Valproate (Epilim▼) – Educational Materials/Toolkit
The HPRA worked with national stakeholders, including patient representatives and healthcare professionals to implement updated risk-minimisation measures arising from the 2017/2018 European-wide review of valproate (Epilim▼). 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.
Changes to the product information* (Package Leaflet (PL) for patients and Summary of Product Characteristics (SmPC) for healthcare professionals) were implemented to reflect the new conditions arising from the 2017/2018 review, including a pregnancy prevention programme. 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. As the product information for medicines, including valproate (Epilim▼), may be updated on a continual basis as new information emerges, please note that the HPRA encourages healthcare professionals and patients/consumers to regularly review the product information for medicines they take or prescribe to maintain awareness of recommendations and any relevant updates.
*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 all products currently authorised in Ireland are accessible from the HPRA website (www.hpra.ie). 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.
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, now appears on the inner blister and outer packaging of Epilim▼medicines.
Reduced pack size: a reduced pack size of 30 units is available 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 reminder card and visual reminder (text and symbol) at each dispensing.
Educational materials (guidance booklets and forms), which were already available for patients and doctors, have been updated to reflect the new measures and provide age-appropriate advice. These documents have been disseminated to healthcare professionals in hard copy by the Marketing Authorisation Holder (MAH, i.e. license holder for the medicine). Further hard copies are available on request from the MAH and are also available to download below. The educational materials include the following:
An annual risk acknowledgement form, which should be used at time of treatment initiation and during each annual review of valproate treatment by the specialist.
A guide for prescribers, pharmacists and other healthcare professionals potentially involved in the care of girls and women of childbearing potential treated with valproate (Epilim▼).
A guide for patients, which the prescriber should provide to all girls and women of child-bearing potential who start treatment with valproate (Epilim▼) or who are already on treatment.
Patients can now also access the patient guide and package leaflets electronically by scanning the QR code printed on the Epilim package leaflet, which will link to the company webpage.
A patient alert card is attached to the packaging of valproate-containing medicines (Epilim▼) to facilitate discussions between the pharmacist and the patient each time valproate (Epilim▼) is dispensed. Healthcare professionals are reminded that, in exceptional circumstances where legacy1 Epilim▼ stock or broken bulk must be dispensed, additional copies of the patient card have been distributed by the manufacturer for supply to patients, along with the most up-to-date package leaflet and sticker bearing a visual and text warning for packaging.
1: Legacy stock with variations of older packaging may remain on the market for some time. Batch numbers remaining on the Irish market: expiring late 2020: 7R019, 7R037, 7A221, 7A533, A7816, A7767, 289; expiring early 2021: numbers 8R003, 8A300, 8A514, 303