is to evaluate the effectiveness of the isotretinoin pregnancy prevention plan, to identify potential factors associated with its effectiveness and to provide practical recommendations for improving the effectiveness of pregnancy prevention plans in Europe.
• Data analysis plan:
  The prevalence (with CI95) of oral isotretinoin use in women of childbearing age will be calculated and the demographic and clinical characteristics, including use of contraception, of oral isotretinoin users will be described. The incidence (with CI95) of pregnancy among women of childbearing age using oral isotretinoin will be calculated for the five data sources separately and, if appropriate, combined. Characteristics of isotretinoin users who become pregnant will be compared with those who do not in order to identify factors associated with a higher or lower likelihood of pregnancy. Differences in proportions will be tested using chi-square tests, differences in means will be tested using student’s t-tests, and predictors of the risk of becoming pregnant in the isotretinoin user population will be identified using logistic regression. The transcripts of interviews and the workshop will be reviewed and analysed using thematic and content analysis.

Documents

Study results

Draft isotretinoin report_July2013

Study, other information

Appendix I_Isotretinoin systematic review