Valproate and the Pregnancy Prevention Programme: A Guide for Care Staff in Ireland

This guide covers Ireland. For the UK equivalent, see our guide: Valproate Safety: A Care Staff Guide to the Pregnancy Prevention Programme.

Valproate, sold in Ireland as Epilim, is a medicine used for epilepsy and bipolar disorder. Taken during pregnancy it can seriously harm an unborn child, which is why the Health Products Regulatory Authority (HPRA) requires a Pregnancy Prevention Programme for girls and women who could become pregnant. This guide sets out what the HPRA and HSE pages say, who is affected, and what care staff in Dublin and across Ireland should know and pass on. Prescribing decisions stay with prescribers; care staff support the person, they do not change the plan.

Valproate sits squarely within safe medicines practice, so it helps to read this alongside our guide to medication management training for healthcare staff in Ireland.

What valproate is and where the rules come from

According to the HPRA, valproate-containing medicines (sodium valproate or valproic acid), sold as Epilim, are approved in Ireland for epilepsy and bipolar disorder. The HSE medicines page says that in February 2018 the European Medicines Agency recommended new restrictions, including a Pregnancy Prevention Programme, and that the HPRA introduced them in Ireland. The HPRA page on valproate use by women and girls shows no overall last-updated date, but lists documents dated between 2024 and 2025. The HSE patient information page is marked "Version 6 October 2020", so where the two differ, treat the HPRA page as the more recent source.

The risks the sources describe

The HPRA states that valproate taken in pregnancy "can seriously harm an unborn child". For children exposed in the womb, the HPRA page gives these figures:

• birth defects: 11%
• lower-than-expected birth weight for age: 11 to 15%
• problems with early childhood development: 30 to 40%
• a higher risk of a neurodevelopmental diagnosis, including autism spectrum disorder and ADHD (no percentage given)

The HSE page describes the same risks in plainer terms: about 1 in 10 babies may have a body malformation at birth, and about 3 or 4 in 10 children may have serious developmental disorders. It also says the risk of childhood autism is about five times higher than in the general population.

Who is affected and what the programme requires

The programme applies to girls and women who can become pregnant. The HPRA page sets out the core conditions:

• Treatment must be started and supervised by a specialist experienced in epilepsy or bipolar disorder.
• Valproate must not be used in girls and women of childbearing potential unless other treatments are ineffective or not tolerated, and the terms of the Pregnancy Prevention Programme are followed.
• The aim is that the patient understands the risks and the need to avoid pregnancy while taking the medicine.

The HSE page adds detail on how this works for the patient. It says pregnancy tests are done before starting and may be repeated, that effective contraception is needed, and that treatment is reviewed at least once a year with a signed Annual Risk Acknowledgement Form. For a girl who has not reached childbearing age, it says the patient and parents or guardians should know the risks and should contact the specialist service when periods start.

The programme materials and pharmacy changes

The HPRA lists a set of educational materials, each shown with its own date:

• a patient guide for women and girls, which prescribers should give to all women and girls of childbearing potential who start or are already on treatment (08/01/2025)
• a guide for healthcare professionals (08/01/2025)
• the Annual Risk Acknowledgement Form, used by the specialist with the patient at the start of treatment and at each annual review (12/05/2025)
• a patient card attached to the medicine packaging to support pharmacist and patient discussions at each dispensing (12/05/2025)
• a warning sticker, a visual warning on the inner blister and outer packaging, and a pharmacy poster and shelf barker (all 08/01/2025)

The HPRA also states that a pack size of 30 units is now the only authorised presentation, excluding injections and oral solutions, to reduce broken-bulk dispensing and make sure every patient gets a package leaflet. If broken-bulk dispensing cannot be avoided, the HPRA says a copy of the package leaflet should always be provided with a warning sticker added.

What the HSE says patients and carers should do

The HSE page gives clear messages for patients and for the people who support them:

• Do not stop valproate without medical advice. The HPRA warns that sudden discontinuation of epilepsy treatment can cause seizures with serious consequences, including for an unborn child if the woman is pregnant.
• If pregnant: do not stop taking it, contact the GP urgently, and then ask for an urgent review with the epilepsy clinic, psychiatrist or relevant specialist clinic.
• If considering pregnancy: keep taking valproate and keep using contraception until the person has talked with a specialist or GP, because the medicine may need to be changed well before pregnancy.
• If not planning pregnancy: use effective contraception, read the patient guide, and have treatment reviewed at least yearly.
• If a child may have been exposed in pregnancy: talk to the GP first, who may refer the child to a paediatrician or another specialist.

