Qualitative Study – Barriers and Facilitators Assessment of adherence to the Risk Minimisation Measures (RMMs), specifically Pregnancy Prevention Programme (PPP) for Women of Childbearing Potential Using Oral Retinoids (acitretin, alitretinoin, and isotretinoin)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  TOCTINO

  NEOTIGASON

  ROACCUTANE
• Medicinal product name, other:
  Oral retinoids:; • Acitretin: D05BB02; • Alitretinoin: D11AH04; • Isotretinoin: D10BA01

Population studied

• Short description of the study population:
  The study target population includes HCPs who prescribe or educate on oral retinoids PPP measures, WCBP taking or having taken oral retinoid therapies, or parents of adolescents WCBP taking or having taken oral retinoid therapies.
• Age groups:
  • Adults (18 to < 46 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  100

Study design details

• Study design:
  This is a non-interventional qualitative cross-sectional study that will be conducted in multiple European countries (i.e., France, Germany, Poland, and Spain). The data will be collected using qualitative interviews.
• Main study objective:
  In Europe, what are the barriers and reasons for low adherence to the oral retinoid therapy PPP measures from the perspectives of (i) healthcare professionals (HCPs) who prescribe or dispense oral retinoid therapy to women of childbearing potential (WCBP), (ii) WCBP who recently used or are currently using oral retinoid therapy, (iii) parents, guardians, or caregivers of adolescent WCBP who recently used or are currently using an oral retinoid; therapy?; ; The overarching global objectives for all three populations of this study are the following:; P1. To describe the understanding of oral retinoid therapy PPP measures; P2. To describe the perception of oral retinoid therapy PPP measures; P3. To identify barriers and potential facilitators influencing adherence to oral retinoid; therapy PPP measures
• Setting:
  The inclusion criteria for HCPs include being a medical specialist (dermatologists, paediatricians, and/or general practitioners) or an allied HCP (pharmacists and/or nurses, if applicable per country) who dispensed and/or educated WCBP on oral retinoid therapy PPP measures) at least once in the last 6 months in France, Germany, Spain or Poland. ; ; The inclusion criteria for WCBP include being aged 18-49 and currently or recently (in the past 6 months) using any oral retinoid therapies in France, Germany, Spain, or Poland.; ; The inclusion criteria for parents, guardians, or caregivers, the primary inclusion criterion is being a parent, caregiver, or guardian of an adolescent WCBP aged 13-17 currently or recently (in the last 6 months) using oral retinoids (except alitretinoin) in France, Germany, Spain, or Poland. ; ; Recruitment channels include clinician referral, patient advocacy groups, social media outreach, and IQVIA's in-house physician and patient panels.; ; The study population will include a sample, per country, of: ; • 30 HCPs including 20 oral retinoid therapy prescribers (dermatologists, paediatricians, or general practitioners) and 10 dispensers and/or educators (pharmacists and/or nurses, if applicable in the targeted country about oral retinoid therapy PPP measures);; • 25 to 28 WCBP aged 18-49 per country, who currently or recently (in the past 6 months) used oral retinoid therapy, aiming with a distribution to represent:; o 15 WCBP aged 18-49 using isotretinoin (n=60 across all countries),; o 5 WCBP* aged 18-49 using acitretin (n=20 across all countries), and ; o 5-8 WCBP* aged 18-49 using alitretinoin in France, Germany, and Spain (n=20 across all countries); ; • 10 parents, guardians, or caregivers of adolescent WCBP aged 13-17 currently or recently (in the past 6 months) used oral retinoid therapies, excluding alitretinoin
• Data analysis plan:
  Data obtained during the study interviews will be summarized in table and/or narrative format with supportive; quotes. A combination of descriptive and qualitative analysis approaches will be used to present participants’; experiences, opinions and responses to interview questions. ; Illustrative table shells are presented for each of the study populations included in the study and for each; specific objective described in the semi-structured discussion guide topics. ; Preferences for ordering of results; as presented in future deliverables (e.g., qualitative study report) will be confirmed at the time of report outlining.