Awareness, knowledge and practice of healthcare professionals following implementation of a Pregnancy Prevention Program for sodium valproate in Ireland: a multi-stakeholder cross-sectional study

Abstract

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.

Valproate utilisation trends among women of childbearing potential in Ireland between 2014 and 2019: A drug utilisation study using interrupted time series

“…The decline among 16–24 year olds in our study may indicate that the 2014 intervention reduced first‐time prescribing of valproate among neurologists in Ireland. These patterns observed, support our recent survey study findings from the Irish HCP setting, which found that all responding neurologists reported that they had considered an alternative treatment before initiating their patient on valproate 29 . In addition, a recent drug utilisation study examined valproate prescribing patterns in five European countries (France, Germany, Spain, Sweden and the UK) and found that, in all countries, the proportion of WCBP prescribed valproate had decreased (between 30.1% and 52.3%) following the 2014 intervention 30 .…”

“…These patterns observed, support our recent survey study findings from the Irish HCP setting, which found that all responding neurologists reported that they had considered an alternative treatment before initiating their patient on valproate. 29 In addition, a recent drug utilisation study examined valproate prescribing patterns in five European countries (France, Germany, Spain, Sweden and the UK) and found that, in all countries, the proportion of WCBP prescribed valproate had decreased (between 30.1% and 52.3%) following the 2014 intervention. 30 Similarly, our study identified an overall decline in the month-to-month use of valproate among WCBP (16-44 years) following the 2014 EMA intervention.…”

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

“…A cross‐sectional anonymous survey study was conducted that aimed to examine the effectiveness of risk minimisation measures in preventing harm from teratogenic medicines within an Irish healthcare setting. Further information on the study design and methods is previously described 14 . Briefly, the overarching survey design was adapted for the 2018 isotretinoin PPP, which outlines specific actions for prescribers and pharmacists to minimise the risk of exposure to isotretinoin during pregnancy.…”

“…While obstetricians and gynecologists are less likely to prescribe isotretinoin, they may be involved in the care of women of childbearing potential (WCBP) who use retinoids, and they were recipients of the 2018 “Direct Healthcare Professional Communication” (DHPC) and educational materials. The participating HCPs were identified via their respective professional representative or regulatory body as outlined previously 14 …”

“…Further information on the study design and methods is previously described. 14 Briefly, the overarching survey design was adapted for the 2018 isotretinoin PPP, which outlines specific actions for prescribers and pharmacists to minimise the risk of exposure to isotretinoin during pregnancy. The implementation of the PPP is supported by regulatory‐approved educational materials to facilitate implementation in clinical practice.…”