The HSE page also says folic acid is generally recommended for those trying to conceive but is unlikely to reduce valproate-linked birth defects, so pregnancy prevention remains necessary.

Male patients

The HPRA has a separate page on precautionary measures for men. It says there is a potential risk of neurodevelopmental disorders in children born to fathers treated with valproate in the three months before conception, but that the evidence is inconsistent and the risk uncertain. Male patients must not stop taking valproate without consulting their doctor. The page says the European Medicines Agency's safety committee (PRAC) recommended that the precautionary measures stay in place in a review it dates to June 2026, that a further study is ongoing, and that results are expected in 2028. Prescribers should give the male patient guide to men who start or are already on valproate. The page does not mention contraception and contains no specific advice for carers.

What care staff should know and escalate

The HPRA and HSE pages are written for prescribers, pharmacists and patients. They do not set out duties for care staff. The following points are therefore our reading of how staff can act within their role, and they are not legal requirements.

• Our suggestion: know who is on valproate. Make sure the medicines record shows clearly which people take valproate, and who the prescribing specialist is.
• Our suggestion: never advise a change. Staff should not stop, skip or alter doses or give advice about contraception or pregnancy beyond the service's own procedures. If a person misses doses or refuses the medicine, follow the prescriber's and the service's procedure and tell the GP or specialist promptly.
• Our suggestion: escalate promptly. If a woman or girl taking valproate may be pregnant, or says she is planning a pregnancy, the HSE message is to contact the GP urgently and not to stop the medicine. Tell your manager and follow your service's escalation route.
• Our suggestion: support the annual review. Help the person attend the yearly specialist review and bring the patient card and guide. Where the person may not fully understand the risks, raise this with the specialist so communication supports can be considered. Our guide to safeguarding vulnerable adults training in Ireland covers wider duties to people who may be at risk.
• Our suggestion: keep records. Record conversations, appointments, the date of the last annual review and any concerns raised, so that handovers and inspections can follow the trail.

For the wider picture of how regulated services are inspected, see our overview of HIQA inspections and staff training in Ireland.

Reporting suspected side effects

Valproate medicines are under additional monitoring, shown by an inverted black triangle on the product information. The HPRA asks both healthcare professionals and the public to report suspected adverse reactions through its reporting forms. The up-to-date Summary of Product Characteristics (for professionals) and Package Leaflet (for patients) are available through the HPRA's Find a Medicine search.

What the pages do not say

The HPRA women-and-girls page does not describe what to do if a patient becomes pregnant, nor does it give pregnancy test or detailed contraception requirements; the HSE page covers those points in general terms. Neither page assigns specific tasks to care assistants or support workers. Where your service has its own medicines policy, that policy governs what staff do day to day, and the prescriber decides on treatment.

Learnsignal's offices are off Baggot Street in Dublin, and we offer in-person training from there. For current details, see our CPD pages.

Frequently asked questions

Should a woman stop taking valproate if she thinks she is pregnant?

No. The HSE page says she should not stop the medicine, should contact her GP urgently, and then request an urgent review with her specialist clinic. The HPRA warns that stopping epilepsy treatment suddenly can cause seizures with serious consequences.

Does the Pregnancy Prevention Programme apply to everyone on valproate?

It applies to girls and women who can become pregnant. Men are covered by separate precautionary measures described on a different HPRA page, which says the risk is uncertain.

Can care staff change or stop valproate?

No. Treatment is started and supervised by a specialist, and the prescriber decides on any change. Staff should follow the prescriber's and the service's procedures and report concerns to the GP or specialist.

Why has the pack size changed?

The HPRA says a 30-unit pack is the only authorised presentation (excluding injections and oral solutions) so that fewer packs are split and each patient receives the package leaflet.

Where can staff report a suspected side effect?

The HPRA asks healthcare professionals and the public to report suspected adverse reactions through its reporting forms.

Valproate safety is a shared responsibility between prescribers, pharmacists, patients and the staff who support them, and the HPRA and HSE pages remain the place to check for the latest materials.