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PSI investigating statutory complaint on Epilim supply

A statutory complaint has been made to the Pharmaceutical Society of Ireland (PSI) in relation to the supply of sodium valproate (Epilim) to a patient. Epilim is licensed in Ireland to treat epilepsy and bipolar disorder. If a woman becomes pregnant while taking the drug, her baby is at risk of serious birth defects and developmental disorders.

Two “matters” have been brought to the PSI’s attention in regard to the supply of Epilim to patients since March 2019.

 “One of these was raised as a concern and the PSI is seeking observations from the relevant pharmacy on the matter,” a spokesperson said.

 “The other was raised as a statutory complaint. The latter is still in deliberative process (which is confidential) and I am unable to provide any further details on it.”

In March 2019, the PSI said it had received 13 “concerns” in relation to Epilim since April 2018. The information it received “indicated that supplies of valproate medicines have been made without the required alerts, educational material or counselling by pharmacists.”

At the time, the spokesperson said it had followed-up on these concerns where specific information was provided. During 2019, a reminder to pharmacists about the appropriate supply and counselling of patients receiving valproate was included in a PSI newsletter. 

“The PSI is the appropriate body to which any person may provide information or make a complaint in relation to their concern about how they have been treated in a pharmacy and about a pharmacist’s care, behaviour or practice. And the PSI will take the appropriate regulatory action,” according to its spokesperson.  

In recent years, the Organisation for Anticonvulsant Syndrome (OACS) Ireland has highlighted numerous instances of patients receiving ‘Epilim in a bag’ without any warning materials.