It is not possible to monitor sodium valproate (Epilim) prescription on an individual basis in Ireland, according to the HSE.
There is also no national data available on the number of pregnancies that occur while a woman is prescribed sodium valproate, the Executive stated.
A HSE spokesperson said this data is not centrally collected. “The prescribing data on the Primary Care Reimbursement System on drug payment schemes shows a continual trend towards a reduction in prescribing of valproate in women of childbearing age,” they stated.
The HSE has been exploring the possibility of auditing electronic dispensing systems to capture more information on dispensing of the medicine.
The spokesperson added: “We are hopeful that the development of the national electronic patient record and the move towards electronic prescribing will enable the HSE to collect and monitor safety data on valproate prescribing in women of childbearing potential on an individual level.”
Meanwhile, the spokesperson also stated the HSE has “committed to establishing, funding, and supporting the necessary clinical and statistical resources within the IT infrastructure to create an epilepsy pregnancy registry”. No timeline for the establishment of the registry was provided.
Sodium valproate is an effective and essential treatment for some patients. However, valproate-containing medicines can cause birth defects, neuro-developmental disorders and autism in children whose mothers are prescribed these medicines during pregnancy.
In February 2018, the European Medicines Agency (EMA) announced strengthened restrictions on the use of sodium valproate including a pregnancy prevention programme.
Sodium valproate must no longer be used in women or girls of childbearing potential unless the terms of the pregnancy prevention programme are followed. Treatment with valproate must be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder.
In 2024, the EMA’s safety committee recommended precautionary measures to address a potential increased risk of neuro-developmental disorders in children born to men treated with valproate during the three months before conception. It is conducting further analysis after the results of a Danish study did not suggest this increased risk.
People who have been prescribed sodium valproate should not stop taking the medicine without consulting their doctor.
Leave a Reply
You must be logged in to post a comment.