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

Abstract

Purpose: In 2018, following an EU-wide safety review, a revised pregnancy prevention programme (PPP) was introduced for isotretinoin (Roaccutane ® ). This study aimed 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 fetal 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.

Compliance with Pregnancy Prevention Recommendations for Isotretinoin Following the Amendment of the European Union Pregnancy Prevention Program: A Repeat Study in Estonia

“…Following the implementation of the revised isotretinoin PPP, the awareness, knowledge, and experience of implementing the PPP in clinical practice has been studied in Ireland. Hughes et al [ 10 ] showed that healthcare professionals were highly aware (≥ 87%) that isotretinoin should not be prescribed to women of childbearing age unless PPP conditions are met. However, the implementation of this knowledge varied greatly in clinical practice.…”

“…Similarly, 47.6% of specialists provided patients with a reminder card when initiating the treatment, while only 11.8% of general practitioners did the same. Only 26.1% of community pharmacists provided patients with a reminder card at each dispensing [ 10 ]. It is questionable whether sending hard copies or emailing safety information to physicians is an efficient way to implement risk minimization measures in daily practice.…”

“…a user-independent method) or two complementary user-dependent methods [ 5 ]. A recent survey conducted in Ireland found that although healthcare professionals were highly aware that isotretinoin should not be prescribed to women of childbearing age unless PPP conditions are met, the application of this knowledge differed significantly in clinical practice [ 10 ].…”

Community pharmacists’ knowledge and awareness about isotretinoin therapy and its dispensing practice in Jordan

“…Earlier studies in the Netherlands, Belgium, and France found that 81.8 %, 43.1 %, and 60 % of pharmacists, were aware of this fact, respectively [ 31 , 35 ]. In Ireland, 39.5 % of healthcare professionals, including pharmacists limited isotretinoin prescriptions to 30 days to support regular follow‐up [ 36 ]. The implementation of an isotretinoin dispensing education program in these countries could explain the gap in awareness about isotretinoin dispensing practices when compared with Jordan.…”