The UK epilepsy organisations listed below are joining together in an urgent call for a decision by the Medicines and Healthcare products Regulatory Agency (MHRA) and Ministers to be paused immediately.
A new policy announced to the public on December 12th, 2022 brings in a blanket approach requiring all people under 55 (including children and men for the first time) that are prescribed sodium valproate to have two signatures from specialists confirming that there is no suitable alternative medication.
This is a dramatic shift in practice and risk for people with epilepsy without regard to each person’s situation and life choices and totally out of proportion to the risks to patient safety.
The lack of consultation has been significant by its absence; accountability is unclear which is why we have written with one voice to the UK Secretary of State for Health and Social Care calling for the plans to be paused immediately which you can read here.
The vital importance of openness and consultation with our community on the scientific basis and impact of the new policy is because epilepsy medicines are used as the best way to help treat 7 out of every 10 patients achieve seizure-freedom.
Like other chronic conditions, being on a medicine that works is the main way to help people live full and active lives. For 10% of people who experience generalised epilepsies it is also the first line of defence against visits to A&E and SUDEP (Sudden Unexpected Death in Epilepsy). We know that that a Commission on Human Medicines implementation group has also warned of the broad harms from the policy but we were told that the scope of the group does not include altering the decision.
The new policy will significantly increase pressures across the NHS and social care at the very time when it needs life support because of rising pressures and long-standing epilepsy workforce shortages that will worsen. It will make it less likely that women will access counselling or the full and clear information they need about epilepsy medicines for their treatment. The valproate families and charities have been calling for this for decades.
The change in policy follows a safety review by the Commission of Human Medicines. We have not seen this and note that not only was our community not consulted but the CHM’s Sodium Valproate Expert Working Group on which people with epilepsy as well as senior clinicians are represented was not consulted.
The MHRA response to a Freedom of Information request is clear that we will not be given any opportunity to understand and give our views on the scientific basis for the extension to children and men until this is ready for release to patients, clinicians and the public.
After months tirelessly trying to seek the reassurance we need in private to restore confidence, we remain as concerned as ever, most especially given recent evidence of rising inequalities in people with epilepsy and their families. There are at least 21 deaths a week, mainly in the young, and many avoidable.
The charities and our beneficiaries need to see and be consulted on the scientific basis for the regulatory decision and the impact it is likely to have on patient safety. Ministers and the MHRA need to pause and allow time for a considered response to be given to the recommendations listed in this letter.
These call for an urgent review and scrutiny of this policy; a commitment to a national and local framework for epilepsy – for the safeguarding of life and a commitment to research. In the meantime we have advised all people with epilepsy not to stop or alter their prescribed medication and charity helplines are available for information and support.
For all press enquiries and spokespersons about this joint statement from the epilepsy coalition please contact rob.harris@sudep.org
THIS STATEMENT HAS BEEN AGREED BY – AND REFLECTS THE VIEWS OF – THE FOLLOWING ORGANISATIONS:
Epilepsy Nurses Association (ESNA)
International League Against Epilepsy (ILAE, British Branch)
