Patient and Prescriber Survey: Effectiveness measures to investigate awareness, knowledge and adherence to the Risk Minimisation Measures (RMMs) of the Pregnancy Prevention Program (PPP) for Oral Retinoids (Acitretin, Alitretinoin, and Isotretinoin)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50298
• EU PAS number:
  EUPAS38096
• Study ID:
  50298
• Official title and acronym:
  Patient and Prescriber Survey: Effectiveness measures to investigate awareness, knowledge and adherence to the Risk Minimisation Measures (RMMs) of the Pregnancy Prevention Program (PPP) for Oral Retinoids (Acitretin, Alitretinoin, and Isotretinoin)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Greece

  Norway

  Poland

  Spain

  United Kingdom
• Study description:
  This survey aims to assess the effectiveness of the updated risk minimisation measures (RMMs) among female oral retinoid patients who are of childbearing potential and their prescribers and to assess patients’ and prescribers’ (HCPs’) awareness and knowledge of and adherence to the pregnancy prevention programme (PPP). Primary objective: to assess the effectiveness of the PPP based on pre-defined success thresholds for PPP awareness, knowledge, and adherence in HCPs and patients. Secondary objectives: (1) to assess HCPs’ and patients’ awareness of the updated PPP (2) to assess HCPs’ and patients’ knowledge of the risks and RMMs associated with the use of oral retinoids (3) to assess whether HCPs and patients adhere to the RMMs of the updated PPP
• Study status:
  Finalised

Research institution and networks

Institutions

Real World Solutions, IQVIA

Netherlands

United Kingdom (Northern Ireland)

Study timelines

Date when funding contract was signed

Planned: 30/06/2018

Actual: 30/11/2018

Study start date

Planned: 31/03/2021

Actual: 24/03/2021

Data analysis start date

Planned: 01/10/2021

Actual: 07/10/2021

Date of final study report

Planned: 31/03/2022

Actual: 15/02/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

A Consortium of Marketing Authorization Holders for oral retinoids

Study protocol

Initial protocol

20200727_Oral Retinoids_PASS_Survey_Protocol_v5.0_Redacted_NO ANNEX

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)