Epilim risk minimisation measures ‘need scrutiny’

The Pharmaceutical Society of Ireland (PSI) has received three “concerns” this year in relation to the supply to patients of teratogenic drug sodium valproate (Epilim). The Society “sought responses” from the relevant pharmacies, according to a spokesperson.

A statutory complaint into supply of the drug was examined in 2019 and was now “closed”. The PSI circulated a Health Products Regulatory Authority (HPRA) communication on Epilim to pharmacists in May, which included a copy of a HPRA drug safety newsletter containing information on the teratogenicity of valproate-containing medicines. A reminder to pharmacists was included in the PSI’s July newsletter.

In recent years, patient group Organisation for AntiConvulsant Syndrome (OACS) Ireland has highlighted numerous instances of Epilim dispensed without the appropriate warning materials. Despite measures instigated by the HPRA and other stakeholders, on foot of European Medicines Agency stipulations in 2018, there is growing concern among patient groups about their adequacy and implementation.

In July, an Epilepsy Ireland survey of 150 women taking the drug found that 17 per cent were unaware that exposure in utero can cause serious birth defects, while 33 per cent were unaware it can cause learning and developmental problems in children.

Less than 30 per cent of women had heard about the mandatory pregnancy prevention programme. Three-in-10 women had never had a discussion on the risks with a healthcare professional.

Mr Peter Murphy, CEO of Epilepsy Ireland, said only two of six epilepsy specialist nurse posts – under a women’s health in epilepsy programme – had been filled. A programme consultant post was also unfilled. He questioned the regulatory approach to pharmacies that inappropriately dispensed the drug and renewed a call for a multi-stakeholder group under the aegis of the Department of Health.

Mr Murphy said it was critical to monitor the effectiveness of measures on an ongoing basis. Data from a HPRA/RCSI study on risk minimisation measures is also raising red flags as to their effectiveness, the Medical Independent understands.

A HPRA spokesperson said a research manuscript for publication and wider circulation is being prepared.

Meanwhile, patient advocates are due to meet Minister for Health Stephen Donnelly later this month, where they will renew their call for an independent inquiry into prescription of the drug.

An inquiry was recommended by the Oireachtas Health Committee in 2018 and Minister Donnelly stated “100 per cent” support for such an investigation while in opposition.