Female patients aged 16-to-44 receiving reimbursement support for sodium valproate (Epilim) prescriptions stood at
1,691 in 2020, a decline from 1,801 in 2019. The teratogenic drug is licensed for use in epilepsy and bipolar disorder.
The data provided by the HSE related to valproate reimbursements through the long-term illness and GMS schemes.
2016, the number of females in this age group in receipt of valproate was 2,142 and in 2018 it was 1,909.
Valproate should only be initiated in a girl or woman of childbearing potential by a specialist in epilepsy or bipolar disorder and where there is no effective alternative. Patients are advised not to stop taking valproate without a consultation with their doctor.
“The HSE notes the reductions in reimbursed prescriptions over the period 2016–2020. The HSE plans to analyse the data available to inform any additional guidance to the health service on further actions. The HSE is very aware that for some patients the medicine is essential,” according to a spokesperson.
The HSE Clinical Programme in Neurology “provides surveillance mechanisms to monitor the utilisation of the Health Products Regulatory Authority risk assessment form process, and guidance to the health service on further actions”, added the spokesperson.
“The infrastructure to support the surveillance data has been delayed secondary to the pandemic and cyberattack. The HSE remains committed to embedding this infrastructure to inform valproate prescribing in Ireland.”
The Executive was commenting amid concerns about suboptimal implementation of a pregnancy prevention programme (PPP) for women taking valproate, as required following a 2018 review by the European Medicines Agency.
These concerns have been raised by Epilepsy Ireland and the Organisation for Anticonvulsant Syndrome Ireland, and were underlined by the findings of a recent State-funded study published in Expert Opinion on Drug Safety. In 2018 six specialist nursing posts were approved to support the implementation of the PPP. However, only two of these posts have been filled.
“To date there have been 5.8 whole-time equivalent posts recruited to support the service, this includes two advanced nurse practitioners appointed as part of the pregnancy prevent programme. The HSE has sought funding for the remaining four advanced nurse practitioners as part of the 2022 estimate process.”