Use in women of childbearing potential and during pregnancy

The approved product information*, which contains the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL), includes detailed warnings and recommendations for healthcare professionals and patients regarding the use of valproate, including the need for treatment to be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. Copies of the current versions of the product information are available from the HPRA website, by searching for 'valproate' or 'Epilim' in the Find a Medicine search box.

* What is contained in the product information? 

The product information is comprised of the Summary of Product Characteristics (SmPC) and Package Leaflet (PL). These documents are issued when a medicine is first licensed for use and are reviewed and updated as necessary throughout the lifetime of a medicine. The SmPC is mainly intended for use by healthcare professionals and includes detailed information on the use, dosing recommendations, precautions for use and the known side-effects of the medicine concerned. SmPCs for products currently authorised in Ireland are accessible from the HPRA's Find a Medicine function. The package leaflet (PL) reflects the more comprehensive information described in the SmPC but is required to be presented in an abbreviated and easy-to-read format for patients. The PL should be included in your box of medicine received from your pharmacist.

The current valproate pregnancy prevention programme, called prevent, was introduced in 2018 on the recommendation of the European Medicines Agency’s (EMA’s) safety committee (PRAC) following a EU-wide review (further information is available on the EMA's valproate webpage. The HPRA worked with national stakeholders, including patient representatives and healthcare professionals to implement the updated risk-minimisation measures introduced following this review. This work included developing materials to support safe prescribing and dispensing of valproate (Epilim^▼) and, in particular, to ensure that patients and/or carers are fully informed of the risks and can discuss options with their doctor. These materials include the following guides and forms:

• A guide for healthcare professionals potentially involved in the care of girls and women of childbearing potential treated with valproate (Epilim^▼).
• A patient guide for women and girls, which the prescriber should provide to all girls and women of childbearing potential who start treatment with valproate (Epilim^▼) or who are already on treatment.
• An annual risk acknowledgement form, which should be used at time of treatment initiation and during each annual review of valproate (Epilim^▼)treatment by the specialist with their patient.
• A patient card is attached to the packaging of valproate (Epilim^▼)to facilitate discussions between the pharmacist and the patient each time valproate (Epilim^▼) is dispensed. In situations where broken bulk dispensing cannot be avoided, then a copy of the package leaflet should always be provided with a warning sticker added. The package leaflets for all valproate containing medicines can be found on the information page for each medicine.
• A visual warning to alert healthcare professionals and patients of the risks to the unborn child if used during pregnancy, and advising use of effective contraception, appears on the inner blister and of the outer packaging of (Epilim▼) medicines. See a sample of the  sample of the outer packaging.
• Pharmacy materials (A4 poster and shelf barker) to assist pharmacists in dispensing and advising patients taking Epilim^▼
• Reduced pack size: a pack size of 30 units is now the only available presentation to mitigate against the need for broken bulk dispensing at pharmacy level and to ensure that all patients receive a package leaflet and the outer carton with the patient card at each dispensing.

The HPRA has issued communications to healthcare professionals, advising of the recommendations for use of in girls and women of childbearing potential following two EU-wide reviews of Valproate (Epilim^▼) in 2014 and 2017/2018.

The HPRA communications, listed below, include Direct Healthcare Professional Communications (DHPCs) and articles in the HPRA Drug Safety Newsletter. These were distributed to healthcare professionals such as general practitioners, general hospital doctors, medical specialists including neurologists, gynaecologists/obstetricians, psychiatrists, pharmacists (both community and hospital), specialist epilepsy nurses and family planning clinics), healthcare professional regulatory bodies, and patient organisations.

In addition, the HPRA provided reminder articles which were published in MIMS (Ireland) and the Irish Medicines Formulary (IMF). All of these communications were published on the HPRA website and are linked below.

Further information on the EU-wide reviews of valproate is available from the EMA's valproate webpage.