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PSI accepts more ‘clarity’ may be required on processes

The statement comes following queries from the Medical Independent (MI) in relation to cases of Epilim (sodium valproate) being dispensed in plastic bags without the required patient information. 

The PSI said no “complaints” had been made on this issue, but it had received “a small number of concerns” in recent months relating to supply of Epilim with insufficient patient information.

Babies born to women 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.

A complaint to the PSI instigates a process underpinned by legislation requiring the regulator to assess whether it is a fitness to practise issue. A PSI spokesperson told MI: “To date, the PSI has been contacted in relation to nine supplies of valproate medicines indicated to have been made without the required alerts, educational material or counselling by pharmacists.”

The information has been assessed, further information requested where necessary and actions taken with pharmacies, the spokesperson said.

In April, the PSI met with representatives of Epilepsy Ireland and the Organisation for Anti-Convulsant Syndrome (OACS) Ireland. “In that meeting, the Registrar reiterated that the PSI was open to receiving information from people who believed their supply of Epilim in a pharmacy was not adequately following the European-wide Pharmacovigilance Risk Assessment Committee (PRAC) recommendations. He explained the process the PSI would follow to assess any information that might be received and take actions accordingly, and clarified the concerns-handling process, as well as the complaint process.”

Ms Karen Keely, Chairperson of OACS Ireland, said it expects the PSI to take appropriate steps to remind or reprimand pharmacists who do not follow the latest guidelines.

OACS Ireland is aware of a mother who recently went to a pharmacy and asked the pharmacist if he had the Epilim alert card. “The mother watched in disgust as the pharmacist went looking for them as he did not know where they were. He also did not know about the [warning] stickers, even though the mother told him about it.”

Ms Keely commented: “Treating women’s complaints as just that — a complaint — is in our view the best possible way to stop those pharmacists who still appear not to have got the message.”

Separately, the Department is aware that the State Claims Agency “has received notice of proceedings” from solicitors representing clients allegedly suffering from foetal anticonvulsant syndrome due to exposure to sodium valproate in the womb.  

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