Regulator warns pharmacists over anticonvulsant drug

Concerns over the dispensing of an anticonvulsant drug known to cause birth defects has prompted a State regulator to write to all pharmacists over the information they supply to patients.

The Pharmaceutical Society of Ireland (PSI), which regulates the profession, said it had received 10 "concerns" over the dispensing of sodium valproate, a drug used to control seizures among patients with epilepsy.

The PSI said it had contacted all pharmacists to remind them they must ensure patients were counselled on the risks of taking valproate-containing medicines, and that patients must receive a leaflet and alert card when these were dispensed.

The concerns raised by a patient advocacy group related to the drug being supplied without the required written information and, in some cases, without patient counselling.

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A spokesperson for the pharmacy regulator confirmed the “concerns are being dealt with accordingly using the regulatory mechanisms available”.

Listed by the World Health Organisation (WHO) as an essential medicine, sodium valproate is an important drug in the treatment of epilepsy. It is manufactured by Sanofi and marketed in Ireland under the brand name Epilim. It causes developmental disability in 30-40 per cent of children when used during pregnancy, and 10 per cent of babies will be born with a birth defect.

The European Medicines Agency (EMA) strengthened warnings on valproate-based medicines in 2014 and a further review in 2017 found warnings were still not effective enough.

Sodium valproate is now contraindicated in women and girls of childbearing potential, unless a pregnancy-prevention plan is in place, and may be prescribed only when other treatments are not suitable.

Harmful effects

Women who have been prescribed the medication long term are most at risk of being under-informed about its potential harmful effects during pregnancy. The youngest child in Ireland affected is two years old.

Women taking valproate should consult their doctor before making any changes to their treatment.

Foetal valproate syndrome is part of a spectrum of disorders known as foetal anticonvulsant syndromes (FACS).

A representative for the advocacy group that expressed concern, Foetal Anticonvulsant Syndrome Forum, said it was encouraged by the PSI’s commitment to ensuring that all women receiving valproate were provided with the required information and support required.

“The forum highlighted a number of examples of patients continuing to receive valproate in plastic bags without the package insert, patient card or appropriate counselling, and we are hopeful that appropriate steps will be taken by the PSI to address this issue in future including, where appropriate, via the PSI’s complaints procedure.”

Some of the issues may have arisen because the drug is available only in one package size, and this may need to be divided up to provide the required amount of medication for a patient at the time of dispensing.