Charity Survey Findings

Women Still Unaware Of Risks Around Epilepsy Medicines In Pregnancy

A recently published survey by epilepsy charities Epilepsy Action, Epilepsy Society and Young Epilepsy found one in ten (11%) women who are currently taking the epilepsy medicine valproate are unaware of the possible risk of birth defects if taken in pregnancy. Furthermore, one in five (18%) don’t know that, when taken in pregnancy, the medicine could also cause learning and developmental delays in children.

Under the current regulations, valproate must no longer be used for women and girls who are able to become pregnant unless there is a Pregnancy Prevention Plan (PPP) in place. The PPP, mandatory at prescription, is an intervention from the MHRA designed to make sure patients are fully aware of the risks of valproate use in pregnancy and the need to avoid becoming pregnant.

The survey found that many women with epilepsy are still not receiving information from health professionals about the risks of valproate, leaving their potential future children at risk of harm.

” Valproate dispensing from the pharmacist

• Just under half of respondents (49%, 251/514) said they had had no discussion with their pharmacist about the risks associated with taking valproate during pregnancy. Only 14% (72/514) said they had this discussion every time they collected a prescription.
• 29% (150/514) of respondents stated that when their valproate was dispensed in a plain package, the box never had a sticker with the warning pictogram. Only 60% (306/514) of respondents stated that a prescription in a manufacturer’s packaging always included the warning pictogram.
• Over half (51%, 261/514) of respondents said they had never received the Patient Card from their pharmacist when receiving their prescription “

The full report can be accessed here

Reminder:

PHARMACISTS are asked to take the following IMPORTANT ACTIONS:

• Provide a Patient Card every time you dispense a valproate medicine to ALL female patients. Please also note that the outer boxes of valproate are being changed in order to include a removable patient card, to be detached and given to the female patient at the time of dispensation.
• When dispensing any valproate preparation to female children, adolescents, women of childbearing potential, or pregnant women check that their prescriber has discussed the risks of exposure in pregnancy with them and they are aware of these and subsequently they are taking effective contraception unless already pregnant.
• If the prescriber has not discussed the risks with the patient or the patient is not taking effective contraception, tell them to contact their GP or specialist for an urgent follow-up appointment.
• Advise the patients not to stop valproate medication and to immediately contact their GP or specialist in case of suspected pregnancy.
• Ask if they have received the Patient Guide and provide a copy if they have not received this or no longer have it in their possession.
• Dispense valproate in the original package with the outer warning and avoid repacking. In the situations where this cannot be avoided, always provide a copy of the package leaflet, patient card, and add a warning sticker to the outer box.

To order new or further PPP materials, please contact Sanofi medical information department on 0845 372 7101 or email UK-Medicalinformation@sanofi.com.