(216) Evaluating Awareness, Knowledge and Practice of Healthcare Professionals Following Implementation of a Revised Pregnancy Prevention Programme for Isotretinoin in Ireland: A Multi-Stakeholder Cross-Sectional Study

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 547

Presenting Author(s)

John E. Hughes, MPharm
– School of Population Health, RCSI University of Medicine and Health Sciences, Dublin 2, Ireland., Dublin, Dublin, Ireland

Co-Author(s)

Niamh Buckley
– Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland., Ireland
Yvonne Looney
– Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland., Ireland
Gráinne Kirwan
– Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland., Ireland
Maeve Mullooly
– Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland., Ireland
Kathleen E. Bennett, PhD
– Division of Population Health Sciences, Royal College of Surgeons in Ireland, Dublin 2, Ireland., Dublin, Ireland

Background: Isotretinoin is highly teratogenic and exposure during pregnancy is associated with a high risk of severe congenital malformations and an increased risk of spontaneous abortion. In 2018, following an EU-wide safety review, a revised pregnancy prevention programme (PPP) was introduced. To date, however, little is known in respect of knowledge of and compliance with this revised PPP in current clinical practice.

Objectives: To examine awareness, knowledge, and experience implementing the revised isotretinoin PPP in clinical practice across three healthcare professional (HCP) groups in Ireland.

Methods: A cross-sectional study using anonymous online surveys among general practitioners (GPs), community pharmacists, and specialist consultants was undertaken. Descriptive analyses are presented.

Results: Across all HCP groups there was high (≥87%) awareness that oral isotretinoin is contraindicated in women of childbearing potential (WCBP) unless the conditions of the PPP are fulfilled, but varying awareness among GPs (54.9%) and community pharmacists (45.9%) that exposure during pregnancy can cause both severe foetal malformations and spontaneous abortions. Implementation of the PPP in clinical practice varied across HCP groups. When initiating isotretinoin in WCBP, 66.7% of specialists and 40.8% of GPs indicated they had considered alternative treatment options, and 71.4% of specialists and 31.6% of GPs reported they first requested a pregnancy test. There was limited provision of the patient reminder card to WCBP, where 26.1% of community pharmacists provide this at each dispensing, while 47.6% of specialists and 11.8% of GPs ensured WCBP had a copy of the card when initiating treatment. Across all HCP groups, there was high (≥81.6%) awareness of the need for urgent consultation and immediate cessation of isotretinoin in the event of an unplanned or suspected pregnancy.

Conclusions: Reinforcement of the provision and utilisation of the isotretinoin patient reminder card may be required, and further targeted education on specific elements of the PPP should be considered for GPs and community pharmacists.