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The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that regulatory measures intended to reduce the harm of anti-epileptic medication sodium valproate must be introduced from January 2024.
Under the measures, which come into effect on 31 January 2024, valproate must not be started in new patients aged younger than 55 years, unless two specialists independently agree there is no other effective or tolerated treatment, or there are “compelling reasons” that the reproductive risks do not apply.
Women who can become pregnant who are currently taking valproate will be reviewed annually using a revised risk form, which includes the need for a second doctor’s agreement if the patient is to continue with the medication. A similar system will be introduced later in 2024 for male patients currently taking valproate.
Babies exposed to valproate in the womb are at significant risk of developing foetal valproate spectrum disorder — the collective name for a variety of disorders and development issues, including spina bifida, autism and malformations of the brain, heart and kidneys.
The drug is also known to cause risk of impaired fertility in males, which may be reversible upon discontinuation.
In December 2022, the MHRA announced the two-doctor requirement for prescribing valproate, following a recommendation by the Commission on Human Medicines.
At the time, it said that the new measures would be introduced “via a phased programme currently under development according to patient safety priorities, and developed in collaboration with the healthcare bodies, to ensure ongoing patient care is not disrupted”.
Commenting on the introduction of the safety measures, Alison Cave, chief safety officer at the MHRA, said: “Valproate use in pregnancy carries significant risk of harm to the unborn child and should only be used in girls and women of child-bearing potential if a pregnancy prevention programme is in place. It also carries a risk of impaired fertility in males.
“To better protect patients from these harms, we are taking robust regulatory action to ensure greater scrutiny of valproate prescribing. Valproate should only be used when no other treatment is effective.”
Henrietta Hughes, patient safety commissioner for England, said: “We must dramatically reduce the number of babies exposed to teratogens, which can cause physical and learning disabilities in children. To do this, all organisations must ensure they bring in new measures from January 2024.”
Minutes from a meeting of the NHS England Valproate Safety Implementation Group, held in November 2021 and seen by The Pharmaceutical Journal, said the new measures could have a “negative impact” on patients, whose “perspective should be taken into account”.
In March 2023, 11 epilepsy charities published a statement calling for the requirement for two doctors to sign off valproate prescriptions to be “paused”, claiming that it was “totally out of proportion to the risks to patient safety”.
Commenting on the MHRA’s announcement, Jaspreet Sohal, communications lead at the College of Mental Health Pharmacy (CMHP), said it would be writing to the MHRA, urging it to include pharmacists in the list of clinicians who could sign off valproate prescriptions.
“The CMHP was disappointed that specialist pharmacists were not included in the suggested list of second specialist signatories for the initiation and ongoing prescribing of valproate in men and women under the age of 55 [years],” she said.
“Whilst this is a suggested list, not being included reflects the lack of recognition by the CHM and MHRA on the role of specialist pharmacists in mental health, and other clinical specialities, of the work that they have done on ensuring the safe and effective prescribing of valproate since the PPP [pregnancy prevention programme] was implemented.”
Philip Lee, chief executive at Epilepsy Action, which backed the statement, said the introduction of the new regulations “represents a dramatic shift in clinical practice”, adding that the group had “expressed concerns when it came to their impact on patient safety and workability for healthcare professionals”.
“With the new policy being rolled out from the end of January 2024, we hope that all healthcare providers will be given the time to safely implement it, at a time when these systems face unprecedented waiting times, resource limitations and access issues,” he said.
“We hope that all people with epilepsy affected by this policy will receive personalised information about their epilepsy and associated risks from their health professionals.”
