Pharmacy regulator investigated eight complaints about sodium valproate dispensing

The General Pharmaceutical Council (GPhC) has investigated eight complaints around sodium valproate and the Pregnancy Prevention Programme (PPP) from the charity INFACT, which supports people who have taken the medicine during pregnancy.

Sodium valproate is prescribed for epilepsy and bipolar disorder; however, it can significantly increase developmental disorders and birth defects in babies when taken during pregnancy.

According to the Medicines and Healthcare products Regulatory Agency (MHRA), 40% of babies born to mothers who use valproate during pregnancy are at risk of developmental disorders, and around 10% of babies are at risk of birth defects.

In 2018, the MHRA issued guidance stating that women of childbearing age should not be prescribed valproate unless they are following a PPP. When dispensing the medicine, pharmacists should remind women of the risks and ensure that they receive a patient card highlighting the same information.

A spokesperson for the GPhC told The Pharmaceutical Journal that it has investigated the eight reported cases, adding that in three cases, “our inspectors conducted a full investigation into the allegations, which involved communicating with the patients and speaking with the registrants involved”. They added: “These three cases have now been closed with written advice given to the registrants.”

The other five cases had to be closed because in four cases no patient details were available and in the fifth case, the person who raised the concern did not give consent to be contacted further “so we were unable to verify the allegation”, the spokesperson added.

In October 2018, the GPhC said its pharmacy inspectors would “systematically check” compliance with the MHRA’s PPP during inspections of registered pharmacies.

Jeremy Hunt, former health secretary and chair of the House of Commons Health and Social Care Committee, has also called for a “ban” on prescribing sodium valproate to pregnant women with epilepsy, following the publication of data from NHS Digital, showing that 247 women had been prescribed the drug during their pregnancy since April 2018.

Speaking in the House of Commons on 19 April 2022, Hunt said: “Last year, the government consulted on putting warning labels on valproate. Is it not time to go much further and ban the prescription of sodium valproate to epileptic pregnant mothers?”

In response, Sajid Javid, the health secretary, told the Commons that “it is right that we reconsider this and make sure that sodium valproate, and any other medicine, is given only in the clinically appropriate setting”.

In a statement issued on 16 April 2022, following the publication of the data, Martin Marshall, chair of the Royal College of GPs, said that sodium valproate “should not be prescribed to women of childbearing age unless they are on a PPP or there are exceptional circumstances”.

The government is currently analysing responses to a consultation on original pack dispensing for valproate, meaning that pharmacists would be able to dispense a valproate quantity of 10% more or less than on the prescription to avoid the need to split packs. This, the government said, would help patients take the medicine correctly and reduce the risk of a patient not seeing the patient information leaflet.

Read more: Beyond valproate — treatment dilemmas for women with epilepsy continue