Government responds to safety review on valproate

Published: February 04 2021
Last updated: October 11 2022

The UK government is planning to appoint a Patient Safety Commissioner to advocate for patients, after recommendations made in last year’s safety review into sodium valproate, Primodos and vaginal mesh.

The government is responding to the recommendations made by the Independent Medicines and Medical Devices Safety (IMMDS) Review published in July last year. The recommendations were made to improve patient safety, after the review found major failings by the healthcare system over three “public health scandals”.

As well as the Patient Safety Commissioner, the government is putting together a Valproate Safety Implementation Group. This will work to reduce the number of women prescribed valproate and support those women for whom valproate is the only option.

This group will include clinical specialists in neurology and mental health, data experts and system leaders. Other aims for the group include raising awareness of the issues around taking valproate during pregnancy, and trying to ensure the Pregnancy Prevention Programme (PPP) is followed.

A Valproate Safety Register has also been created to monitor the use of valproate, adherence to the PPP and babies born to women taking valproate. A report on the first data collected by the registry on women currently prescribed valproate in England and any exposed pregnancies, is expected soon.

The government is also responding to recommendations to improve data collection on medicines and medical devices. The Medicines and Healthcare products Regulatory Agency (MHRA) has created an Expert Working Group on Optimising Data on Medicines used During Pregnancy to ensure better data collection and analysis.

A Safer Medicines in Pregnancy and Breastfeeding Consortium has also been set up, made up of 16 organisations, including NHS, regulator and charitable organisations. In addition, the government is putting steps in place to create a UK-wide medical device information system to collect data on medical devices.

Health Secretary Matt Hancock has said that research is ongoing into maternity and neonatal services. He added that the National Institute for Health Research (NIHR) welcomes funding applications for research, including into the use of epilepsy medicines in pregnancy.

Recent findings from a safety review by the MHRA suggest that other epilepsy medicines aside from valproate can also carry a risk if taken during pregnancy. Organisations such as Epilepsy Action have called for more research into these and other epilepsy medicines.

The Health secretary said that there are no plans to introduce a PPP for other epilepsy medicines. The government said that “neither the magnitude nor the nature of the risks observed with the reviewed epilepsy medicines are as severe as [those] associated with the use of valproate during pregnancy”.

The government is also still considering a number of the recommendations, six months after the IMMDS review made them. One is the creation of a scheme to help people harmed by these medical scandals to pay for the extra care and support needed. Another is putting in place specialist centres to provide treatment, care and advice to those affected by medicines taken during pregnancy.

Philip Lee, Epilepsy Action chief executive, said: “We are pleased to see updates about how the government, NHS England and MHRA are working to make everyone aware of the risks of sodium valproate, and other epilepsy medications when they are taken in pregnancy. However, we are concerned to see that the other epilepsy medicines recently recognised as potentially harmful will not be covered by a Pregnancy Prevention Plan like valproate currently is. This safety net would increase the chances that doctors will talk with women, girls and their families about the risks of the medicines they are taking to control their epilepsy. Without this in place, we are concerned that these conversations will continue to not happen. This is unacceptable. No woman or girl should be taking an epilepsy medicine without knowing the potential risks it may cause if she were to become pregnant.

“It is vitally important that no woman stops or changes their epilepsy medication, even if they are pregnant, without talking to their doctor or nurse. Doing so would put them at risk of harm. If a woman with epilepsy discovers she is pregnant, or is thinking of becoming so, it is important she talks to her health professional as soon as possible.

“More information is needed about the risks of epilepsy medicines in pregnancy so women can work with their doctors and nurses to make informed decisions. While we are pleased to see the government welcoming funding applications for research of this nature, this information is needed urgently to ensure that women can make an informed choice about their medication. Epilepsy Action would therefore urge the Government to make funding this research a priority. We would also happily support any funding applications of this nature.”

A call for more transparency about the relationships between healthcare professionals and medical device and pharmaceutical companies, made by the IMMDS review, is also still being considered.

The government has said it has no plans to act on a few of the recommendations made by the IMMDS review.