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‘Urgent’ need for stakeholder group to address valproate risks – Epilepsy Ireland CEO

A new study of healthcare professionals’ (HCPs) implementation of the valproate pregnancy prevention programme (PPP) reflects an “urgent” need for a stakeholder group on risk reduction, as well as the filling of vacant nursing posts, the CEO of Epilepsy Ireland has told the Medical Independent (MI).

Mr Peter Murphy was renewing the organisation’s call for these measures in light of a recent study, published in Expert Opinion on Drug Safety, examining awareness, knowledge and practice of Irish HCPs in implementing the sodium valproate (Epilim) PPP. Such prevention programmes were mandated by the European Medicines Agency (EMA) in 2018.

The research, which was funded by the Health Products Regulatory Authority (HPRA) and Health Research Board, found that continued efforts were needed to “ensure optimal implementation” of the PPP, including further targeted education and collaborative learning among HCPs.

Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-to-40 per cent of cases) and congenital malformations (in approximately 10 per cent of cases).

Women and girls of childbearing potential must not be prescribed valproate unless the conditions of the PPP are met, including an annual specialist review. The medication should only be prescribed in females if other drugs have proven ineffective.

According to the study, only 66 per cent of GPs, 82 per cent of community pharmacists, and 59 per cent of specialists (consultants/higher specialist trainees in neurology and obstetrics/gynecology) indicated that they had received information relating to the PPP, the main source being ‘Dear Doctor/Pharmacist’ letters approved by the HPRA.

Some 22 per cent of GPs said that they prescribe valproate “occasionally to frequently”; 78 per cent said they renewed a valproate prescription in the past 12 months; and four out of 73 GPs indicated they had initiated valproate treatment in the past 12 months (the PPP provides that valproate should only be initiated by a specialist in the management of epilepsy or bipolar disorder).

Knowledge of the magnitude of the risks associated with valproate use in pregnancy varied across the three HCP groups.

The authors acknowledged study limitations including a low response rate. While recognising these limitations, Mr Murphy said the findings tallied with a small patient survey undertaken by Epilepsy Ireland, which found significant deficiencies in the implementation of the PPP.

Epilepsy Ireland noted the study responses from GPs as particularly concerning, with one-in-three saying they had not received communications about the PPP; four-in-five stating they did not use the patient guide; and 60 per cent ensuring their patients understood the risks and used effective contraception.

Epilepsy Ireland has been calling for a stakeholder group, reporting to the Minister for Health/Department, to facilitate a “collaborative” effort on eliminating risk and monitoring the effectiveness of measures.

According to Mr Murphy, several organisations including State bodies have undertaken positive work since the EMA’s 2018 review. However, “there isn’t really any communication between these different organisations and State bodies.” While not pre-empting the potential proposals from a stakeholder group, Mr Murphy said these could include better use of IT communications between primary and hospital care, as well as training initiatives.

Mr Murphy added that the filling of vacant specialist nursing posts in epilepsy services was another crucial component of the PPP. “In 2018, the HSE approved six specialist nursing posts specifically for the implementation of the pregnancy prevention plan around valproate and four of those posts are still vacant.”

Capacity constraints in epilepsy services and the healthcare system were also impacting on implementation of the PPP.
Nevertheless, Mr Murphy said the ongoing shortfalls in risk reduction were unacceptable given the serious risks to children exposed in utero.

In November 2020, Minister Stephen Donnelly announced the establishment of an inquiry into historical prescription of sodium valproate. The Department has recently communicated on a proposed meeting with patient groups Epilepsy Ireland and Organisation for Anti-Convulsant Syndrome (OACS) Ireland.

A Department spokesperson told MI the establishment of a stakeholder group was “under consideration” by officials. According to the HPRA, it is committed to continuing engagement with stakeholders and healthcare professionals and health system partners “responsible for implementing the Epilim pregnancy prevention programme for women and girls for whom treatment with valproate is considered to remain necessary”.

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