A HSE clinical advisor warned senior colleagues last year that the executive knew the names and addresses of 1,700 women of childbearing-age who were prescribed a drug that can harm the foetus, and must consider its “duty of care” by potentially writing to them directly.
According to a report in The Medical Independent, the advice was sent in October by HSE National Clinical Advisor and Group Lead, Primary Care, David Hanlon, to Áine Carroll, HSE National Director for Clinical Strategy and Programmes and colleagues.
The Medical Independent said it understands that direct communication from the HSE to patients 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 child-bearing potential who have received the drug 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 medicines containing valproate during pregnancy have a 30%-40% risk of developmental disability and a 10% 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.
The HSE said yesterday that GPs and clinicians would be sent updated information on the drug from this week, followed by direct communication with the patients.
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 has been communicating with prescribers and dispensers on the EMA findings.