RPS welcomes MHRA measures on sodium valproate

New guidance from the MHRA to improve patient safety

The RPS welcomes new measures announced today by the MHRA to help prevent harm to women taking sodium valproate.

These include:

  • All women of childbearing age taking part in a pregnancy prevention programme
  • Women to be reviewed once a year by their specialist
  • Packaging changes to show the risks of taking valproate during pregnancy
  • Risk assessment to be simultaneously completed by prescriber and patient
  • Card on packaging to remind pharmacists to discuss risks with women when dispensing

The RPS has worked with the MHRA and a variety of stakeholders to produce clear, up to date information leaflets for patients which will be available soon from the MHRA.

RPS President Ash Soni said:

“The RPS fully supports these new measures implemented today by the MHRA (LINK) to ensure women understand the risks of taking sodium valproate during pregnancy. They must get the right information from health professionals in order to make informed choices about their health and parenting options.

“Valproate is an effective medicine and women should never suddenly stop taking it without talking to a health professional. Pharmacists are ideally placed to give information and support when providing sodium valproate and are committed to reducing harm from medicines, enabling women to make the choices that are right for them.”

RPS will update its guidance for pharmacists once the MHRA publishes its updated resources for health professionals. In the meantime the MHRA have issued a drug safety update and you can view our current guidance and the video on valproate we collaborated on with the MHRA and RCGP.