Valproate National Patient Safety Alert – GPhC tells what pharmacists need to do

Pharmacy teams should be prepared to discuss the current warnings and upcoming measures with their patients

The General Pharmaceutical Council (GPhC) on Thursday sent an email to all pharmacy professionals to update them about a Valproate National Patient Safety Alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

From January 2024, the MHRA is introducing the first phase of new regulatory measures to reduce the known harms of valproate, a drug used to treat epilepsy and bipolar disorder.

The health regulator has cautioned that the drug may cause serious harm to the baby, if taken during pregnancy, and lead to impaired fertility in males.

Integrated Care Boards in England and Health Boards in Scotland and Wales have been instructed to designate a new or existing group to prepare for and co-ordinate the implementation of the measures for oversight of prescribing valproate to new patients and existing female patients.

Meanwhile, the GPhC has informed pharmacy teams that they should be prepared to discuss the current warnings and upcoming measures with their patients.

However, pharmacist should continue to dispense valproate, as well as remind patients who are taking the drug that they must not stop taking their treatment without advice from their specialist.

Additionally, the regular have gathered existing resources and information about valproate and made it available on its website to help pharmacists to stay up-to-date.

The GPhC has also appealed to pharmacy teams to spread this important information in the sector.

New regulatory measures for valproate prescribing

The MHRA says:

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 unless there are compelling reasons that the reproductive risks do not apply. For the majority of patients, other effective treatment options are available.

Women of childbearing potential and and girls who are currently taking valproate should be reviewed at their next annual specialist review, using a revised valproate Annual Risk Acknowledgement Form, which will include the need for a second opinion’s signature if the patient is to continue with valproate.

The regulatory measures will be introduced in a phased manner to ensure ongoing patient care is not disrupted, as recommended by the independent group Commission on Human Medicines