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HSE clinical advisor warned about ‘duty of care’ on valproate risk

By Mindo - 24th May 2018 | 22 views

A HSE clinical advisor warned a senior national manager and colleagues that the Executive knew the names and addresses of 1,700 women of childbearing age prescribed a drug that can harm the foetus in pregnancy and must consider its “duty of care” by potentially writing to them directly.

The advice was sent in October by HSE National Clinical Advisor and Group Lead, Primary Care, Dr David Hanlon, to Dr Áine Carroll, HSE National Director for Clinical Strategy and Programmes and colleagues.

The Medical Independent (MI) understands that direct communication from the HSE has not occurred to date. However, letters were issued to GPs and pharmacists in February and March this year, advising them to identify females of childbearing potential who have received valproate  recently and contact any identified patients “directly in the next few days”. The risks should be reviewed as well as the need for effective contraception, according to the letter.

The women are being dispensed Epilim (sodium valproate), which is licensed in Ireland for epilepsy and bipolar disorder. Babies born to mothers who take valproate-containing medicines during pregnancy have a 30-to-40 per cent risk of developmental disability and a 10 per cent risk of birth defects. The risks have been known for many years.

According to 2016 data, around 1,700 women aged 16-to-44 were being dispensed Epilim through the community drug schemes.

In February this year, the European Medicines Agency (EMA) announced additional protective measures around valproate, as previous actions were not deemed sufficient in terms of risk management.

The Health Products Regulatory Authority (HPRA) has been communicating with prescribers and dispensers on the EMA findings.

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