As a GP, you have a role in supporting implementation of prevent in cases where you have a patient that is a female child or WCBP, and to whom you provide repeat Epilim prescriptions. The following is a summary of the key actions for which you are responsible:3 Check the patient has a copy of the patient guide and that you have a copy of an up-to-date signed Annual Risk Acknowledgement Form each time a repeat prescription is issued 3 Unless there are compelling reasons to indicate that there is no risk of pregnancy, ensure continuous use of highly effective contraception in all WCBP (consider the need for pregnancy testing for any patient not using a highly effective method of contraception or if there is any reason to suggest lack of compliance with contraception).3 Ensure the patient understands the need to contact you immediately if she suspects there has been a problem with her contraception or she may be pregnant.3 Ensure she is referred back to her specialist for annual review, and urgently in case of unplanned pregnancy (within days) or to plan a pregnancy (see pregnancy section below for further details).Existing patients: refer to the HCP guide for further information on existing patients, who may have initiated treatment prior to prevent and who may not otherwise be under specialist care. Ensure such patients are identified and referred to a specialist, where necessary. The conditions of prevent also apply to such patients.
Purpose: This study aimed to examine trends in valproate use among women of childbearing potential (WCBP) aged 16-44 years in Ireland following two Europeandirected regulatory interventions in December 2014 and April 2018. Methods: This was a repeated cross-sectional study using monthly national pharmacy claims data, to examine trend changes in the prevalence of valproate use among WCBP pre and post two separate regulatory events in December 2014 and April 2018. Annual population estimates from the Central Statistics Office were used to calculate the prevalence rate per 1000 eligible women. Segmented regression analysis of interrupted time series with negative binomial regression was used to examine rates for WCBP aged 16-44 years, and by 10-year age groups. Prevalence ratios (PR) are presented with 95% confidence intervals (CIs).
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.
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