Welcome to this February issue of the Journal of Prescribing Practice.
One thing all prescribers strive for is safety in prescribing practice. As an educator, I am always on the lookout for safety warnings or updated advice on prescribing certain medications or in certain conditions.
The drug valproate has been on the safety in prescribing radar for quite a while, with a change to regulatory measures meaning that no woman or girl of childbearing age can be prescribed it unless there is a pregnancy prevention programme in place, or there is no other effective treatment available.
In November 2023, the MHRA instructed health organisations to plan for new measures to reduce ongoing serious harm from sodium valproate, which came into effect on 31 January 2024 (MHRA, 2023). The MHRA statement means that, from January 2024, valproate must not be started in new patients (male or female) younger than 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment, or there are compelling reasons that the reproductive risks do not apply. For most patients, other effective treatment options are available.
The teratogenic risk in females has long been known, but this new regulation is to address the issue of valproate reducing fertility in male patients. The MHRA urges patients to attend any offered appointments to discuss their treatment plan, and to talk to a health professional if they are concerned. This means if you are involved in prescribing this drug now or in the future you will have to be reviewing patients already on this, and considering alternatives. For new patients this drug is now likely to be considered less frequently, except where other medications have proved ineffective and risks are outweighed by benefits.
The Epilepsy Society has outlined the key messages on its website so that patients are well informed (https://epilepsysociety.org.uk/news-changes-valproate). It also imparts the vital advice that no one should stop taking their medication without consulting their prescribing health professional. This will, no doubt, be an initial added burden to review these patients, but as patient safety is paramount it is necessary. This is a worry for the charity as it questions whether the NHS has the capacity to implement the measures in a timely manner.
The charity is also concerned that the new restrictions may leave some patients vulnerable to seizures, as they acknowledge that valproate is an effective anticonvulsant, and that many other drugs for epilepsy also carry elevated risks of side effects as the government guidance also confirms (MHRA, 2021). This may be a worrying time for our patients affected by this, but also for clinicians who will be dealing with the implementation and review. Directing patients to the epilepsy medicines and pregnancy leaflet may be a good place to start (MHRA, 2021).