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 identification

• EU PAS number:
  EUPAS1000000721
• Study ID:
  1000000721
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Poland

  Spain
• Study description:
  Retinoic acid analogues, known as retinoids, are prescribed for various skin disorders, but their use poses teratogenic risks, leading to strict Pregnancy Prevention Programme (PPP) since 2003.; ; Based on results from the drug utilisation study (DUS)/survey study, the PRAC has requested marketing authorisation holders’ (MAHs) to conduct a qualitative study to investigate adherence to PPP issues despite high awareness of the measures. The PRAC's request for a qualitative study stem from a recognition of the persistent issue of poor adherence to the PPP, despite high levels of awareness among healthcare professionals and WCBP as shown in the DUS/survey study. The committee seeks a deeper understanding of the underlying factors contributing to this low compliance to inform more effective interventions. By imposing a qualitative study, the PRAC aims to explore the nuanced barriers and drivers of adherence behaviour beyond mere awareness. This qualitative study allows for a comprehensive assessment of the sociocultural, psychological, and systemic factors; influencing adherence to PPPs.; ; This study, categorized as a Category 3 PASS, aims to utilize an implementation science framework, specifically aligning with the PRECEDE-PROCEED Model. By adopting the PRECEDE-PROCEED framework, the study seeks to support targeted interventions and improve PPP implementation in real-world clinical settings, addressing the; persistent gaps in adherence to PPP measures while WCBP using oral retinoid therapies.
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned:01/01/2024

Actual:03/04/2024

Study start date

Planned:01/10/2025

Data analysis start date

Planned:03/11/2025

Date of interim report, if expected

Planned:13/07/2026

Date of final study report

Planned:12/07/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

The joint initiative involves several companies via a consortium: 2CARE4GENERICS, ALFASIGMA ESPAÑA, ALMIRALL, AUROBINDO, AXXON, BAILLEUL, BAUSCH HEALTH COMPANIES, CHEPLAPHARM, DERMAPHARM,
ENNOGEN, ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A. EXPANSCIENCE, FIDIA, GALENPHARMA, GAP, GSK, HEXAL AG, IASIS PHARMA, INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A., ISDIN, MEDINFAR, MYLAN PHARMACEUTICALS LIMITED, ORIFARM, PELPHARMA, PHARMATHEN, PIERRE FABRE, ROCHE, SMB, STADA, SUN PHARMA, TARGET, and TEVA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)