Abstract
ABSTRACT Objectives To establish awareness, knowledge, use and experience in practice of a sodium valproate pregnancy prevention program (PPP) in Ireland (“prevent”) among three healthcare professional (HCP) groups. Methods A cross-sectional study using anonymous online surveys was conducted among general practitioners (GPs), pharmacists, and specialist consultants. Descriptive analyses are presented. Results HCP response rates were 5.8% for GPs (90/1544), 10.7% for pharmacists (219/2052), and 7.6% for specialists (17/224). Across HCP groups, there was high awareness (>90%) for specialist referral when female valproate patients are planning pregnancy, or become pregnant, but less awareness to refer annually for specialist review. While awareness of a possible teratogenic effect at any stage of pregnancy was high (>80%), most GPs (62.2%, 95% CI: 51.3, 71.9%) and community pharmacists (53.1%, 95% CI: 43.2, 62.8%) were unsure of the magnitude of risk for developmental disorders, while most specialists under-estimated this risk (46.7%, 95% CI: 24.8, 69.9%). Although >70% of the respondents identified valproate to be contraindicated in any woman of childbearing potential unless the conditions of the PPP are fulfilled, experience implementing key elements in practice varied. Conclusions Our findings suggest continued effort is needed to ensure optimal implementation of “prevent” into clinical practice in Ireland.
Highlights
Healthcare professionals are reminded that Summary of Product Characteristics (SmPC) for all products currently authorised in Ireland are accessible on the HPRA website
Due to the known teratogenic effects, Epilim should not be used in female children and women of childbearing potential[1] (WCBP), unless other treatments are ineffective or not tolerated
The purpose of this article is to remind Healthcare professionals (HCPs) of the high teratogenic potential of Epilim, as well as the conditions of prevent and the necessary actions for HCPs to take in order to minimise the risk of exposure in pregnancy for their patients
Summary
Teratogenicity of valproate-containing medicines (Epilim ) – Reminder of important restrictions for use in women and girls. Due to the known teratogenic effects, Epilim should not be used in female children and women of childbearing potential[1] (WCBP), unless other treatments are ineffective or not tolerated. The purpose of this article is to remind HCPs of the high teratogenic potential of Epilim , as well as the conditions of prevent and the necessary actions for HCPs to take in order to minimise the risk of exposure in pregnancy for their patients. Conditions oespfffeetchciteaivlipestrcorogenrvatiremawcmeoepftiionthcnel3utdchoeron(utbignuuhteoadurteatrpnepoarttomlpimerinaittte,edpnreetsogs)notahnfectyrneteaeetsmdtinefgnotrpwrhioiigtrhhtloEypiniliitmiatio,Panana(dartenivedGineawitsrrloGesfquuthiidreeedrisdfkousrriwngWithtroeim nadtmievenidnut)a,lapnaatniennutas,l pregnancy planning and pregnancy management This booklet is for you (or your parent/legal guardian) if you are a girl (of any age) or a woman of childbearing potential taking any medicine containing valproate (Epilim). Always use effective contraception during treatment options and understand the risks of in-utero exposure to valproate foyorur an unborn child. Even if she has amenoArUrThHoOeRaISsEhDeBYmTuHsEt HfoPlRloAw all the advice on highly effective contraception
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