Wed 4 November 2026
Pharmacists lead Australian-first guidance on valproate use in pregnancy
Advanced Pharmacy Australia (AdPha) has published new guidance for clinicians working in mental health, neurology, paediatrics and obstetrics around the use of sodium valproate – an anti-seizure medication, approved for use in the treatment of epilepsy and bipolar disorder, and widely used for neuropathic pain and migraine prophylaxis.
Sodium valproate is a medication with significant risks if taken during pregnancy. However, until now, there has been no consistent national guidance available in Australia to support pharmacists and clinicians managing treatment with this medication in patients who may become pregnant.
To address this gap in guidance, Viandro Borja FANZCAP (Lead&Mgmt, MentalHlth), Chair of the AdPha Mental Health Leadership Committee, led a collaboration of members from the AdPha Mental Health, Women's & Newborn Health, Paediatrics & Neonatology and Medication Safety Leadership Committees to develop Consensus Guidance: Reproductive Safety and Use of Sodium Valproate.
The Australian-first guidance, developed with contributions from MotherSafe, Safer Care Victoria, the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), gives pharmacists and clinicians a consistent, evidence-based framework – from informed consent, counselling and contraception through to annual review, managing a suspected pregnancy and paternal exposure.
Mr. Borja says while sodium valproate remains an important treatment option, inconsistent practice across Australia has resulted in ongoing exposure risks for patients who may become pregnant.
‘Sodium valproate is an effective medicine, and for some people with epilepsy it may be the only option that controls their seizures. But it carries well-established risks in pregnancy - including significant increased incidence of congenital malformations such as neural tube defects, and a higher risk of developmental delays, autism and lower birthweight for gestational age.
‘Despite longstanding safety alerts, risk mitigation in practice remains inconsistent across Australia. Between 2013 and 2021, 69 per cent of women starting valproate were not covered by PBS-subsidised contraception.
‘This guidance will help ensure every patient receives accurate, person-centred advice and can make informed decisions about their treatment.’
AdPha President Assoc. Prof. Tom Simpson FANZCAP (Lead&Mgmt) says the project, which brought together members from four specialty practice areas across six states, is a great example of member collaboration powered by AdPha’s Leadership Committees.
‘This guidance shows what’s possible when expertise from across our specialty areas comes together. Pharmacists working in mental health, women’s and newborn health, paediatrics and medication safety each brought a different lens, and the result is practical guidance that will make a real difference to patient safety. It has already led to two conference presentations, in pharmacy and obstetrics.
‘It also shows how being part of a Leadership Committee gives pharmacy professionals the opportunity to influence practice nationally, collaborate with colleagues across states and specialties, and broaden their professional networks.
‘I’d like to acknowledge Viandro Borja for leading this work, the committee members who contributed, and the many organisations involved in the review process for bringing such an important piece of guidance to life.’