Evaluation of the effectiveness of pregnancy prevention programme (PPP) for oral retinoids (acitretin, alitretinoin, and isotretinoin): a European before-after drug utilization study (DUS) using secondary data

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Multicountry, multisource, observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000095363

  acitretin

  100000095629

  isotretinoin

  100000095664

  alitretinoin

Population studied

• Short description of the study population:
  The study population included females of childbearing potential aged 13-49 years old received treatment with oral retinoids (i.e., acitretin, alitretinoin and isotretinoin) identified through the selected data sources in the targeted European countries (i.e., France, Germany, Spain, and Sweden). ; Inclusion criteria: ; • Female gender; • Childbearing potential (13-49 years of age, inclusive) ; • Received or prescribed at least one prescription of the oral retinoids acitretin, alitretinoin, or isotretinoin in either the pre-implementation or post-implementation period; ; Exclusion criteria: ; • All females in the age group 13 to 49 years with available information that they are not of childbearing potential before initiation of oral retinoids (such as records of hysterectomy or sterilisation) will be excluded. ; • Data for the oral retinoids acitretin, alitretinoin, and isotretinoin will only be extracted from databases in target countries where the respective active substance has been granted market authorisation.; • No further exclusion criteria will be applied.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

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

  Women of childbearing potential using contraception
• Estimated number of subjects:
  150000

Study design details

• Main study objective:
  The main objective of the study is to assess if there is a difference in physicians' prescribing and monitoring practice in the periods before and after the update of the pregnancy prevention programme (PPP) for the oral retinoids acitretin, alitretinoin, and isotretinoin when treating women of chil
• Outcomes:
  To evaluate the changes in the prescribing and monitoring practices following the update of the PPP in females of childbearing potential receiving prescriptions of the oral retinoids acitretin, alitretinoin, or isotretinoin by comparing contraceptive use, prescription interval, and laboratory preganancy tests in the period before and after the implementation of the updated PPP, The secondary outcome of the study is to described the patient profile, the prescriber profile, the exposure characteristics, incidence of pregnancies during oral retinoid exposure, trends in the physician's prescribing and monitoring practice, and assess the elements of the primary outcomes by active substance.
• Data analysis plan:
  The data extracted from the data sources will be analysed by country and by active substance for the elements of the primary outcomes. The analysis will descriptively analyse the prescribing and monitoring patterns in females of childbearing potential treated with oral retinoids before and after the implementation of the updated pregnancy prevention programme. The secondary outcomes will be analysed descriptively as well. To assess the trends in the prescribing and monitoring practice of oral treatment, an interrupted time series analysis will be performed.

Documents

Study results

32302_20221202_OR DUS_FinalReport_V1.0_Abstract